PRESENTATION OF NOVEL GYNECOLOGIC ONCOLOGY PROCEDURES M.D. ANDERSON CANCER CENTER, UNIVERSITY OF TEXAS November 15, 2006

Transcription

1 PRESENTATION OF NOVEL GYNECOLOGIC ONCOLOGY PROCEDURES M.D. ANDERSON CANCER CENTER, UNIVERSITY OF TEXAS November 15, :00:11 ANNOUNCER: This program is made possible through an educational grant from Ethicon Edo-Surgery. During the next hour in this live presentation from M.D. Anderson Cancer Center at the University of Texas, doctors Pedro Ramirez and David Kushner will present novel gynecologic oncology procedures. This includes a total laparoscopic hysterectomy for uterine cancer. Using harmonic technology, laparoscopic pelvic and periaortic lymphadenectomy will also be demonstrated. Many patients previously were not candidates for the surgery due to anatomical concerns. Now see how they can benefit. During the program, viewers may ask the physicians questions by clicking the MDirect Access button on the computer screen. 00:01:01 PEDRO RAMIREZ, MD: Hello, and welcome to Ethicon Endo-Surgery live casts. My name is Pedro Ramirez. I m associate professor in the department of gynecologic oncology at the University of Texas M.D. Anderson Cancer Center. Joining me today is Dr. David Kushner. He s assistant professor in the division of gynecologic oncology at the University of Wisconsin. Welcome, David. 00:01:21 DAVID KUSHNER, MD: Thank you. It s great to be here in Houston. What we re going to be talking about today on this webcast is the procedures of total laparoscopic hysterectomy as well as the public lymph-node dissection, mostly for endometrial cancer, but also for cervix cancer, periaortic lymph-node dissection, and then a new and interesting procedure, which is the radical trachelectomy 00:01:40 PEDRO RAMIREZ, MD: Great. I also want to alert our viewers that during anytime during the webcast, they can send in their their questions by pressing the button on the screen, and even after the webcast, we ll try to answer as many questions as possible. Thank you. 00:01:54 DAVID KUSHNER, MD: Great, thanks, Pedro. So we re going to be starting by talking about some background into uterine cancer staging laparoscopically, and I think we owe some of the the beginning of this field to Dr. Childers, and what he showed back in his report back in 1993 was that laparoscopic-assisted vaginal hysterectomy for uterine cancer is a feasible thing to do and that he patients tolerated it very well and were out of the hospital without major complications. Then many other studies followed, but ultimately, the major trial was the G.O.G. lab II trial, and this was the ultimate trial to show that although the survival data is not back yet that this is a safe procedure. What they found in this trial, which was recently reported, will be shown here. First, that the laparoscopic procedure, in terms of interoperative complications, didn t have more complications in any way, if any, other than just the arteries that were injured. And although that sounds like a horrible thing, we re talking mostly about anterior abdominal wall inferior epigastric vessels, and as you

2 know, these are mostly people at the beginning of their learning curves. Yeah. So you end up seeing, at institutions where they re just starting this procedure, getting more comfortable with putting in ports. They re hitting that inferior epigastric artery a little but more. In terms of post-operative complications, we would expect more in the laparotomy group, and we are seeing more in the laparotomy group, mostly arrhythmias, pneumonias, things that you d expect from from a more difficult surgery taking longer, bigger incision. 00:03:33 PEDRO RAMIREZ, MD: Yeah, and I think also, this is reflective of some of the same data we were seeing in some of the retrospective studies. 00:03:39 DAVID KUSHNER, MD: Mm-hmm, I agree. In terms of outcomes, I think we both know that especially at the beginning, it takes longer. You really at the beginning of doing laparoscopic surgery, I talk about taking the pain that that is on the patient and moving it onto the surgeon, and that is true when you first start, and it takes longer, and you need to be patient with it, and that was shown as well. 00:04:00 PEDRO RAMIREZ, MD: Yeah, and I think also, as you become proficient with your skills, certainly the times to achieve the same procedure and get through the same procedure is very comparable in laparoscopy as it is in laparotomy, and there are a number of factors that that one could potentially look at when looking at at those end points, one being patient selection. Any typically, I recommend to any surgeon who s beginning the learning curve to be very selective in which patients they re going to start doing these procedures on and other factors, like the team in the operating room, your assistants can potentially factor into the time that you re in the operating room. 00:04:39 DAVID KUSHNER, MD: Absolutely. You know, and just to finish up talking about the Lab II trial, I think it was really interesting that they looked at quality of life, and this was the first, you know, prospective study to look at quality of life because it s what we talk about with laparoscopy. It s why we re here. It s to try to make the quality of life for our patients better, and what laparoscopy has found to show in this study is that there was improved quality of life and people went back to their normal activities quicker and they had better body image, and those things are really important. 00:05:08 PEDRO RAMIREZ, MD: I agree, and I think that it is crucial not only that that was included in this particular trial but in any prospective trial from here on forward comparing laparoscopy to laparotomy. I think the element of quality of life has to be taken into consideration very, very seriously. 00:05:22 DAVID KUSHNER, MD: Absolutely. So I think we should go to our first video. We can take a look at the total laparoscopic hysterectomy, and I think we ll focus a bit, too, on the harmonic scalpel and why it s such a helpful thing. So here in this video, we re starting just by looking around the abdomen, and of course, washings are obtained prior to any major dissection. 00:05:44 PEDRO RAMIREZ, MD: The video is demonstrating the typical setup. Typically in my cases, I place four ports for a laparoscopic hysterectomy. The initial entry port I place at the umbilicus, and then I place two additional ports, one in the left and one in the right lower quadrant, and then one last port, a 5-millimeter port in the midline over the super-pubic arch. 00:06:09

3 DAVID KUSHNER, MD: And that s exactly the way I do it as well, and that allows you to to do this surgery as well as do the lymph-node dissection. When I m doing just a pure laparoscopic hysterectomy without doing periaortic lymph nodes, I actually won t use a super-pubic port. I find it to be slightly more awkward than putting two ports on the same side. I think this is a good example of how you can move very quickly with a harmonic and that it s able to take care of those vessels quite easily. 00:06:35 PEDRO RAMIREZ, MD: In this particular segment, the harmonic is through the leftlower-quadrant port, and the grasper is through the super-pubic port as well as through the right-lower-quadrant port. 00:06:48 DAVID KUSHNER, MD: Pedro, we have our first question. It s from a viewer in Connecticut, who asks, How many cases does it take to get up to your learning curve or to get passed your learning curve for a laparoscopic hysterectomy? 00:07:00 PEDRO RAMIREZ, MD: Dave, I think that question comes up frequently, and I think that there are a number of elements that play into the learning curve. Certainly, the amount of training that that surgeon has had in their residency and fellowship, and I think certainly, it s extremely important that every fellowship program integrate laparoscopy into their curriculum, but certainly the amount of training. Also, the patient selection, the team, the instrumentation that you re using can factor into the number of cases. So I don t think there is a specific number of cases that one can potentially quote as a consistent number that will be sufficient to achieve that learning curve. 00:07:41 DAVID KUSHNER, MD: I agree. You do get to a point where you feel you re over it, however. There s definitely a learning curve, and one day, things just start to flow really well. Instrumentation really helps with that and all the other things you mentioned. So in the procedure here, these are the physiologic adhesions that you usually see on the left side. These are being taken down with the harmonic. 00:07:59 PEDRO RAMIREZ, MD: And I think also this segment demonstrates also the multiple functions of this instrument. As you see, it s being used as a coagulator, as a cutting instrument, as a dissector, mobilizing the tissue very safely, and certainly, this is some of the potential qualities that could improve on the time in the operating room. 00:08:22 DAVID KUSHNER, MD: Our next question here is actually something I was going to bring up anyway, so that works well, which is: what is are we using in the what is being used in the uterus here for manipulation? 00:08:31 PEDRO RAMIREZ, MD: Mm-hmm. Typically, I use a uterine manipulator that has a ring attached to it, and that ring allows me to delineate exactly the junction between the vagina and the cervix, and that also shows me exactly where I need to make that colpotomy while still maintaining pneumoperitoneum. 00:08:54 DAVID KUSHNER, MD: Notice here that we re taking the infundibulopelvic ligament with the harmonic by taking some tension off of that, and that s a really important point is that if you don t take tension off of a vessel, it will bleed. So you really need to take that tension off and then go through it, you know, until it s done. Just be patient. So you were mentioning the manipulator. There are a couple different brands of manipulators that you can use made by different companies, and I ve used two or three of them, and they all seem to work. Find one that works well for you,

4 but it s a matter of using something that identifies the vagina, which we ll show in a couple minutes. 00:09:32 PEDRO RAMIREZ, MD: I think this also highlights the speed of the instrument as well. As you re going across that bladder flap, you re going across fairly quickly. And also, I think it should be highlighted the fact that the field is very, very clean. There is very little char left from the instrumentation as it s coagulating. At this point, we re actually transecting the left uterine vessels, and as Dave, as you mentioned before, I think it s important to highlight the fact that we do take tension off of the tissue so that you will achieve the best hemostasis. 00:10:09 DAVID KUSHNER, MD: We have another question here: Please define the exact location of your lower-quadrant ports. Are the they same for hysterectomy and for lymphadenectomy? 00:10:17 PEDRO RAMIREZ, MD: In my case, certainly I leave the and I use the same ports for laparoscopic hysterectomy, laparoscopic pelvic lymphadenectomy, and laparoscopic periaortic lymphadenectomy. Typically, the lower-quadrant ports, because of the fact that many of the patients who are operated on are fairly obese patients, it s difficult to see some of the vasculature that is concerned for entry site, like the inferior epigastric vessel. So generally, one of the ways to avoid that and I find that that has been very, very effective, at least in my practice is that I feel where the the anterior superior iliac crest is, and I go about two two centimeters or finger breadths medial to that along the [ unknown ] line. And clearly, that will always place you lateral to the rectum abdominus muscle. And you have excellent access to the pelvis and also to the periaortic all the way up to the level of the renal vessels. 00:11:10 DAVID KUSHNER, MD: Excellent. I want to point out here something which we both do, which is we go across the table, across the uterus to go down the cardinal ligament. So you re going from the patient s left to go down the patient s right cardinal ligament, and it lines up very nicely. 00:11:25 PEDRO RAMIREZ, MD: And this is also from the same side. So you don t have to change sides to go from you know, if you want to coagulate the left uterine vessels, you don t have to come across if you re sitting on the if you re standing on the right and equally for the opposite side. Both sides are coagulated from the same side. As you see here, this is the demarcation of the of the ring, and the pneumoperitoneum is maintained. 00:11:57 DAVID KUSHNER, MD: One of the nice benefits of this procedure is that you can maintain the uterosacral ligament if you desire. And you see in this case it s not taken down completely. It s still attached to the vagina. I think that s a real benefit. 00:12:09 PEDRO RAMIREZ, MD: This is an instrument which is a suction irrigator and monopolar technology. You can also make your colpotomy with the active blade of the harmonic. However, you need to be selective as to which ring you use on the manipulator because ideally, you d want to use a metal ring if you re going to use the harmonic to do the colpotomy as opposed to the plastic ring, which you see in this segment which was used with the monopolar. 00:12:38 DAVID KUSHNER, MD: It does eat into that plastic ring no matter which company you re using. If you do use the metal ring, it will make a pretty loud noise when it

5 goes up against that metal, so you have to be prepared for that. I also spend a lot of time on these lateral the lateral aspect here because this is where it s going to bleed. So as opposed to just going through it quickly with the unipolar hook, taking a little extra time to get this done right with the harmonic I think makes a lot of sense. 00:12:28 PEDRO RAMIREZ, MD: Dave, we have another question here from your home state of Wisconsin. They re concerned about any evidence of positive cytology from using these manipulators in a patient with uterine cancer. As you concerned that you re going to have a positive cytology by manipulating the uterus prior to the procedure. 00:13:48 DAVID KUSHNER, MD: That s a good question. It s a debatable question. I think it is a concern. At least theoretically, it s a concern, and there s some data to show that that may be the case, that you re increasing the incidence of positive washings. So what I ll do is I ll if I know I m doing a procedure for endometrial cancer, I ll actually go in and tie the Fallopian tubes or just use the harmonic to seal them prior to starting the procedure, prior to giving the washings. 00:14:12 PEDRO RAMIREZ, MD: I agree with you. I think there is there is some evidence in the literature to suggest that you could potentially increase the risk of positive cytology. There was a recent study that looked at evidence at taking the washings prior to any uterine manipulation, taking the washings immediately after uterine manipulations, and taking a third set of washings at the end of the case, and there wasn t any increased risk of positive cytology. So again, it s something that I think is still a point of debate, but it does it does come up frequently. 00:14:49 DAVID KUSHNER, MD: Well, very nice. So we re not going to be talking about the pelvic lymph-node dissection. 00:14:53 PEDRO RAMIREZ, MD: Absolutely. I think that in a patient with endometrial cancer, generally is a patient has an indication to proceed with a pelvic or periaortic lymphadenectomy, we are able to perform this procedure safely also by laparoscopy. The some of the initial evidence of this came about about 13 years ago when Jeff Fowler looked at a very small study. It was a pilot study of about 12 patients, and these are patients who were going to have a laparotomy. And then the decision was made to have a laparoscopy pelvic lymphadenectomy prior to the laparotomy and then evaluate the residual number of lymph nodes that were left after the laparoscopy. And what they found was that the average number of lymph nodes was about 23 to 24 lymph nodes, which certainly is comparable to what we see in the laparotomy setting. But interestingly, what they found was that there was, again, the initial evidence of a learning curve. In the first six patients, the lymph-node yield was about 63%, but in the last six patients, the lymph-node yield was much higher. It was about 85%, again, telling us that as you do more of these cases, you re certainly going to get better with regards to that lymph-node yield. Subsequent to that, there was a study from the G.O.G. published in 2002 where they looked at patients with cervical cancer, and the objectives of the study was looking a the adverse effect of the laparoscopic lymphadenectomy and the adequacy of a lymph-node removal. Again, sort of like that same concept of the initial; pilot study. And what they found that was on average, approximately 30 lymph nodes by laparoscopy, and there was occult residual lymph nodes in about 15% of the cases. But interestingly, in none of the lymph nodes that were remaining was there any evidence of metastatic disease, so therefore suggesting that most likely, the treatment would not have varied based on those on those findings. 00:16:38

6 DAVID KUSHNER, MD: I think you need to look at that study carefully, though, because you re really designing a study to to sort of end up with the result against laparoscopy because you re asking in advance you know you re going to be doing laparoscopy and then opening the patient and looking for whatever nodes are remaining. So you re going to be looking incredibly hard for extra nodes wherever they might be where those might not be nodes that would be routinely removed. 00:17:02 PEDRO RAMIREZ, MD: Absolutely. But again, fortunately the number of lymph nodes was fairly equivalent. One of the other questions that I think that comes up is, well, how much time should it take to do an adequate lymphadenectomy? And certainly, there are multiple elements that go into answering that that question. But a lot of the information has come, as you know, from the groups in Germany, and this is the first evidence from the group of Christhardt Kohler and Achim Schneider looking at their experience with 650 patients that asked the specific question as an endpoint: how long should it take to do a laparoscopic pelvic a periaortic lymphadenectomy, and routinely, the periaortic lymphadenectomy is about an hour, and a bilateral pelvic lymphadenectomy, once you achieve proficiency and skills generally is about 30 minutes. But I think that we will both agree that, again, that depends on your patient selection. 00:17:56 DAVID KUSHNER, MD: Absolutely, especially the periaortics. I think that is truly the biggest outlier because you can have patients where you really have to spend a lot of time getting visualization for the periaortics and other patients where the bowel is just very easily out of the way. 00:18:07 PEDRO RAMIREZ, MD: That s right. Do you have any special techniques, particularly for the periaortic, for the very obese patient as to how to achieve exposure, particular over the inferior mesenteric artery? 00:18:19 DAVID KUSHNER, MD: Well, I think you need to not be afraid to put in extra ports. You know, people get used to their four ports and always using their same ports, but an extra 5-millimeter port ultimately especially for an obese patient is not going to make a major difference, and to use that extra port to put in an extra retractor to hold things up, I think, is really important. And to be able to use Trendelenberg. And, you know, there are lots of different tricks that people use. We use a gel pad, and we actually put alcohol on a patient s back so that they stick to the gel pad and put them in Trendelenberg that way, but there are lots of different ways to do that. 00:18:51 PEDRO RAMIREZ, MD: Yeah, and I think it s important, as you highlighted the issue of the Trendelenberg, that if a patient is somewhat of an obese patient or a heavy patient, to let the anesthesiologist know that you re going to need the most Trendelenberg for the periaortic portion of the procedure, because that s where you re going to be most challenged by that weight. One of the other things that sometimes it works very well for me is that if I see the bowel continuously falling over the area that I m interested in, the periaortic or the precaval area, I will have the anesthesiologist turn the patients towards me, airplane the patient towards me, and oftentimes, that bowel will retract towards the left-upper quadrant. 00:19:28 DAVID KUSHNER, MD: That s a great idea. 00:19:29 PEDRO RAMIREZ, MD: I think, again, there are a number of questions that still remain as to what is an adequate number of lymph nodes, and I think that remains even for the open procedures. But at least from the study of the G.O.G. in the

7 laparoscopic approach, we saw on average of about 30 lymph nodes in the pelvis and about 13 to14 lymph nodes in the periaortic area. Another question that comes up is, well, how long should it take me? And I think that judging from the study of Christhardt Kohler and Achim Schneider, these are very skilled laparoscopic surgeons, and typically, after you achieve that learning curve, that proficiency, on average, in the pelvis, about 30 minutes, and in the periaortic area, about an hour. And lastly, the question of the learning curve. I don t think that there is much information in the literature as to what is the appropriate number for achieving that proficiency and what is that learning curve. And again, as I said, multiple factors will play into that, but from the evidence in the literature we have about 20 to 40 cases published by Childers and about 100 cases published by Achim Schneider. 00:20:36 DAVID KUSHNER, MD: 100 seems a bit much, I would think. 00:20:37 PEDRO RAMIREZ, MD: I think so, too. I think so, too. Now, this video is going to demonstrate a pelvic lymphadenectomy in a patient that we operated on, and this patient s B.M.I. was :20:48 DAVID KUSHNER, MD: Which is not uncommon for endometrial cancer. 00:20:51 PEDRO RAMIREZ, MD: Absolutely. Absolutely. So as you see in this video, again, the the setup is four ports: one port in the umbilicus, two ports in the left and right lower quadrant, and again, another port in the super-pubic midline. I should also point out that if a patient has any history of previous laparotomies that that initial port, I would recommend placing it in the left-upper quadrant because there is a low likelihood of having adhesion set at that point, and frankly, even in a patient who has had just a pervious laparoscopy, now I make my initial incision either above the umbilicus or in the left-upper quadrant. 00:21:36 DAVID KUSHNER, MD: I think that s an important skill for every laparoscopist to have at every level is to be able to enter in the left-upper quadrant because you there are just so many patients that could potentially have adhesions around the umbilicus. I will use that also for pregnant patients, patients with large masses. So it s a really important skill. 00:21:54 PEDRO RAMIREZ, MD: As you see, this is the right side of the pelvis. The nodes are being removed over the right external iliac vessels, and the right external iliac vein is shown. And this is very typical of an obese patient where you have very, very fatty nodal tissue and oftentimes, very sticky tissue as well. 00:22:23 DAVID KUSHNER, MD: Of course, there s no electricity being used here at all. So you re able to use the harmonic very close to the artery and vein without worrying about spread. Especially in deep spaces, like the obturator space, that s really nice. 00:22:37 PEDRO RAMIREZ, MD: Dave, we have a question from Miami, Florida, and the question is: Do you remove the lymph nodes individually, or do you remove them all together in a bag prior to the resection? 00:22:52 DAVID KUSHNER, MD: You know, I think that you know, that s an issue that it s sort of similar whether you re doing it open or laparoscopically. I tend to try to remove them together. I think that allows for a more anatomical dissection, and it s nice to be able to remove them all in one bag, and there are some, you know, rare

8 instances of port-site metastases, and removing them in a bag has been recommended to decrease that risk as well. 00:23:21 PEDRO RAMIREZ, MD: What I typically do -- and particularly in a patient that has very fatty tissue, frequently, what I ll do is I ll place all the lymph nodes in the cul de sac and then place them in the bag at the completion of the lymphadenectomy and then remove them all together. This segment of the video now demonstrates going to the left side of the pelvis, and in this particular approach, I typically don t change sides to do the ipisilateral lymphadenectomy. I will do the right pelvic lymphadenectomy and the left pelvic lymphadenectomy still standing on the patient s left side. Do you do the same? 00:24:04 DAVID KUSHNER, MD: No, actually, I go around to the other side of the patient. And I think what you re talking about is kind of an advanced move. It s a little bit tougher to see, visualize from that side. It s nicer because you don t have to go to the other side of the patient. You can keep moving along. What I ve found is with the newgeneration harmonic, with the Harmonic Ace, having the hand activation is really nice because we re not moving pedals because I do move across from the right to the left side, and I do that again for periaortic. So I m moving twice, and it doesn t take long for me to move around and not have to move the pedal. But, you know, I think to start with, it might be easier for people to visualize by moving to the other side of the table. 00:24:43 PEDRO RAMIREZ, MD: And also, I think that one should point out that and again, it s creating the individual preference by those surgeons is I prefer to see the vessels from 3:00 to 9:00 position horizontally on the monitor. For me, it makes it easier because it mimics what I m seeing open. There are other surgeons who like to see the vessels along the axis of 12:00 to 6:00, and again, it s just an individual s preference. 00:25:13 DAVID KUSHNER, MD: I agree. I do the same thing that you do in terms of turning it like that. It, again, is more similar to what you re doing with laporotomy. 00:25:19 PEDRO RAMIREZ, MD: This in this particular segment, the grasper is coming in through the super-pubic port, and the Harmonic Ace is coming in through the leftlower-quadrant port. And as I mentioned, the surgeon is on the patient s left side. 00:25:36 DAVID KUSHNER, MD: You know, it s interesting: it may be that I go to the other side because I originally was doing these surgeries with unipolar electrosurgery. And the thought of going into the obturator space and having a unipolar instrument draped over the artery and vein was unacceptable. So I had to come from the other side. But there s probably not a real reason I need to do that now using the Harmonic Ace because you just don t have to worry about anything but what s going on at the tip. 00:25:59 PEDRO RAMIREZ, MD: And I find also that not having to change sides certainly saves time in the operating room and saves frustration as well, and no one else needs to rearrange their position. So as you see here, the assistant is mobilizing that superior vesicle artery medially so that we can get access to that obturator space, and although conceptually, it might seem difficult from the ipsilatereral side, it s actually not because as you see here, there s no traction on the vessels along the left pelvic side wall. Generally, also, one can see the safety of this instrumentation. As you see in multiple segments on this video and in the upcoming video in periaortic area, you

9 can actually lay the active blade of the instrument very close to the to the wall of the blood vessels as long as you re not placing traction or pressure towards or inward towards the wall of those of those vessels. 00:27:19 DAVID KUSHNER, MD: I notice here that you re picking up on the artery with the grasper. Is that something you commonly do? 00:27:25 PEDRO RAMIREZ, MD: Yes, I think certainly, to gain exposure to the lymph nodes lateral to the to the vessels, ideally one would want to isolate the vessels from the side wall and get those lymph nodes in between the vessels and the side wall. So the artery, I think, is safe to grasp and mobilize medially. I certainly wouldn t recommend doing that to the vein, and once the that initial entry has been performed, then using the harmonic as a dissector is also very, very helpful in getting those lymph nodes exposed. 00:28:12 DAVID KUSHNER, MD: One of the nice benefits of laparoscopy as well is the ability to see that genital femoral nerve so well. You don t always see it as well via laporotomy. There s lots of things that can mimic that. 00:28:22 PEDRO RAMIREZ, MD: Absolutely. I think also, I would recommend, for those surgeons who are starting to do their pelvic lymphadenectomy laparoscopically, this is the one step in the procedure where you need to be most gentle with the tissue until you gain that level of comfort in knowing how much traction you can place on those vessels medially. I always tell our fellows that you can probably is laporoscopy, you can probably do more harm with a non-operating hand than with the one that has the operating instrument because you focus so much on the hand that is holding either the harmonic or the the monopolar technology that you lose sight of how much tension you have on that left hand, and this is particular true in the periaortic and the precable dissection. So as you see here, the lymph nodes are exposed, and there is very easy access to that space to remove the lymph nodes lateral to the blood vessels. It s also important, once you re removing these lymph nodes to make sure that you identify the obturator nerve before you resect those nodes. And as you see here now, grasping the artery again and having now the assistant grasp the artery so that we can remove the lymph nodes in the space between the artery and the vein. 00:29:51 DAVID KUSHNER, MD: That brings us to our next question that was just ed in: Are you normally using one assistant or two assistants to perform the surgery? 00:30:00 PEDRO RAMIREZ, MD: Typically it s one assistant. The assistant will stand on the patient s right side. The assistant holds the camera that is at the umbilicus with their left hand and the grasper to assist with the surgery on their right hand. But certainly in practicing at M.D. Anderson, more and more frequently, I m being the assistant rather than the operator. 00:30:25 DAVID KUSHNER, MD: I find that two assistants is helpful for fatigue and holding the camera. Sometimes the person holding your camera, as you re looking towards them, especially in the periaortic dissection will start to get tired. It s nice to have somebody on your side holding that camera. So occasionally, I ll use two assistants for that reason. 00:30:42 PEDRO RAMIREZ, MD: Absolutely, and I think the next video that we have set up for the audience is on the approach to laparoscopic periaortic lymphadenectomy, and I

10 think we probably should cover both of our approaches in terms of where the monitors are located in the room and where the trocars are located. How do you do it? 00:31:00 DAVID KUSHNER, MD: Well, I set it up, again, for ease of, sort of, continuing. I just continue with the with the video monitor the scope going directly through the umbilicus, and everything else is the same. You have the super-pubic port, and that would be the patient s my left hand if we re operating on the right and then the harmonic going through the left lower quadrant port. The assistant is in the right lower quadrant port, and that s what you re seeing here, the harmonic in my right hand, which would be in the left lower quadrant port. The monitor is we have one still down between the legs, but we try to take if we re in a room that has booms, we can move the monitors up, we ll move them towards the patient s head. 00:31:39 PEDRO RAMIREZ, MD: Just to before I discuss my setup for the periaortic area, we should highlight that here, on the top of the screen, is the patient s right side. The bottom of the screen is the patient s left side. The right side of the screen is toward the patient s head, and the left side of the screen is toward the patient s feet. One of the things that I also highlight when I talk about our approach to the periaortic lymphadenectomy is that that monitor is moving from the right lower extremity to the right upper extremity, and before the case, I alert the team that that monitor s going to have to be in that location. SO therefore, there s the least amount of commotion during the case to change that monitor over to the patient s right shoulder. 00:32:26 DAVID KUSHNER, MD: Absolutely. Just to continue orienting the viewer here, the initial incision that was made was over the common iliac artery on the right, which you now see along the bottom of the screen, and that s made from the level of the ureter, which was well-seen, up to above the I.M.A. just to start with so that that area s completely opened, and then the ureter was well visualized, and the ureter was retracted laterally so it s out of the way. And these lower periaortic nodes and upper common iliac nodes are then exposed. 00:32:56 PEDRO RAMIREZ, MD: Yeah, I think it s important to emphasize, too, that one should expose as much as possible of the area of dissection before the actual dissection begins because one of the things you want to have is a complication to a vascular site and not have adequate exposure. 00:33:16 DAVID KUSHNER, MD: Absolutely. And I think here, I think here, you know, this is a very typical view. You know, when you re first starting, the concern is are you going to be able to see in this area? But it is quite easy to see. You know, there are different ways of retracting the bowel out of the way. We talked a little bit about that earlier. I use a retractor, and endo-mini retract. It s like a little [ unknown ] that fits underneath the ureter and holds it out of the way. In this case, it s staying nicely over to the side. You can either use a regular retractor or something like that. 00:33:48 PEDRO RAMIREZ, MD: Absolutely. And I think again, this highlights the point that I was making before about the safety of the technology. As you see, the active blade is being placed immediately adjacent to the wall of that vessel without concern for injury. But again, as I mentioned, that is without placing any inward traction or or pressure, I should say, towards those vessels. This is the dissection all immediately blow the inferior mesenteric artery. 00:34:26

11 DAVID KUSHNER, MD: I think, again, in terms of learning curve, it s nice to start with some endometrial cancers, lower-grade endometrial cancers that you re comfortable with going up to the level of the I.M.A. and then work your way up above the I.M.A. so you re able to do that for restaging of ovarian cancerws or in patients that you want to be staging up to the level of the renals for any reason whatsoever. We re continuing up the aorta here. Since the camera is in the umbilicus, we re now getting above that level, above the umbilicus. So you can see that it s been turned somewhat, The patient s head is slight more to the upper part of the screen as well as just to the right. 00:35:14 PEDRO RAMIREZ, MD: This is completing the dissection over the left common iliac vein. And again, I think it s important to establish the plane and the appropriate plane in this area because oftentimes, it can come up fairly quickly on your dissection, and so you have to be alert of just like in the open cases as to how to approach that area. 00:35:45 DAVID KUSHNER, MD: This here I think is a major advantage of the harmonic, which is on the left side, when you pull these lymph nodes out from under the aorta, there s always the possibility that you re pulling one of the lumbricle vessels with it, and those are definitely small enough to be taken with the harmonic on a low setting. And so I m now using this on my open procedures as well in this area because it s just a nice way to dissect those out without having to worry about that. 00:36:10 PEDRO RAMIREZ, MD: And again, you see the same point: that active blade of the harmonic went directly next to the aorta without any concern for injury. 00:36:24 DAVID KUSHNER, MD: Are you using this instrument in your open procedures as well? 00:36:27 PEDRO RAMIREZ, MD: Yes. Absolutely. 00:36:29 DAVID KUSHNER, MD: What type of procedures do you typically use it for? 00:36:31 PEDRO RAMIREZ, MD: Well, generally, to do the hysterectomy although it s becoming and rarer to do a hysterectomy open for routine endometrial cancer but in the setting of advanced ovarian cancer, I use the the harmonic, and now, actually, there s a new instrumentation that is going to be called the harmonic wave that certainly has the capacity to coagulate larger-diameter vessels. So as you see here, this is the upper point of the dissection. The left renal vein was seen crossing over the aorta. The inferior mesenteric artery is noted here. And the dissection is continued above the inferior mesenteric artery to the level of the left renal vein. You can actually also start seeing the right gonadal vessels coming into the inferior vena cava. And as you see, if you re having difficulty with exposure, you can use that fan to lift the mesentery of the bowel and expose the tissue very well. 00:37:54 DAVID KUSHNER, MD: I think anybody would agree that this is an adequate dissection. You re really as high as you need to be, and the vessels are very well exposed. So we have our next question here, and that is: What order are you normally proceeding with these different steps? Do you always to the hysterectomy first, then pelvis, then periaortic as shown today? 00:38:22 PEDRO RAMIREZ, MD: I I typically will do the hysterectomy first because that s the site of disease that you re most interested in, obviously. Then, because the

12 periaortic, I consider, requires the most concentration between the pelvic and periaortic, and certainly, it could be the most taxing on you, then I will do the periaortic lymphadenectomy second and then finish with the laporascopic pelvic lymphadenectomy. 00:38:50 DAVID KUSHNER, MD: I have a similar approach, although I actually start with this procedure, the periaortic dissection, for that exact reason, that it does take the most concentration. It takes the most Trendelenberg, and I want to make sure that I get that done, because that seems to be the limiting factor. If for some reason I m not going to able to stage a patient laparoscopically, it s going to be the periaortics, and I want to know that right away. So get that over with because if not, I m going to end up opening them to get it done. Although that doesn t happen often, when it does, I just want to know at that point and now when I m already down with the hysterectomy. So here you re doing the pre-sacral nodes? 00:39:25 PEDRO RAMIREZ, MD: Mm-hmm, absolutely. Great. So concludes our our approach to the pelvic and periaortic lymphadenectomy, and I think that although there are some small variations between our techniques, our approach is fairly similar. 00:39:43 DAVID KUSHNER, MD: Yeah, it s very similar, actually. 00:39:45 PEDRO RAMIREZ, MD: Well, why don t we move now to the segment addressing the patients with early cervical cancer, patients who are interested in future fertility. As you know, a lot of this credit has to be given to the late Daniel Darjon, who has been a mentor to many of us, and the groups now, again, in France, in Germany, in Canada who have certainly perfected and mastered this technique and are the contributors to most of the information that s in the literature. For us, our approach is through the abdominal route, and I know that you favor the vaginal approach. So maybe you can talk a little bit about that and why you favor that versus the abdominal. 00:40:25 DAVID KUSHNER, MD: Sure, I mean, I think there are pros and cons to both approaches. There is more data on the vaginal approach. That was the first way that it was performed. It s nice because it makes some logical sense. You re down there, you re able to remove the cervix and area around the cervix without having to lift up on the uterus, not worrying about the uterine arteries as much. And of course, it s more minimally invasive. The problem is it does take extra training. It is not similar to any other procedure that we do, and there s a much longer learning curve. So I think it is more generalizable to be able to do it in the similar manner that we do a regular radical hysterectomy. 00:41:02 PEDRO RAMIREZ, MD: I absolutely agree. Now, our indications for a patient who is a candidate for a radical trachelectomy typically is a patient who is interested in future fertility, obviously. Now, we have a selective criteria for the size of the tumor. Typically, we don t operate on patients who have tumors greater than two centimeters. So typically it s a patient with a stage 1A-2 or a 1B-1 that has a lesion that is less than two centimeters. The reason for that is because I think that from all the data that we have and the literature and this is primarily data from the radical vaginal trachelectomy patients about 8% of those patients actually had lesions that were greater than 2 centimeters, but of those patients, 23% of them recurred. So I think it s wise I think it s wise to keep the the indication that s less than 2 centimeters. I think another area of debate has been histology, and for many years, it was discussed as to whether adenocarcinoma would be an indication for a

13 trachelectomy. I think that there s increasing evidence in the literature from from the studies that have been published that there s probably even an equal number of patients having squamous carcinoma as opposed to adenocarcinoma as well. 00:42:10 DAVID KUSHNER, MD: You have to be slightly more concerned in those patients that it might extend up to the uterus, that it could even extend up into the upper uterine segment into the ovaries because that doesn t happen as much in squamous carcinoma. But that s what MRI is for, pre-operatively to try to 00:42:24 PEDRO RAMIREZ, MD: Do you perform MRIs on every patient who s about to have a trachelectomy or only on adenocarcinoma patients. 00:42:31 DAVID KUSHNER, MD: We perform them on all the patients, but it s much more important, I think, in the adenocarcinomas. 00:42:36 PEDRO RAMIREZ, MD: We do the same. Typically we get an MRI as well. I think that just reviewing some of the most recent literature, the group from Quebec had contributed a significant amount as well, and about two years ago in 2000, the published their experience of 72 patients, fairly long follow-up of about 600 months. Most lesions were less than two centimeters. About 10% to 12% of patients abandoned the procedure we had to abandon the procedure for multiple factors that you can see the audience can see on this slide. Generally, most patients again, stage 1A-2 or 1B-1s, but as I mentioned before, the number of patients having squamous carcinoma as opposed to adenocarcinoma, fairly similar. I think it s interesting and important to highlight the fact that the recurrence rate and the death rate is very similar to patients undergoing a radical hysterectomy. I think that in very carefully selected patients, we can achieve excellent prognosis for these patients as well. 00:43:34 DAVID KUSHNER, MD: This has done an incredible incredibly good deed for these patients who desire fertility and without really compromising their survival. 00:43:43 PEDRO RAMIREZ, MD: Absolutely. This is some of the data on the pregnancy outcomes because obviously, we don t want to expose a patient to a novel procedure. Before, it was thought, Well, why expose the patient to a potentially poor prognosis component that will impact on the outcome of those patients? Now we have evidence that the recurrence rate and the death rate are are very similar, but generally, it was, Well, if we re going to expose the patients to this procedure, what are we seeing in terms of the pregnancy outcomes? And in this slide, you see that the first trimester pregnancy loss are very similar to that of the general population, as is the second trimester pregnancy loss, and I think that there were variations in the number of patients having second trimester pregnancy losses because of the amount of tissue that was removed at the time of the trachelectomy the amount of cervix that was removed at the time of the trachelectomy. 00:44:30 DAVID KUSHNER, MD: And it does seem to be directly related. Some of the earlier studies out of France where they weren t leaving any cervix behind had up to a 50% chance of a second-trimester loss. But now, in the more modern studies, it s routinely somewhere less than 5%, which is amazing. 00:44:46 PEDRO RAMIREZ, MD: Absolutely. And this will take us to the next video, our last video. This is a patient who had a trachelectomy done, again, through the abdominal approach. This is a turning incision, and this incision, actually, I think provides

14 excellent exposure to the to the pelvis. In this particular patient also, we did a lymphatic mapping procedure. So you ll see, as we try to identify the sentinel nodes. 00:45:18 DAVID KUSHNER, MD: You know, we ve been performing a lot of sentinel lymphnode dissection as well, and I think that the Harmonic Ace is really vital for that because you really want a bloodless dissection. All you need is to get one bleeder and then you can t see the blue very well at all. 00:45:43 PEDRO RAMIREZ, MD: We have a question from Los Angeles, California: Do you make a decision as to whether to continue with the radical hysterectomy based on frozen-section evaluation of the sentinel node if the sentinel node appears normal? 00:46:00 DAVID KUSHNER, MD: Yes, and again, that s another debatable point, but we would we would favor chemo radiation for patients with one or more positive nodes whether that node is grossly positive or not. And so, if at the time of sentinel lymph node or for whatever reason at the time of surgery we find a positive lymph node, then we would abandon the surgery. We actually would then proceed with the full pelvic and periaortic dissection for treatment purposes. 00:46:28 PEDRO RAMIREZ, MD: Yes, and our case is similar. We would certainly if we have a lymph node that appears grossly abnormal, then we send that lymph node for frozen section. But if the sentinel lymph node appears completely normal, then we don t we don t send that lymph node for frozen section evaluation. But if it does in fact appear abnormal, we do complete the periaortic lymphadenectomy but not the pelvic lymphadenectomy and send that patient for chemotherapy and radiation. 00:46:57 DAVID KUSHNER, MD: In that last segment, you were untunneling the ureter, it appeared, and you do that entirely with the harmonic? 00:47:03 PEDRO RAMIREZ, MD: Yes, and I think, again, it highlights the safety of the instrumentation. It has an active blade and a non-active blade. So we rest the nonactive blade, which is the one that you see on the screen with the white pad on the ureter, and certainly, there is no transfer of any heat at all to that to that structure. I think it s important to highlight, also, the fact that in some of the initial literature, particularly in a radical abdominal trachelectomy, there was a concern for spending time isolating the uterine arteries and making sure that these were not transected. I think now, there s increasing evidence in the literature that one can coagulate and transect the uterine vessels because there s sufficient blood supply to the uterus from the infundibular pelvic vessels. 00:47:58 DAVID KUSHNER, MD: The number of reports is still low. I don t know that I would routinely remove them or transect them if you could leave them intact, but if you needed to transect them, it may be a safe thing to do. 00:48:09 PEDRO RAMIREZ, MD: At this point, we re transecting the cervix the upper cervix from the uterus, amputating the specimen. Once this is completed, them we gently mobilize the uterus to the upper abdomen until the cervix and perimetrium has been removed. Again, you see the the residual uterus, and now we focus on the resection of the cervix. Here we re transecting that cervix and upper vagina from the lower vagina to ensure at least a 2-centimeter cuff of vaginal tissue. Generally, we will send the specimen to the pathologist to perform a frozen-section evaluation to tell us the distance of any residual from the upper margin of the specimen. Because we want to know that there s at least a one-centimeter free margin to that specimen.

15 If there isn t, then the patient has been consented for a radical hysterectomy, and we proceed as such. I know that there are some centers that allow for less than a centimeter. Some reports have shown that there criteria is 5 millimeters from the upper margin. 00:49:36 DAVID KUSHNER, MD: And this is a cerclage you re placing here, correct? And what suture are you using? 00:49:40 PEDRO RAMIREZ, MD: This is Ethibond suture. 00:49:43 DAVID KUSHNER, MD: And we routinely place that at about a centimeter up from the or from what is now the new external os of the cervix. Is that the same place 00:49:52 PEDRO RAMIREZ, MD: Yes, absolutely. Do you use the same type of suture? 00:49:54 DAVID KUSHNER, MD: No, we use Proline and then tighten it around a dialator a 5- millimeter dialator so it doesn t tighten too tight because it s easy to overtighten it. 00:50:01 PEDRO RAMIREZ, MD: Sure. This is this segment shows a portion of the pediatric catheter that has been placed in the in the uterus, and this is just kept in for about 5 to 7 days to maintain the patency of that canal. And again, this is just the final steps of the procedure, approximating the uterus to the upper vagina. Typically, patients will stay in the hospital about anywhere from 3 to 5 days. 00:50:47 DAVID KUSHNER, MD: That s obviously the biggest difference between the abdominal and the vaginal approach because the patients will go home the next day with the vaginal approach. 00:50:59 PEDRO RAMIREZ, MD: I think it s also important to highlight the fact that when you re looking at the pregnancy rates and how many patients have have achieved a pregnancy after this procedure to note that not every patient that has undergone this procedure immediately tries to get pregnant. So therefore, the true pregnancy rate may be much higher than what we re seeing reported. 00:51:23 DAVID KUSHNER, MD: True. You know, in Darjon s original series, many of those patients were already pregnant, which is why he decided to try this procedure at that time. Have you had any pregnant patients you performed this on? 00:51:33 PEDRO RAMIREZ, MD: Not yet because we actually we started our experience about a year ago, and as I mentioned before, a lot of these patients, they want to have this as an option in the future, and some of them are not even married yet. 00:51:46 DAVID KUSHNER, MD: There s also some new data out of Quebec about possibly using chemotherapy to shrink larger tumor and then perform this. What do you think of that? 00:51:54 PEDRO RAMIREZ, MD: Well, I think, obviously, they have been innovators for many, many years, and obviously, we look to them as as as our leaders in the field. So certainly, that may be a possibility that may become routine in the future. I think that, as you said, it s a small number of patients I believe it was three patients and the follow-up is not very long, but certainly may be an option that if it proves safe in the future, that would expand the number of patients that could potentially be candidates for this procedure.

16 00:52:28 DAVID KUSHNER, MD: Yeah. We got one last question that was about it was related to starting a laparoscopic practice when you re not doing it at all and how a gynecologist or oncologist who wants to perform these kinds of laparoscopy and is now just doing tubaligations and removing cysts would get this kind of practice going. How do you do that? How do you set that up? 00:52:50 PEDRO RAMIREZ, MD: I think there are multiple components to setting up a successful team. I think it begins with the team around you, not only the surgeon, certainly the assistants that you re going to have, the circulating nurse, the scrub nurse. Ideally, if you had the same team consistently, that will significantly impact very favorably on your learning curve because they re going to know exactly the type of steps that you re going to be taking. They re going to know the technology that you re going to be using. They know everything about that specific procedure from day in, day out. So I think that that s very important. I think it s also important to emphasize choosing the right technology, the safest technology and not to embark on very difficult cases, as you said. If you re doing the cystectomies, if you re doing the simple hysterectomies, perhaps it s not ideal to go from that to immediately doing a laparoscopic radical hysterectomy or a periaortic lymph-node dissection above the inferior mesenteric artery without any supervision from a surgeon who is skilled and comfortable with this with this approach. I think certainly having cases proctored by other surgeons, it helps tremendously. 00:54:02 DAVID KUSHNER, MD: That s actually what I was thinking is I think you can t underestimate the importance of that, of having some amount of proctoring. It s being sort of on your own doing cases where it s very easy to say, Well, I m just going to stop and open this patient. I m getting a little uncomfortable here, and that may be the right thing to do, but with a proctor there and not necessarily somebody from out of town. Sometimes it can be another surgeon in your area who s who s doing this sort of thing. Many people are getting partners who are new out of fellowship who are who are doing these procedures, and they can teach the partners that have been in practice for a long time. 00:54:35 PEDRO RAMIREZ, MD: Absolutely. And I think also, one of the other factors that helped me personally is getting involved in education and in trying to take as many courses as possible, courses to highlight on advanced laparoscopic procedures that potentially will bring those skills to your operating room. So I think that those are the multiple factors, and certain, again, I stress patient selection. Patient selection is extremely important as you re going through your learning curve. Choose patients where the procedure is going to be less challenging at first, and then you gain those skills, then you can move on to the more challenging cases. 00:55:14 DAVID KUSHNER, MD: Yeah, my residents know in my clinic that the first thing I want to know about somebody when they re presenting and we re considering a laparoscopic surgery is what is their BMI? Because BMI is was directly related in the lab II trial to the chance of opening that patient. And I started off with my BMI cutoff under 25, and then I moved it to 30, and then I moved it to 35, and then I moved it to 50, and it s another issue of how high you can go, but for these periaortic dissections, I find that once you get to 50, it s really getting impossible to do. If I m not going to be doing any of the periaortics and it s just a hysterectomy, 60 is about my cutoff. But it takes a long time to get comfortable to that degree. 00:55:52

17 PEDRO RAMIREZ, MD: I agree, and that s the same rationale that I apply in my practice as well. Well, Dave, we re running short on time. Any closing comments you want to add to our audience? 00:56:03 DAVID KUSHNER, MD: No, I wanted to thank you for having me, and I think that we covered a lot today. 00:56:08 PEDRO RAMIREZ, MD: Thank you very much. Thank you for your time and for being here, and again, I want to stress to our audience if you have any remaining questions, please send them to us, and we ll address them in a timely fashion. Thank you so much, and have a good night. 00:56:19 DAVID KUSHNER, MD: Thank you. 00:56:21 ANNOUNCER: this has been a live presentation of novel gynecological oncology procedures. For more information about this presentation, just click on the Request information buttons on the screen. This program is made possible through an educational grant from Ethicon Edo-Surgery. 00:56:55 [ END OF FILE ]