E L E C T R O S U R G E R G Y / W A T E R J E T S U R G E R Y E S D W o r k s t a t i o n w i t h H y b r i d K n i f e Endoscopic Submucosal Dissec tion fast, safe and easy with the HybridKnife.
introduc tion ERBE TechnOLOgy Endoscopic submucosal resection spares the patient open surgery and with it possible intra- and postoperative complications. Using the EMR (endoscopic mucosal resection) and the ESD (endoscopic submucosal dissection) methods, such minimally invasive interventions have found application for the treatment of early carcinomas, adenomas and lesions in the gastrointestinal tract in general for some years. ERBE Elektromedizin has advanced the development of this precise ESD method in collaboration with leading Japanese and European experts. Safety aspects have been improved considerably, the surgical procedure has been simplified, and operating times have been reduced. Internationally renowned gastroenterologists already work using this method. More and more users convinced of its merits will adopt it, applying it for lesions of the stomach and increasingly also of the colon and the esophagus. With its VIO GI workstation, Erbe Elektromedizin has established itself in the field of gastroenterology worldwide and has many years of profound know how in interventional endoscopy. The system consists of the VIO electrosurgical unit, which acts as the master module, as well as an Argon Plasma Coagulation unit for devitalizing gastrointestinal structures and coagulating diffuse bleeding. The ERBEJET 2 waterjet surgical unit is a new, additional system component for ESD. Both technologies, electrosurgery and waterjet surgery, are activated and applied using the ERBE HybridKnife as a combination instrument. For the first time, all working steps involved in the ESD procedure can be performed with just one instrument: marking of the resection margin, elevation of the mucosa, incision/dissection of the submucosa and coagulation of the resection bed. In this brochure we wish to demonstrate to you the advantages of the ESD method using the Hybrid- Knife, describe the steps involved in the procedure, and provide you with additional information and useful adviced. Medical progress never stands still. Thus we not only aim to provide what is currently the most effective, state-of-the-art procedure for endoscopic resection. We will continue to keep abreast of clinical insights and incorporate them into our research and development so that you obtain even better results in the treatment of your patients in the future. Important note ERBE Elektromedizin GmbH has taken the greatest possible care when compiling these recommendations. Nevertheless, it is impossible to exclude the possibility that errors may be contained herein. The information and recommendations given here may not be construed as constituting any basis for any claims against ERBE Elektromedizin GmbH. Should legal regulations stipulate liability, such liability shall be limited to intentional misconduct or gross negligence. The data respecting recommended settings, areas of application, application duration or the use of instruments is based on clinical experience, although it is important to remember that individual centers and physicians may favor settings which differ from the recommended settings given here. All values are merely guidelines and their applicability must be verified by the operator. Depending on the circumstances, it may be necessary to deviate from the values and settings given in this brochure. Medical science is subject to a process of permanent change based on research and clinical experience. It may therefore also be appropriate to deviate from the values and settings given in this brochure on the basis of the results of such research and experience. 02 HybridKnife
ERBE VIO electrosurgical unit ENDO CUT Q This electrosurgical unit provides the cutting and coagulation modes necessary to obtain the tissue effects required for ESD and EMR. ENDO CUT Q DRY CUT FORCED COAG The ENDO CUT Q fractionated cutting mode with alternating cutting and coagulating cycles was specifically developed for endoscopic interventions. The ENDO CUT Q is employed for snare ablation as well as circular incision and resection of lesions using an electrosurgical cutting electrode. The voltage and arc regulation which the VIO generator technology features allow for high quality and reproducible cutting effects. During the entire cutting process, controlled cutting and reliable hemostasis as well as low risk of perforation are ensured. The principle as much coagulation as necessary (prevention of bleeding), as little as possible (prevention of perforation). U Voltage Figure 1: GI workstation: VIO 200 D electrosurgical unit, APC 2 Argon Plasma Coagulation unit, ERBEJET 2 waterjet surgical unit and EIP 2 endoscopic irrigation pump Coagulation cycle Cutting cycle t Time Figure 2: ENDO CUT Q fractionated cut The alternating cutting and coagulation cycles which characterize ENDO CUT Q can be varied dependent on size, shape and localization of the lesion in question in terms of levels of effect, cutting duration and cutting interval. (For more detailed information on ENDO CUT Q consult ERBE brochure no. 85800-117.) HybridKnife 03
DRY CUT ERBEJET 2 waterjet surgical unit This mode provides a cut with high coagulation effect and ensures reliable hemostasis even when relatively large blood vessels are involved. Reproducible effects with low degree of smoke plume formation can be obtained through voltage regulation. In numerous disciplines, waterjet surgery has clear advantages over alternative surgical procedures. Its classic application is hepatic surgery. ERBE has gathered many years of experience with this technology in other surgical disciplines as well. Figure 1: Marking of the lesion margin Figure 3: Layer-specific elevation of the mucosa using the waterjet FORCED COAG Marking of the lesion is carried out using FORCED COAG. During resection, bleeding can be coagulated using the FORCED COAG mode and also any necessary post-coagulation of the resection bed. APC 2 Argon Plasma Coagulation Apart from classic electrosurgical modes, another GI module, the APC 2 Argon Plasma Coagulation unit, provides safe methods for marking the lesion margins and can also be used for hemostasis during and after the resection process. The APC 2 unit enables non-contact coagulation; thus there is no risk of tissue adhesion. Coagulation depth is limited, controlled and homogenous. This almost completely rules out any risk of perforation. The resection bed can be coagulated with the APC completely and homogenously. The waterjet pressure can be adjusted from effect 1 to effect 80 (this corresponds approximately to 1-80 bar). For gastroenterology applications, an effect between 10 and 50 should be selected for the specific organ in question. Please consult the table on page 10 for precise setting recommendations. At low effect settings blood vessels and nerves are spared, as are adjacent tissue structures and organs, for the waterjet procedure works tissue-selectively without producing any thermal effects. These very features are what makes waterjet technology ideally suited for mucosal elevation before endoscopic resection: the selective waterjet penetrates the mucosa and separates the tissue layers without use of needles while respecting anatomical layers. The separation medium accumulates in the submucosa located beneath the mucosa, forming a fluid cushion between the mucosa and the muscularis. The mucosa with the infiltrated lesion is elevated and can be resected without the muscularis being injured. For further information on waterjet surgery, argon plasma coagulation and the endoscopic irrigation pump please go to www.erbe-med.com or consult individual brochures. Figure 2: Surface coagulation with APC 2 04 HybridKnife
HybridKnife The flexible, multi-function probe combines both technologies, electrosurgery and waterjet surgery, in one instrument. The four working steps marking, elevation, incision/dissection and coagulation require no change of instrument. The variably adjustable tip of the HybridKnife has a diameter of 0.7 mm and a micro-capillary. For the various segments of the gastrointestinal tract we recommend using needles in the following lengths: Figure 3: Needleless elevation of mucosa using the HybridKnife Stomach, approx. 3 mm Colon, approx. 1.5 mm Esophagus, approx. 2 mm The probe has an overall length of 190 cm; its external diameter of 2.3 mm makes it suitable for use with any standard endoscope. Needleless waterjet elevation raises the mucosa particularly quickly and it creates a considerably larger fluid cushion than one created by conventional needle injection. Figure 4: HybridKnife, I-type Figure 5: HybridKnife, T-type Figure 1: Elevation using waterjet function Figure 6: HybridKnife, O-type Figure 2: Marking, incision/dissection and coagulation using the electrosurgical electrode tip which varies in length and finds versatile application in the esophagus, stomach and colon HybridKnife 05
PROCEDURE Figures 1+2: Piecemeal method used in EMR for relatively large lesions EMR and ESD are interventional procedures for treating early carcinomas and lesions which potentially constitute focal carcinomas. The prerequisite for a curative approach is complete resection of the lesion (R0 resection). Limits of EMR Using the EMR method, only lesions measuring up to 2 cm can be removed en bloc. For lesions with a diameter of more than 2 cm, only successive partial resection (piecemeal method) is possible using the EMR method. The disadvantage is that EMR harbors the risk of lesions larger than 2 cm in diameter not being ablated completely with a safe resection margin and carcinogenic cells remaining in the mucosa. When ESD is used, the lesion can be resected en bloc with a safe resection margin. From this perspective it is plausible that in the case of EMR, the recurrence rate is much higher than for the more precise but more difficult to learn ESD method. Figures 3+4: Complete resection of lesion using ESD with R0 approach ESD method using the HybridKnife The advantages of the ESD method developed by ERBE derive from synergetic utilization of waterjet technology in connection with electrosurgery. The individual working steps marking, elevation, incision/dissection and coagulation can be performed with the multi-function HybridKnife without change of instrument while achieving the highest possible degree of safety. 06 HybridKnife
The working steps Figure 1: Marking Step 1: Marking Before elevation, the lateral safety margin is marked with coagulation points at smallest possible intervals with the lesion demonstrating a peripheral zone of 5-7 mm. The APC non-contact method using the PULSED APC mode is also suitable for this procedure. Step 2: Elevation The HybridKnife is positioned on the mucosa with a slight amount of pressure and an application angle of approx. 20. The waterjet penetrates the soft mucosa and accumulates in the collagenous fibers of the submucosa, which becomes bloated in a pillow-like fashion. The muscularis, which lies below the submucosa, is not penetrated until considerably higher amounts of pressure are reached than those required to penetrate the mucosa. Tissue elevation occurs on the basis of differing tissue consistencies layer-selectively and safely and, when performed properly, without any risk of perforating the organ. Figure 2: Elevation The cushioned submucosa forms a safety margin to the muscularis, thus minimizing the risk of perforation during initial and circular incision of the lesion when the ESD method is used and when the EMR snare ablation method is employed. The submucosal cushion also provides protection against thermal damage of the muscularis. The cushion remains intact during dissection and resection and additional fluid can be added if necessary to ensure its protective function throughout the entire course of the ESD procedure. Since the blood vessels are compressed by the fluid cushion, risk of bleeding is minimized. The operation can be performed with little bleeding and a good view of the target area. Figure 3: Incision/dissection Step 3: Incision/dissection VIO modes ENDO CUT Q and DRY CUT, which are used for initial and circular incision and resection of the lesion, provide optimal cutting features. Figure 4: Coagulation Step 4: Coagulation Blood vessels and leakages are coagulated during and after resection with FORCED COAG. Hemostasis is enhanced by the compressive fluid cushion. You will find recommendations for settings on page 10. HybridKnife 07
APPLIC ATION In the following we wish to take a closer look at some special aspects concerning elevation and dissection of the mucosa and demonstrate some further advantages of the ESD method using the HybridKnife. Diagnosis/localization Reduction of bleeding During elevation of the mucosa, initial diagnostic prognoses in terms of tumor infiltration can be made because tumor-infiltrated lesions which occur in the colon in particular cannot be elevated. Should no elevation be detected during waterjet activation, despite having set the effect correctly, this is indicative of a tumor which has infiltrated deeper tissue layers. In this case, the indication for curative ESD is no longer given. Through the water pressure, small capillary blood vessels within the submucosa cushion are compressed. The result: bleeding is reduced and the view of the target area remains unimpaired. Unlike needle injection, use of the waterjet practically rules out risk of injury to blood vessels. This aspect ensures additional reduction of possible bleeding. An additional diagnostic tool which facilitates the detection and visual identification of tumor boundaries is a contrast medium which can be added to the separation medium. The altered tissue of the lesion already becomes visible through elevation alone. However, the contrast medium makes the difference between healthy and pathological tissue even more distinct. Should any bleeding nevertheless occur, it can be rinsed using the waterjet and coagulated afterwards electrosurgically. Figure 1: The tumor is visualized using contrast medium Figure 2: Reduction of bleeding, thus good view of the operating field 08 HybridKnife
Protection against perforation R0 resection of relatively large lesions In the case of needle injection, the separation medium is injected underneath the mucosa. Here the risk of injuring blood vessels arises. When performing the needle-injection procedure, a change of instrument is required if fluid is added in the course of the intervention, and thus the tendency is to perform resection using a less pronounced submucosal cushion. This in turn increases the risk of thermal and mechanical perforation of the muscularis. Using the ESD method, large-surface tissue lesions can also be resected en bloc. The resection bed has a smooth resection surface which heals homogenously and with practically no scarring approximately 4 weeks post-operatively. Since waterjet elevation can be performed at any time, it is possible to keep the cushion volume constant during and after dissection and resection. Thus the safety margin to the muscularis is preserved. Figure 1: Waterjet elevation is possible at all times Figure 2: Homogenous resection bed free of bleeding after ESD with HybridKnife Aspects of cost The separation medium used for ERBEJET 2, a common physiological saline solution, is much more cost-economic than the solution enriched with additives which is used for needle injection. Administering needle injections requires force, in particular when fluids with a high degree of viscosity are involved. And a further aspect of cost-efficiency is that when using the waterjet method, no additional personnel is required for assisting in the elevation process. As a multi-function probe, the HybridKnife performs all four working steps: marking, elevation, incision/dissection and coagulation. No additional two-channel endoscope is needed for performing ESD with the HybridKnife; a singlechannel endoscope fulfills all the requirements. HybridKnife 09
RECOMMENDED SET TINGS The following tables give you guideline values for the various gastrointestinal segments. These values should provide you with some orientation in selecting settings for waterjet pressure and CUT and COAG modes. ERBEJET 2 VIO system ESOPHAGUS Mucosal elevation Effect: 30-50 Marking PULSED APC, 20 Watts FORCED COAG, effect 1, 20 Watts Incision/dissection ENDO CUT Q, effect 2, cutting duration 3, cutting interval 3 DRY CUT, effect 2, 80 Watts (higher degree of hemostasis) Coagulation FORCED COAG, effect 2, 60 Watts STOMACH Mucosal elevation Effect: 30-50 Marking PULSED APC, 20 Watts FORCED COAG, effect 1, 20 Watts Incision/dissection ENDO CUT Q, effect 2, cutting duration 3, cutting interval 3 DRY CUT, effect 2, 80 Watts (higher degree of hemostasis) Coagulation FORCED COAG, effect 2, 60 Watts right COLON Mucosal elevation Effect: 10-15 Marking PULSED APC, 20 Watts FORCED COAG, Effekt 1, 20 Watts Incision/dissection ENDO CUT Q, effect 2, cutting duration 3, cutting interval 3 DRY CUT, effect 2, 80 Watts (higher degree of hemostasis) Coagulation FORCED COAG, effect 2, 60 Watts rec tum left COLON Mucosal elevation Effect: 20-30 Marking PULSED APC, 20 Watts FORCED COAG, Effekt 1, 20 Watts Incision/dissection ENDO CUT Q, effect 2, cutting duration 3, cutting interval 3 DRY CUT, effect 2, 80 Watts (higher degree of hemostasis) Coagulation FORCED COAG, effect 2, 60 Watts 10 HybridKnife
advise on use BIBLIOGR APHY On the basis of previous applications we have gathered some valuable experience which should help simplify the use of the HybridKnife for you. Position of the patient The patient should always be positioned in such a way that gravity causes the lesion to fall away from the wall. Kaehler GF, Sold MG, Fischer K, Post S, Enderle M. Selective fluid cushion in the submucosal layer by water jet: advantage for endoscopic mucosal resection. European Surgical Research 2007; 39: 93-97. Schumacher B. Therapie von Magenadenomen und Frühkarzinomen. Endoluminal Therapy of Adenoma and Early Stomach Cancer. Endoskopie heute 2007; 20(4):236-240. Flexible endoscope with transparent cap We recommend using an elastic, transparent cap which is placed on the distal end of the endoscope. This ensures a better view of the resection surface and the already resected mucosa segment can be kept away from the lens and the tip of the instrument in this way. Distance between marking points We recommend as short a distance as possible, with the individual marking points being 2-3 mm apart. This facilitates a good overview of the operating site and increases the reliability of R0 resection. Schumacher B, Neuhaus H, Enderle MD. Utilisation expérimentale d un nouvel instrument de mucosectomie. Acta Endoscopica 2007; 37(5):673-678. Schumacher B, Deinert K, Philipper M, Neuhaus H. Experimetal testing of a new Hybrid Knife for endoscopic submucosal dissection (ESD) in the esophagus. Gastrointestinal Endoscopy 2007; 65(5): AB278. Fernandez-Esparrach G, Matthes E, Maurice D, Enderle MD, Thompson CC, Carr-Locke D. A Novel Device for Endoscopic Submucosal Dissection That Combines Water-Jet Submucosal Hydrodissection and Elevation with Electrocautery. Gastrointestinal Endoscopy 2008; 67(5):AB141. Extension of elevation The lesion need not be completely elevated before dissection is performed. When using the ESD method, it can prove advantageous to alternate between elevation and dissection in segments. Adding another dye (such as indigo carmine) to the NaCl solution may be helpful as a means of improving contrast. Ryou M, Shaikh SN, Yao M, Fernandez-Esparrach G, Henry FP, Kochevar I, Maurice D, Matthes EL, Enderle MD, Carr-Locke DL, Redmond RW, Christopher C. Thompson CC. Next Generation Access and Closure for NOTES: Tissue-Selective Hydro-Dissection for Efficient Gastric Flap Access with Photochemical Tissue Bonding for Secure Closure. Gastroenterology 2008; 134(4):A105. Sold MG, Grobholz R, Post S, Enderle MD, Kaehler GF. Submucosal cushioning with water jet before endoscopic mucosal resection: Which fluids are effective? Surgical Endoscopy 2008; 22: 443-447. Yahagi N, Neuhaus H, Schumacher B, Neugebauer A, Kaehler GF, Schenk M, Fischer K, Fujishiro M, Enderle MD. Comparison of Standard Endoscopic Submucosal Dissection (ESD) Versus an Optimized ESD Technique for Colon: An animal study. Endoscopy, 2009, accepted. Kähler et al. Combination of Water-Jet Dissection and Needle-Knife as a HybridKnife Simplifies Endoscopic Submucosal Dissection. Surgical Endoscopy 2009, accepted. Neuhaus H, Mayershofer R, Wirths K, Seelhoff A, Vieth M, Schumacher B. First clinical trial of endoscopic submucosal resection (ESD) of early gastric neoplasia with a water-jet HybridKnife (ESDH). Abstract accepted for DDW 2009. Neuhaus H, Wirths K, Schenk M, Enderle MD, Schumacher B. Randomized controlled study of endoscopic mucosal resection (EMR) versus endoscopic submucosal dissection with a water-jet Hybrid- Knife (ESDH) of esophageal lesions in a porcine model. Gastrointestinal Endoscopy 2009 Mar 13 (Epub ahead of print). Hyett B, Maurice, D, Matthes E, Carr-Locke D. Needle-Less Elevation for Endoscopic Mucosal Resection (EMR) in the Esophagus, Stomach and Colon. Abstract accepted for DDW 2009. HybridKnife 11
ERBE Elektromedizin GmbH Waldhoernlestraße 17 72072 Tuebingen Germany Phone +49 7071 755-0 Fax +49 7071 755-179 info@erbe-med.com www.erbe-med.com 85800-123 12.10 ERBE Elektromedizin GmbH 2010