Endoluminal Bariatric Revision. Todd David Wilson, MD

Transcription

1 Endoluminal Bariatric Revision Todd David Wilson, MD

2 Surgical Endoscopy and the Bariatric Surgeon Preoperative Endoscopy Postoperative Endoscopy Revisional Endoscopy Primary Endoluminal Bariatrics

3 Preoperative Evaluation 60-80% abnormal 12-30% H. pylori 5-10% Barrett s Hiatal Hernia Polyps, Masses 6-8% changed plan For revisions it is a must

4 Revisional Endoscopy Manage complications Fix the patients tool

5 Self Expanding Stents Leaks Fistulas Strictures Erosions

6 Alveolus Alimaxx-E Temporary placement 2-4 weeks

7 Stent Induced Erosion of Fixed Gastric Band

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17 Stent Induced Erosion of Fixed Gastric Band Can use with any fixed band Evaluate the stomach with endoscopy Pass a guidewire Position stent over the obstruction Deploy with fluoroscopy Discharge home on liquids Remove in a few weeks Treat with PPI

18 Stent Induced Erosion of Fixed Gastric Band We have done over 20 cases Complications include pain, stent intolerance, and stenosis (5%)

19 Principles of Revisional Bariatric Surgery Inadequate weight loss (<25%?) is inevitable in some bariatric surgery patients. What truly is a failure? We cannot cure every patient (or any patient) The enemy of good is perfect--big Picture Cause of inadequate weight loss is multifactorial: Genetics Nutritional Education Exercise Education Psychology Anatomy of primary procedure

20 Pouch and Stoma Dilation Stoma Injection Stoma Plication Pouch Plication

21 Goals Reduce size of gastric pouch Possible to reduce size of stoma Reduce compliance in the gastric pouch

22 Endoluminal Injection of Anastomosis with Sclerosant 28 patients underwent injections with sodium morrhuate around their anastomosis over a 3 year period 8-20 cc (14.5 cc) injected to achieve a diameter of 1.2 cm or less (2.3 average injection sessions) Goal was to achieve weight loss of >75 % of the weight the patient gained after nadir weight Catalano MF, Rudic R, Anderson AJ, Chua TY. Weight gain after bariatric surgery as a result of a large gastric stoma: endotherapy with sodium morrhuate may prevent the need for surgical revision. Gastrointes Endosco. Vol 66, No. 2, ( )

23 Endoluminal Injection of Anastomosis with Sclerosant 18/28 (64%) achieved success Ğ 1 patient developed stenosis requiring balloon dilatation x 2. Mean follow up 18 months Mean weight loss 22.3 (+ 9.2 kg) Catalano MF, Rudic R, Anderson AJ, Chua TY. Weight gain after bariatric surgery as a result of a large gastric stoma: endotherapy with sodium morrhuate may prevent the need for surgical revision. Gastrointes Endosco. Vol 66, No. 2, ( )

24 Endoluminal Injection of Anastomosis with Sclerosant Pre injection Post Injection

25 Stomaphyx Cleared in the United States for tissue approximation in the GI tract 230 patients treated since April 07

26 Bariatric revision Gastric pouch reduction Stoma reduction GERD Hypoglycemia dumping syndrome including diarrhea Closure of perforation or fistula Closure of trans-gastric opening (NOTES) Closure of colorectal fistula

27 H Over the Wire Delivery H H Duckbill Suction Port H H H Braided Scope Tube

28 A full thickness fold of tissue is pulled into the chamber Stylet crosses the tissue at the base of the fold Fastener rides over the stylet and provides tension-free serosa to serosa contact Completed plications

29 Stomaphyx Pre Post

30 Stomaphyx Results BMI drop of 3.5 at 1 year

31 Latest Stomaphyx Results Number Time EBWL 39 2 weeks 7.4% 34 1 month 10.6% 26 2 months 13.1% 15 3 months 13.1% 14 6 months 17.0% 6 12 months 19.5%

32 Latest ROSE Results 116 patients studied 112 had successful ROSE procedure Average pouch length reduction 44% Average stoma diameter reduction 50%

33 Rose Procedure USGI Weight Loss BMI drop of 4 at 6 months

34 Summary Advanced flexible endoscopy is becoming a larger part of management of bariatric patients Managing complications endoscopically is safe and effective Endoscopic approaches to bariatric revision surgery is reasonable

35 Thank You

36 Endoluminal Bariatric Surgery Intragastric Balloon Endoluminal Restriction-TOGA Endoluminal Restriction and Malabsorption-ValenTx

37 BioEnterics Intragastric Balloon (BIB):

38 BioEnterics Intragastric Balloon (BIB): A short-term, double-blinded, randomized, controlled, crossover study on weight reduction in morbidly obese patients. Jan-Dec 2003: 32 pts in study Mean BMI 43.5 No complications related to balloon Mean time to place the balloon: 15 min BIB was filled with 500 cc of Saline and 10 cc Methylene Blue 1000 cal diets Genco et, Int J Obes Jan;30(1):129-33

39 BioEnterics Intragastric Balloon (BIB): a short-term, double-blind, randomized, controlled, crossover study on weight reduction in morbidly obese patients. Group A: BIB followed by removal after 3 months Group B: Sham followed by BIB after 3 months Group A: Significant decrease of BMI: 43.5 to 38.0 Ğ Decrease % EBWL: 34 Group B: No significant decrease of BMI: 43.6 to 43.2 Ğ Decrease % EBWL: 2.1 After cross over at 3 months Ğ Group A: BMI decreased from 38.0 to 37.1 Ğ Group B: BMI decreased from 43.2 to 38.8 Genco et, Int J Obes Jan;30(1):129-33

40 Is Weight loss surgery needed after BIB? Jan 2000 Ğ March 2004, 175 pts had BIB Mean age 37, BMI 54.4 All patients initially schedule for surgery After BIB removal ĞGroup A: 86 pts under Lap Band, L RYGPB, DS ĞGroup B: 82 pts decline surgery Angrisani et al. Is bariatric surgery necessary after intragastric balloon treatment? Obes Surg 2006; Sep;16(9):

41 Is Weight loss surgery needed after BIB? Group n BMI at start BMI after 6 months %EBWL after 6 months with BIB BMI 18 months later BIB and Surgery BIB-No Surgery Conclusion: Weight loss surgery IS HIGHLY RECOMMENDED

42 Objectives of the TOGA Procedure Transoral procedure that creates restrictive anatomy similar to existing restrictive procedures Utilizes existing technology titanium staples Outpatient procedure Eliminates key risks of surgery (leaks, pulmonary and cardiovascular AEs, wound infection, hernias, band migration) Adjustable / revisable

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44 The TOGA Sleeve Stapler and Restrictor Stapler

45 QuickTime and a decompressor are needed to see this picture.

46 TOGA Barium at 3 months

47 TOGA Pilot Clinical Study OUS centers Erasme Hospital, Brussels Policlinico Gemelli, Rome 1 de Octubre, Mexico City 109 patients to date (Ph I = 21, Ph II = 87) Primary endpoints: safety and endoscopic appearance of pouch Secondary endpoints: weight loss, QOL, comorbidity improvement Follow-up: up to 12 months

48 Ph I - % EWL and Excess BMI Loss

49 TOGA Pilot Study Phase II Weight Loss

50 TOGA Pivotal FDA Trial 9 National Centers patient requests 4 high volume centers Cedars Sinai, Columbia, Wash U, UT Houston University of Texas is the only center in the South 6400 patient requests 275 blinded patients with 1 year crossover 1/3 Sham 2/3 TOGAs

51 TOGA=Vertical Banded Gastroplasty?

52 Endolumenal Sleeves Development and testing of an attachable gastric cuff and small intestinal exclusion sleeve as a new flexible endoscopic method for treatment of obesity. Mitchell Dann, Josh Butters, Mary Lynn Wilmore, Dick Thomas, Tom Baldwin, Clay Robinson, Ray Olsen, Paul Swain St MaryÕs Hospital and Imperial College, London, ValenTx, Inc. Wilson, Wyoming USA

53 ValenTx Endoluminal Gastric Bypass 1. Designed to mimic the functions of a Roux en Y gastric bypass with minimal upper pouch and exclusion of stomach and duodenum 2. Delays mixing of nutrients and digestive at 100 cm into the jejunum 3. Desinged for long term placement with a replaceable sleeve for long term therapy.

54 Endoluminal Gastric Bypass

55 ValenTx Endoluminal Gastric Bypass 1. Initial pilot study cases performed by S. Horgan (US), R. Rumbaut(Mex), P. Swain(UK) patients at 3 months-40 % EWL 3. 6 month follow up accruing