Endoscopic therapy for obesity and complications of bariatric surgery Jacques Devière, MD, PhD Erasme University Hospital Brussels Belgium jacques.deviere@erasme.ulb.ac.be
Obesity Affects 300 millions people worldwide (WHO) Is linked to 500000 deaths/year in western countries 100 billions dollars direct healthcare expenditures/year in USA (where 22 millions adults are MORBIDLY obese) Incidence (and indications for treatment) increased by 800% over the last 15 years Lancet 2005;366:1197, NEJM 2007;356:21
Complications of bariatric surgery Cardiopulmonary insufficiency. Anastomotic fistula. Wound infections. Digestive occlusions. Bleeding. Incisional hernias. Migration of implanted material. Having an effective procedure which does not require transabdominal access would be appealing
Balloon implantation
Bioenterics BIB 10 series, 900 patients, mainly retrospective, rare controlled series Major indications Before surgery for superobese Non morbid obesity (BMI < 40) 6 months treatment Results : Median Excess Weight Loss around 30%, Median BMI loss 5 kg/m2
Transoral vertical gastroplasty in 64 patients Fogel et al, GIE 2008 ; 68 : 51-59 Endocinch suture.
Transoral vertical gastroplasty in 64 patients Fogel et al, GIE 2008 ; 68 : 51-59 % EWL 12 months = 58% Too beautiful to be true? Bessler, GIE 2008 ; 68 : 59-60
Transoral gastroplasty (TOGa) Deviere et al Surg Endosc 2008, Moreno et al Endoscopy 2008 Video Forum Nishi GK et al, 1016
Main results of the first human pilot trial Average BMI decreased from 43.3 pretreatment to 38.6 at 6 months (p<0.0001) Absolute mean weight loss was 8 kgs, 11.1 kgs and 13 kgs at 1, 3 and 6 months, respectively Mean excess weight loss was 16%, 22% and 24.4% at 1, 3 and 6 months, respectively Mid stomas were observed between the 2 staple lines in 9/21 patients Deviere et al, Surg Endosc 2008; 22: 589
Adjustable septum TOGA Pilot Trial Phase II 1 and 2 sleeves
TOGA Pilot Trial Phase II : Weight Loss TOGA N Engl J Med 2007;357:741-52
TOGa, Balloon and 3 Surgical techniques in a single bariatric center : Absolute Weight loss Poids (Kg) 60 55 50 45 40 35 30 25 20 15 10 5 0 1 mois 3 mois 6 mois 9 mois 12 mois 18 mois 24 mois Banding Bypass SRVG BIG TOGa1 TOGa2
Prospective randomized study 11 centers, 10 US, 1 Europe Sham-controlled, 2:1 303 patients, inclusion completed 1 perforation due to wire looping
RYGBP after TOGa 4 patients, after 1 year follow up Stapling visible in 3/4 Mean operative time 112 minutes vs 110 min for the last 10 primary RYGBP and 142 min for the last 10 RYGBP after restrictive surgery by the same operator Closset et al, Obes Surg, ip
Implantable Devices EndoBarrier (GIDynamics) Pilot clinical results: weight loss and improvement of diabetes Others: Barosense, ValenTx
Endoscopic treatment of GI complications after bariatric surgery Dilatation of anastomotic/ post gastroplasty stenoses Removal of partially migrated Rings and Lapbands Treatment of leakages/ fistulae
Strictures Etiology: Ischemia, Ulceration (RYGBP), Band related (LapBand, Gastroplasty) Treatment: Dilatation, starting 12-15 mm.. in RYGBP.. Band Removal... Surgical Revision
Various cases.. Ring or band dysfunction type I. Slipping II. Stenosis with pouch dilation IIIa. Minor Erosion IIIb. Major Erosion or intragastric migration Symptoms Weight gain, reflux or obstruction Nausea, vomiting, weight loss Weight gain, abdominal pain (port-site infection) Weight gain, abdominal pain Diagnosis Contrast RX Contrast RX/ Endoscopy UGI Endoscopy UGI Endoscopy
Technique, success and complications Case n Dysfunction type SEPS placement Band or ring cutting Endoscopic success 1 II + + Yes No 2 II + - Yes No 3 II + - Yes No 4 II + - Yes No 5 IIIa + + Yes No 6 IIIa + + Yes No 7 IIIa + - Yes No 8 II + - Yes No 9 IIIb - + Yes No 10 IIIa + + Yes No 11 IIIb - + No Failure 12 II - + Yes No 13 II + - Yes No Complication Blero et al, GIE, submitted
Leakages/fistulae: Surgical principles 1. Control of leakage 2. Clearance of mediastinal or peritoneal contamination/collections by lavage & drainage 3. Antibiotics 4. Nutritional support TO BE FOLLOWED WHEN ENDOSCOPIC TREATMENT IS FORESEEN!
Clips/Sutures do not work Early diagnosis (hours) Delayed diagnosis (days) Chronic situation (weeks) Leak/Fistula + + + Abcess / Collection Primary repair - + +/- + - -
GIE 1996;44:477
Treatment of post operative fistulae after bariatric surgery : 21 pts Type of fistula Gastro-Cutaneous/Per 18 Duodeno-Cutaneous 2 Gastro-Bronchial 1 Revision laparoscopies None 5 One 11 Two 5 Median delay between laparoscopic bariatric surgery and endotherapy (days) 30 (21-199) Endoscopy 2007; 39:625
Sequencial Endotherapy 1. SEMS (Ultraflex) in order to cover the fistula ( 2-3 months)
Sequencial Endotherapy SEPS (Polyflex) to remove both stents (pressure induced necrosis, 10-15 days)
PROXIMAL DISTAL HYPERPLASIA AFTER ULTRAFLEX 2 months by after radial placement forces RETRIEVAL PLASTIC AFTER STENT POLYFLEX TO INDUCE RETRIEVAL NECROSIS (15 days OF HYPERPLASIA in place) Major Major disappearence disappearence of of proximal distal hyperplasia Proximal part hyperplasia
Success (Complete fistula healing after stent removal with > 2mo f-up) Primary (1 stenting period: 13/21pts) Complementary stenting plus sealant (4/8 residual pts) Success with endoscopic treatment: 17/21 pts (81 %) Endoscopy 2007; 39:625
For refractory fistulae Fistula Plug Surgisis Submucosal intestinal preparation (pig) Allows fibroblastic migration and enhance healing of anal fistulae
Fistula Plug implantation
Results of Fistula Plug use in chronic fistulae 10 patients with cutaneous fistulae refractory to previous surgical/endoscopic treatments 1 to 3 Plugs inserted according to fistula diameter Covered by a stent 60 % of patients healed with a median follow-up of 7 months Toussaint et al, Endoscopy, 2009
Collections / Abcesses after gastric bypass Voermans, GIE 2007; 66: 1013
Conclusions Endoscopic techniques may offer alternative approaches to obesity (Morbid, grade 1?, bridge to RYGBP) Endoscopy plays a growing role in managing complications of bariatric surgery A multidisciplinary approach and case volume are the cornerstone of an optimal management of these patients