title: One-year human experience with a novel endoluminal, endoscopic gastric bypass sleeve for morbid obesity.
abstract: BACKGROUND
  Here, we report the first series of patients with 1-year implantation of a novel, endoluminal, endoscopically delivered and retrieved gastro-duodeno-jejunal bypass sleeve (GJBS) (ValenTx, Inc. Carpinteria, CA, USA). In this report, we present the safety, feasibility of the device, weight loss, and changes in comorbidities.
  
  
  METHODS
  A prospective, single-center, 12-month trial was designed. The patients are morbidly obese individuals who meet the NIH criteria for bariatric surgery. The GJBS is a 120-cm sleeve secured at the esophago-gastric junction with endoscopic and laparoscopic techniques that is designed to create an endoluminal gastro-duodeno-jejunal bypass. The device was implanted and, at the completion of the trial, retrieved with an endoscopic technique. The primary endpoints were safety and incidence of adverse events. The secondary outcomes included the percentage of excess weight loss (EWL) and changes in comorbidities, specifically glucose control, use of antihyperglycemics, and changes in hemoglobin A1C levels.
  
  
  RESULTS
  From July 2009 until October 2009, 13 patients were prospectively enrolled for the 1-year trial. The study included five men and eight women with a mean preoperative BMI of 42 kg/m(2). One patient was excluded, at the time of endoscopic evaluation, due to inflammation at the GE junction. Two additional patients required early explantation of the device, within the first 4 weeks, due to patient intolerance. Upon explant of the device, both patients' symptoms improved. In the remaining ten patients, the device was implanted, left in situ for 12 months, and then retrieved endoscopically. Safe delivery of the cuff at the gastro-esophageal junction was seen in all ten patients whom had device implants, without complication. No esophageal leak was seen immediately post-procedure or during follow-up. The sleeve device was well tolerated within the bowel lumen during the 12-month study, specifically, no bowel erosions, ulceration, or pancreatitis was observed. All ten patients reached the 1-year mark. Of the ten, six had fully attached and functional devices throughout the follow-up, verified by endoscopy. The mean percentage EWL, at 1 year, in this group was 54 %. In the remaining four patients, partial cuff detachment was observed at follow-up endoscopy. The percentage EWL was lower in this group. Of the six patients that reached a year with a fully attached device, five were followed at an average of 14-months post-explant (26 months from the time of device implant). These five maintained an average percentage EWL of 30 % at the 14-month post-explant follow-up. Co-morbidites measured included diabetes mellitus, hypertension, hyperlipidemia, and use of antihyperglycemics. Each of the measured comorbidities showed improvement during the 12-month trial.
  
  
  CONCLUSIONS
  The endoluminal, GJBS can be safely placed and retrieved. The short-term data show it is well tolerated with a good safety profile. It achieves excellent weight loss results with over 70 % of all comorbidities resolved or significantly improved.
authors: Division of Minimally Invasive Surgery, Department of Surgery, UC San Diego, San Diego, CA, USA. bsandler@ucsd.edu.
authors: Bryan J
authors: BJ
authors: Sandler
authors: Hospital de Tec de Monterrey, Monterrey, Mexico.
authors: Roberto
authors: R
authors: Rumbaut
authors: Imperial College of London, London, UK.
authors: C Paul
authors: CP
authors: Swain
authors: Hospital de Tec de Monterrey, Monterrey, Mexico.
authors: Gustavo
authors: G
authors: Torres
authors: Hospital de Tec de Monterrey, Monterrey, Mexico.
authors: Luis
authors: L
authors: Morales
authors: Hospital de Tec de Monterrey, Monterrey, Mexico.
authors: Lizcelly
authors: L
authors: Gonzales
authors: Division of Minimally Invasive Surgery, Department of Surgery, UC San Diego, San Diego, CA, USA.
authors: Sarah
authors: S
authors: Schultz
authors: Department of Surgery, Stony Brook Medicine, Stony Brook, NY, USA.
authors: Mark A
authors: MA
authors: Talamini
authors: Division of Minimally Invasive Surgery, Department of Surgery, UC San Diego, San Diego, CA, USA.
authors: Garth R
authors: GR
authors: Jacobsen
authors: Division of Minimally Invasive Surgery, Department of Surgery, UC San Diego, San Diego, CA, USA.
authors: Santiago
authors: S
authors: Horgan
mesh_terms: D000328:Adult; D000368:Aged; D020878:Device Removal; D016099:Endoscopy, Gastrointestinal / Q000295:instrumentation* / Q000379:methods; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D015390:Gastric Bypass / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000601:surgery*; D011183:Postoperative Complications; D011446:Prospective Studies; D019736:Prostheses and Implants; D016896:Treatment Outcome; D015431:Weight Loss
keywords: Bariatric; Clinical papers/trials/research; Endocrinology; G-I < endoscopy; Surgical < technical
references: Surg Endosc. 2011 Sep;25(9):3028-33
references: 21487876
references: Surg Obes Relat Dis. 2010 May-Jun;6(3):290-5
references: 20510293
references: Surg Clin North Am. 2005 Aug;85(4):853-68, vii
references: 16061090
references: Curr Opin Pediatr. 2011 Oct;23(5):552-6
references: 21804384
references: Cochrane Database Syst Rev. 2004;(3):CD004094
references: 15266516
references: Minim Invasive Ther Allied Technol. 2009;18(5):273-9
references: 19707933
references: Surg Obes Relat Dis. 2010 Nov-Dec;6(6):689-94
references: 20947451
references: Gastrointest Endosc Clin N Am. 2011 Apr;21(2):315-33
references: 21569983
references: Lancet. 2011 Aug 27;378(9793):815-25
references: 21872750
references: Curr Opin Endocrinol Diabetes Obes. 2009 Oct;16(5):353-8
references: 19625958
references: Surg Endosc. 2008 Mar;22(3):772-6
references: 18270770