title: First human experience with endoscopically delivered and retrieved duodenal-jejunal bypass sleeve.
abstract: BACKGROUND
  We report the first human experience with an endoscopic duodenal-jejunal bypass sleeve (DJBS) in a community hospital.
  
  
  METHODS
  The DJBS is a 60-cm sleeve anchored in the duodenum to create a duodenal-jejunal bypass. In a 12-patient prospective, open-label, single-center, 12-week study, the device was endoscopically implanted, left in situ, and retrieved. The study included 5 men and 7 women, with a mean body mass index of 43 kg/m(2). Of the 12 patients, 4 had type 2 diabetes. The primary endpoints were the incidence and severity of adverse events. The secondary outcomes included the percentage of excess weight loss and changes in co-morbid status.
  
  
  RESULTS
  The DJBS was endoscopically delivered and retrieved in all patients (mean implant/explant time of 26.6 and 43.3 min, respectively). Of the 12 patients, 10 were able to maintain the device for 12 weeks and 2 underwent explantation after 9 days secondary to poor device placement. Several self-limited adverse events were possibly or definitely related to the device, including 6 episodes of abdominal pain, 18 of nausea, and 16 of vomiting, mainly within 2 weeks of implantation. Two partial pharyngeal tears occurred during explantation. Implant site inflammation was encountered in all patients. No device-related event was considered severe. The average percentage of excess weight loss for the 10 patients with the device in place for 12 weeks was 23.6%, with all patients achieving at least 10% excess weight loss. All 4 diabetic patients had normal fasting plasma glucose levels without hypoglycemic medication for the entire 12 weeks. Of these 4 patients, 3 had decreased hemoglobin A(1c) of > or =.5% by week 12.
  
  
  CONCLUSIONS
  The DJBS can be safely delivered and removed endoscopically and left in situ for 12 weeks. The device had a favorable safety and encouraging efficacy profile. Randomized prospective trials are warranted.
authors.affiliation: Centro de Cirugía de la Obesidad, Hospital DIPRECA, Las Condes, Santiago de Chile.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Rodriguez-Grunert
authors.forename: Manoel Passos
authors.initials: MP
authors.lastname: Galvao Neto
authors.forename: Munir
authors.initials: M
authors.lastname: Alamo
authors.forename: Almino Cardoso
authors.initials: AC
authors.lastname: Ramos
authors.forename: Percy Brante
authors.initials: PB
authors.lastname: Baez
authors.forename: Michael
authors.initials: M
authors.lastname: Tarnoff
mesh_terms: D000328:Adult; D050110:Bariatric Surgery / Q000295:instrumentation*; D015992:Body Mass Index; D015331:Cohort Studies; D020878:Device Removal; D004386:Duodenum; D004724:Endoscopy; D005260:Female; D006801:Humans; D007583:Jejunum; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000601:surgery*; D011474:Prosthesis Design; D019919:Prosthesis Implantation; D016896:Treatment Outcome