Initial human experience with restrictive duodenal-jejunal bypass liner for treatment of morbid obesity.
BACKGROUND
The duodenal-jejunal bypass liner is an endoscopically placed and removable intestinal liner that creates a duodenal-jejunal bypass, leading to diabetes improvement and weight loss. The aim of the present study was to evaluate the clinical effects and safety of the duodenal-jejunal bypass liner combined with a restrictor orifice (flow restrictor).


METHODS
The device was endoscopically implanted in 10 patients (body mass index 40.8 +/- 4.0 kg/m(2)) and removed after 12 weeks. Dilation of the restrictor orifice was performed as clinically indicated with a 6-, 8-, or 10-mm diameter through-the-scope balloon. The measured outcomes included the percentage of excess weight loss, total weight loss, adverse events, and gastric emptying (GE) at baseline, weeks 4 and 12 of implantation, and 3-5 months after device removal. GE was measured by scintigraphy at 1, 2, and 4 hours after implantation.


RESULTS
The percentage of excess weight loss and total weight loss at explantation was 40% +/- 3% (range 21-64%) and 16.7 +/- 1.4 kg (range 12.0-26.0), respectively. The 4-hour GE was 98% +/- 1% at baseline, 72% +/- 6% at 4 weeks (P = 0.001 versus baseline), and 84% +/- 5% at 12 weeks (P <.05 versus baseline). After explantation, the rate of GE returned to normal in 7 of 8 subjects, but remained slightly delayed in 1 subject (84% at 4 hours). Episodes of nausea, vomiting, and abdominal pain required endoscopic dilation of the restrictor orifice with a 6-mm through-the-scope balloon in 7 patients and a 10-mm balloon in 1, with no clinically significant adverse events.


CONCLUSIONS
Endoscopic implantation of a combination flow restrictor and duodenal-jejunal bypass liner induced substantial weight loss. The implanted patients exhibited delayed GE that was reversed after device removal.
Escalona
Alex
A
Department of Digestive Surgery, Pontificia Universidad Católica de Chile Faculty of Medicine, Santiago, Chile.
Yáñez
Ricardo
R
Pimentel
Fernando
F
Galvao
Manoel
M
Ramos
Almino Cardoso
AC
Turiel
Dannae
D
Boza
Camilo
C
Awruch
Diego
D
Gersin
Keith
K
Ibáñez
Luis
L
D000293:Adolescent; D000328:Adult; D050110:Bariatric Surgery / Q000379:methods*; D004386:Duodenum / Q000601:surgery; D016099:Endoscopy, Gastrointestinal; D006801:Humans; D007583:Jejunum / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000601:surgery*; D010865:Pilot Projects; D019919:Prosthesis Implantation / Q000379:methods*; D055815:Young Adult