TY - JOUR
T1 - Open-label, sham-controlled trial of an endoscopic duodenojejunal bypass liner for preoperative weight loss in bariatric surgery candidates
AU - Gersin, Keith S.
AU - Rothstein, Richard I.
AU - Rosenthal, Raul J.
AU - Stefanidis, Dimitrios
AU - Deal, Stephen E.
AU - Kuwada, Timothy S.
AU - Laycock, William
AU - Adrales, Gina
AU - Vassiliou, Melina
AU - Szomstein, Samuel
AU - Heller, Stephen
AU - Joyce, Anne Marie
AU - Heiss, Frederick
AU - Nepomnayshy, Dmitry
N1 - Funding Information:
DISCLOSURE: The following author disclosed financial relationships relevant to this publication: K.S. Gersin: Consultant to and shareholder in GI Dynamics. All other authors disclosed no financial relationships relevant to this publication. This work was supported by funding from GI Dynamics, Inc.
PY - 2010/5
Y1 - 2010/5
N2 - Background: The duodenojejunal bypass liner (DJBL) (EndoBarrier Gastrointestinal Liner) is an endoscopically placed and removable intestinal liner that creates a duodenojejunal bypass resulting in weight loss and improvement in type 2 diabetes mellitus. Objective: Weight loss before bariatric surgery to decrease perioperative complications. Design: Prospective, randomized, sham-controlled trial. Setting: Multicenter, tertiary care, teaching hospitals. Patients: Twenty-one obese subjects in the DJBL arm and 26 obese subjects in the sham arm composed the intent-to-treat population. Interventions: The subjects in the sham arm underwent an EGD and mock implantation. Both groups received identical nutritional counseling. Main Outcome Measurements: The primary endpoint was the difference in the percentage of excess weight loss (EWL) at week 12 between the 2 groups. Secondary endpoints were the percentage of subjects achieving 10% EWL, total weight change, and device safety. Results: Thirteen DJBL arm subjects and 24 sham arm subjects completed the 12-week study. EWL was 11.9% ± 1.4% and 2.7% ± 2.0% for the DJBL and sham arms, respectively (P < .05). In the DJBL arm, 62% achieved 10% or more EWL compared with 17% of the subjects in the sham arm (P < .05). Total weight change in the DJBL arm was -8.2 ± 1.3 kg compared with -2.1 ± 1.1 kg in the sham arm (P < .05). Eight DJBL subjects terminated early because of GI bleeding (n = 3), abdominal pain (n = 2), nausea and vomiting (n = 2), and an unrelated preexisting illness (n = 1). None had further clinical symptoms after DJBL explantation. Limitations: Study personnel were not blinded. There was a lack of data on caloric intake. Conclusions: The DJBL achieved endoscopic duodenal exclusion and promoted significant weight loss beyond a minimal sham effect in candidates for bariatric surgery. (Clinical trial registration number: NPT00469391.).
AB - Background: The duodenojejunal bypass liner (DJBL) (EndoBarrier Gastrointestinal Liner) is an endoscopically placed and removable intestinal liner that creates a duodenojejunal bypass resulting in weight loss and improvement in type 2 diabetes mellitus. Objective: Weight loss before bariatric surgery to decrease perioperative complications. Design: Prospective, randomized, sham-controlled trial. Setting: Multicenter, tertiary care, teaching hospitals. Patients: Twenty-one obese subjects in the DJBL arm and 26 obese subjects in the sham arm composed the intent-to-treat population. Interventions: The subjects in the sham arm underwent an EGD and mock implantation. Both groups received identical nutritional counseling. Main Outcome Measurements: The primary endpoint was the difference in the percentage of excess weight loss (EWL) at week 12 between the 2 groups. Secondary endpoints were the percentage of subjects achieving 10% EWL, total weight change, and device safety. Results: Thirteen DJBL arm subjects and 24 sham arm subjects completed the 12-week study. EWL was 11.9% ± 1.4% and 2.7% ± 2.0% for the DJBL and sham arms, respectively (P < .05). In the DJBL arm, 62% achieved 10% or more EWL compared with 17% of the subjects in the sham arm (P < .05). Total weight change in the DJBL arm was -8.2 ± 1.3 kg compared with -2.1 ± 1.1 kg in the sham arm (P < .05). Eight DJBL subjects terminated early because of GI bleeding (n = 3), abdominal pain (n = 2), nausea and vomiting (n = 2), and an unrelated preexisting illness (n = 1). None had further clinical symptoms after DJBL explantation. Limitations: Study personnel were not blinded. There was a lack of data on caloric intake. Conclusions: The DJBL achieved endoscopic duodenal exclusion and promoted significant weight loss beyond a minimal sham effect in candidates for bariatric surgery. (Clinical trial registration number: NPT00469391.).
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U2 - 10.1016/j.gie.2009.11.051
DO - 10.1016/j.gie.2009.11.051
M3 - Article
C2 - 20304396
AN - SCOPUS:77951652721
SN - 0016-5107
VL - 71
SP - 976
EP - 982
JO - Gastrointestinal endoscopy
JF - Gastrointestinal endoscopy
IS - 6
ER -