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Gastrointest Endosc. 2010 May;71(6):976-82. doi: 10.1016/j.gie.2009.11.051. Epub 2010 Mar 20.

Open-label, sham-controlled trial of an endoscopic duodenojejunal bypass liner for preoperative weight loss in bariatric surgery candidates.

Author information

1
Carolinas Medical Center, Charlotte, North Carolina 28203, USA.

Abstract

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.).

PMID:
20304396
DOI:
10.1016/j.gie.2009.11.051
[Indexed for MEDLINE]

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