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Safety and Effectiveness of an Endoscopically Placed Duodenal-Jejunal Bypass Device (EndoBarrier®): Outcomes in 114 Patients

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Abstract

Background

The duodenal-jejunal bypass liner (DJBL) is an endoscopically placed device designed to achieve weight loss and improve glycemic control in obese patients. Previous studies report promising results but typically included small patient numbers and short follow-up. This study aims to determine the safety and effectiveness of the device.

Methods

Study design:

A series of all patients treated by the DJBL at our institutions.

Outcome measurements:

Weight loss, biochemical measures, complications.

Results

Between July 2012 and March 2015, 114 consecutive patients were treated for a mean 51.1 weeks (standard deviation (SD) 19.9 weeks). Mean total body weight change from baseline was 12.0 kg (SD 8.5 kg, p < 0.001). Mean percent total body weight loss (%TWL) was 10.5% (SD 7.3%). Mean HbA1c was not significantly improved, but of 10 patients on insulin, 4 ceased insulin and 4 reduced insulin dosages. There was a significant decrease in hemoglobin and total cholesterol and a significant increase in serum alkaline phosphatase. Seventy-four percent of patients experienced at least one adverse event, some of them serious including 6 device obstructions, 5 gastrointestinal hemorrhages, 2 liver abscesses, and 1 acute pancreatitis. Seventy-four percent of patients experienced weight gain after removal with a mean 4.5 ± 6.1 kg (p < 0.0001) within the first 6 months after explantation.

Conclusions

The DJBL provides significant but highly variable weight loss. Glycemic control was variable. Most insulin-requiring T2DM patients ceased or reduced insulin. Most patients experience an adverse event and most regain significant weight after device removal. Major adverse events can occur, including the potentially life-threatening complications of hepatic abscess and gastrointestinal hemorrhage.

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Author information

Authors and Affiliations

  1. St. Vincent’s Centre for Applied Medical Research, Sydney, Australia

    Patrice M. Forner & John E. Farey

  2. St. Vincent’s Centre for Applied Medical Research and University of New South Wales, Suite 606, 438 Victoria Street, Darlinghurst, Sydney, NSW, 2010, Australia

    Timothy Ramacciotti & Reginald V. Lord

  3. Department of Surgery, School of Medicine, University of Notre Dame, Sydney, Australia

    Timothy Ramacciotti & Reginald V. Lord

Authors
  1. Patrice M. Forner
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  2. Timothy Ramacciotti
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  3. John E. Farey
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  4. Reginald V. Lord
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Contributions

Patrice M. Forner—study concept and design, acquisition of data, analysis and interpretation of data, drafting of manuscript, statistical analysis.

Timothy Ramacciotti—clinical care, study concept and design, acquisition of data, study supervision

John E. Farey—acquisition of data, manuscript revision.

Reginald V. Lord—device implantation and removal, clinical care, study concept and design, critical revision of manuscript, study supervision.

Corresponding author

Correspondence to Reginald V. Lord.

Ethics declarations

Informed consent was obtained from all individual participants included in the study.

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institution and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Conflict of Interest

The authors declare that they have no conflict of interest.

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Forner, P.M., Ramacciotti, T., Farey, J.E. et al. Safety and Effectiveness of an Endoscopically Placed Duodenal-Jejunal Bypass Device (EndoBarrier®): Outcomes in 114 Patients. OBES SURG 27, 3306–3313 (2017). https://doi.org/10.1007/s11695-017-2939-4

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  • DOI: https://doi.org/10.1007/s11695-017-2939-4

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