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Feasibility of Conversion of a New Bariatric Fully Endoscopic Bypass Procedure to Bariatric Surgery: a Porcine Pilot Study

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Abstract

Purpose

Bariatric endoscopic procedures are emerging as alternatives to bariatric surgical procedures. This study aimed to assess if a natural orifice transluminal endoscopic surgery (NOTES) bariatric procedure could be converted to a surgical duodenal-jejunal bypass (DJB) or sleeve gastrectomy (SG).

Materials and Methods

This 12-week prospective study compared 4 test pigs to 3 control (no procedures) pigs aged 3 months at baseline. The test pigs received a fully endoscopic NOTES-based bypass including measurement of the bypassed limb and creation of a gastrojejunal anastomosis (GJA) using gastrojejunal lumen-apposing metal stents (GJ-LAMS) at Week 0, placement of a duodenal exclusion device (DED) at Week 2, and randomization to DJB or SG surgery at Week 8 with subsequent 4-week follow-up. At Week 12, the pigs were sacrificed and necropsy was performed.

Results

Endoscopic procedures were technically successful. One pig did not receive a DED due to early GJ-LAMS migration leading to premature closure of the GJA. At Week 8, all 4 pigs were doing well, and the remaining 3 GJ-LAMS and 3 DEDs were uneventfully endoscopically removed. Two one-anastomosis DJB were performed, and 2 SG were performed, closing in one case the site of the previous GJA. The surgical procedures were technically feasible and uneventful during follow-up. Necropsy assessments showed no local or peritoneal inflammation or abscess and no leakage or fistula.

Conclusion

An endoscopic bariatric bypass can be transitioned to a one-anastomosis duodenal-jejunal bypass or sleeve gastrectomy, without complications.

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Data Availability

The data, analytic methods, and study materials for this study may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).

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Acknowledgements

The authors acknowledge the contributions of Joe Gorman, BFA (professional medical illustrator), and Boston Scientific Corporation employees Edmund McMullen, MMath (statistical analysis), and Margaret Gourlay, MD, MPH (writing assistance).

Funding

Funding was provided by the Boston Scientific Corporation.

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Authors and Affiliations

  1. Department of Hepatogastroenterology, Hôpital Nord, Assistance Publique-Hôpitaux de Marseille, Aix-Marseille University, Marseille, France

    Jean-Michel Gonzalez, Sohaib Ouazzani & Marc Barthet

  2. Faculty of Medicine, Aix-Marseille University, Chemin des Bourrely, Cedex 20, 13915, Marseille, France

    Jean-Michel Gonzalez, Pauline Duconseil, Stephane Berdah & Marc Barthet

  3. Centre for Surgical Teaching and Research (CERC), Aix-Marseille University, Marseille, France

    Jean-Michel Gonzalez, Pauline Duconseil, Stephane Berdah & Marc Barthet

  4. Department of Digestive Surgery, Hôpital Nord, Assistance Publique-Hôpitaux de Marseille, Aix-Marseille University, Marseille, France

    Pauline Duconseil & Stephane Berdah

  5. Brussels Medical Device Center (BMDC), Brussels, Belgium

    Nicolas Cauche & Cecilia Delattre

  6. Endoscopy Division, Boston Scientific Corporation, Marlborough, MA, USA

    Joyce A. Peetermans, Ornela Gjata & Agostina Santoro-Schulte

Authors
  1. Jean-Michel Gonzalez
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  2. Pauline Duconseil
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  10. Marc Barthet
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Corresponding author

Correspondence to Jean-Michel Gonzalez.

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Ethics Approval

All applicable institutional and/or national guidelines for the care and use of animals were followed.

Consent to Participate

Informed Consent does not apply.

Conflict of Interest

The authors disclose the following: Jean-Michel Gonzalez and Marc Barthet report funding from Boston Scientific Corporation for research. Nicolas Cauche and Cecilia Delattre are full-time employees of the Brussels Medical Device Center, which received a cooperative engineering grant from Boston Scientific Corporation. Joyce A. Peetermans, Ornela Gjata, and Agostina Santoro-Schulte are full-time employees of Boston Scientific Corporation. Pauline Duconseil, Sohaib Ouazzani, and Stephane Berdah have no conflict of interest.

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Key Points

Few eligible patients undergo bariatric surgery.Endoscopic alternatives with potential for conversion to bariatric surgery are needed.

In the current study, a natural orifice transluminal endoscopic surgery (NOTES)-based endoscopic bypass procedure was successfully converted to a one-anastomosis duodenal-jejunal bypass or sleeve gastrectomy in a growing porcine model.

A NOTES bypass procedure appears as a complementary technique to bariatric surgery allowing adaptive management from incisionless to more invasive surgical procedures.

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Gonzalez, JM., Duconseil, P., Ouazzani, S. et al. Feasibility of Conversion of a New Bariatric Fully Endoscopic Bypass Procedure to Bariatric Surgery: a Porcine Pilot Study. OBES SURG 32, 2280–2288 (2022). https://doi.org/10.1007/s11695-022-06065-1

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  • DOI: https://doi.org/10.1007/s11695-022-06065-1

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