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Background <p>Minimally invasive surgery may be further advanced with the novel biofragmentable magnetic anastomosis compression system. Two magnets may be swallowed, or placed by flexible endoscopy, in a side-to-side magnetic jejuno-ileostomy (MagJI) bipartition for weight and type 2 diabetes (T2D) reduction. MagJI markedly reduces the major complications of enterotomy, stapling/suturing, and retained foreign materials.</p> Methods <p>This was a prospective first-in-human investigation of feasibility, safety, and preliminary efficacy in adults with body mass index (BMI, kg/m<sup>2</sup>) ≥ 30.0– ≤ 40.0. After serial introduction via swallowing or endoscopy, linear magnets were laparoscopically guided to the distal ileum and proximal jejunum where they were aligned. Magnets fused over 7–21 days forming jejuno-ileostomy. Primary endpoints: feasibility and severe adverse event (SAEs) incidence (Clavien-Dindo grade); secondary endpoints: weight, T2D reduction.</p> Results <p>Between 3–1 - 2024 and 6–30 - 2024, nine patients (mean BMI 37.3 ± 1.1) with T2D (all on T2D medications; mean HbA1<sub>C</sub> 7.1 ± 0.2%, glucose 144.8 ± 14.3 mg/dL) underwent MagJI. Mean procedure time: both magnets swallowed, 86.7 ± 6.3 min; one magnet swallowed with second delivered endoscopically, 113.3 ± 17.0 min. Ninety-day feasibility confirmed in 100.0%: 0.0% bleeding, leakage, infection, mortality. Most AEs grade I–II; no SAEs. At 6-month radiologic confirmation, all anastomoses were patent. Excess weight loss 17.5 ± 2.8 kg; mean BMI reduction 2.2 ± 0.3, HbA1<sub>C</sub> 6.1 ± 0.1% (<i>p</i> &lt; 0.01), glucose 115.5 ± 6.5 mg/dL (<i>p</i> = 0.19); 83.0% dropped below 6.5% HbA1<sub>C</sub> and had markedly reduced anti-T2D medications.</p> Conclusions <p>The swallowable, biofragmentable magnetic anastomosis system appeared to be feasible and safe in achieving incisionless, sutureless jejuno-ileostomy. The first-in-human MagJI procedure may offer minimally complicated anastomosis creation and moderate MBS weight loss and T2D reduction.</p>

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First-in-Human Linear Magnetic Jejuno-Ileal Bipartition: Preliminary Results with Incisionless, Sutureless, Swallowable Technique

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月7日

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  • Michel Gagner,
  • Martin Fried,
  • David Michalsky,
  • Karen Dolezalova,
  • Petra Sramkova,
  • Jan Brezina,
  • Dasa Baliarova,
  • Lucie Hlavata,
  • Michal Novak,
  • Jaroslav Bartos,
  • Sarka Mullerova

摘要

Background

Minimally invasive surgery may be further advanced with the novel biofragmentable magnetic anastomosis compression system. Two magnets may be swallowed, or placed by flexible endoscopy, in a side-to-side magnetic jejuno-ileostomy (MagJI) bipartition for weight and type 2 diabetes (T2D) reduction. MagJI markedly reduces the major complications of enterotomy, stapling/suturing, and retained foreign materials.

Methods

This was a prospective first-in-human investigation of feasibility, safety, and preliminary efficacy in adults with body mass index (BMI, kg/m2) ≥ 30.0– ≤ 40.0. After serial introduction via swallowing or endoscopy, linear magnets were laparoscopically guided to the distal ileum and proximal jejunum where they were aligned. Magnets fused over 7–21 days forming jejuno-ileostomy. Primary endpoints: feasibility and severe adverse event (SAEs) incidence (Clavien-Dindo grade); secondary endpoints: weight, T2D reduction.

Results

Between 3–1 - 2024 and 6–30 - 2024, nine patients (mean BMI 37.3 ± 1.1) with T2D (all on T2D medications; mean HbA1C 7.1 ± 0.2%, glucose 144.8 ± 14.3 mg/dL) underwent MagJI. Mean procedure time: both magnets swallowed, 86.7 ± 6.3 min; one magnet swallowed with second delivered endoscopically, 113.3 ± 17.0 min. Ninety-day feasibility confirmed in 100.0%: 0.0% bleeding, leakage, infection, mortality. Most AEs grade I–II; no SAEs. At 6-month radiologic confirmation, all anastomoses were patent. Excess weight loss 17.5 ± 2.8 kg; mean BMI reduction 2.2 ± 0.3, HbA1C 6.1 ± 0.1% (p < 0.01), glucose 115.5 ± 6.5 mg/dL (p = 0.19); 83.0% dropped below 6.5% HbA1C and had markedly reduced anti-T2D medications.

Conclusions

The swallowable, biofragmentable magnetic anastomosis system appeared to be feasible and safe in achieving incisionless, sutureless jejuno-ileostomy. The first-in-human MagJI procedure may offer minimally complicated anastomosis creation and moderate MBS weight loss and T2D reduction.