Obesity surgery · 2025
First-in-Human Linear Magnetic Jejuno-Ileal Bipartition: Preliminary Results with Incisionless, Sutureless, Swallowable Technique.
СтатьяНазвание и аннотация: Перевод в очереди
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Gagner Michel, Fried Martin, Michalsky David, Dolezalova Karen, Sramkova Petra, Brezina Jan, Baliarova Dasa, Hlavata Lucie, Novak Michal, Bartos Jaroslav, Mullerova Sarka
Аннотация
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.
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.