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First-in-Human Linear Magnetic Jejuno-Ileal Bipartition: Preliminary Results with Incisionless, Sutureless, Swallowable Technique
M. Gagner, M. Fried, D. Michalsky, K. Dolezalova, P. Sramkova, J. Brezina, D. Baliarova, L. Hlavata, M. Novak, J. Bartos, S. Mullerova
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články
- MeSH
- anastomóza chirurgická metody MeSH
- diabetes mellitus 2. typu * chirurgie MeSH
- dospělí MeSH
- hmotnostní úbytek MeSH
- ileum * chirurgie MeSH
- index tělesné hmotnosti MeSH
- jejunostomie * metody přístrojové vybavení MeSH
- jejunum * chirurgie MeSH
- laparoskopie metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- magnetismus MeSH
- magnety * MeSH
- prospektivní studie MeSH
- studie proveditelnosti MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
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.
Charles University Prague Czech Republic
Hôpital du Sacré Cœur de Montréal Montreal Canada
Institute of Clinical and Experimental Medicine Prague Czech Republic
Citace poskytuje Crossref.org
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- $a Gagner, Michel $u Westmount Square Surgical Center, Westmount, Canada. gagner.michel@gmail.com $u Hôpital du Sacré-Cœur de Montréal, Montreal, Canada. gagner.michel@gmail.com
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- $a 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.
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