Michel Gagner, Martin Fried, David Michalsky, Karen Dolezalova, Petra Sramkova, Jan Brezina, Dasa Baliarova, Lucie Hlavata, Michal Novak, Jaroslav Bartos, Sarka Mullerova
{"title":"人类首次线性磁性空肠-回肠双分割：无切口、无缝合线、可吞咽技术的初步结果。","authors":"Michel Gagner, Martin Fried, David Michalsky, Karen Dolezalova, Petra Sramkova, Jan Brezina, Dasa Baliarova, Lucie Hlavata, Michal Novak, Jaroslav Bartos, Sarka Mullerova","doi":"10.1007/s11695-025-07861-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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><p><strong>Methods: </strong>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.</p><p><strong>Primary endpoints: </strong>feasibility and severe adverse event (SAEs) incidence (Clavien-Dindo grade); secondary endpoints: weight, T2D reduction.</p><p><strong>Results: </strong>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% (p < 0.01), glucose 115.5 ± 6.5 mg/dL (p = 0.19); 83.0% dropped below 6.5% HbA1<sub>C</sub> and had markedly reduced anti-T2D medications.</p><p><strong>Conclusions: </strong>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>","PeriodicalId":19460,"journal":{"name":"Obesity Surgery","volume":" ","pages":"2067-2080"},"PeriodicalIF":2.9000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130062/pdf/","citationCount":"0","resultStr":"{\"title\":\"First-in-Human Linear Magnetic Jejuno-Ileal Bipartition: Preliminary Results with Incisionless, Sutureless, Swallowable Technique.\",\"authors\":\"Michel Gagner, Martin Fried, David Michalsky, Karen Dolezalova, Petra Sramkova, Jan Brezina, Dasa Baliarova, Lucie Hlavata, Michal Novak, Jaroslav Bartos, Sarka Mullerova\",\"doi\":\"10.1007/s11695-025-07861-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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><p><strong>Methods: </strong>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.</p><p><strong>Primary endpoints: </strong>feasibility and severe adverse event (SAEs) incidence (Clavien-Dindo grade); secondary endpoints: weight, T2D reduction.</p><p><strong>Results: </strong>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% (p < 0.01), glucose 115.5 ± 6.5 mg/dL (p = 0.19); 83.0% dropped below 6.5% HbA1<sub>C</sub> and had markedly reduced anti-T2D medications.</p><p><strong>Conclusions: </strong>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>\",\"PeriodicalId\":19460,\"journal\":{\"name\":\"Obesity Surgery\",\"volume\":\" \",\"pages\":\"2067-2080\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2025-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12130062/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Obesity Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s11695-025-07861-1\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/5/7 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Obesity Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s11695-025-07861-1","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/5/7 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"SURGERY","Score":null,"Total":0}
First-in-Human Linear Magnetic Jejuno-Ileal Bipartition: Preliminary Results with Incisionless, Sutureless, Swallowable Technique.
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.
期刊介绍：
Obesity Surgery is the official journal of the International Federation for the Surgery of Obesity and metabolic disorders (IFSO). A journal for bariatric/metabolic surgeons, Obesity Surgery provides an international, interdisciplinary forum for communicating the latest research, surgical and laparoscopic techniques, for treatment of massive obesity and metabolic disorders. Topics covered include original research, clinical reports, current status, guidelines, historical notes, invited commentaries, letters to the editor, medicolegal issues, meeting abstracts, modern surgery/technical innovations, new concepts, reviews, scholarly presentations and opinions.
Obesity Surgery benefits surgeons performing obesity/metabolic surgery, general surgeons and surgical residents, endoscopists, anesthetists, support staff, nurses, dietitians, psychiatrists, psychologists, plastic surgeons, internists including endocrinologists and diabetologists, nutritional scientists, and those dealing with eating disorders.
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