First-in-Human Linear Magnetic Jejuno-Ileal Bipartition: Preliminary Results with Incisionless, Sutureless, Swallowable Technique
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu časopisecké články
PubMed
40332740
PubMed Central
PMC12130062
DOI
10.1007/s11695-025-07861-1
PII: 10.1007/s11695-025-07861-1
Knihovny.cz E-zdroje
- Klíčová slova
- Biofragmentable, First-in-human, Jejuno-ileostomy, Magnetic compression anastomosis, Metabolic/bariatric surgery, Obesity, Swallowable, T2D, Type 2 diabetes,
- 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
Zobrazit více v PubMed
Centers for Disease Control and Prevention. Adult obesity facts. Fact Sheet 2022. https://www.cdc.gov/obesity/data/adult.html#print.
Eurostat. Overweight and Obesity - BMI Statistics 2021. https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Overweight_and_obesity_-_BMI_statistics#Obesity_by_age_group
Carlsson LMS, Carlsson B, Jacobson P, et al. Association between delay in diabetes development and mortality in people with obesity: up to 33 years follow-up of the prospective Swedish Obese Subjects study. Diabetes Obes Metab. 2025;27(1):238–46. 10.1111/dom.16010. PubMed PMC
Gasoyan H, Tajeu G, Halpern MT, Sarwer DB. Reasons for underutilization of bariatric surgery: the role of insurance benefit design. Surg Obes Relat Dis. 2019;15(1):146–51. 10.1016/j.soard.2018.10.005. PubMed PMC
Murtha JA, Alagoz E, Breuer CR, et al. Individual-level barriers to bariatric surgery from patient and provider perspectives: a qualitative study. Am J Surg. 2021;224(1 Pt B):429–36. 10.1016/j.amjsurg.2021.12.022. PubMed PMC
Arterburn DE, Telem DA, Kushner RF, et al. Benefits and risks of bariatric surgery in adults. JAMA. 2020;324(9):879. 10.1001/jama.2020.12567. PubMed
Eisenberg D, Shikora SA, Aarts E, et al. American society for metabolic and bariatric surgery (ASMBS) and international federation for the surgery of obesity and metabolic disorders (IFSO): indications for metabolic and bariatric surgery. Surg Obes Relat Dis. 2022;18(12):1345–56. 10.1016/j.soard.2022.08.013. PubMed
Schauer PR, Bhatt DL, Kirwan JP, et al. STAMPEDE Investigators Bariatric surgery versus intensive medical therapy for diabetes — 5-year outcomes. N Engl J Med. 2017;376(7):641–51. 10.1056/NEJMoa1600869. PubMed PMC
Kirwan JP, Courcoulas AP, Cummings DE, et al. Diabetes remission in the alliance of randomized trials of medicine versus metabolic surgery in type 2 diabetes (ARMMS-T2D). Diabetes Care. 2022;45(7):1574–83. 10.2337/dc21-2441. PubMed PMC
Yang Y, Miao C, Wang Y, He J. The long-term effect of bariatric/metabolic surgery versus pharmacologic therapy in type 2 diabetes mellitus patients: a systematic review and meta-analysis. Diabetes Metab Res Rev. 2024;40(5):e3830. 10.1002/dmrr.3830. PubMed
Jamshidi R, Stephenson JT, Clay JG, et al. Magnamosis: magnetic compression anastomosis with comparison to suture and staple techniques. J Pediatr Surg. 2009;44(1):222–8. 10.1016/j.jpedsurg.2008.10.044. PubMed
Evans LL, Lee WG, Karimzada M, et al. Evaluation of a magnetic compression anastomosis for jejunoileal partial diversion in Rhesus macaques. Obes Surg. 2024;34:515–23. 10.1007/s11695-023-07012-4. PubMed PMC
Gagner M, Krinke T, LaPointe-Gagner M, Buchwald JN. Side-to-side duodeno-ileal magnetic compression anastomosis: design and feasibility of a novel device in a porcine model. Surg Endosc. 2023;37(8):6197–207. 10.1007/s00464-023-10105-x. PubMed
Gagner M, Abuladze D, Koiava L, et al. First-in-human side-to-side magnetic compression duodeno-ileostomy with the Magnet Anastomosis System. Obes Surg. 2023;33(8):2282–92. 10.1007/s11695-023-06708-x. PubMed PMC
Gagner M, Cadiere GB, Sanchez-Pernaute A, et al. Side-to-side magnet anastomosis system duodeno-ileostomy with sleeve gastrectomy: early multi-center results. Surg Endosc. 2023;37(8):6452–63. 10.1007/s00464-023-10134-6. PubMed PMC
Gagner M, Almutlaq L, Cadiere GB, et al. Side-to-side magnetic duodeno-ileostomy in adults with severe obesity with or without type 2 diabetes: early outcomes with prior or concurrent sleeve gastrectomy. Surg Obes Relat Dis. 2024;20(4):341–52. 10.1016/j.soard.2023.10.018. PubMed
Cadière GB, Poras M, Maréchal MT, et al. Sleeve gastrectomy with duodenoileal bipartition using linear magnets: feasibility and safety at 1-year follow-up. J Gastrointest Surg. 2024;28(5):640–50. 10.1016/j.gassur.2024.02.001. PubMed
Gagner M, Almutlaq L, Gnanhoue G, et al. Magnetic single-anastomosis side-to-side duodeno-ileostomy for revision of sleeve gastrectomy in adults with severe obesity: 1-year outcomes. World J Surg. 2024;48(10):2337–48. 10.1002/wjs.12304. PubMed
Dziakova J, Torres A, Odovic M, et al. Spanish experience with latero-lateral duodeno-ileostomy + sleeve gastrectomy with Magnet Anastomosis System. Obes Surg. 2024;34(9):3569–75. 10.1007/s11695-024-07432-w. PubMed
Fried M, Dolezalova K, Chambers AP, et al. A novel approach to glycemic control in type 2 diabetes mellitus, partial jejunal diversion: pre-clinical to clinical pathway. BMJ Open Diabetes Res Care. 2017;5(1):e000431. 10.1136/bmjdrc-2017-000431. PubMed PMC
Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009;250(2):187–96. 10.1097/SLA.0b013e3181b13ca2. PubMed
American Diabetes Association. Standards of care in diabetes-2023 abridged for primary care providers. Clin Diabetes 2022 Winter;41(1):4–31. 10.2337/cd23-as01. Erratum in: Clin Diabetes 2023 Spring;41(2):328. 10.2337/cd23-as01 PubMed PMC
Gagner M, Abuladze L, Buchwald JN, Almutlaq L. First-in-human side-to-side duodeno-ileal bipartition for weight loss and type 2 diabetes with the swallowable biofragmentable magnetic anastomosis system. J Am Coll Surg 2025; in press. PubMed