First-in-Human Side-to-Side Duodenoileal Bipartition for Weight Loss and Type 2 Diabetes with the Swallowable Biofragmentable Magnetic Anastomosis System.

IF 3.8 2区 医学 Q1 SURGERY
Michel Gagner, David Abuladze, Jane Buchwald, Levan Koiava, Lamees Almutlaq
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引用次数: 0

Abstract

Background: Anastomosis creation using a novel magnetic compression technique may provide an alternative minimally invasive approach to gastrointestinal surgery. The biofragmentable magnetic anastomosis system (BMAS) is endolaparoscopically placed to effect magnetic duodenoileostomy (MagDI) bipartition for reduction of weight and type 2 diabetes (T2D). MagDI obviates major risks associated with enterotomy, stapling or suturing, and retained foreign materials.

Study design: This was a first-in-human prospective investigation of feasibility, safety, and efficacy in adults with BMI 30.0 or more to 35.0 or less kg/m 2 . An initial BMAS magnet, swallowed by the patient or delivered under anesthesia by endoscopy, was guided laparoscopically to the distal ileum; a second magnet was endoscopically positioned in the postpyloric duodenum; magnets were aligned to fuse for 7 to 21 days forming the duodenoileostomy. Primary endpoints are feasibility and severe adverse event (AE) incidence by Clavien-Dindo grade. Secondary endpoints are weight and T2D reduction.

Results: Between December 20, 2022, and May 21, 2024, 15 patients (mean BMI 33.0 ± 0.4 kg/m 2 ), all with T2D (glycosylated hemoglobin 8.2% ± 0.4%, glucose 187.9 ± 15.5 mg/dL, on T2D medications) underwent MagDI. The mean operative time was 51.3 ± 5.3 minutes. Feasibility at 90 days was confirmed in 100.0% with 0.0% leakage, bleeding, infection, stricture, and mortality; 89.4% of AEs were mild; and 3 Clavien-Dindo-III severe AEs were resolved. At 1 year, 100.0% of anastomoses were patent, BMI was (8) 30.1 ± 0.9 kg/m 2 , excess weight loss was 38.8%, glycosylated hemoglobin was 6.6% ± 0.1%, and glucose was 142.8 ± 9.5 mg/dL.

Conclusions: The novel swallowable, BMAS was feasible, safe, and effective in achieving incisionless, suture- or staple-free magDI. The device and procedure provide a promising minimally invasive option for moderate, clinically meaningful weight loss and T2D mitigation.

采用可吞咽生物碎片磁吻合系统治疗减肥和2型糖尿病的人类首个十二指肠-回肠侧对侧双配。
背景:利用一种新型磁压缩技术创建吻合口可能为胃肠道手术提供另一种微创方法。在腹腔镜下放置生物可碎性磁吻合系统(BMAS)以实现磁性十二指肠-回肠造口术(MagDI)双配,以减轻体重和2型糖尿病(T2D)。MagDI避免了与肠切开、缝合和异物残留相关的主要风险。研究设计:对体重指数(BMI)≥30.0至≤35.0 kg/m2的成人进行可行性、安全性和有效性的首次人体前瞻性研究。初始BMAS磁铁由患者吞下或在内镜麻醉下递送,经腹腔镜引导至回肠远端;内镜下在幽门后十二指肠放置第二个磁铁;磁铁对准融合7-21天形成十二指肠-回肠造口术。主要终点:可行性和严重不良事件(SAEs)发生率按Clavien-Dindo (CD)分级。次要终点:体重和T2D降低。结果:在2022年12月20日至2024年5月21日期间,15例T2D患者(HbA1C 8.2±0.4%,葡萄糖187.9±15.5 mg/dL,服用T2D药物)接受了MagDI治疗,平均BMI为33.0±0.4 kg/m2。平均手术时间51.3±5.3分钟。术后90天的可行性证实率为100.0%,渗漏、出血、感染、狭窄、死亡率为0.0%。89.4%的ae为轻度ae;解析CD-III sa 3例。1年时,100.0%的吻合口通畅;BMI (n=8) 30.1±0.9;超重减重38.8%;糖化血红蛋白6.6±0.1%;葡萄糖142.8±9.5 mg/dL。结论:新型可吞咽、生物可碎性磁性吻合系统可行、安全、有效,可实现无切口、无缝线/无钉的十二指肠-回肠磁性吻合。该设备和程序为中度、临床意义的体重减轻和T2D缓解提供了一种有希望的微创选择。
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来源期刊
CiteScore
6.90
自引率
5.80%
发文量
1515
审稿时长
3-6 weeks
期刊介绍: The Journal of the American College of Surgeons (JACS) is a monthly journal publishing peer-reviewed original contributions on all aspects of surgery. These contributions include, but are not limited to, original clinical studies, review articles, and experimental investigations with clear clinical relevance. In general, case reports are not considered for publication. As the official scientific journal of the American College of Surgeons, JACS has the goal of providing its readership the highest quality rapid retrieval of information relevant to surgeons.
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