背景:使用经典缝线和/或金属钉的胃肠道吻合导致大量出血和渗漏率。这项多站点研究评估了可行性,安全,以及新型线性磁压缩吻合装置的初步有效性,磁体系统(MS),以形成侧侧十二指肠回肠造口术(DI)转移,以减轻体重和2型糖尿病(T2D)。
方法:在II级和III级肥胖患者中(体重指数[BMI,kg/m2]≥35.0-≤50.0,有/无T2D[HbA1C>6.5%]),在腹腔镜辅助下,将两个线性MS磁体通过内窥镜输送到十二指肠和回肠,并对齐,初始DI;增加袖状胃切除术(SG)。没有肠切口或保留的缝线/钉。熔融磁体自然排出。不良事件(AE)按Clavien-Dindo分类(CDC)进行分级。
结果:2021年11月22日至2022年7月18日,24名患者(83.3%为女性,平均值±SEM重量121.9±3.3kg,BMI44.4±0.8)在三个中心接受了磁DI。磁体在中值48.5天排出。各自的平均BMI,总重量损失,和6个月时的过度体重减轻(n=24):32.0±0.8,28.1±1.0%,和66.2±3.4%;在12个月时(n=5),29.3±1.5,34.0±1.4%,80.2±6.6%。组平均各自的平均HbA1C和葡萄糖水平降至1.1±0.4%和24.8±6.6mg/dL(6个月);2.0±1.1%和53.8±6.3mg/dL(12个月)。有0个与设备相关的不良事件,3个与手术相关的严重不良事件。没有吻合口出血,泄漏,狭窄,或死亡率。
结论:在多中心研究中,在III类肥胖的成年人中,用SG进行侧侧磁体系统十二指肠回肠造口术似乎是可行的,安全,和有效的减肥和T2D分辨率在短期内。
Gastrointestinal anastomoses with classical sutures and/or metal staples have resulted in significant bleeding and leak rates. This multi-site study evaluated the feasibility, safety, and preliminary effectiveness of a novel linear magnetic compression anastomosis device, the Magnet System (MS), to form a side-to-side duodeno-ileostomy (DI) diversion for weight loss and type 2 diabetes (T2D) resolution.
In patients with class II and III obesity (body mass index [BMI, kg/m2] ≥ 35.0- ≤ 50.0 with/without T2D [HbA1C > 6.5%]), two linear MS magnets were delivered endoscopically to the duodenum and ileum with laparoscopic assistance and aligned, initiating DI; sleeve gastrectomy (SG) was added. There were no bowel incisions or retained sutures/staples. Fused magnets were expelled naturally. Adverse events (AEs) were graded by Clavien-Dindo Classification (CDC).
Between November 22, 2021 and July 18, 2022, 24 patients (83.3% female, mean ± SEM weight 121.9 ± 3.3 kg, BMI 44.4 ± 0.8) in three centers underwent magnetic DI. Magnets were expelled at a median 48.5 days. Respective mean BMI, total weight loss, and excess weight loss at 6 months (n = 24): 32.0 ± 0.8, 28.1 ± 1.0%, and 66.2 ± 3.4%; at 12 months (n = 5), 29.3 ± 1.5, 34.0 ± 1.4%, and 80.2 ± 6.6%. Group mean respective mean HbA1C and glucose levels dropped to 1.1 ± 0.4% and 24.8 ± 6.6 mg/dL (6 months); 2.0 ± 1.1% and 53.8 ± 6.3 mg/dL (12 months). There were 0 device-related AEs, 3 procedure-related serious AEs. No anastomotic bleeding, leakage, stricture, or mortality.
In a multi-center study, side-to-side Magnet System duodeno-ileostomy with SG in adults with class III obesity appeared feasible, safe, and effective for weight loss and T2D resolution in the short term.