PDF(Pubmed)
Abstract：
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.
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.
摘要：
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。
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。
