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帽辅助内镜下黏膜切除术与标准注射-切割内镜下黏膜切除术治疗大肠侧向发育型肿瘤的随机多中心研究(附视频)。

Cap-assisted EMR versus standard inject and cut EMR for treatment of large colonic laterally spreading tumors: a randomized multicenter study (with videos).

机构信息

Gastroenterology Department, Santa Corona General Hospital, Savonese, Italy; Polyclinique St George, Nice, France.

Gastroenterology and Digestive Endoscopy Department, General Hospital, Perugia, Italy.

出版信息

Gastrointest Endosc. 2022 Nov;96(5):829-839.e1. doi: 10.1016/j.gie.2022.06.002. Epub 2022 Jun 11.

Abstract

BACKGROUND AND AIMS

Piecemeal EMR of colorectal laterally spreading tumors (LSTs) >20 mm is effective. Experience is limited in the use of cap-assisted EMR (EMR-C) for resection of colonic lesions. We compared the efficacy and the safety of EMR-C for the removal of colonic LSTs ≥30 mm with "inject-and-cut" standard EMR (EMR-S).

METHODS

In this randomized trial from 4 Italian centers, 138 patients were treated with EMR-C and 102 with EMR-S. The rates of residual lesions, percentage of recurrence after 12 months, and adverse events were evaluated.

RESULTS

One hundred forty-three lesions were resected with EMR-C and 102 with EMR-S. Argon plasma coagulation (APC) was used as adjunctive treatment in 2.9% of EMR-Cs and in 22.5% of EMR-Ss (P < .001). The median time required was 20 minutes for EMR-C and 30 minutes for EMR-S (P < .001). Adverse events (AEs) occurred in 14 EMR-Cs (10.1%; 2 perforations, 11 bleeding events, and 1 stenosis) and in 22 EMR-Ss (21.6%; 1 perforation and 21 bleeding events) (P = .017). Intraprocedural AEs occurred in 3.6% of EMR-Cs and 16.7% of EMR-Ss (P = .001). Overall, residual lesions within 12 months were found to be significantly higher with EMR-S (32 patients, 31.4%) than with EMR-C (8 patients, 5.8%) (P < .001). Recurrence at follow-up colonoscopy in 12 months occurred in 7 EMR-Cs (5.1%) and 17 EMR-Ss (16.7%; P < .001).

CONCLUSIONS

The study demonstrated the feasibility and safety of EMR-C for removing large colorectal LSTs, with higher eradication rates, shorter resection time, and less use of APC when compared with EMR-S. (Clinical trial registration number: NCT03498664.).

摘要

背景和目的

分片式大肠侧向扩展肿瘤(LST)>20mm 的内镜黏膜切除术(EMR)是有效的。在使用帽辅助内镜黏膜切除术(EMR-C)切除结肠病变方面,经验有限。我们比较了 EMR-C 与“注射-切割”标准 EMR(EMR-S)切除≥30mm 结肠 LST 的疗效和安全性。

方法

在这项来自 4 个意大利中心的随机试验中,138 例患者接受 EMR-C 治疗,102 例患者接受 EMR-S 治疗。评估残留病变的发生率、12 个月后复发的百分比以及不良事件。

结果

用 EMR-C 切除了 143 个病变,用 EMR-S 切除了 102 个病变。氩等离子凝固(APC)作为辅助治疗在 EMR-C 中使用 2.9%,在 EMR-S 中使用 22.5%(P<0.001)。EMR-C 需要的中位时间为 20 分钟,EMR-S 需要的中位时间为 30 分钟(P<0.001)。EMR-C 发生 14 例不良事件(10.1%;2 例穿孔,11 例出血,1 例狭窄),EMR-S 发生 22 例不良事件(21.6%;1 例穿孔,21 例出血)(P=0.017)。EMR-C 术中不良事件发生率为 3.6%,EMR-S 为 16.7%(P=0.001)。总体而言,12 个月内发现 EMR-S 组的残留病变明显高于 EMR-C 组(32 例,31.4%)(P<0.001)。12 个月时在随访结肠镜检查中,EMR-C 组有 7 例(5.1%)和 EMR-S 组有 17 例(16.7%)复发(P<0.001)。

结论

与 EMR-S 相比,EMR-C 用于切除大型结直肠侧向扩展肿瘤具有更高的根除率、更短的切除时间和更少使用 APC,且具有可行性和安全性。(临床试验注册号:NCT03498664.)

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