冷圈套器内镜黏膜切除术与标准热技术治疗大肠大扁平无蒂病变的随机对照试验

Cold snare endoscopic mucosal resection versus standard hot technique for large flat nonpedunculated colonic lesions: a randomized controlled trial.

作者信息

Nogales Oscar, Carbonell Blanco Carlos, Montori Pina Sheyla, Pellisé María, Martínez Sempere Juan F, Riu Pons Fausto, Mangas-Sanjuan Carolina, Daca-Alvarez María, Uchima Hugo, Aranda-Hernández Javier, Alvarez Delgado Alberto, Rodríguez de Santiago Enrique, Santiago García Jose, Cañete Ruiz Ángel, Miranda García Pablo, Núñez Rodriguez Henar, Herreros-de-Tejada Alberto, Valdivielso Cortazar Eduardo, De María Pedro, Busquets David, Elosua Alfonso, Rivero-Sánchez Liseth, López-Ibáñez María, Alvarez-Gonzalez Marco A, Albéniz Eduardo

机构信息

Department of Gastroenterology and Hepatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.

Gastroenterology Research Unit, Navarrabiomed, Hospital Universitario de Navarra (HUN), Universidad Pública de Navarra (UPNA), IdiSNA, Navarra Institute for Health Research, Pamplona, Spain.

出版信息

Endoscopy. 2025 Aug;57(8):851-861. doi: 10.1055/a-2542-9759. Epub 2025 Feb 19.

DOI:10.1055/a-2542-9759

PMID:39970943

Abstract

BACKGROUNDS

Cold snare EMR (CS-EMR) in large flat nonpedunculated colonic lesions (LFNPCLs) is an alternative to the standard EMR procedure with a better safety profile, but scientific evidence on its efficacy is unavailable. This study aimed to compare the recurrence rate between the two techniques at 6 months. Secondary aims were comparison of the safety profile and procedure-related outcomes.

METHODS

This was a noninferiority, multicenter, open-label, randomized controlled trial of consecutive large (≥ 20 mm) LFNPCLs without suspicious features of submucosal invasion.

RESULTS

229 patients were randomized to receive CS-EMR (n = 115) or EMR (n = 114). The median lesion size was 25 mm and 74.6 % were adenomas. The trial was stopped early by clinical consensus according to a safety monitoring board. At first surveillance colonoscopy (n = 220) the recurrence rate was significantly greater in the CS-EMR group than in the EMR group: 33.0 % vs. 16.2 % ( = 0.004) and 34.7 % vs. 14.8 % ( = 0.001) in the intention-to-treat and per-protocol analyses, respectively. According to the subgroup analysis, the recurrence rate was significantly greater after CS-EMR for LFNPCLs ≥ 30 mm (43.1 % vs. 18.2 %). There was no difference in the rate of adverse events. The use of clips was more common in the EMR group (52.6 % vs. 27.8 %).

CONCLUSIONS

The recurrence rate of LFNPCLs after CS-EMR was significantly greater than after the standard hot technique. A similar safety profile was found between groups.

摘要

背景

对于大的扁平无蒂结肠病变（LFNPCLs），冷圈套器内镜黏膜切除术（CS-EMR）是标准EMR手术的一种替代方法，具有更好的安全性，但缺乏关于其疗效的科学证据。本研究旨在比较两种技术在6个月时的复发率。次要目的是比较安全性和与手术相关的结果。

方法

这是一项非劣效性、多中心、开放标签、随机对照试验，纳入连续的大（≥20mm）LFNPCLs且无黏膜下浸润可疑特征的患者。

结果

229例患者被随机分配接受CS-EMR（n = 115）或EMR（n = 114）。病变的中位大小为25mm，74.6%为腺瘤。根据安全监测委员会的临床共识，试验提前终止。在首次监测结肠镜检查时（n = 220），CS-EMR组的复发率显著高于EMR组：在意向性分析和符合方案分析中分别为33.0%对16.2%（P = 0.004）和34.7%对14.8%（P = 0.001）。根据亚组分析，对于≥30mm的LFNPCLs，CS-EMR后的复发率显著更高（43.1%对18.2%）。不良事件发生率无差异。EMR组使用夹子更为常见（52.6%对27.8%）。