冷圈套器内镜切除术治疗大肠大息肉：一项随机试验

Cold snare endoscopic resection for large colon polyps: a randomised trial.

作者信息

Pohl Heiko, Rex Douglas K, Barber Jeremy, Moyer Matthew T, Elmunzer B Joseph, Rastogi Amit, Gordon Stuart R, Zolotarevsky Eugene, Levenick John M, Aslanian Harry R, Elatrache Mazen, von Renteln Daniel, Wallace Michael B, Brahmbhatt Bhaumik, Keswani Rajesh N, Kumta Nikhil A, Pleskow Douglas K, Smith Zachary L, Abu Ghanimeh Mouhanna K, Simmer Stephen, Sanaei Omid, Mackenzie Todd A, Piraka Cyrus

机构信息

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA

VA Medical Center, White River Junction, Vermont, USA.

出版信息

Gut. 2025 May 19. doi: 10.1136/gutjnl-2025-335075.

DOI:10.1136/gutjnl-2025-335075

PMID:40393701

Abstract

BACKGROUND

Complications of endoscopic mucosal resection (EMR) of large colorectal polyps remain a concern.

OBJECTIVE

We aimed to compare safety and efficacy of cold EMR (without electrocautery) to hot EMR (with electrocautery) of large colorectal polyps.

DESIGN

In this multicentre randomised trial, patients with any large (≥20 mm) non-pedunculated colon polyp were assigned to cold or hot EMR (primary intervention), and to submucosal injection with a viscous or non-viscous solution (secondary intervention) following a 2×2 design. The primary outcome was the rate of severe adverse events (SAEs). The secondary outcome was polyp recurrence. In this study, we report results of the primary intervention.

RESULTS

660 patients were randomised and analysed. An SAE was observed in 2.1% of patients in the cold EMR group and in 4.3% in the hot EMR group (p=0.10) (per protocol analysis 1.4 vs 5.0%, p=0.017) with fewer perforations following cold EMR (0%) compared with hot EMR (1.6%, p=0.028). Postprocedure bleeding did not differ (1.5% vs 2.2%, p=0.57). The effect of cold resection was independent of the type of submucosal injection solution, polyp size or antithrombotic medications. Recurrence was detected in 27.6% and 13.6% in the cold and hot EMR groups, respectively (p<0.001). Recurrence was not significantly different for 20-29 mm polyps (18.6% vs 13.4%, p=0.24) and for sessile serrated polyps (14.1% vs 8.5%, p=0.33).

CONCLUSION

Universal application of cold EMR did not significantly lower SAEs (unless cold EMR could be completed) and doubled the recurrence rate compared with hot EMR.

TRIAL REGISTRATION DETAILS

ClinicalTrials.gov, number: NCT03865537.

摘要

背景

大肠大息肉的内镜黏膜切除术（EMR）并发症仍是一个令人担忧的问题。

目的

我们旨在比较大肠大息肉冷EMR（无电灼）与热EMR（有电灼）的安全性和有效性。

设计

在这项多中心随机试验中，任何患有大的（≥20毫米）无蒂结肠息肉的患者按照2×2设计被分配接受冷或热EMR（主要干预），以及接受粘性或非粘性溶液的黏膜下注射（次要干预）。主要结局是严重不良事件（SAE）发生率。次要结局是息肉复发率。在本研究中，我们报告主要干预的结果。

结果

660例患者被随机分组并进行分析。冷EMR组2.1%的患者和热EMR组4.3%的患者观察到SAE（p = 0.10）（按方案分析为1.4%对5.0%，p = 0.017），与热EMR（1.6%，p = 0.028）相比，冷EMR后穿孔较少（0%）。术后出血无差异（1.5%对2.2%，p = 0.57）。冷切除的效果与黏膜下注射溶液类型、息肉大小或抗血栓药物无关。冷EMR组和热EMR组的复发率分别为27.6%和13.6%（p < 0.001）。20 - 29毫米息肉（18.6%对13.4%，p = 0.24）和无蒂锯齿状息肉（14.1%对8.5%，p = 0.33）的复发率无显著差异。