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

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

我们的目标是比较冷EMR（不使用电凝术）与热EMR（使用电凝术）在切除大型大肠息肉时的安全性和有效性。

Methods

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.

在这项多中心随机试验中，任何大的（≥20毫米）非带蒂结肠息肉患者被分配到冷或热EMR（主要干预措施），以及按照2×2设计，随后进行粘膜下注射粘稠或非粘稠溶液（次要干预措施）。

The primary outcome was the rate of severe adverse events (SAEs).

主要结果是严重不良事件（SAEs）的发生率。

The secondary outcome was polyp recurrence.

次要结果是息肉复发。

In this study, we report results of the primary intervention.

在这项研究中，我们报告了主要干预措施的结果。

Results

660 patients were randomised and analysed.

共有660名患者被随机分配并进行了分析。

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).

在冷电镜切除术（EMR）组中，观察到2.1%的患者出现严重不良事件（SAE），而在热EMR组中为4.3%（p=0.10）（按方案分析，冷EMR组为1.4%，热EMR组为5.0%，p=0.017），并且与热EMR组的1.6%相比，冷EMR组的穿孔发生率较低（0%，p=0.028）。

Postprocedure bleeding did not differ (1.5% vs 2.2%, p=0.57).

术后出血的发生率没有差异（1.5%对比2.2%，p=0.57）。

The effect of cold resection was independent of the type of submucosal injection solution, polyp size or antithrombotic medications.

冷切除的效果与粘膜下注射溶液的类型、息肉大小或抗血栓药物无关。

Recurrence was detected in 27.6% and 13.6% in the cold and hot EMR groups, respectively (p<0.001).

在冷EMR组和热EMR组中，分别检测到27.6%和13.6%的复发率（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).

对于20-29毫米的息肉，复发率没有显著差异（18.6%对比13.4%，p=0.24），对于无蒂锯齿状息肉，复发率也没有显著差异（14.1%对比8.5%，p=0.33）。

Conclusions

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.

冷EMR的普遍应用并没有显著降低严重不良事件（除非能够完成冷EMR），并且与热EMR相比复发率翻了一番。

trial_registration_details

ClinicalTrials.gov, number: NCT03865537.

ClinicalTrials.gov，编号：NCT03865537。