Prophylactic clip closure after endoscopic submucosal dissection of large flat and sessile colorectal polyps: a multicentre randomised controlled trial (EPOC trial).

To compare clinically significant delayed bleeding rates between a clip closure and a control group for flat and sessile 20-50 mm colorectal polyps following ESD.

为了比较在ESD后，对于平坦和无蒂的20-50毫米结直肠息肉，夹闭术组与对照组之间临床显著的延迟出血率。

Methods

A multicentre randomised controlled trialconducted at four Japanese institutions randomly assigned patients to closure or non-closure groups.

在日本四家机构进行的一项多中心随机对照试验，随机将患者分配到闭合组或非闭合组。

Significant postprocedural bleeding (haematochezia) was classified as severe (requiring endoscopic haemostasis or blood transfusion in patients with haemoglobin levels <70 g/L or haemorrhagic shock) or mild.

显著的术后出血（血便）被分类为严重（需要内镜止血或血红蛋白水平<70 g/L的患者需要输血或出血性休克）或轻度。

Results

The closure and control groups comprised 150 and 149 cases in the intention-to-treat(ITT) analysis and 142 and 141 cases in the per-protocol (PP) analysis, respectively.

在意向性治疗(ITT)分析中，闭合组和对照组分别包括150例和149例病例；在按方案(PP)分析中，分别包括142例和141例病例。

Rates of complete clip closure were 88.7% (ITT) and 93.0% (PP).

完全夹闭率分别为88.7%(ITT)和93.0%(PP)。

The ITT analysis revealed delayed bleeding rates of 6.7% and 20.1% (OR: 0.28; 95% CI: 0.13 to 0.60; p<0.001; absolute risk difference (ARD): 13.5%; 95% CI: 5.6% to 20.9%) and severe delayed bleeding rates of 1.3% and 8.7% (OR: 0.14; 95% CI: 0.03 to 0.64; p=0.003; ARD: 7.4%; 95% CI: 2.2% to 12.4%) in the closure and control groups, respectively.

意向治疗(ITT)分析显示，封堵组和对照组的延迟出血率分别为6.7%和20.1%（OR: 0.28; 95% 置信区间: 0.13 到 0.60; p<0.001; 绝对风险差异(ARD): 13.5%; 95% 置信区间: 5.6% 到 20.9%）以及严重延迟出血率分别为1.3%和8.7%（OR: 0.14; 95% 置信区间: 0.03 到 0.64; p=0.003; ARD: 7.4%; 95% 置信区间: 2.2% 到 12.4%）。

These differences were confirmed in the PP analysis.

这些差异在符合方案(PP)分析中得到了证实。

Delayed perforation was not observed, and the post-ESD coagulation syndrome rate was not significantly different between the two groups.

未观察到延迟穿孔，且两组之间的ESD后凝固综合征发生率没有显著差异。

Multivariate logistic regression analyses identified prophylactic clip closure as a significant independent preventive factor for both delayed bleeding (OR: 0.22; 95% CI: 0.08 to 0.50; p<0.001) and severe delayed bleeding (OR: 0.22; 95% CI: 0.05 to 0.76; p=0.015).

多变量逻辑回归分析确定预防性夹闭作为延迟出血（OR: 0.22; 95% CI: 0.08至0.50; p<0.001）和严重延迟出血（OR: 0.22; 95% CI: 0.05至0.76; p=0.015）的显著独立预防因素。

Conclusions

Prophylactic clip closure, successfully achieved in approximately 90% of cases, reduced the delayed bleeding rate after resection of colorectal polyps measuring 20-50 mm.

预防性夹闭术在约90%的病例中成功实施，减少了20-50毫米结直肠息肉切除后的延迟出血率。

trial_registration_number

UMIN000043675.

UMIN000043675。