Clip Closure After Resection of Large Colorectal Lesions With Substantial Risk of Bleeding

Clip Closure After Resection of Large Colorectal Lesions With Substantial Risk of Bleeding
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DOI:
10.1053/j.gastro.2019.07.037
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发表时间:
2019-11-01
期刊:
影响因子:
29.4
通讯作者:
Enguita-German, Monica
Enguita-German, Monica
中科院分区:
医学1区
文献类型:
--
作者:
Albeniz, Eduardo;Antonio Alvarez, Marco;Enguita-German, Monica

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背景与目的:目前尚不清楚结肠内镜下粘膜切除术(EMR)后用夹子闭合粘膜缺损是否能预防迟发性出血,尽管在风险较低时似乎没有保护作用。我们进行了一项随机试验,以评估在估计有平均或高延迟出血风险的患者中,EMR后大的(>= 2 cm)无蒂结直肠病变完全夹闭的疗效。方法:我们于2016年5月至2018年6月在西班牙的11家医院进行了一项单盲试验,包括235名连续患者,这些患者接受了EMR治疗大型无蒂结直肠病变,具有平均或高延迟出血风险(基于西班牙内镜学会内镜切除组评分)。参与者被随机分配到使用11 mm通过内窥镜夹(治疗组,n = 119)或无夹(对照组,n = 116)闭合瘢痕的组。主要结局是各组中迟发性出血患者的比例,迟发性出血定义为结肠镜检查后15天内需要医疗干预的明显便血。研究结果:在金属夹组中,68例(57%)病例完全闭合,33例(28%)病例部分闭合,18例(15%)病例闭合失败。对照组14例(12.1%)患者和金属夹组6例(5%)患者发生迟发性出血(绝对风险差异,金属夹组降低7%; 95%置信区间,-14.7%至0.3%)。完成成形夹闭合后,仅1例(1.5%)迟发性出血(绝对风险差异,降低10.6%; 95%置信区间,-4.3%至17.9%)。结论:在一项对接受EMR的大型无蒂结直肠病变患者进行的随机试验中,我们发现,在有出血风险的患者中,粘膜缺损的夹子闭合可能是一项挑战,但也减少了延迟出血。预防迟发性出血需要完全闭合金属夹。
BACKGROUND & AIMS: It is not clear whether closure of mucosal defects with clips after colonic endoscopic mucosal resection (EMR) prevents delayed bleeding, although it seems to have no protective effects when risk is low. We performed a randomized trial to evaluate the efficacy of complete clip closure of large (>= 2 cm) nonpedunculated colorectal lesions after EMR in patients with an estimated average or high risk of delayed bleeding. METHODS: We performed a single-blind trial at 11 hospitals in Spain from May 2016 through June 2018, including 235 consecutive patients who underwent EMR for large nonpedunculated colorectal lesions with an average or high risk of delayed bleeding (based on Spanish Endoscopy Society Endoscopic Resection Group score). Participants were randomly assigned to groups that received closure of the scar with 11-mm through-the-scope clips (treated, n = 119) or no clip (control, n = 116). The primary outcome was proportion of patients in each group with delayed bleeding, defined as evident hematochezia that required medical intervention within 15 days after colonoscopy. RESULTS: In the clip group, complete closure was achieved in 68 (57%) cases, with partial closure in 33 (28%) cases and failure to close in 18 (15%) cases. Delayed bleeding occurred in 14 (12.1%) patients in the control group and in 6 (5%) patients in the clip group (absolute risk difference, reduction of 7% in the clip group; 95% confidence interval, -14.7% to 0.3%). After completion of the clip closure, there was only 1 (1.5%) case of delayed bleeding (absolute risk difference, reduction of 10.6%; 95% confidence interval, -4.3% to 17.9%). CONCLUSIONS: In a randomized trial of patients with large nonpedunculated colorectal lesions undergoing EMR, we found that clip closure of mucosal defects in patients with a risk of bleeding can be a challenge, but also reduces delayed bleeding. Prevention of delayed bleeding required complete clip closure.