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6 - 10毫米无蒂结直肠息肉的冷圈套与热圈套内镜黏膜切除术:一项随机试验

Cold versus hot endoscopic mucosal resection for nonpedunculated colorectal polyps sized 6-10 mm: a randomized trial.

作者信息

Papastergiou Vasilios, Paraskeva Konstantina D, Fragaki Maria, Dimas Ioannis, Vardas Emmanouil, Theodoropoulou Angeliki, Mathou Nicoletta, Giannakopoulos Athanasios, Karmiris Konstantinos, Mpitouli Afroditi, Apessou Dimitra, Giannikaki Linda, Karagiannis John A, Chlouverakis Grigorios, Paspatis Gregorios A

机构信息

Department of Gastroenterology, Konstantopouleio General Hospital, Athens, Greece.

Department of Gastroenterology, Venizeleio General Hospital, Heraklion, Greece.

出版信息

Endoscopy. 2018 Apr;50(4):403-411. doi: 10.1055/s-0043-118594. Epub 2017 Sep 12.

DOI:10.1055/s-0043-118594
PMID:28898922
Abstract

BACKGROUND AND STUDY AIMS

Cold snare polypectomy is an established method for the resection of small colorectal polyps; however, significant incomplete resection rates still leave room for improvement. We aimed to assess the efficacy of cold snare endoscopic mucosal resection (CS-EMR), compared with hot snare endoscopic mucosal resection (HS-EMR), for nonpedunculated polyps sized 6 - 10 mm.

PATIENTS AND METHODS

This study was a dual-center, randomized, noninferiority trial. Consecutive adult patients with at least one nonpedunculated polyp sized 6 - 10 mm were enrolled. Eligible polyps were randomized (1:1) to be treated with either CS-EMR or HS-EMR. Both methods involved submucosal injection of a methylene blue-tinted normal saline solution. The primary noninferiority end point was histological eradication evaluated by postpolypectomy biopsies (noninferiority margin - 10 %). Secondary outcomes included occurrence of intraprocedural bleeding, clinically significant postprocedural bleeding, and perforation.

RESULTS

Among 689 patients screened, 155 patients with 164 eligible polyps were included (CS-EMR n = 83, HS-EMR n = 81). The overall rate of histological complete resection was 92.8 % in the CS-EMR group and 96.3 % in the HS-EMR group (difference 3.5 %; 95 % confidence interval [CI] - 4.15 to 11.56), showing noninferiority of CS-EMR compared with HS-EMR. CS-EMR was shown to be noninferior both for polyps measuring 6 - 7 mm (CS-EMR 93.3 %; HS-EMR 100 %; 95 %CI - 7.95 to 21.3) and those of 8 - 10 mm (92.5 % vs. 94.7 %, respectively; 95 %CI - 7.91 to 13.16). Rates of intraprocedural bleeding were similar between the two groups (CS-EMR 3.6 %, HS-EMR 1.2 %;  = 0.30). No clinically significant postprocedural bleeding or perforation occurred in either group.

CONCLUSIONS

CS-EMR appears to be a valuable modification of the standard cold snare technique, obviating the need to use diathermy for nonpedunculated colorectal polyps sized 6 - 10 mm.

摘要

背景与研究目的

冷圈套息肉切除术是切除小的结直肠息肉的既定方法;然而,较高的不完全切除率仍有改进空间。我们旨在评估冷圈套内镜黏膜切除术(CS-EMR)与热圈套内镜黏膜切除术(HS-EMR)相比,对6-10mm无蒂息肉的疗效。

患者与方法

本研究是一项双中心、随机、非劣效性试验。纳入至少有一个6-10mm无蒂息肉的连续成年患者。符合条件的息肉被随机(1:1)分配接受CS-EMR或HS-EMR治疗。两种方法均包括黏膜下注射亚甲蓝染色的生理盐水溶液。主要非劣效终点是通过息肉切除术后活检评估的组织学根除情况(非劣效界值-10%)。次要结局包括术中出血、临床上显著的术后出血和穿孔的发生情况。

结果

在689例筛查患者中,155例患者的164个符合条件的息肉被纳入研究(CS-EMR组n=83,HS-EMR组n=81)。CS-EMR组的组织学完全切除率为92.8%,HS-EMR组为96.3%(差异3.5%;95%置信区间[CI]-4.15至11.56),表明CS-EMR与HS-EMR相比具有非劣效性。对于6-7mm的息肉(CS-EMR 93.3%;HS-EMR 100%;95%CI-7.95至21.3)以及8-10mm的息肉(分别为92.5%和94.7%;95%CI-7.91至13.16),CS-EMR均显示出非劣效性。两组术中出血率相似(CS-EMR 3.6%,HS-EMR 1.2%;P=0.30)。两组均未发生临床上显著的术后出血或穿孔。

结论

CS-EMR似乎是标准冷圈套技术的一种有价值的改良方法,对于6-10mm的无蒂结直肠息肉无需使用透热法。

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