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夹线辅助牵引式经内镜结肠直肠黏膜下剥离术的疗效:一项前瞻性随机研究。

Efficacy of traction-assisted colorectal endoscopic submucosal dissection using a clip-and-thread technique: A prospective randomized study.

机构信息

Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.

Department of Gastroenterology, Okayama University Hospital, Okayama, Japan.

出版信息

Dig Endosc. 2018 Jul;30(4):467-476. doi: 10.1111/den.13036. Epub 2018 Mar 11.

Abstract

BACKGROUND AND AIM

Colorectal endoscopic submucosal dissection (ESD) remains challenging because of technical difficulties, long procedure time, and high risk of adverse events. To facilitate colorectal ESD, we developed traction-assisted colorectal ESD using a clip and thread (TAC-ESD) and conducted a randomized controlled trial to evaluate its efficacy.

METHODS

Patients with superficial colorectal neoplasms (SCN) ≥20 mm were enrolled and randomly assigned to the conventional-ESD group or to the TAC-ESD group. SCN ≤50 mm were treated by two intermediates, and SCN >50 mm were treated by two experts. Primary endpoint was procedure time. Secondary endpoints were TAC-ESD success rate (sustained application of the clip and thread until the end of the procedure), self-completion rate by the intermediates, and adverse events.

RESULTS

Altogether, 42 SCN were analyzed in each ESD group (conventional and TAC). Procedure time (median [range]) for the TAC-ESD group was significantly shorter than that for the conventional-ESD group (40 [11-86] min vs 70 [30-180] min, respectively; P < 0.0001). Success rate of TAC-ESD was 95% (40/42). The intermediates' self-completion rate was significantly higher for the TAC-ESD group than for the conventional-ESD group (100% [39/39] vs 90% [36/40], respectively; P = 0.04). Adverse events included one intraoperative perforation in the conventional-ESD group and one delayed perforation in the TAC-ESD group.

CONCLUSION

Traction-assisted colorectal endoscopic submucosal dissection reduced the procedure time and increased the self-completion rate by the intermediates (UMIN000018612).

摘要

背景与目的

由于技术难度大、手术时间长、不良事件风险高,结直肠内镜黏膜下剥离术(ESD)仍然具有挑战性。为了促进结直肠 ESD 的发展,我们开发了一种使用夹和线的牵引辅助结直肠 ESD(TAC-ESD),并进行了一项随机对照试验来评估其疗效。

方法

纳入了直径≥20mm 的浅层结直肠肿瘤(SCN)患者,并随机分为常规-ESD 组或 TAC-ESD 组。SCN≤50mm 采用两种中间治疗,SCN>50mm 采用两种专家治疗。主要终点是手术时间。次要终点是 TAC-ESD 成功率(夹和线持续应用直至手术结束)、中间治疗师的自我完成率以及不良事件。

结果

每个 ESD 组(常规和 TAC)均分析了 42 个 SCN。TAC-ESD 组的手术时间(中位数[范围])明显短于常规-ESD 组(分别为 40[11-86]min 和 70[30-180]min;P<0.0001)。TAC-ESD 的成功率为 95%(40/42)。TAC-ESD 组的中间治疗师自我完成率明显高于常规-ESD 组(分别为 100%[39/39]和 90%[36/40];P=0.04)。不良事件包括常规-ESD 组术中穿孔 1 例,TAC-ESD 组延迟穿孔 1 例。

结论

牵引辅助结直肠内镜黏膜下剥离术缩短了手术时间,提高了中间治疗师的自我完成率(UMIN000018612)。

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