Background and Aims

We previously reported preliminary safety results for a new method, endoscopic detachable snare ligation (EDSL), for diverticular hemorrhage. This method does not need endoscope removal to attach a ligation device after detection of the bleeding site. The aim of the present study was to evaluate the efficacy and safety of EDSL in a larger patient population.

Methods

This prospective study was conducted in 12 institutions. Patients suspected of having diverticular hemorrhage without serious systemic disease were enrolled. The primary endpoint was early (within 30 days) recurrent bleeding rate in patients treated with EDSL. The secondary endpoints were overall early recurrent bleeding rate in patients with definite diverticular bleeding and adverse events in patients treated with EDSL.

Results

From June 2015 to March 2017, bleeding diverticula were detected in 123 (60%) of 205 enrolled patients, of whom 101 (82%) were treated with EDSL. Most patients (n=20/22) in whom EDSL was not successful were treated with clipping. The early recurrent bleeding rate was 7.9% (95% confidence interval [CI], 2.6%-13.2%; n=8/101) in patients who could be treated with EDSL. The median total endoscopic and EDSL procedure time was 40 (interquartile range [IQR] 15–71) and 4 (IQR 1–7) minutes, respectively. Two mild adverse events, colonic diverticulitis and temporary abdominal pain, were observed.

Conclusions

EDSL was confirmed to be useful and safe for treatment of colonic diverticular hemorrhage.

中文翻译：

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最新开发的内镜可拆式网罗结扎治疗结肠憩室出血：一项多中心II期临床试验（带视频）

背景和目标

我们之前报道了一种新的方法安全性初步结果，即内镜下可分离网罗结扎术（EDSL）用于憩室出血。在检测到出血部位后，无需拆除内窥镜即可连接结扎装置。本研究的目的是评估EDSL在更多患者人群中的疗效和安全性。

方法

这项前瞻性研究在12个机构中进行。怀疑患有憩室出血而没有严重全身疾病的患者入组。主要终点是接受EDSL治疗的患者的早期（30天内）复发出血率。次要终点是明确的憩室出血患者的总体早期复发出血率以及接受EDSL治疗的患者的不良事件。

结果

从2015年6月到2017年3月，在205例入组患者中，有123例（60％）发现了憩室出血，其中101例（82％）接受了EDSL治疗。EDSL失败的大多数患者（n = 20/22）都接受了削波治疗。可以接受EDSL治疗的患者的早期复发出血率为7.9％（95％置信区间[CI]，2.6％-13.2％； n = 8/101）。内镜和EDSL手术的总时间中位数分别为40分钟（四分位间距[IQR] 15-71）和4分钟（IQR 1-7）。观察到两个轻度不良事件，结肠憩室炎和暂时性腹痛。

结论

EDSL被证实对于治疗结肠憩室出血是有效和安全的。