Early precut versus primary precut sphincterotomy to reduce post-ERCP pancreatitis: randomized controlled trial (with videos),Gastrointestinal Endoscopy

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Early precut versus primary precut sphincterotomy to reduce post-ERCP pancreatitis: randomized controlled trial (with videos)
Gastrointestinal Endoscopy ( IF 6.7 ) Pub Date : 2020-06-29 , DOI: 10.1016/j.gie.2020.06.064
Sudhir Maharshi ₁ , Shyam Sunder Sharma ₁

Affiliation

Background and Aims

Precut sphincterotomy, usually performed after prolonged and failed cannulation, is considered a risk factor for post-ERCP pancreatitis (PEP). There are limited studies on primary needle-knife precut for the prevention of PEP. The aim of this study was to assess the safety and efficacy of primary precut.

Methods

A randomized controlled trial was conducted in a tertiary care setting on patients who underwent ERCP. Patients were randomized to very early precut (group A, precut after 2 failed attempts of wire-guided sphincterotome cannulation) and primary precut (group B, direct needle-knife precut). All procedures were done by an experienced endoscopist. The primary outcome of the study was to compare the incidence of PEP between the 2 groups.

Results

Three hundred three patients were randomized to group A (n = 152, age 48.2 ± 15.4 years, 61 men) and group B (n = 151, age 46.7 ± 13.8 years, 65 men). There was no significant difference in baseline characteristics and indications for ERCP between the 2 groups. Development of PEP (5.2% vs .67%; P = .04) and asymptomatic hyperamylasemia (12.5% vs 2.6%; P = .01) were lower in group B compared with group A. The bile duct cannulation time (13.8 ± 2.2 vs 7.2 ± 1.7 minutes; P = .001) was lower in group B, whereas the overall cannulation success rate (98% vs 98.6%; P = 1.0) was similar in both the groups.

Conclusions

Primary precut by an experienced endoscopist results in low risk of PEP. (Clinical trial registration number: CTRI/2017/08/009510.)

中文翻译：

早期预切与初次预切括约肌切开术以减少 ERCP 术后胰腺炎：随机对照试验（附视频）

背景和目标

预切括约肌切开术，通常在长时间插管失败后进行，被认为是 ERCP 术后胰腺炎 (PEP) 的危险因素。关于预防 PEP 的初级针刀预切的研究有限。本研究的目的是评估初级预切的安全性和有效性。

方法

在三级医疗机构对接受 ERCP 的患者进行了一项随机对照试验。患者被随机分配至极早期预切（A 组，2 次线引导括约肌切开插管失败后的预切）和初次预切（B 组，直接针刀预切）。所有程序均由经验丰富的内镜医师完成。该研究的主要结果是比较两组之间 PEP 的发生率。

结果

303 名患者被随机分配到 A 组（n = 152，年龄 48.2 ± 15.4 岁，61 名男性）和 B 组（n = 151，年龄 46.7 ± 13.8 岁，65 名男性）。两组的基线特征和 ERCP 指征无显着差异。与 A 组相比，B 组的 PEP（5.2% 对 0.67%；P = .04）和无症状性高淀粉酶血症（12.5% 对 2.6%；P = .01）的发生率较低。胆管插管时间（13.8 ± 2.2 B 组与 7.2 ± 1.7 分钟相比；P = .001）较低，而两组的总体插管成功率（98% 对 98.6%；P = 1.0）相似。