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十二指肠内醋酸灌注对内镜逆行胰胆管造影时胰管插管的影响:一项双盲、随机对照试验。

Impact of intraduodenal acetic acid infusion on pancreatic duct cannulation during endoscopic retrograde cholangiopancreatography: A double-blind, randomized controlled trial.

机构信息

Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.

Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, China.

出版信息

J Gastroenterol Hepatol. 2018 Oct;33(10):1804-1810. doi: 10.1111/jgh.14148. Epub 2018 May 4.

Abstract

BACKGROUND AND AIM

Endoscopic retrograde cholangiopancreatography (ERCP) is associated with risk of complications. Methods to facilitate ductal cannulation may reduce complications. Intraduodenal acid infusion is a physiological approach to stimulate secretin release in human body and may facilitate cannulation. The objective of this study was to investigate the effect of intraduodenal acid infusion on pancreatic duct cannulation during ERCP.

METHODS

It was a single center, double-blind, randomized controlled trial. Consecutive patients undergoing first ERCP for pancreatic diseases were randomized toreceive 50 mL acetic acid intraduodenal infusion at ERCP (acetic acid group) or 50 mL saline (control group). The primary outcome, difficult cannulation rate (cannulation time >5 min), in the two groups was compared.

RESULTS

Two hundred ten patients were included in the final analysis (105 in each group). The difficult cannulation rate were 39.1% in the control group and 20.9% in the acetic acid group, and the difference was statistically significant (P = 0.004). The overall successful deep cannulation rate was 89.5% and 85.7%, respectively (P = 0.402). The cannulation time was remarkably shortened (182 vs 286 s, P = 0.018), and the cannulation attempts were significantly decreased (3.4 vs 4.4, P = 0.008). The fluoroscopy time was also significantly reduced (60 vs 86 s, P = 0.028). The incidence of post-ERCP pancreatitis and hyperamylasemia was comparable (7.6% vs 10.5% and 10.5% vs 19.1%, P > 0.05).

CONCLUSION

Intraduodenal acetic acid infusion can significantly decrease difficult pancreatic cannulation rate, facilitate pancreatic duct cannulation, and reduce radiation exposure (ClinicalTrials.gov number, NCT02800772).

摘要

背景与目的

内镜逆行胰胆管造影术(ERCP)与并发症的发生风险相关。促进胆管插管的方法可能会降低并发症的发生风险。十二指肠内酸灌注是一种刺激人体分泌缩胆囊素的生理性方法,可能有助于插管。本研究旨在探讨 ERCP 时十二指肠内酸灌注对胰管插管的影响。

方法

这是一项单中心、双盲、随机对照试验。连续纳入因胰腺疾病首次行 ERCP 的患者,随机接受 ERCP 时十二指肠内灌注 50 mL 乙酸(乙酸组)或 50 mL 生理盐水(对照组)。两组的主要结局(插管时间>5 min 的困难插管率)进行比较。

结果

最终纳入 210 例患者进行分析(每组 105 例)。对照组的困难插管率为 39.1%,乙酸组为 20.9%,差异有统计学意义(P=0.004)。总体深度插管成功率分别为 89.5%和 85.7%(P=0.402)。插管时间显著缩短(182 s 比 286 s,P=0.018),插管尝试次数明显减少(3.4 次比 4.4 次,P=0.008)。透视时间也显著减少(60 s 比 86 s,P=0.028)。ERCP 后胰腺炎和高淀粉酶血症的发生率相当(7.6%比 10.5%和 10.5%比 19.1%,P>0.05)。

结论

十二指肠内乙酸灌注可显著降低胰管插管困难率,促进胰管插管,并减少辐射暴露(ClinicalTrials.gov 编号:NCT02800772)。

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