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临床试验/NCT04492137
NCT04492137Unknown不适用

Prospective Comparison Between Ultra Early NKF Versus Standard Cannulation Alone in a Group of High and Low Risk of Pep, Submitted to Pep Prophylaxis

University of Minho2 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
334
试验地点
2
主要终点
Technical success

研究概览

简要总结

Compare the ultra early fistulotomy strategy with standard cannulation methods for accessing the bile duct during endoscopic retrograde cholangiopancreatography (ERCP)

详细描述

  1. Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced procedure which is widely used in the diagnosis and treatment of a variety of benign and malignant pancreatobiliary disorders1,2,3,4,5.

Selective cannulation of the common bile duct (CBD) is the most important and challenging step in a biliary endoscopic retrograde cholangiopancreatography6,7. However, in the first ERCP, even in experienced hands, biliary cannulation may fail in up to 15 % - 35 % of cases when using standard methods alone8. In this subset of patients, additional cannulation techniques are needed to access the CBD in order to continue with the ERCP.

Precut is the most common strategy used by experienced endoscopists, when conventional methods have failed7. Needle knife fistulotomy (NKF) and conventional precut are the two most common variants. Recently published guidelines recommend opting for NKF, as evidence suggests a lower risk of adverse events, especially pancreatitis, when used early in the biliary cannulation algorithm7,9.

Technically NKF is the creation of an artificial fistula between the most protuberant portion of the papilla, which represents the intraduodenal portion of the CBD and the biliary tract by using a diathermic cutter of the needle type6,10,11,12,13,14,15,16,17,18. Its big advantage over conventional precut is that it avoids the contact of the cutting device with the papillary orifice and therefore avoiding direct thermal injury to the pancreatic duct.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ERCP with indication for biliary access
  • Naïve papilla

排除标准

  • Flat papillas
  • Intradiverticular / Diverticular border papillas
  • Patients unable to sign or understand the informed consent
  • Patients with surgically altered anatomy
  • Patients with tumors of the papilla
  • Previous sphincterotomy
  • Spontaneous papillary fistula
  • Papilla not visualized

结局指标

主要结局

Technical success

时间窗: 1 day (same day of the procedure)

Comparison of technical success between the two strategies

Adverse events

时间窗: 30 days from the procedure

Comparison of adverse event rate between the two strategies

次要结局

  • Technical success among sub groups(1 day (same day of the procedure))
  • Adverse event rate among sub groups(30 days from the procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luis Lopes

Assistant Professor (MD, PhD, MBA)

University of Minho

研究点 (2)

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