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临床试验/NCT06315647
NCT06315647已完成不适用

Comparative Study Between Double Guide Wire Technique Versus Trans Pancreatic Sphincterotomy Versus Precut and Fistulotomy Techniques for Difficult Biliary Cannulation

Menoufia University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Comparative Study Between Different Interventional Techniques for Difficult Common Bile Duct Cannulation In Endoscopic Retrograde Cholangio-pancreatography

研究概览

简要总结

This study aims to compare the efficacy and outcomes between double guidewire technique (DGT), trans pancreatic sphincterotomy (TPS) as well as precut and fistulotomy techniques in ERCP in patients defined as having difficult biliary cannulation.

详细描述

Endoscopic retrograde cholangiopancreatography (ERCP) is the standard procedure for diagnostic and therapeutic interventions for pancreatobiliary diseases. Bile duct cannulation is the most basic and important technique for carrying out diagnostic and therapeutic biliary interventions.

Since the advent of ERCP selective cannulation of the biliary duct is the most important step for successful treatment of biliary tract diseases during ERCP procedures, despite various accessory devices, the standard biliary cannulation technique has been reported to fail in approximately 5-20% cases.

Various endoscopic techniques for Selective Bile duct cannulation have been reported, including standard techniques (e.g. contrast injection technique, wire-guided cannulation ), pancreatic guidewire technique (e.g. double guidewire technique [DGW]), precut sphincterotomy, endoscopic papillectomy, endoscopic ultrasound-guided rendezvous procedure, and percutaneous transhepatic biliary drainage-guided procedure.

Bile duct cannulation can be difficult because of; different anatomical features, inflammatory processes, and adenomas of the papilla or periampullary diverticulum. Large prospective studies have demonstrated that difficult cannulation is an independent risk factor for post ERCP pancreatitis.

As the technique developed, several supplementary techniques have been recommended to facilitate the access to the common bile duct in cases of standard biliary cannulation failure, these are known to significantly increase not only the success rate of selective biliary cannulation but also the complication rate .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

入排标准

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

入选标准

  • •Patients having different biliary tract disorders for which ERCP is indicated and after which they defined as having difficult CBD cannulation.

排除标准

  • •Age of less than18 years.
  • •Coagulopathy in terms of INR>
  • •Patients with severe heart disease defined as patients with decompensated heart diseases or EF > 40%.
  • •Subjects who underwent prior biliary or pancreatic sphincterotomy or dilatation or stenting of either duct.
  • •Complicated acute pancreatitis defined as patients with moderate to sever acute pancreatitis according to Revised ATLANTA criteria

研究组 & 干预措施

Patients enrolled for double guide wire technique.

Active Comparator

干预措施: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation (Procedure)

Patients enrolled for trans - pancreatic sphincterotomy technique.

Active Comparator

干预措施: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation (Procedure)

Patients enrolled for needle knife precut technique or fistulotomy technique.

Active Comparator

干预措施: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation (Procedure)

结局指标

主要结局

Comparative Study Between Different Interventional Techniques for Difficult Common Bile Duct Cannulation In Endoscopic Retrograde Cholangio-pancreatography

时间窗: Baseline

compare efficacy of different cannulation techniques for difficult CBD cannulation

次要结局

未报告次要终点

研究者

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

Ahmed El Said Salam

Dr

Menoufia University

研究点 (1)

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