Comparative Study Between Double Guide Wire Technique Versus Trans Pancreatic Sphincterotomy Versus Precut and Fistulotomy Techniques for Difficult Biliary Cannulation
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.
干预措施: DGT vs TPS vs Precut and fistulotomy in Difficult CBD cannulation (Procedure)
Patients enrolled for trans - pancreatic sphincterotomy technique.
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.
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
Ahmed El Said Salam
Dr
Menoufia University
