Pre-cut Versus Intentional Double Guidewire for ERCP Cannulation: Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 840
- 主要终点
- Safe Success
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable therapeutic procedure in the management of a wide spectrum of pancreaticobiliary disorders, including choledocholithiasis, benign and malignant biliary strictures, pancreatic ductal obstructions, and postoperative bile leaks. The procedure has revolutionized the management of these conditions, often obviating the need for surgery.Precut papillotomy and Double Guidewire Technique (DGT) are both salvage techniques used in ERCP when standard biliary cannulation fails.
Precut (Needle-Knife Precut): An endoscopic incision made into the papilla to gain access to the bile duct when conventional methods fail.
Intentional Double Guidewire Technique (DGT): A technique where a guidewire is intentionally placed into the pancreatic duct to act as a "guide" or anchor, straightening the biliary axis and allowing a second guidewire to be inserted into the bile duct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Age > 18 years.
- •Valid indication for ERCP (benign or malignant obstruction).
- •Native papilla (no prior sphincterotomy).
- •Difficult Biliary Cannulation (DBC) defined by ESGE "5-5-2" criteria:
- •> 5 minutes of cannulation attempts.
- •> 5 contacts with the papilla.
- •> 1 inadvertent pancreatic duct cannulation.
排除标准
- •Ampullary mass or tumor preventing standard cannulation view.
- •Surgically altered anatomy (e.g., Billroth II, Roux-en-Y).
- •Uncorrectable coagulopathy (INR > 1.5 or Platelets < 50,000).
- •Acute pancreatitis present prior to ERCP.
研究组 & 干预措施
Precut Sphincterotomy Arm
Participants undergo biliary cannulation using precut sphincterotomy as the initial rescue cannulation technique during ERCP.
干预措施: Double Guidewire Technique (Procedure)
Double Guidewire Technique Arm
Participants undergo biliary cannulation using the double guidewire technique, with placement of a guidewire in the pancreatic duct followed by attempted biliary cannulation during ERCP.
干预措施: Precut Sphincterotomy (Procedure)
结局指标
主要结局
Safe Success
时间窗: 30 Days
SUCCESS: Deep cannulation of the Common Bile Duct (CBD) achieved using the randomized technique within 15 minutes. * AND ABSENCE OF Post ERCP adverse events. Post ERCP adverse events include Post ERCP Pancreatitis, Hemorrhage, cholangitis and perforation.
次要结局
- Incidence of Post-ERCP Pancreatitis(30 days)
- Severity of Post-ERCP Pancreatitis(30 days)
- Overall ERCP-Related Adverse Events(30 days)
- Cannulation Time(During the ERCP procedure)
- Total Procedure Time(During the ERCP procedure)
- Need for Rescue Cannulation Technique(During the ERCP procedure)
- Hyperamylasemia Without Clinical Pancreatitis(At 24 hours after ERCP)
- Hospital Length of Stay(Up to 30 days after ERCP)
- 30-Day All-Cause Readmission(Up to 30 days after ERCP)
研究者
Mohan Ramchandani
Consultant Gastroenterology
Asian Institute of Gastroenterology, India