Comparison Between an Angled-tip and Straight-tip Guidewire in Biliary Cannulation: a Prospective, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Neev Mehta
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Cannulation
研究概览
简要总结
The investigators aim is to compare outcomes between an angled-tip guidewire and a straight-tip guidewire in cannulation of the common bile duct during ERCP. This is a randomized, controlled, single-blinded study. The primary outcome is success of cannulation and secondary outcomes are incidence of post-ERCP pancreatitis, procedure duration, and rate of complication between the angled wire and straight wire.
详细描述
Wire-guided cannulation of the common bile duct is a standard technique utilized during Endoscopic Retrograde Cholangio-Pancreatography (ERCP) to ensure safe and effective access to the common bile duct via the ampulla of Vater. Due to the anatomy of the ampulla, and the orientation of the biliary orifice, a guidewire with an angled tip may allow easier and safer access to the common bile duct without inadvertent manipulation of the pancreatic duct. The investigators aim to assess the technical and clinical outcomes between an angled-tip guidewire (GW) compared to a straight-tip guidewire in wire-guided cannulation of the common bile duct. The investigators hypothesize that an angled-tip GW is associated with increased rate of successful cannulation, decreased procedure time and decreased rate of post-ERCP pancreatitis in wire-guided biliary cannulation during ERCP.
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
- Single (Participant)
盲法说明
Single-blinded study with masking of participant
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients undergoing ERCP for cholangiography, bile or tissue sampling from the gallbladder or bile duct
- •patients undergoing ERCP for treatment of biliary diseases (removal of common bile duct stones, biliary stent placement)
排除标准
- •Patients who are less than 18 years old
- •Pregnant patients
- •Patients who have undergone previous bile duct cannulation or sphincterotomy
- •Patients who have undergone prior endoscopic balloon dilation or needle-knife fistulotomy
- •Patients who have undergone gastric surgery (Billroth gastrectomy II, Roux-en-Y gastric bypass)
- •Patients with acute pancreatitis
- •Patients who refuse endoscopic intervention
- •Patients with ampullary tumor, duodenal stenosis, or pre-operatively proven pancreaticobiliary malunion
结局指标
主要结局
Cannulation
时间窗: Day of Procedure
Rate of successful cannulation of common bile duct
次要结局
- Post ERCP Pancreatitis(Procedure day and up to day 5 post procedure)
- Duration(Day of procedure)