Study Assessing the Interest of the Double-guidewire Technique for Catheterization of the Common Bile Duct.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 16
- 主要终点
- Biliary cannulation success rate
研究概览
简要总结
This is a prospective randomized comparative multicentric study. Briefly, we will analyze the technical success, performance and clinical outcomes of early versus delayed double-guidewire technique (DGT) in difficult biliary cannulation.
详细描述
This is a prospective study performed in 20 tertiary medical centers in France. We aim to recruit 150 patients from 2016 to 2020. Patients with a native papilla scheduled for ERCP (endoscopic retrograde cholangiopancreatography) are screened for the study. Patients with a difficult biliary cannulation are included in the study if the guidewire is inserted in the pancreatic duct. At that point, patients are randomized in two arms: early versus delayed DGT. The early arm attempts biliary cannulation using the double-guidewire technique immediately and the delayed arm uses the double-guidewire technique only if 10 more minutes of standard cannulation technique does not allow biliary cannulation. The primary outcome is the biliary cannulation rate success. Secondary outcomes are complications rate and performance of the technique in both arms. Follow-up is 30 days.
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
- None
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 18 years old and more
- •Native papilla
- •Clinical indications of ERCP
- •Difficult biliary cannulation defined by unintentional guidewire insertion into the pancreatic duct before biliary cannulation is successful
- •Informed consent completed by the patient
排除标准
- •Contraindication to upper gastrointestinal endoscopy
- •ERCP with direct biliary cannulation success
- •ERCP with inability to cannulate the bile duct nor the pancreatic duct
- •Coagulation or hemostasis disorder (TP < 60%, TCA> 40 sec. et plaquettes < 60000/mm3).
- •Patient under active antiaggregant or anticoagulant medication other than aspirin
- •Endoscopic treatment of chronic pancreatitis
- •Pregnancy or breastfeeding
- •ERCP performed by another operator than an investigator
- •Patient's voluntary withdrawal
- •Withdrawal decision by the investigator or sponsor
研究组 & 干预措施
early double-guidewire technique (DGT)
First arm: early double-guidewire technique The early arm attempts biliary cannulation using the DGT immediately once the guidewire is inserted in the pancreatic duct in cases of difficult biliary cannulation.
干预措施: Double-guidewire cannulation technique (Procedure)
delayed double-guidewire technique (DGT)
In the delayed arm, once the guidewire is inserted in the pancreatic duct, the operator continues to attempt biliary cannulation with conventional technique (contrast- or guidewire-assisted). DGT is used only if 10 more minutes of conventional cannulation technique does not allow biliary access.
干预措施: Double-guidewire cannulation technique (Procedure)
结局指标
主要结局
Biliary cannulation success rate
时间窗: During the ERCP procedure
The percentage of biliary cannulation success in both arms.
次要结局
- Immediate morbidity(From the start, until 30 minutes after completion of ERCP)
- Delayed morbidity(30 minutes after ERCP completion and up to 30 days)
- procedural time(time from the first guidewire insertion into the pancreatic duct up to the end of cannulation.)
研究者
Dr Arthur Laquiere
Gastroenterologist
Société Française d'Endoscopie Digestive