A Prospective, Multicenter Clinical Study of the Effect of the Order of Dilatation of Papillary Muscle and Mechanical Lithotripsy on the Efficacy and Postoperative Complications of ERCP in the Treatment of Choledocholithiasis.
试验速览
- 阶段
- 不适用
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Lithotomy time
研究概览
简要总结
Choledocholithiasis is a common and frequently occurring disease in China, accounting for 15.3% ~ 31.7% of the total cholelithiasis.According to its source, can be divided into primary and secondary choledocholithiasis.For large choledocholithiasis, it is difficult to remove all calculi after dilatation of large diameter balloon or mechanical stone following alone.Therefore, we used the method of balloon dilation combined with mechanical lithotripsy after EST.There are few researches on the sequence of balloon dilation and mechanical lithotripsy at home and abroad, and there is no unified standard.
Through the ERCP balloon expansion of duodenal papilla sphincter and mechanical lithotripsy in the treatment of common bile duct calculi in patients with clinical observation, the balloon expansion and mechanical lithotripsy time order of take stone, stone residues rate and the influence of recent complications such as postoperative pancreatitis, ERCP in the treatment of huge stones optimization procedure was formulated.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •For patients with choledocholithiasis found by MRCP and feasible ERCP lithotomy, the diameter of calculi ≥1cm should be indicated (number of calculi should be indicated >5 or<5)
- •During ERCP, the surgeon determined that the calculi should be removed by combining EPBD and mechanical lithotripsy, and the calculi could be removed by a single ERCP
- •Previous cholecystectomy or planned recent cholecystectomy or liver lobectomy can also be included
- •Subjects voluntarily participate in this study and sign the informed consent
排除标准
- •Coagulation disorders (INR>1.3) and peripheral blood plate count significantly decreased<50x10^9/L
- •Preoperative complicated with acute pancreatitis
- •Preoperative biliary hemorrhage
- •Complicated with severe liver disease and primary sclerosing cholangitis
- •Mirizzi syndrome and intrahepatic bile duct stones
- •Complicated malignant tumor of hepatobiliary and pancreatic system
- •Complicated with obvious stricture of the lower segment of the bile duct
- •intraoperative bile duct duodenal fistula was found
- •Previous EST or EPBD
- •Previous history of gastrointestinal reconstruction surgery
- •Other ERCP contraindications
研究组 & 干预措施
First lithotripsy and then EPBD
After successful selective bile duct intubation, contrast agent was injected to measure the thickness of the bile duct and the size of bile duct stones under fluoroscopy. For those meeting the inclusion criteria, sphincterotomy was performed first.Papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken line to suitable size after the switch to expanding balloon EPBD and further kidney stones, papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken balloon to suitable size after the switch to expansion, expansion size 10-12 mm, according to the lower bile duct diameter, expansion time of 30 seconds.Then, the stones were removed with a net basket or balloon, and the nasobiliary duct was placed to end the operation.
干预措施: First lithotripsy and then EPBD (Procedure)
First EPBD and then lithotripsy
After puncture of the papillary sphincter, the guide wire was indwelled in the bile duct, and the columnar dilating balloon was inserted in exchange. The dilation size was 10-12mm, and the dilation time was 30 seconds according to the diameter of the lower end of the bile duct.At the end of the expansion, the stones were broken to a suitable size using a one-piece gravel net basket.The calculi were removed by using a stone net basket or balloon, and the nasobiliary duct was placed to end the operation.
干预措施: First EPBD and then lithotripsy (Procedure)
结局指标
主要结局
Lithotomy time
时间窗: About 20 minutes
The time required from completion of papillary myotomy to completion of lithotomy, including the time of cylindrical balloon dilation
Stone residual rate
时间窗: about 2 days
Routine indwelling of the nasobiliary duct was performed, and nasobiliary angiography before removal was performed to confirm the presence of residual stones
次要结局
未报告次要终点
研究者
Xuefeng Wang
Chief surgeon of general surgery department
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine