Choledocholithiasis Clinical Trial
Official title:
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.
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.
Status | Recruiting |
Enrollment | 480 |
Est. completion date | January 2023 |
Est. primary completion date | January 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. >18 years of age 2. 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) 3. 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 4. Previous cholecystectomy or planned recent cholecystectomy or liver lobectomy can also be included 5. Subjects voluntarily participate in this study and sign the informed consent Exclusion Criteria: 1. Coagulation disorders (INR>1.3) and peripheral blood plate count significantly decreased<50x10^9/L 2. Preoperative complicated with acute pancreatitis 3. Preoperative biliary hemorrhage 4. Complicated with severe liver disease and primary sclerosing cholangitis 5. Mirizzi syndrome and intrahepatic bile duct stones 6. Complicated malignant tumor of hepatobiliary and pancreatic system 7. Complicated with obvious stricture of the lower segment of the bile duct 8. intraoperative bile duct duodenal fistula was found 9. Previous EST or EPBD 10. Previous history of gastrointestinal reconstruction surgery 11. Other ERCP contraindications |
Country | Name | City | State |
---|---|---|---|
China | Xinhua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | RenJi Hospital, Shanghai Pudong Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lithotomy time | The time required from completion of papillary myotomy to completion of lithotomy, including the time of cylindrical balloon dilation | About 20 minutes | |
Primary | Stone residual rate | Routine indwelling of the nasobiliary duct was performed, and nasobiliary angiography before removal was performed to confirm the presence of residual stones | about 2 days |
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