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Comparison of efficacy and safety of three protocols: EST, EPBD and ESBD in the treatment of <=10 mm common bile duct stones: a multicenter prospective randomized controlled trial

Comparison of efficacy and safety of three protocols: EST, EPBD and ESBD in the treatment of <= 10 mm common bile duct stones: a multicenter prospective randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046540
Enrollment
Unknown
Registered
2021-05-21
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choledocholithiasis

Interventions

Incision group (EST group):Endoscopic sphincterotomy
Expansion group (EPBD group):Endoscopic papillary balloon dilation
Incision combined expansion group (ESBD group):Endoscopic sphincterotomy combined with endoscopic papillary balloon dilation

Sponsors

the First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.ERCP was used to remove choledocholithiasis before operation; 2.Aged >= 18 years; 3.The subjects voluntarily participated in the trial and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1.Coagulation dysfunction (INR > 1.3); 2.Malignant tumor; 3.Thrombocytopenia (platelet < 50 x 10^9); 4.Taking anticoagulant or antiplatelet drugs; 5.Combined with acute pancreatitis, recurrent history of pancreatitis, chronic pancreatitis; 6.Acute obstructive suppurative cholangitis: those whose infection has been controlled can be included in the group; 7.The diameter of the stones was more than 10 mm and the number of stones was more than 5; 8.ERCP sphincterotomy or dilation was performed in the past; 9.During the operation, it was judged that EST or EPBD was not suitable, such as diverticulum papilla, small papilla, ampulla tumor, digestive tract diversion (after Bi II or total gastrectomy), benign and malignant stricture of common bile duct; 10.Risk factors of PEP related to operation: using pre incision intubation, pancreatic sphincterotomy, guide wire entering pancreatic duct more than once during operation, pancreatic duct development, difficult intubation (intubation time more than 5 minutes, intubation times more than 5 times); 11.Pancreatic duct stents were placed to prevent pep; 12.Incarceration of duodenal papillary stones; 13.Intrahepatic bile duct stones; 14.Cholecystocolonic fistula; 15.Pregnant women; 16.Primary sclerosing cholangitis; 17.Heart, lung or liver failure.

Design outcomes

Primary

MeasureTime frame
Success rate of one-stage stone extraction;Post-procedure complication;

Secondary

MeasureTime frame
Frequency of use of mechanical lithotripsy;Time of procedure;Total success rate of stone extraction;Total success rate of stone extraction;

Countries

China

Contacts

Public ContactZhu Hong, Xu Shunfu

the First Affiliated Hospital of Nanjing Medical University

zhuhong1059@126.com+86 13851895504, +86 13851547488

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026