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Multicenter randomized controlled study of ursodeoxycholic acid in the treatment of patients with choledocholithiasis suffering from recurrent bile duct stones and residual stones after undergoing ERCP.

Multicenter randomized controlled study of ursodeoxycholic acid in the treatment of patients with choledocholithiasis suffering from recurrent bile duct stones and residual stones after undergoing ERCP.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17011783
Enrollment
Unknown
Registered
2017-06-28
Start date
2017-06-01
Completion date
Unknown
Last updated
2017-07-03

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

Conditions

choledocholithiasis

Interventions

The group of successful operation (The control group):No intervention
The group of successful operation (The experimental group):Ursodeoxycholic acid will be administered at the dose of 13-15mg/kg for 1-2 times every day , and the treatment time more than 6 months
The group of stent implantation after the failed operation (The experimental group):Ursodeoxycholic acid will be administered at the dose of 13-15mg/kg for 1-2 times every day, and the treatment time
The group of stent implantation after the failed operation (The control group):No intervention

Sponsors

Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who were diagnosed as choledocholithiasis with preoperative imaging, confirmed by ERCP and treated voluntarily with ursodeoxycholic acid were enrolled in this study.

Exclusion criteria

Exclusion criteria: 1. Patients under 18 years old or without autonomy; 2. Patients for whom ERCP was not suitable. 3. Patients accompanied by basic diseases associated with heart ,lung and liver. 4. Patients with malignant tumors; 5. Patients who have undergone surgery(if they would be willing to join the latter follow- up, they could bedivided into a sigle group); 6. Patients who were pregnant or during breast feeding period; 7. Patients known to suffer from side effects associated with ursodeoxycholic acid or had been treated with ursodeoxycholic acid regularly.

Design outcomes

Primary

MeasureTime frame
bilirubin;Total bile acid;phospholipid;Lecithin;Bile salt;Cholesterol;

Secondary

MeasureTime frame
calcium ion;ß-glucosidas;

Countries

China

Contacts

Public ContactXu Jianming

Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University

xujm1017@163.com+86 13955157272

Outcome results

None listed

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