Skip to content

A multicenter, prospective cohort clinical study on the efficacy and safety of tauroursodeoxycholic acid capsules in preventing stone recurrence in patients with choledocholithiasis after ERCP lithotomy

A multicenter, prospective cohort clinical study on the efficacy and safety of tauroursodeoxycholic acid capsules in preventing stone recurrence in patients with choledocholithiasis after ERCP lithotomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300071425
Enrollment
Unknown
Registered
2023-05-15
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Recurrence of stones after ERCP lithotomy

Interventions

Exposed group (Conventional treatment +Take taurine ursodeoxycholic acid capsule):None
Non-exposed group (Conventional treatment + Blank control):None

Sponsors

The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Subjects must meet all of the following inclusion criteria to be enrolled in this study: 1. Age 18-75 (including boundary value), gender is not limited. 2. Imaging examination diagnosed primary choledocholithiasis, and ERCP lithotomy was performed, and no residual choledocholithiasis was found in the common bile duct after surgery. 3. The subject expressed informed consent, volunteered to be tested, signed informed consent, and agreed to participate in all visits and examinations as required by the test protocol.

Exclusion criteria

Exclusion criteria: Subject will be excluded if any of the following: 1. Complicated with serious diseases of the heart, brain, lung, liver or kidney, malignant tumor or mental illness, or known or confirmed active ulcers or duodenal ulcers, acute cholecystitis and cholangitis, obstruction of the biliary tract (common bile duct or gallbladder duct), recurrent biliary colic attacks, calcification or radiopaque gallstones, impaired gallbladder motor function, Or other conditions deemed unsuitable for participation in the clinical trial by the investigator; 2. Pregnant or lactating women; 3.Allergic to any ingredient contained in tauroursodeoxycholic acid capsules, or allergic constitution.

Design outcomes

Primary

MeasureTime frame
Recurrence rate of stone 1 year after operation;

Secondary

MeasureTime frame
Stone recurrence rate at 24 weekends after surgery;Changes of blood lipid levels compared with postoperative baseline at 4, 12, 24, 36 and 48 weeks after surgery;Changes in liver function from baseline at 4, 12, 24, 36, 48 weeks after surgery;

Countries

the People's Republic of China

Contacts

Public ContactZhaoshen Li

The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)

onerain@126.com+86 13974866177

Outcome results

None listed

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