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Comparison of balloon occlusion versus basket irrigation on post-ERCP cholangitis and stone recurrence: a multicenter, single-blind, prospective randomized controlled trial

Comparison of balloon occlusion versus basket irrigation on post-ERCP cholangitis and stone recurrence: a multicenter, single-blind, prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121090
Enrollment
Unknown
Registered
2026-03-25
Start date
2026-03-31
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Common bile duct stones

Interventions

Group A (Occlusion Balloon Irrigation Group):Occlusion balloon-assisted saline irrigation of the bile duct
Group B (Basket irrigation group):basket-assisted saline irrigation of the bile duct

Sponsors

The First Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years; 2. Diagnosed with common bile duct stones (CBDS) and scheduled for ERCP treatment; 3. Stones can be successfully removed by ERCP or are expected to be completely removed; 4. Agree to participate in the study and sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients in whom common bile duct stones cannot be successfully cleared during ERCP; 2. Patients with a single common bile duct stone 1.5) or thrombocytopenia (platelet count < 50 × 10?/L); 5. Patients currently taking anticoagulants or antiplatelet agents that cannot be temporarily discontinued; 6. Patients with a history of gastrectomy with Roux-en-Y reconstruction or Billroth II surgery; 7. Patients with concurrent malignant hepatobiliary or pancreatic tumors, or common bile duct stricture; 8. Patients with concurrent severe liver disease, acute moderate-to-severe pancreatitis, or acute moderate-to-severe suppurative cholangitis; 9. Patients with concurrent primary sclerosing cholangitis, Mirizzi syndrome, or intrahepatic bile duct stones; 10. Patients with cholecystoduodenal fistula or recent gastrointestinal bleeding; 11. Pregnant women; 12. Other conditions deemed inappropriate for enrollment by the investigator

Design outcomes

Primary

MeasureTime frame
Incidence of post-ERCP cholangitis;

Secondary

MeasureTime frame
Recurrence rate of common bile duct stones;Total ERCP operation time;Fluoroscopy time;Irrigation time;Postoperative hospital stay;Hospitalization costs;Re-intervention rate due to intervention;Mortality rate;

Countries

China

Contacts

Public ContactYue Pin

The First Hospital of Lanzhou University

dryueping@sina.com+86 150 9535 4426

Outcome results

None listed

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