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The role of endoscopic sphincterotomy in biliary stent deployment due to biliary stricture-a prospective, multicentre, single-blind, randomized controlled study

The role of endoscopic sphincterotomy in biliary stent deployment due to biliary stricture-a prospective, multicentre, single-blind, randomized controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108241
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-06-22
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Biliary strictures patients

Interventions

No sphincterotomy group:After successful cannulation, standardized ES will not be performed, then proceed with subsequent ERCP operations
Sphincterotomy group:After successful cannulation, standardized ES was performed using a sphincterotome with blended current, then proceed with subsequent ERCP operations

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults aged >=18 years; 2. In patients with biliary stricture, ERCP (endoscopic retrograde cholangiopancreatography) is required to place a transpapillary biliary stent (primary ERCP, primitive duodenal papilla). 3. Be able to understand and comply with the clinical research protocol, and voluntarily sign the informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with biliary stent placement above the nipple. 2. History of gastrointestinal reconstruction surgery (except Billroth type I). 3. The presence of acute pancreatitis. 4. The main duodenal papilla could not be reached during ERCP. 5. Duodenal papilla biliary fistula, ectopic duodenal papilla, pancreaticobiliary maljunction and annular pancreas may affect the operation. 6. Severe acute cholangitis. 7. Prothrombin time and international normalized ratio (INR) >=1.5, and platelet count <50,000/mm³. 8. Severe heart, lung, brain disease, severe liver disease (Child-Pugh score B-C), severe renal insufficiency (requiring maintenance hemodialysis). 9. Anticoagulation or antiplatelet agents cannot be stopped. 10. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Incidence of PEP;

Secondary

MeasureTime frame
Incidence of bleeding after ERCP;Incidence of cholangitis after ERCP;Recurrence rate of biliary obstruction;Incidence of Cholecystitis after ERCP;

Countries

China

Contacts

Public ContactJunbo Hong/Xiaojiang Zhou

The First Affiliated Hospital of Nanchang University

doctorhjb@126.com+86 13767042550

Outcome results

None listed

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