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Comparison of the efficacy and saftey of a novel biliary spontaneous dislodgement spiral stent with endoscopic nasobiliary drainage tube in temporary biliary drainage after complete removal of stones in the common bile duct: A prospective, non-inferiority, multi-center, randomized controlled trial

Comparison of the efficacy and saftey of a novel biliary spontaneous dislodgement spiral stent with endoscopic nasobiliary drainage tube in temporary biliary drainage after complete removal of stones in the common bile duct: A prospective, non-inferiority, multi-center, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104699
Enrollment
Unknown
Registered
2025-06-20
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Biliary stones of common bile duct

Interventions

Trial group:Dislodgement spiral stent are inserted after complete removal of bile duct stones by ERCP.
Comparison:Nasobiliary tube are inserted after complete removal of bile duct stones by ERCP.

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. patients who volunteer to participate and sign the informed consent form; 2. patients who are scheduled to undergo complete removal of common bile duct stone by ERCP.

Exclusion criteria

Exclusion criteria: 1. failure in cannulation or removal of stones during ERCP; 2. incomplete removal of common bile duct stones; 3. patients who concurrently have bile duct stenosis that need long-term stent drainage; 4. patients who have moderate to severe acute cholangitis or pancreatis before ERCP; 5. patients who have percutaneous transhepatic cholangial drainage; 6. patients who have gastrointestinal bleeding; 7. patients who have a history of intestinal obstruction; 8. patients who are pregant or in lactation period; 9. patientz who have rerouting of the gastrointestinal tract.

Design outcomes

Primary

MeasureTime frame
Post-ERCP cholangitis;Post-ERCP pancreatis;

Secondary

MeasureTime frame
Stent-related gastrointestinal injury;Stent retention;Nasobiliary tube-related adverse event;Bleeding;Perforation;Post-ERCP hospital stay;Evacuation time of stent;Time of removing nasobiliary tube;Medical cost;

Countries

China

Contacts

Public ContactBing Hu

West China Hospital of Sichuan University

hubingnj@163.com+86 189 8060 1278

Outcome results

None listed

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