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Safety Performance and Contributing Factors in Emergency Endoscopic Bile Duct Drainage During the Mid-Night Hours

Safety Performance and Contributing Factors in Emergency Endoscopic Bile Duct Drainage During the Mid-Night Hours, Multicenter Observational Study - Mid-night ERC study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000056891
Enrollment
100
Registered
2025-03-01
Start date
2024-10-30
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Acute cholangitis, stone pancreatitis, acute cholecystitis, post-operative bile leakage, acute hemobilia

Interventions

None listed

Sponsors

National Hospital Organization, Hokkaido Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. From April 1, 2021 to March 31, 2025, Patients with the following biliary emergencies who require urgent EBD. 2. Acute cholangitis, stone pancreatitis, acute cholecystitis, post-operative bile leakage, acute hemobilia 3. Age 18 years or older. 4. The subject or his/her representative has not expressed any refusal to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Patients with postoperative altered anatomy other than Billroth I. 2. Patients who mainly underwent pacreatic duct drainage. 3. Non-urgent endoscopic biliary drainage 4. Patients whose required information cannot be verified in the medical record. 5. Patients deemed inappropriate by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Incidence of adverse event within two hospital days after endoscopic biliary drainage

Secondary

MeasureTime frame
1. Severity of adverse event 2. Incidence of intraoperative event 3. Success rate of bile duct cannulation and the time required 4. Total procedure time 5. Procedure completion rate 6. Procedure background and characteristics 7. Operator background and characteristics 8. Clinical success rate 9. Post-procedure hospitalization period

Countries

Japan

Contacts

Public ContactShin Kato

National Hospital Organization, Hokkaido Medical Center Department of Gastroenterology

shinchan1231@gmail.com011-611-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026