Status:
NOT_YET_RECRUITING
Organoids for Bile Leaks
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Biliary Anastomosis Complication
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
Background: Bile leakage remains a major complication after hepatobiliary surgery and liver transplantation. While most cases are managed through standard radiologic or endoscopic interventions, a sub...
Eligibility Criteria
Inclusion
- Age over 18 years old
- Undergone HPB surgical procedure with hepatic duct reconstruction
- Presence of anastomotic bile leakage untreatable with radiological or endoscopic approach
- Presence of bile duct specimen
Exclusion
- Age under 18 years old
- Undergone HPB surgical procedure without hepatic duct reconstruction
- Absence of anastomotic bile leakage untreatable with radiological or endoscopic approach
- Absence of bile duct specimen
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07214649
Start Date
January 1 2026
End Date
December 1 2030
Last Update
October 9 2025
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