Organoids for Bile Leaks

NCT ID: NCT07214649

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2030-12-31

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 subset of patients fails to respond and may face recurrent interventions or even retransplantation. Recent advances in regenerative medicine, particularly the development of extrahepatic cholangiocyte organoids (ECOs), offer a promising alternative.

Objective: This prospective, 5-year study aims to evaluate the feasibility, safety, and efficacy of autologous ECO-based cell therapy to reconstruct bile ducts in patients with persistent bile leakage unresponsive to standard care.

Methods: Patients undergoing hepatobiliary or liver transplant surgery will have a biopsy of extrahepatic bile duct tissue collected perioperatively. The tissue will be processed and stored in a dedicated biobank. Upon development of a refractory bile leak, ECOs will be generated from the stored tissue and delivered to the site of injury through radiological or endoscopic routes, as decided by a multidisciplinary team. Success will be evaluated by resolution of leakage (radiologically or endoscopically) and absence of further intervention.

Significance: The use of patient-specific ECOs holds transformative potential. Organoids can be derived and expanded in vitro while maintaining cholangiocyte identity and function. Preclinical studies in murine and human models show successful engraftment and functional integration into biliary epithelium.

Expected Outcomes: This project aims to pioneer a novel, minimally invasive, personalized regenerative therapy for otherwise intractable biliary complications.

Conditions

Biliary Anastomosis Complication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Organoid Arm

Group Type: EXPERIMENTAL

Organoid-guided treatment

Intervention Type: BIOLOGICAL

Engrafment of the Cholangiocyte Organoids in the common bile duct with leakage

Interventions

Organoid-guided treatment

Engrafment of the Cholangiocyte Organoids in the common bile duct with leakage

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

PASCALE MARCO MARIA

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Marco M Pascale, MD

Role: CONTACT

pascale.marco.maria@gmail.com

0039 3888264297

Other Identifiers

2025001

Identifier Type: REGISTRY

Identifier Source: secondary_id

FPG

Identifier Type: OTHER

Identifier Source: secondary_id

2025001

Identifier Type: -

Identifier Source: org_study_id