Organoids for Bile Leaks (ASCORB)

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase

Not yet enrolling

Phase 2

Conditions

Biliary Anastomosis Complication

Treatments

Biological: Organoid-guided treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT07214649

2025001

FPG (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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