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Organoids for Bile Leaks

NCT07214649 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-10-09

No results posted yet for this study

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

Interventions

BIOLOGICAL

Organoid-guided treatment

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

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2030-06-30
Completion
2030-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07214649 on ClinicalTrials.gov