Biliary Anastomosis ComplicationPhase 2ASCORBNCT07214649
Organoids for Bile Leaks
A Phase 2 study testing Organoid-guided treatment in people with Biliary Anastomosis Complication, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Biliary Anastomosis Complication
- What is being tested?
- Organoid-guided treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Study Using Patient-Derived Extrahepatic Cholangiocyte Organoids for Refractory Bile Leaks
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.
Read more
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
- Being tested
- Organoid-guided treatment
- Keywords
- biliary leaks, cholangiocyte organoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organoid-guided treatmentBiological
Engrafment of the Cholangiocyte Organoids in the common bile duct with leakage
| Study group | Role | What they receive |
|---|---|---|
| Organoid Arm | Experimental | Not described Receives: Biological: Organoid-guided treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of the leaks
Absence of leak at radiological or endoscopic evaluation
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study startJan 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Anastomosis ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PASCALE MARCO MARIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214649
- Sponsor's protocol ID
- 2025001
- Other IDs
- 2025001, FPG
- Acronym
- ASCORB
- Status last verified
- Oct 2025
- First submitted
- 3 Oct 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Using Patient-Derived Extrahepatic Cholangiocyte Organoids for Refractory Bile Leaks
- ClinicalTrials.gov ID
- NCT07214649
- Acronym / sponsor ID
- ASCORB / 2025001
- Conditions
- Biliary Anastomosis Complication
- Keywords
- biliary leaks, cholangiocyte organoids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Organoid Arm | Experimental | Biological: Organoid-guided treatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organoid-guided treatmentEngrafment of the Cholangiocyte Organoids in the common bile duct with leakage | Biological | Organoid Arm |
Primary outcome
Treatment of the leaks
Time frame: 1 week
Absence of leak at radiological or endoscopic evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Organoid-guided treatment in people with Biliary Anastomosis Complication, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco M Pascale, MD (0039 3888264297, pascale.marco.maria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of the leaks (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.