Liver Transplant DisorderSTEBINANSIEDNCT05761483
Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation.
An observational study of Liver Transplant Disorder and Ischemic Cholangiopathy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The study will evaluate the results of endoscopic treatment of NON-anastomotic biliary strictures following liver transplantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Disorder, Ischemic Cholangiopathy, Non-anastomotic Biliary Stricture
- What is being tested?
- ERCP
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 12 Mar 2020to 1 Jan 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that underwent liver transplantation and has a diagnosis of biliary strictures secondary to ischemic cholangiopaty (biliary stenoses involving bile ducts of the donor and extending to the hilum)
Who may be able to join
- Age > 18
- Non anastomotic biliary strictures diagnosed by direct cholangiogram (T-tube) or MRCP
- Stricture involving the hepatic hilum until secondary branches
- Increase of liver function tests
- Signature of the informed consent
Who cannot join
- Previopus endoscopic or percutaneous treatments
- Patient candidate to metal stents placement
- Previous surgery resulting in altered anatomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Gemelli IRCCS
Roma, RM, 00168
Andrea Tringali, +393287372601, andrea.tringali@unicatt.it
About this study
Official title: Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation. Registry of the Italian Society of Digestive Endoscopy.
The study will evaluate the results of endoscopic treatment of NON-anastomotic biliary strictures following liver transplantation
- Conditions
- Liver Transplant Disorder, Ischemic Cholangiopathy, Non-anastomotic Biliary Stricture, Biliary Stricture, Biliary Stents (Plastic)
- Being tested
- ERCP
- Keywords
- ERCP, Biliary stents, Liver transplantation, Ischemic cholangiopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Also called Biliary stents placement
Endoscopic Retrograde Cholangiopancreatography, placement of stents using a duodenoscope and making an access through the papilla of Vater
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of endoscopic treatment of non-anastomosis biliary strictures
Evaluate biliary stricture resolution rate
Measured: 2 Years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start12 Mar 2020
- Primary completion31 Oct 2026 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant DisorderStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tringali Andrea, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Andrea Tringali, MD, PhD, Principal investigator, Fondazione Policlinico Gemelli IRCCS, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761483
- Sponsor's protocol ID
- 2766
- Acronym
- STEBINANSIED
- Status last verified
- Jan 2026
- First submitted
- 25 Feb 2023
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation. Registry of the Italian Society of Digestive Endoscopy.
- ClinicalTrials.gov ID
- NCT05761483
- Acronym / sponsor ID
- STEBINANSIED / 2766
- Conditions
- Liver Transplant Disorder, Ischemic Cholangiopathy, Non-anastomotic Biliary Stricture, Biliary Stricture, Biliary Stents (Plastic)
- Keywords
- ERCP, Biliary stents, Liver transplantation, Ischemic cholangiopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 9 Mar 2023 (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.
The study will evaluate the results of endoscopic treatment of NON-anastomotic biliary strictures following liver transplantation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that underwent liver transplantation and has a diagnosis of biliary strictures secondary to ischemic cholangiopaty (biliary stenoses involving bile ducts of the donor and extending to the hilum)
Key inclusion criteria (5 listed)
- Age > 18
- Non anastomotic biliary strictures diagnosed by direct cholangiogram (T-tube) or MRCP
- Stricture involving the hepatic hilum until secondary branches
- Increase of liver function tests
- Signature of the informed consent
Key exclusion criteria (3 listed)
- Previopus endoscopic or percutaneous treatments
- Patient candidate to metal stents placement
- Previous surgery resulting in altered anatomy
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 |
|---|---|---|
| ERCPAlso: Biliary stents placementEndoscopic Retrograde Cholangiopancreatography, placement of stents using a duodenoscope and making an access through the papilla of Vater | Procedure or surgery | – |
Primary outcome
Evaluation of endoscopic treatment of non-anastomosis biliary strictures
Time frame: 2 Years follow-up
Evaluate biliary stricture resolution rate
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 29 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Liver Transplant Disorder
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
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.
Andrea Tringali, MD, PhD principal investigator
Fondazione Policlinico Gemelli IRCCS, Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant Disorder and Ischemic Cholangiopathy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Andrea Tringali, MD, PD (+393287372601, andrea.tringali@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of endoscopic treatment of non-anastomosis biliary strictures (time frame: 2 Years follow-up). 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 29 Jan 2026.