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New registry tracks best way to fix bile duct blockages in liver transplant patients

NCT ID NCT05761483

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 40 liver transplant patients who develop non-anastomotic biliary strictures—narrowing of the bile ducts not at the connection point. Doctors use an endoscope to place plastic stents and then track how well the strictures resolve. The goal is to gather real-world data to improve treatment guidelines.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this registry could help doctors better treat bile duct narrowing after liver transplants, improving patient outcomes.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove which treatment is best. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2020

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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)

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Previopus endoscopic or percutaneous treatments * Patient candidate to metal stents placement * Previous surgery resulting in altered anatomy

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Conditions

The condition(s) this trial relates to.

secondary sclerosing cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary stents (plastic) Biliary stricture Ischemic cholangiopathy Liver transplant disorder Non-anastomotic biliary stricture

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione Policlinico Gemelli IRCCS

    RECRUITING

    Roma, RM, 00168, Italy

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