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Rare bile duct cysts: how often do they turn into cancer?

NCT ID NCT05404503

Knowledge-focused Sponsor: María Teresa Moreno Asencio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study reviews medical records of 300 people diagnosed with choledochal cysts (bile duct cysts) between 2000 and 2020 in Western hospitals. The goal is to find out how often these cysts lead to bile duct cancer and what factors increase that risk. By analyzing symptoms, treatments, and outcomes, researchers hope to provide clearer guidance on whether surgery or monitoring is best for each patient.

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 300 people

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

Started

Oct 2022

Expected to finish

Dec 2026

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

All patients with a radiological diagnosis of choledochal cyst. Those patients diagnosed by the radiology service are included

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: \- A radiological diagnosis (diagnosed by the radiology service) of choledochal cyst, understood as a dilatation of the extra or intrahepatic bile duct (fusiform or saccular, following the Todani classification) Exclusion Criteria: * An objectified obstructive cause that justifies a dilatación of bile duct (lithiasis, papillitis or neoplasia) * A definitive imaging test that rules out an initial diagnosis of choledochal cyst. * Intraoperative diagnosis of choledochal cyst without subsequent radiological confirmation. * Patients with cystic lesions of another nature (biliary cysts, simple cysts, cystic neoplasms).

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Conditions

The condition(s) this trial relates to.

bile duct cyst cholangiocarcinoma

As listed by the trial registrant

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

Choledochal cyst monitoring Incidence of cholangiocarcinoma on choledochal cysts Postoperative complications in choledochal cysts

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Juan Ramón Jimenez Hospital

    Huelva, 21005, Spain