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New rule could spare bile leak patients from unnecessary repeat ERCP

NCT ID NCT05141942

Knowledge-focused Sponsor: University of Calgary 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a simple rule to see if a bile leak stent can be safely removed using a less invasive gastroscopy instead of a repeat ERCP. The rule uses four easy-to-check factors, like normal blood test results and the type of leak. If validated, this approach could reduce radiation exposure, lower costs, and make care more accessible for 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 200 people

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

Started

Nov 2019

Expected to finish

Jun 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

Patients having ERCP for suspected post-surgical biliary leak;

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: * Patients having ERCP for suspected post-surgical biliary leak; * age 18 years or older * able to give informed consent to involvement. Exclusion Criteria: * Unable or unwilling to provide informed consent; * age \< 18 years; * non-surgical biliary leak; * previous ERCP with sphincterotomy; * previous treatment or attempted treatment of biliary leak; * unsuccessful initial ERCP.

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As listed by the trial registrant

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

Bile leak

Contacts and locations

Locations

  • University of Calgary

    Calgary, Alberta, T2N 4Z6, Canada

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