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Stent showdown: double stents may clear tough bile stones in cirrhosis patients

NCT ID NCT07337291

Disease control Sponsor: National Liver Institute, Egypt 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at 400 people with liver cirrhosis who had large or complex bile duct stones that couldn't be removed during a first procedure. Doctors placed either one or two plastic stents to help drain the bile and make stones easier to remove later. The goal was to find the best stent choice for successful stone clearance and fewer complications in these high-risk 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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

400 people

The number who actually took part.

Started

Jan 2022

Finished

Jan 2026

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.

Ages

18 to 75 years

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: 1. Adults with established liver cirrhosis. 2. Presence of large or complex common bile duct (CBD) stones that were non-retrievable during the initial ERCP. 3. Classified as high-risk due to moderate to severe liver disease and/or substantial comorbidities, making them unable to safely tolerate extended endoscopic procedures or surgical intervention. 4. Clinically stable and capable of undergoing the scheduled diagnostic and therapeutic procedures. 5. Provided signed informed consent before enrollment. Exclusion Criteria: 1. Non-cirrhotic patients. 2. Patients with non-calculous causes of biliary obstruction (e.g., portal biliopathy, benign biliary strictures, or malignant biliary obstruction). 3. Acute suppurative cholangitis. 4. Contraindications to ERCP. 5. Inability to complete the scheduled 12-month follow-up time.

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Conditions

The condition(s) this trial relates to.

choledocholithiasis cirrhosis of liver hepatic vascular disorder

As listed by the trial registrant

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

Choledocholithiasis Liver circulation STENT

Contacts and locations

Locations

  • National Liver Institute, Menoufia University, Egypt.

    Shibīn al Kawm, Menoufia, 32511, Egypt

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