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Can a tiny plastic stent keep gallstones away before surgery?

NCT ID NCT07331142

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether placing a temporary plastic tube (stent) in the bile duct after removing gallstones helps prevent stones from returning while patients wait for gallbladder surgery. 200 adults with both gallbladder and bile duct stones took part. Half got the stent, half did not. The goal was to see if the stent reduces stone recurrence and other bile-related problems within 3 months.

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

200 people

The number who actually took part.

Started

Mar 2024

Finished

Nov 2025

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. Age 18 to 75 years at the time of enrollment 2. Diagnosis of concomitant cholelithiasis and choledocholithiasis 3. Successful ERCP with complete choledocholithiasis clearance documented on occlusion cholangiogram during the index procedure 4. Endoscopic sphincterotomy (EST) performed during ERCP 5. Ability to provide informed consent 6. Scheduled for laparoscopic cholecystectomy within 2-4 weeks of ERCP 7. No contraindications to cholecystectomy Exclusion Criteria: 1. Incomplete choledocholithiasis clearance (residual stones on occlusion cholangiogram) 2. Altered biliary anatomy (e.g., previous bilioenteric anastomosis, Roux-en-Y reconstruction) 3. Active cholangitis or sepsis at the time of ERCP 4. Immunocompromised status (HIV/AIDS, active chemotherapy, chronic corticosteroid use) 5. Coagulopathy or anticoagulation therapy that cannot be safely interrupted 6. Pregnancy or lactation 7. Severe cardiopulmonary disease precluding safe anesthesia 8. Contraindications to cholecystectomy (e.g., unresectable malignancy, severe cirrhosis with portal hypertension) 9. Participation in another clinical trial within the past 30 days 10. Unable or unwilling to comply with follow-up protocol

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Conditions

The condition(s) this trial relates to.

choledocholithiasis cholelithiasis

As listed by the trial registrant

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

Choledocholithiasis

Contacts and locations

Locations

  • National Liver Institute, Menoufia University, Egypt.

    Shibīn al Kawm, 32511, Egypt

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