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Simple needle trick may make gallbladder surgery safer

NCT ID NCT07378410

Symptom relief Sponsor: Aswan University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether using a needle to drain a swollen gallbladder during laparoscopic removal makes the operation easier and safer. 70 patients with acute cholecystitis, gallbladder mucocele, or empyema were randomly assigned to have their gallbladder drained or not. The goal was to see if aspiration reduces complications like gallbladder rupture, bile duct injury, and the need to switch to open surgery.

What this could mean

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

Active substance
laparoscopic needle aspiration
What this could lead to
If successful, this could make gallbladder removal surgery safer and easier by reducing the risk of gallbladder rupture and complications.
What could go wrong
This is a small, completed Phase 3 trial with only 70 participants, so results may not apply to all patients. Aspiration itself carries a small risk of bile leakage or infection.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

70 people

The number who actually took part.

Started

Jul 2023

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

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: * Patient with calcular cholecystitis, GB mucocele or GB empyema * Distended gallbladder: shiny, over distended, long, difficult to grasp and manipulate gallbladder. * Acute or chronic calcular cholecystitis Exclusion Criteria: * Obstructive jaundice * Non distended gallbladder * Previous upper abdomen operations * Pregnant

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Conditions

The condition(s) this trial relates to.

acute cholecystitis cholecystitis gallbladder mucocele, non-human animal hydrops of gallbladder

As listed by the trial registrant

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

Acute calculous cholecystitis Gallbladder empyema Gallbladder mucocele

Contacts and locations

Locations

  • Aswan University

    Aswān, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.