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Drainage showdown: which Non-Surgical route best treats gallbladder attacks?

NCT ID NCT07696546

Disease control Sponsor: Orlando Health, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This trial compares two non-surgical drainage methods for acute cholecystitis (gallbladder inflammation) in people who are too sick for surgery. One method uses a tube through the skin, the other uses an endoscope to place a stent. Researchers will track complications, repeat procedures, and hospital readmissions over three years to see which approach works better.

What this could mean

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

What this could lead to
If one method proves safer or more effective, it could become the preferred drainage option for high-risk gallbladder patients.
What could go wrong
This is a single-center trial with 110 participants, so results may not apply broadly. Both procedures carry risks like infection or bleeding.

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

About 110 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2032

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.

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 with suspected or confirmed acute calculous cholecystitis, diagnosed per Tokyo guidelines * Age ≥ 18 years * Patients due to severe comorbidity who are deemed to be never-surgery candidates by the multidisciplinary team or patients who refuse to undergo surgery. * Patients can undergo EUS-guided drainage and percutaneous cholecystostomy tube placement. * Written informed consent by the patient or guardian who can understand the nature and possible consequences of participation in the study. Exclusion Criteria: * Pregnancy * Patients who are potential candidates for future cholecystectomy. * Patients unwilling to undergo follow-up assessments. * Patients with suspected gangrene or perforation of the gallbladder * Patients are diagnosed with concomitant liver abscess or necrotizing pancreatitis. * Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum. * Indwelling percutaneous cholecystostomy tube. * Refractory/persistently significant ascites despite paracentesis. * Distance between the gallbladder and gastric/duodenal wall that cannot be bridged by the metal stent. * Abnormal coagulation parameters that cannot be correct: INR \> 1.7 and/or platelets \< 50.000/mm3

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Conditions

The condition(s) this trial relates to.

acute cholecystitis

As listed by the trial registrant

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

Acute cholecystitis

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Orlando Health Digestive Health Institute

    RECRUITING

    Orlando, Florida, 32806, United States

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