Could conscious sedation replace general anesthesia for gallbladder drainage?

NCT ID NCT07704021

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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 Results may not be published yet.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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This study tests whether endoscopic ultrasound-guided gallbladder drainage can be safely performed using conscious sedation given by the endoscopist, instead of deep sedation or general anesthesia. The trial enrolls elderly, high-risk patients with acute cholecystitis who are not candidates for surgery. Researchers will monitor for sedation-related complications such as low oxygen levels or need for airway support, as well as procedure-related problems within 30 days.

What this could mean

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

Active substance
endoscopic ultrasound-guided gallbladder drainage under endoscopist-directed conscious sedation
What this could lead to
If successful, this approach could offer a safer, less invasive drainage option for elderly or frail patients who cannot undergo surgery or tolerate general anesthesia.
What could go wrong
This is a small, single-center study with only 48 participants, so results may not apply broadly. Conscious sedation may still carry risks like oxygen drops or need for emergency deeper sedation.

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

48 people

The number who actually took part.

Started

Apr 2022

Finished

Jun 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.

Who is studied

All consecutive patients undergoing EUS-GBD under conscious sedation at our tertiary referral center between January 2020 and October 2024 were prospectively enrolled.

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: * acute cholecystitis in patients considered unfit for surgery according to ASA Physical Status classification and clinical judgment. Exclusion Criteria: * age \<18 years * patients with acute cholecystitis fit for surgery

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Ospedale Guglielmo da Saliceto di Piacenza

    Piacenza, PC, 29121, Italy

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