Could conscious sedation replace general anesthesia for gallbladder drainage?
NCT ID NCT07704021
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
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Apr 2022
- Finished
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Jun 2026
- Lead sponsor
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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
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18 years and older
- Sex
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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 Hide 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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