An observational study in Cholecystitis, Acute, Pancreas Cancer, Duct Cell Adenocarcinoma and Cholangiocarcinoma, sponsored by Azienda Unita Sanitaria Locale di Piacenza. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Azienda Unita Sanitaria Locale di Piacenza · Observational
This prospective single-center study was designed by the investigators to evaluate the feasibility, safety, and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) performed under endoscopist-directed conscious sedation in elderly, high-risk patients with acute cholecystitis. The study aims to assess whether conscious sedation represents a viable alternative to deep sedation or general anesthesia in this fragile patient population.
Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has emerged as an effective minimally invasive treatment for acute cholecystitis in patients who are poor surgical candidates. Although the procedure is commonly performed under deep sedation or general anesthesia, many patients eligible for EUS-GBD are elderly and have significant comorbidities, making anesthesia management particularly challenging. Data regarding the use of endoscopist-directed conscious sedation for EUS-GBD remain limited.
The investigators designed this prospective single-center study to evaluate the feasibility, safety, and efficacy of EUS-GBD performed under endoscopist-directed conscious sedation in a cohort of elderly, high-risk patients with acute cholecystitis. The study focuses on procedural outcomes and sedation management, with particular attention to ketamine-based conscious sedation as a potential strategy for minimizing anesthesia-related risks in this vulnerable population.
140 studies on the registry are indexed under Cholecystitis, Acute; 30 are open to participants now.
This study's enrollment of 48 is below the median of 216 across 52 observational studies indexed under Cholecystitis, Acute.
Browse Cholecystitis, Acute studies →Azienda Unita Sanitaria Locale di Piacenza is the lead sponsor of 15 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patients undergoing EUS-GBD under conscious sedation at our tertiary referral center between January 2020 and October 2024 were prospectively enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Performing endoscopic ultrasound-guided gallbladder drainage under endoscopist-directed conscious sedation.
Also known as: endoscopic ultrasound- guided gallbladder drainage
Number of participants with sedation-related adverse events during EUS-guided gallbladder drainage
Sedation-related adverse events occurring during or immediately after the procedure, including oxygen desaturation (SpO₂ \<90%), hypotension requiring intervention, bradycardia, need for airway support, unplanned conversion to deep sedation or general anesthesia, and procedure interruption due to sedation-related complications.
Time frame: from April 2022 to April 2028
Number of participants with procedure-related adverse events
Procedure-related adverse events occurring during or within 30 days after EUS-guided gallbladder drainage, classified according to the ASGE lexicon and graded by severity.
Time frame: April 2022-2028
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Unita Sanitaria Locale di Piacenza