Safety and Efficacy of EUS-guided Gallbladder Drainage Under Endoscopist-directed Conscious Sedation

NCT07704021 | Completed

• 1 other identifier: PC01
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholecystitis, Acute; Pancreas Cancer, Duct Cell Adenocarcinoma; Cholangiocarcinoma

Keywords

gallbladder endoscopic ultrasound-guided drainage; sedation; acute cholecystitis

Outcome Measures

Primary Outcomes (1)

• 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.

  from April 2022 to April 2028

Secondary Outcomes (1)

• Number of participants with procedure-related adverse events

  April 2022-2028

Interventions

Sedation DRUG

Performing endoscopic ultrasound-guided gallbladder drainage under endoscopist-directed conscious sedation.

Also known as: endoscopic ultrasound- guided gallbladder drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• acute cholecystitis in patients considered unfit for surgery according to ASA Physical Status classification and clinical judgment.

You may not qualify if:

• age \<18 years
• patients with acute cholecystitis fit for surgery

Sponsors & Collaborators

• Azienda Unita Sanitaria Locale di Piacenza: lead

Study Sites (1)

Ospedale Guglielmo da Saliceto di Piacenza

Piacenza, PC, 29121, Italy

Location

MeSH Terms

Conditions

Cholecystitis, Acute; Pancreatic Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 15, 2026
• Study Start: April 1, 2022
• Primary Completion: April 1, 2026
• Study Completion: June 30, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)