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NCT Number: NCT07704021

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

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.

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Key information

Conditions

Cholecystitis, Acute Adenocarcinoma Biliary Tract Diseases Carcinoma Cholangiocarcinoma Cholecystitis Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gallbladder Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreas Cancer, Duct Cell Adenocarcinoma Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Guglielmo da Saliceto di Piacenza

Piacenza, PC, 29121, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sedation

Drug

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

Other names: endoscopic ultrasound- guided gallbladder drainage

Primary outcomes

  1. Number of participants with sedation-related adverse events during EUS-guided gallbladder drainage

    Time frame: from April 2022 to April 2028

    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.

Secondary outcomes

  1. Number of participants with procedure-related adverse events

    Time frame: April 2022-2028

    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.

Sponsors and collaborators

Lead sponsor

Azienda Unita Sanitaria Locale di Piacenza

Other

Registry information

Official study title

Safety and Efficacy of Endoscopic Ultrasound-guided Gallbladder Drainage Under Endoscopist-directed Conscious Sedation: a Prospective Study

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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