Cholangiocarcinoma, Cholecystitis, Acute, Pancreas Cancer, Duct Cell Adenocarcinoma
Conditions
Keywords
gallbladder endoscopic ultrasound-guided drainage, sedation, acute cholecystitis
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.
Detailed description
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.
Interventions
DRUGSedation
Performing endoscopic ultrasound-guided gallbladder drainage under endoscopist-directed conscious sedation.
Sponsors
Azienda Unita Sanitaria Locale di Piacenza
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with sedation-related adverse events during EUS-guided gallbladder drainage | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with procedure-related adverse events | 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. |
Countries
Italy
Outcome results
None listed