Clinical trial · Observational
Safety and Efficacy of EUS-guided Gallbladder Drainage Under Endoscopist-directed Conscious Sedation
Safety and Efficacy of Endoscopic Ultrasound-guided Gallbladder Drainage Under Endoscopist-directed Conscious Sedation: a Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Cholecystitis, Acute | — | UNRESOLVED | — |
| Pancreas Cancer, Duct Cell Adenocarcinoma | Pancreatic Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sedation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of participants with sedation-related adverse events during EUS-guided gallbladder drainage
- timeFrame
- from April 2022 to April 2028
- description
- 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)
- measure
- Number of participants with procedure-related adverse events
- timeFrame
- April 2022-2028
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available