Outcomes of endoscopic gallbladder drainage in acute cholecystitis with high-surgical risk: transpapillary approach versus endoscopic ultrasound-guided transmural approach

Phase 1

• Conditions: acute calculous cholecystitis with high surgical risk; Cholecystitis; High risk for surgery; Endoscopic retrograde cholangiopancreatography; Endoscopic ultrasonography; Drainage; Gallbladder; Stent; Outcomes

• Registration Number: TCTR20201208003
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-08
• Study Completion: 2021-12-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

aged > 18 years
acute calculous cholecystitis
high surgical risk with Charlson comorbidity index (CCI)> 5 or American Society of Anesthesiologists physical status (ASA-PS) > 2

Exclusion Criteria

Severe coagulopathy
Unstable medical condition
Gallbladder perforation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of recurrence acute cholecystitis until death or the end of the follow-up period observe clinical, LAB and imaging for diagnosis recurrence acute cholecystitis

Secondary Outcome Measures

Name	Time	Method
technical success rate At time of procedure successful placement of a stent in the gallbladder