Outcomes of endoscopic transpapillary gallbladder stenting (ETGS) in gallstones with acute cholangitis patients whose cholecystectomy are deferred: a randomized controlled trial
Phase 3
- Conditions
- gallstone-associated acute cholangitisGallstone, Cholangitis, Transpapillary gallbladder stenting
- Registration Number
- TCTR20240624004
- Lead Sponsor
- The Gastroenterological Association of Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 176
Inclusion Criteria
Age >/= 18 years old
- Gallstone with acute cholangitis patients
- Evaluated by surgical team and cholecystectomy is deferred
Exclusion Criteria
- Acute cholecystitis
- Acute biliary pancreatitis
- Hemodynamic unstable
- Uncontrolled coagulopathy
- Schedule for cholecystectomy within 3 months
- Previous ERCP
- Refuse to provide informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pancreatobiliary events 3 months diagnosis by physician
- Secondary Outcome Measures
Name Time Method technical success rate at the end of the intervention by fluoroscopy,clinical success rate 72 hours Proportion of patients who have resolution of symptoms, liver function test and leukocytosis,procedural related adverse events 2 weeks Proportion of patients who develop adverse events after procedure,rate of pancreatobiliary events during 6-month follow up 6 months Proportion of patients who develop pancreatobiliary events during 6-month follow up