Percutaneous or Endoscopic Gallbladder Drainage: The PEG Trial
Orlando Health, Inc.
Summary
This is a randomized trial of patients with acute calculous cholecystitis who are never-surgery candidates. Patients will be randomized to one of two treatment groups, percutaneous cholecystostomy or endoscopic ultrasound-guided drainage. The aim of the study is to compare between these two treatment methods, the treatment outcomes and quality of life over a follow-up duration of 36 months.
Description
Acute calculous cholecystitis (ACC) is characterized by an inflammatory condition involving the gallbladder wall, most often caused by an obstruction at the infundibulum or cystic duct, with less than 10% of cases provoked by other causes. Surgical cholecystectomy (SC), especially by laparoscopic assistance, is considered the gold standard approach for the treatment of ACC. However, some patients due to high frailty, multiple comorbidities, and clinically significant organ failure are considered suboptimal or "unfit" candidates for surgery. Therefore, less invasive approaches have been develo…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with suspected or confirmed acute calculous cholecystitis, diagnosed per Tokyo guidelines * Age ≥ 18 years * Patients due to severe comorbidity who are deemed to be never-surgery candidates by the multidisciplinary team or patients who refuse to undergo surgery. * Patients can undergo EUS-guided drainage and percutaneous cholecystostomy tube placement. * Written informed consent by the patient or guardian who can understand the nature and possible consequences of participation in the study. Exclusion Criteria: * Pregnancy * Patients who are potential candidate…
Interventions
- ProcedurePercutaneous cholecystostomy
Percutaneous cholecystostomy tube placement by interventional radiology
- ProcedureEUS-guided gallbladder drainage
EUS-guided gallbladder drainage using metal stent
Location
- Orlando Health Digestive Health InstituteOrlando, Florida