Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage
ConditionAcute Cholecystitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOrlando Health, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Pregnancy
Patients who are potential candidates for future cholecystectomy.
Patients unwilling to undergo follow-up assessments.
Patients with suspected gangrene or perforation of the gallbladder
Trial design
Treatments tested in this trial
- Percutaneous cholecystostomy
- EUS-guided gallbladder drainage
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov