Cholecystitis Clinical Trials

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Percutaneous or Endoscopic Gallbladder Drainage: The PEG Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
Orlando Health Digestive Health Institute
RECRUITING
Orlando
Contact Information
Primary
Ji Young Bang, MD MPH
jiyoung.bang@orlandohealth.com
321-842-2273
Backup
Barbara J Broome
barbara.broome@orlandohealth.com
321-841-4356
Time Frame
Start Date: 2026-07
Estimated Completion Date: 2032-12
Participants
Target number of participants: 110
Treatments
Active_comparator: Percutaneous cholecystostomy
Patients with acute calculous cholecystitis who are never-surgery candidates undergoing percutaneous cholecystostomy tube placement
Active_comparator: EUS-guided gallbladder drainage
Patients with acute calculous cholecystitis who are never-surgery candidates, undergoing EUS-guided gallbladder drainage
Related Therapeutic Areas
Sponsors
Leads: Orlando Health, Inc.

This content was sourced from clinicaltrials.gov