NCT07696546 · Orlando Health, Inc.
Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage
(PEG)
What this study is about
This is a randomly assigned trial of patients with acute calculous cholecystitis who are never-surgery candidates. Patients will be randomly assigned to one of two treatment groups, percutaneous cholecystostomy or endoscopic ultrasound-guided drainage.
View original scientific description
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.
Interventions
PROCEDURE
Percutaneous cholecystostomy
Percutaneous cholecystostomy tube placement by interventional radiology
PROCEDURE
EUS-guided gallbladder drainage
EUS-guided gallbladder drainage using metal stent
Primary outcome measures
Composite endpoint of 1) procedure-related adverse events, 2) reintervention for disease recurrence or procedure-related adverse events, and/or 3) readmission due to underlying disease or procedure-related adverse events
Time frame: 36 months
A composite endpoint of 1) procedure-related adverse events, 2) reintervention for disease recurrence or procedure-related adverse events, and/or 3) readmission due to underlying disease or procedure-related adverse events, from index procedure to 36 months post-index intervention.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Patients who are potential candidates for future cholecystectomy.
- Patients unwilling to undergo follow-up assessments.
- Patients with suspected gangrene or perforation of the gallbladder
- Patients are diagnosed with concomitant liver abscess or necrotizing pancreatitis.
- Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum.
- Indwelling percutaneous cholecystostomy tube.
- Refractory/persistently significant ascites despite paracentesis.
- Distance between the gallbladder and gastric/duodenal wall that cannot be bridged by the metal stent.
- Abnormal coagulation parameters that cannot be correct: INR \> 1.7 and/or platelets \< 50.000/mm3
Where
- Orlando, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations