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New treatment option for Acute Cholecystitis
Official title Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage
ClinicalTrials.gov ID: NCT07696546
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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
- 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.
See the full eligibility 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.
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.