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โ† Trials
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Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage

RecruitingNAAges 18 Years - anyAllOrlando Health, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients with suspected or confirmed acute calculous cholecystitis, diagnosed per Tokyo guidelines * Age โ‰ฅ 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 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
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What it tests

  • Percutaneous cholecystostomy
  • EUS-guided gallbladder drainage
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Where

1 site
Orlando Health Digestive Health Institute
Orlando, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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