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Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis

RecruitingPhase 3Ages 18 Years - anyAllHospital General Universitario de Alicante
NCT04924868 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Acute pancreatitis is a common disease (3rd cause of hospital admission for digestive causes), which is associated with significant patient suffering, a 2-4% probability of death and considerable healthcare costs. Sixty percent of acute pancreatitis are due to the presence of stones in the gallbladder. The risk of suffering another acute biliary pancreatitis (ABP, that is to say, pancreatitis due to gallstones) or of other biliary complications in the following weeks or months is high (20% or greater) if measures are not taken to avoid it, being surgical removal of the gallbladder the most effective. Unfortunately, most Spanish centers have a surgical waiting list that makes gallbladder surgery unfeasible in a period of less than weeks or months, which is why readmission for biliary problems derived from the stones is a common problem. This, of course, causes danger and great stress and

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📋 Eligibility rules (as published)
Inclusion Criteria: * 18 years old or older * Hospital admission due to acute pancreatitis (definition: at least 2 of the following criteria: A) Typical pancreatitis pain, B) Amylase and/or lipase higher than 3 times the upper level of normality, C) Imaging compatible with acute pancreatitis * Presence of gallstones according to any imaging technique * Patient informed consent Exclusion Criteria: * Cholecystectomy and/or endoscopic retrograde cholangio-pancreatography and / or endoscopic cholecystostomy prior to recruitment * Recurrent acute pancreatitis (1 or more previous episodes of pancreatitis of any origin) * Current waiting list for cholecystectomy for acute biliary pancreatitis at that center less than 30 days * Randomization more than 3 days after hospital discharge for acute pancreatitis * Ursodeoxycholic acid (UDCA) consumption in the last 5 years or previous UDCA failure to dissolve lithiasis * Allergy, intolerance or presence of contraindications to UDCA (contraindicated in patients with active gastric or duodenal ulcer, liver or intestinal disorders that interfere with the enterohepatic circulation of bile salts and lactation) * Presence of choledocholithiasis diagnosed by imaging tests prior to randomization * Active alcoholism greater than or equal to 5 daily alcoholic drinks in men or 3 in women or high clinical suspicion of clinically significant alcoholism * Recent history of significant therapeutic non-compliance or social problem that makes follow-up difficult * Hypertriglyceridemia greater than 400 mg / dL during admission or history of poorly controlled severe hypertriglyceridemia * Chronic pancreatitis (pancreatic calcifications and / or Wirsung duct 4 or more mm) * Pancreatic cystic lesions not attributed to the pancreatitis itself * Wirsung duct stenosis * Primary hyperparathyroidism * Pregnancy
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What it tests

  • Ursodeoxycholic Acid
  • Placebo
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Where

18 sites
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital General Universitario de Elche
Elche, Spain
Hospital Univerisitario Vall D´Hebron
Barcelona, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, Spain
Consorci Corporació Sanitària Parc Taulí de Sabadell
Sabadell, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Hospital Clínio San Cecilio
Granada, Spain

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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