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Ursodeoxycolic acid for the prevention of relapsing complications after gallstone acute pancreatitis, a double-blind multicenter randomized-controlled trial.
EU CTIS ID: 2024-518237-28-00
What this study is testing
To assess the incidence during follow-up of patients who have had a first episode of PAB, of the main variable of the study: death or complication associated with gallstones (acute pancreatitis, biliary colic, cholecystitis, cholangitis or choledocholithiasis), until have cholecystectomy performed or up to one year after the initial PAB.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adulthood (18 years or older)
- Income from PAB (will meet conditions 1 and 2): 1. Diagnosis of acute pancreatitis, at least 2 of the following 3 criteria (2) i) Acute abdominal pain in upper hemiabdomen or mesogastrium ii) Amylasemia or lipasemia greater than 3 times the upper limit of normal iii) Imaging test compatible with acute pancreatitis 2. Diagnosis of biliary etiology: cholelithiasis, microlithiasis or gallbladder sludge diagnosed by ultrasound, CT, MRI or endoscopic ultrasound.
- Signature of the informed consent.
You likely can't join if
- Endoscopic cholecystectomy and / or sphincterotomy prior to recruitment
- Hypertriglyceridemia greater than 400 mg / dL during admission or a history of poorly controlled severe hypertriglyceridemia.
- Chronic pancreatitis (pancreatic calcifications and / or Wirsung duct of 4 or more mm)
- Pancreatic cystic lesions not attributed to the PAB itself
- Wirsung duct stenosis.
- Primary hyperparathyroidism
See the full eligibility criteria
- Adulthood (18 years or older)
- Income from PAB (will meet conditions 1 and 2): 1. Diagnosis of acute pancreatitis, at least 2 of the following 3 criteria (2) i) Acute abdominal pain in upper hemiabdomen or mesogastrium ii) Amylasemia or lipasemia greater than 3 times the upper limit of normal iii) Imaging test compatible with acute pancreatitis 2. Diagnosis of biliary etiology: cholelithiasis, microlithiasis or gallbladder sludge diagnosed by ultrasound, CT, MRI or endoscopic ultrasound.
- Signature of the informed consent.
- Endoscopic cholecystectomy and / or sphincterotomy prior to recruitment
- Hypertriglyceridemia greater than 400 mg / dL during admission or a history of poorly controlled severe hypertriglyceridemia.
- Chronic pancreatitis (pancreatic calcifications and / or Wirsung duct of 4 or more mm)
- Pancreatic cystic lesions not attributed to the PAB itself
- Wirsung duct stenosis.
- Primary hyperparathyroidism
- Pregnancy
- Recurrent acute pancreatitis (1 or more previous episodes of pancreatitis of any origin)
- Current waiting list at your center for cholecystectomy for PAB less than 30 days
- Randomization more than 3 days after discharge from hospital for PAB
- UDCA consumption in the last 5 years
- Allergy, intolerance or presence of contraindications to UDCA (contraindicated in patients with 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 alcoholic drinks per day or high clinical suspicion of clinically significant alcoholism
- Recent history of significant therapeutic non-compliance or social problem that makes follow-up difficult
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.