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

Launched by HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE · Jun 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Ursodeoxycholic Acid (UDCA) to see if it can help prevent complications in patients who have had acute pancreatitis caused by gallstones. Acute pancreatitis is a painful condition, and many patients experience additional problems after their first episode, especially if they have gallstones. The goal of this trial is to determine if UDCA can reduce the chances of these complications while patients wait for gallbladder surgery, which can often take weeks or months due to long waiting lists.

To be eligible for this trial, participants must be at least 18 years old and have been hospitalized for acute pancreatitis with gallstones. They should not have had any recent surgeries related to their gallstones and must be able to provide informed consent. Participants in the study will receive UDCA and will be monitored for any changes in their health. This trial is important because it could provide a safer option for patients who cannot have surgery right away, helping to reduce their suffering and improve their relationship with the healthcare system.

Gender

ALL

Eligibility criteria

• 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