Using Ursodeoxycholic Acid to Prevent Complications After Gallstone-Related Pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of Ursodeoxycholic Acid in preventing relapsing complications in patients who have experienced acute pancreatitis due to gallstones. Given the high risk of recurrent biliary pancreatitis and other complications while patients await gallbladder surgery, this study aims to provide a non-surgical intervention to mitigate these risks. Participants will be randomly assigned to receive either Ursodeoxycholic Acid or a placebo, with the goal of assessing the drug's ability to reduce the incidence of further complications. The trial is particularly relevant in regions where surgical options are limited due to waiting lists.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital General Universitario de Alicante
  Alicante, Alicante, Spain Recruiting
• Hospital Ramon y Cajal
  Madrid, Madrid, Spain Recruiting
• Hospital Costa del Sol,
  Marbella, Málaga, Spain Recruiting
• Clinica Unversidad de Navarra
  Pamplona, Navarre, Spain Recruiting
• Hospital Universitario Central de Asturias.
  Oviedo, Principality of Asturias, Spain Recruiting
• Hospital Clínico Universitario de Valencia
  Alicante, Valencia, Spain Recruiting

Study contacts

• Principal investigator: Enrique De Madaria, Medicine — Alicante General University Hospital
• Study coordinator: Alicia Vaillo
• Email: vailloalicia@gmail.com
• Phone: (+34) 661302932

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Conservative versus proactive care after EUS-guided gallbladder drainage for acute cholecystitis

  This trial will test whether, for people with acute cholecystitis who cannot have surgery, keeping the endoscopic gallbladder stent in place long-term or doing regular endoscopic cleanings and removing the stent works better.

  Recruiting Hospital General Universitario de Alicante · Alicante, Alicante and 1 other locations · NCT06967597

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.