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Study on Ursodeoxycholic Acid to Prevent Recurrence of Acute Biliary Pancreatitis in Patients After Gallstone-Related Episode

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the prevention of complications after an episode of acute biliary pancreatitis, which is a condition where the pancreas becomes inflamed due to gallstones. The treatment being tested is a medication called Ursodeoxycholic Acid, also known as Ursodiol. This medication is provided in capsule form and is taken orally. The purpose of the study is to see if this medication can help prevent further complications related to gallstones, such as another episode of pancreatitis, gallbladder inflammation, or bile duct infections.

Participants in the study will be monitored over a period of up to one year. During this time, researchers will observe whether the medication helps reduce the risk of complications or the need for surgery to remove the gallbladder, known as a cholecystectomy. Some participants will receive the medication, while others will receive a placebo, which is a capsule that looks like the medication but does not contain the active ingredient.

The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The trial aims to provide valuable information on whether Ursodeoxycholic Acid can effectively prevent complications after an initial episode of acute biliary pancreatitis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are 18 years or older and have experienced a first episode of acute pancreatitis due to gallstones.

    The assessment will involve reviewing your medical history and conducting necessary tests, such as imaging tests, to confirm the diagnosis.

  3. Step 3

    Medication administration

    You will be given a medication called ursodeoxycholic acid, which comes in the form of capsules named URSOBILANE 300 mg.

    The medication is taken orally as per the prescribed dosage and frequency. The exact dosage and frequency will be provided by the study team.

    The duration of the medication administration will continue until a cholecystectomy is performed or up to one year after the initial episode of acute pancreatitis.

  4. Step 4

    Follow-up visits

    Regular follow-up visits will be scheduled to monitor your health and the effects of the medication.

    During these visits, you will undergo various assessments to check for any complications associated with gallstones, such as new episodes of pancreatitis or other related conditions.

  5. Step 5

    End of participation

    Your participation in the study will conclude once a cholecystectomy is performed or after one year from the initial episode of acute pancreatitis, whichever comes first.

    At the end of your participation, a final assessment will be conducted to evaluate your overall health and any outcomes related to the study.

Who can join the trial?

7 criteria

  • Must be an adult (18 years or older).
  • Must have had a first episode of acute biliary pancreatitis (PAB), which means:
    • Having at least two of the following three conditions:
      • Acute abdominal pain in the upper part of the belly or middle of the belly.
      • Blood tests showing amylase or lipase levels more than three times the normal limit. These are enzymes related to the pancreas.
      • An imaging test (like an ultrasound, CT, or MRI) that shows signs of acute pancreatitis.
      • Must have a biliary cause for the pancreatitis, such as:
        • Gallstones (cholelithiasis), which are hard particles that form in the gallbladder.
        • Microlithiasis or gallbladder sludge, which are tiny stones or thick bile in the gallbladder, diagnosed by imaging tests like ultrasound, CT, MRI, or endoscopic ultrasound.
        • Must sign the informed consent, which is a document that explains the study and confirms your agreement to participate.

Who cannot join the trial?

2 criteria

  • Patients who have had a **recurrence** of acute biliary pancreatitis cannot participate. A **recurrence** means having the condition happen again after it has already occurred once.
  • Patients who have not had a **cholecystectomy** performed within one year after the initial episode of acute biliary pancreatitis cannot participate. A **cholecystectomy** is a surgery to remove the gallbladder.
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Investigated drugs

Ursodeoxycolic acid is a medication used in this clinical trial to help prevent complications after a person has had an episode of gallstone-related acute pancreatitis. This medication works by reducing the production of cholesterol in the liver and by dissolving the cholesterol in bile, which can help prevent the formation of new gallstones. In this trial, the goal is to see if taking ursodeoxycholic acid can lower the chances of having more problems related to gallstones, such as inflammation of the pancreas or gallbladder, until the patient can have surgery to remove the gallbladder or for up to one year after their initial episode of pancreatitis.

What is already known about the treatment

Ursodeoxycholic acid – Ursodeoxycholic acid is administered orally, typically in the form of tablets or capsules. It is currently being studied in clinical trials for its potential to prevent complications after an initial episode of gallstone-related acute pancreatitis. The main therapeutic indication for this medication is to reduce the recurrence of acute biliary pancreatitis. At the molecular level, ursodeoxycholic acid works by reducing cholesterol absorption and dissolving cholesterol in bile, which can help prevent the formation of gallstones. It is classified pharmacologically as a bile acid.

Investigated diseases

Acute Biliary Pancreatitis – Acute biliary pancreatitis is a condition where the pancreas becomes inflamed due to a blockage in the bile duct, often caused by gallstones. This blockage leads to the activation of digestive enzymes within the pancreas, causing inflammation and damage to pancreatic tissue. The disease typically begins with sudden and severe abdominal pain, often accompanied by nausea and vomiting. As the condition progresses, the inflammation can lead to complications such as infection, tissue necrosis, or fluid accumulation around the pancreas. In some cases, the inflammation may resolve on its own, but recurrent episodes can occur if the underlying cause is not addressed. The progression of the disease can vary, with some individuals experiencing mild symptoms and others developing severe complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518237-28-00Estimated enrolment332 patientsSponsorHospital General Universitario Dr. Balmis

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