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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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hospital Clinico Universitario De Valladolid Valladolid Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Hospital Costa del Sol Marbella Spain
Hayvvxpe Uumapsqhmmfei De Lv Pcotzpzu Madrid Spain
Hctgfncz Uvnorokmkiimg Mtclwsx Dg Vztbifofgn Santander Spain
Pkjq Tupsz Hzcrsobp Uzxrrztxwwom Sabadell Spain
Hubhwbtk Uyaqdvahxpmee Dqdnphiz Donostia / San Sebastian Spain
Hceasyxg Uopawjplegdfg Dy Cokghinh Gijon Spain
Hfffmqmm Vnfb drcjplbh Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
06.10.2021

Trial locations

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.

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 ID:
2024-518237-28-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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