Obstructive pancreatitis Trials in Disease

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

This clinical trial is investigating whether a medication called Ursodeoxycholic Acid (also known as Ursodiol) can help prevent further complications after someone has experienced an episode of acute biliary pancreatitis caused by gallstones. The pancreas becomes inflamed when gallstones block the bile duct, and this study aims to find out if the medication can reduce the risk of this happening again.

Who can participate:

• Adults aged 18 years or older
• People who have had their first episode of acute biliary pancreatitis, confirmed by symptoms such as acute abdominal pain in the upper or middle belly, blood tests showing elevated pancreatic enzymes (amylase or lipase more than three times the normal limit), or imaging tests showing signs of pancreatitis
• The pancreatitis must have been caused by a biliary problem, such as gallstones, tiny stones, or thick bile in the gallbladder
• Willingness to sign an informed consent form

Who cannot participate:

• Patients who have already experienced a recurrence of acute biliary pancreatitis
• Patients who have already had surgery to remove the gallbladder (cholecystectomy) within one year after their initial episode

What the trial involves:

The main focus of this trial is to determine whether Ursodeoxycholic Acid can effectively prevent complications related to gallstones after an initial episode of pancreatitis. These complications might include another episode of pancreatitis, gallbladder inflammation, or bile duct infections. The study will also look at whether the medication can reduce the need for gallbladder removal surgery.

Participants will take the medication in capsule form (URSOBILANE 300 mg) for up to one year or until they have surgery to remove their gallbladder. The study is designed as a double-blind trial, which means neither the participants nor the researchers will know who is receiving the actual medication and who is receiving a placebo. This design helps ensure accurate and unbiased results.

The investigational drug:

Ursodeoxycholic Acid works by reducing cholesterol production in the liver and dissolving cholesterol in bile, which helps prevent new gallstones from forming. By doing this, the medication may lower the chances of experiencing further gallstone-related problems such as inflammation of the pancreas or gallbladder.

Throughout the study, participants will attend regular follow-up visits where their health will be monitored and any potential complications will be checked. The trial team will conduct various assessments to evaluate the effectiveness of the medication in preventing new episodes and other gallstone-related conditions.