Evaluation of Ursodeoxycholic Acid in Preventing Recurrence of Acute Biliary Pancreatitis: A Double-Blind, Multicenter, Randomized Controlled Trial

The primary objective of this study is to evaluate the **incidence** of death or complications associated with gallstones, such as acute pancreatitis, biliary colic, cholecystitis, cholangitis, or choledocholithiasis, in patients who have experienced a first episode of acute biliary pancreatitis. This assessment will be conducted during the follow-up period until a cholecystectomy is performed or up to one year after the initial episode. This objective is clinically relevant as it aims to understand the recurrence and severity of complications, which can inform treatment strategies and improve patient outcomes.

Secondary objectives include: - Assessing the individual incidence of each biliary complication that constitutes the main variable. - Evaluating resource consumption. - Performing a survival analysis of the main variable (death or biliary complication during follow-up) using the Kaplan-Meier statistic. - Assessing the effectiveness of the treatment in dissolving lithiasis. - Evaluating the quality of life. These objectives provide a comprehensive understanding of the treatment's impact on patient health and healthcare resource utilization.

The clinical trial focuses on individuals who have experienced a **recurrence of acute biliary pancreatitis**. The study population includes both male and female adults aged 18 years and older. Participants are required to have a prior diagnosis of acute pancreatitis, confirmed by specific clinical criteria, and a biliary etiology diagnosed through imaging techniques such as ultrasound, CT, MRI, or endoscopic ultrasound. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants' general health status is not specified beyond the inclusion criteria related to their medical condition. Lifestyle considerations such as diet, physical activity, or habits are not detailed in the available data. Key inclusion criteria include adulthood, a confirmed diagnosis of acute pancreatitis with biliary etiology, and the signing of informed consent. The selection process for the trial population is not explicitly described in the provided information.

The clinical trial is designed to evaluate the efficacy of **ursodeoxycholic acid** in preventing relapsing complications following an initial episode of gallstone acute pancreatitis. This study is a **randomized**, **double-blind**, and **controlled** trial, ensuring that neither the participants nor the researchers know who is receiving the active treatment or the placebo, thereby minimizing bias. The trial is expected to run until December 31, 2025, with recruitment having commenced on October 6, 2021. Participants will be involved in the study for a maximum of 12 months, or until they undergo a cholecystectomy, whichever occurs first.

The sequence of study visits begins with an inclusion (screening) visit, where eligibility is confirmed based on criteria such as age (18 years or older) and a diagnosis of acute pancreatitis with a biliary etiology. Following the screening, participants will be randomly assigned to receive either the active treatment, **URSOBILANE 300 mg capsules**, or a placebo. The primary endpoint is the occurrence of death or complications associated with gallstones, such as a new episode of acute pancreatitis, cholangitis, cholecystitis, choledocholithiasis, or biliary colic, until a cholecystectomy is performed or up to one year after the initial episode.

Participants will attend regular follow-up visits to monitor their health status and any potential side effects. The end-of-study visit will occur at the conclusion of the participant's involvement, either after 12 months or post-cholecystectomy. Conditions that may lead to early termination from the study include withdrawal of consent, significant protocol deviations, or adverse events that necessitate discontinuation of the study drug. The trial aims to provide valuable insights into the prevention of recurrent complications in patients with a history of gallstone acute pancreatitis.

The clinical trial involves the administration of **URSODEOXYCHOLIC ACID** as the experimental medication. This compound is provided in the form of capsules, specifically branded as URSOBILANE 300 mg capsules. The active substance, ursodeoxycholic acid, is chemically derived and is recognized under the ATC code A05AA02. The medication is administered orally, with a maximum daily dose of 300 mg. The treatment period is set for a maximum of 12 months. The pharmaceutical form is a capsule, and the product is manufactured by Laboratorio Estedi, S.L. Compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the prescribed regimen.

In addition to the experimental treatment, a placebo is utilized in the study. The placebo is referred to as "Excipiente número 1 para cápsulas 500 gramos." This substance does not contain any active pharmaceutical ingredients and serves as a control to evaluate the efficacy of the experimental medication. The placebo is also administered in a capsule form, although specific details regarding its pharmaceutical form and administration route are not applicable. The use of a placebo is critical in maintaining the double-blind nature of the trial, ensuring unbiased results.

The efficacy of the clinical trial titled "Ursodeoxycolic acid for the prevention of relapsing complications after gallstone acute pancreatitis, a double-blind multicenter randomized-controlled trial" will be assessed by evaluating the incidence of death or complications associated with gallstones. These complications include acute pancreatitis, biliary colic, cholecystitis, cholangitis, or choledocholithiasis. The primary endpoint is defined as the occurrence of these events until a cholecystectomy is performed or up to one year following the initial episode of gallstone acute pancreatitis (PAB).

The primary endpoint will be measured by tracking the occurrence of death and/or gallstone-related complications. The trial will utilize a double-blind, randomized-controlled design to ensure unbiased assessment of the efficacy of **ursodeoxycholic acid**. The trial is set to conclude by December 31, 2025, with the recruitment phase having commenced on October 6, 2021. The maximum treatment period for participants receiving ursodeoxycholic acid is 12 months, administered in capsule form. The trial aims to provide robust data on the effectiveness of ursodeoxycholic acid in preventing relapsing complications in patients who have experienced a first episode of gallstone acute pancreatitis.