Using Ursodeoxycholic Acid to Prevent Complications After Gallstone-Related Pancreatitis

Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis, a Double-blind Multicenter Randomized-controlled Trial. OSOPOLAR Trial

This study is testing if Ursodeoxycholic Acid can help prevent complications in people who have had pancreatitis from gallstones while they wait for gallbladder surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital General Universitario de Alicante (Academic / other)
• Locations: 18 sites (Santiago de Compostela, A coruña and 17 other locations)
• Trial ID: NCT04924868 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been hospitalized for acute pancreatitis caused by gallstones.

Not a fit: Patients who have previously undergone gallbladder surgery or have recurrent pancreatitis from other causes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of recurrent pancreatitis and improve patient outcomes while they await surgery.

How similar studies have performed: While the use of Ursodeoxycholic Acid for gallstone dissolution has been explored, this specific application for preventing complications after acute pancreatitis is novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Santiago de Compostela, A coruña and 17 other locations

• Hospital Clínico Universitario de Santiago — Santiago de Compostela, A coruña, Spain (Not_yet_recruiting)
• Hospital General Universitario de Alicante — Alicante, Alicante, Spain (Recruiting)
• Hospital General Universitario de Elche — Elche, Alicante, Spain (Not_yet_recruiting)
• Hospital Univerisitario Vall D´Hebron — Barcelona, Barcelona, Spain (Not_yet_recruiting)
• Hospital de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (Not_yet_recruiting)
• Consorci Corporació Sanitària Parc Taulí de Sabadell — Sabadell, Barcelona, Spain (Not_yet_recruiting)
• Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain (Not_yet_recruiting)
• Hospital Clínio San Cecilio — Granada, Granada, Spain (Not_yet_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)
• Complejo Hospitalario de Ourense — Ourense, Ourense, Spain (Not_yet_recruiting)
• Hospital Universitario Central de Asturias. — Oviedo, Principality of Asturias, Spain (Recruiting)
• Hospital Clínico Universitario de Valencia — Alicante, Valencia, Spain (Recruiting)
• Hospital Clínico Universitario de Valladolid — Valladolid, Valladolid, Spain (Recruiting)
• Hospital Universitario de Cruces — Bilbao, Vizcaya, Spain (Recruiting)
• Hospital Clínico Lozano Blesa — Zaragoza, Zaragoza, Spain (Recruiting)
• Hospital Universitario Miguel Servet — Zaragoza, Zaragoza, Spain (Not_yet_recruiting)

Study contacts

• Principal investigator: Enrique De Madaria, Medicine — Alicante General University Hospital
• Study coordinator: Alicia Vaillo

Conditions Acute Pancreatitis Due to Gallstones; Acute pancreatitis; Gallstones; Ursodeoxycholic Acid; Randomized Controlled Trial