Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Acute Pancreatitis Due to Gallstones

In brief

Acute pancreatitis is a common disease (3rd cause of hospital admission for digestive causes), which is associated with significant patient suffering, a 2-4% probability of death and considerable healthcare costs. Sixty percent of acute pancreatitis are due to the presence of stones in the gallbladder. The risk of suffering another acute biliary pancreatitis (ABP, that is to say, pancreatitis due to gallstones) or of other biliary complications in the following weeks or months is high (20% or greater) if measures are not taken to avoid it, being surgical removal of the gallbladder the most effective. Unfortunately, most Spanish centers have a surgical waiting list that makes gallbladder surgery unfeasible in a period of less than weeks or months, which is why readmission for biliary problems derived from the stones is a common problem. This, of course, causes danger and great stress and anger for patients affected by these complications on the waiting list, damaging their relationship with the health system and it is linked to increased cost. In addition, there is a very vulnerable group, those patients who due to age or serious diseases cannot undergo gallbladder surgery but have a high probability of suffering biliary problems due to the stones they have. Ursodeoxycholic acid (UDCA) is very safe drug which is used to dissolve gallstones, but its role in preventing biliary complications after ABP has not been studied adequately so it is not frequently used. Our objective is to investigate if UDCA is useful in this scenario, which would avoid suffering and adverse consequences for the patient and reduce the consumption of resources.

Key facts

Study ID: NCT04924868
Run by: Hospital General Universitario de Alicante
People needed: 332
Starts: 2021-11-10
Expected to finish: 2027-07-01
Last updated by the study team: 2025-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 it is running

Hospital Costa del Sol, — Marbella, Málaga, Spain (enrolling)
Clinica Unversidad de Navarra — Pamplona, Navarre, Spain (enrolling)
Hospital General Universitario de Alicante — Alicante, Alicante, Spain (enrolling)
Hospital Universitario Central de Asturias. — Oviedo, Principality of Asturias, Spain (enrolling)
Hospital Clínico Universitario de Valencia — Alicante, Valencia, Spain (enrolling)
Hospital Clínico Universitario de Valladolid — Valladolid, Valladolid, Spain (enrolling)
Hospital Universitario de Cruces — Bilbao, Vizcaya, Spain (enrolling)
Hospital Clínico Lozano Blesa — Zaragoza, Zaragoza, Spain (enrolling)
Hospital Ramon y Cajal — Madrid, Madrid, Spain (enrolling)
Hospital Universitario Miguel Servet — Zaragoza, Zaragoza, Spain
Hospital General Universitario de Elche — Elche, Alicante, Spain
Hospital Univerisitario Vall D´Hebron — Barcelona, Barcelona, Spain
Hospital de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain
Consorci Corporació Sanitària Parc Taulí de Sabadell — Sabadell, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain
Hospital Clínio San Cecilio — Granada, Granada, Spain
Complejo Hospitalario de Ourense — Ourense, Ourense, Spain
Hospital Clínico Universitario de Santiago — Santiago de Compostela, A coruña, Spain

Full record on ClinicalTrials.gov

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