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

Last updated: March 16, 2025
Sponsor: Hospital General Universitario de Alicante
Overall Status: Active - Recruiting

Phase

3

Condition

Pancreatitis

Liver Disorders

Gall Bladder Disorders

Treatment

Placebo

Ursodeoxycholic Acid

Clinical Study ID

NCT04924868
2020/159
2020-005901-16
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years old or older

  • Hospital admission due to acute pancreatitis (definition: at least 2 of thefollowing criteria: A) Typical pancreatitis pain, B) Amylase and/or lipase higherthan 3 times the upper level of normality, C) Imaging compatible with acutepancreatitis

  • Presence of gallstones according to any imaging technique

  • Patient informed consent

Exclusion

Exclusion Criteria:

  • Cholecystectomy and/or endoscopic retrograde cholangio-pancreatography and / orendoscopic cholecystostomy prior to recruitment

  • Recurrent acute pancreatitis (1 or more previous episodes of pancreatitis of anyorigin)

  • Current waiting list for cholecystectomy for acute biliary pancreatitis at thatcenter 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 failureto dissolve lithiasis

  • Allergy, intolerance or presence of contraindications to UDCA (contraindicated inpatients with active gastric or duodenal ulcer, liver or intestinal disorders thatinterfere 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 inwomen or high clinical suspicion of clinically significant alcoholism

  • Recent history of significant therapeutic non-compliance or social problem thatmakes follow-up difficult

  • Hypertriglyceridemia greater than 400 mg / dL during admission or history of poorlycontrolled 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

Study Design

Total Participants: 332
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 10, 2021
Estimated Completion Date:
July 01, 2027

Connect with a study center

  • Hospital Clínico Universitario de Santiago

    Santiago De Compostela, A coruña 15706
    Spain

    Site Not Available

  • Hospital General Universitario de Elche

    Elche, Alicante 03203
    Spain

    Site Not Available

  • Hospital Universitario Central de Asturias.

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

  • Hospital de Bellvitge

    Hospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Consorci Corporació Sanitària Parc Taulí de Sabadell

    Sabadell, Barcelona 08208
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Costa del Sol,

    Marbella, Málaga 29603
    Spain

    Active - Recruiting

  • Clinica Unversidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Alicante, Valencia 46010
    Spain

    Active - Recruiting

  • Hospital Universitario de Cruces

    Bilbao, Vizcaya 48903
    Spain

    Active - Recruiting

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Active - Recruiting

  • Hospital Univerisitario Vall D´Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Clínio San Cecilio

    Granada, 18016
    Spain

    Site Not Available

  • Hospital Ramon y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • Complejo Hospitalario de Ourense

    Ourense, 32005
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

  • Hospital Clínico Lozano Blesa

    Zaragoza, 50009
    Spain

    Active - Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

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