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NCT Number: NCT04924868

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

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.

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Key information

Conditions

Acute Pancreatitis Due to Gallstones Biliary Tract Diseases Calculi Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallstones Pancreatic Diseases Pancreatitis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clínico Universitario de Santiago, Santiago de Compostela, A coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ursodeoxycholic acid

Drug

Ursodeoxycholic Acid will be administered to patients in the UDCA group as a prophylactic measure of future complications associated to gallstones

Placebo

Drug

Placebo: composition per 100g: colloidal silica 1.95g and cellulose microcrystalline 98.05g.

Primary outcomes

  1. Complication due to gallstones

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    Composite endpoint: incidence of any of the following: acute pancreatitis, acute cholangitis, acute cholecystitis, biliary colic (with or without choledocholithiasis) Definitions are provided in "Secondary Outcome Measures"

Secondary outcomes

  1. Relapse of acute pancreatitis

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    New episode of acute pancreatitis after recruitment Definition of acute pancreatitis (revised Atlanta classification): 2 or more 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

  2. Incidence of acute cholangitis

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    Acute cholangitis after recruitment

    Acute cholangitis definition (Tokyo 2018 guidelines):

    A. Systemic inflammation: A-1. Fever and/or shaking chills; A-2. Laboratory data: evidence of inflammatory response B. Cholestasis: B-1. Jaundice; B-2. Laboratory data: abnormal liver function tests C. Imaging: C-1. Biliary dilatation; C-2. Evidence of the etiology on imaging (stricture, stone, stent etc.) Suspected diagnosis: one item in A + one item in either B or C Definite diagnosis: one item in A, one item in B and one item in C

  3. Incidence of acute cholecystitis

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    Acute cholecystitis after recruitment

    Acute cholecystitis definition (Tokyo 2018 guidelines):

    A. Local signs of inflammation: (1) Murphy's sign, (2) RUQ mass/pain/tenderness B. Systemic signs of inflammation: (1) Fever, (2) elevated CRP, (3) elevated WBC count C. Imaging findings: Imaging findings characteristic of acute cholecystitis Suspected diagnosis: one item in A + one item in B Definite diagnosis: one item in A + one item in B + C

  4. Incidence of biliary colic, with or without choledocholithiasis

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    Biliary colic after recruitment Biliary colic definition: typical biliary colic pain. Choledocholithiasis: presence of stones or biliary sludge in the common bile duct according to imaging or endoscopic retrograde cholangio-pancreatography

  5. Effectiveness of ursodeoxycholic acid in treating gallstones

    Time frame: Abdominal ultrasonography will be performed at 6 and 12 months after recruitment unless cholecystectomy is performed

    Decrease or elimination of gallstones according to ultrasonography

  6. EORTC-QLQ C30 questionnaire

    Time frame: Measurement at 1, 3, 6, 9 and 12 months after recruitment

    EORTC-QLQ C30 questionnaire as a measure of Quality of Life

  7. Hospital stay during follow-up

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    Number of days admitted due to symptomatic gallstone disease

  8. Intensive care unit stay during follow-up

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    Number of days admitted in the intensive care unit due to symptomatic gallstone disease

  9. Adverse events

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    Adverse events due to ursodeoxycolic acid or placebo

  10. Number of visits to emergency room or hospital admissions due to symptomatic gallstone disease

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    Number of visits to emergency room or hospital admissions due to symptomatic gallstone disease

  11. Need for endoscopic retrograde cholangio-pancreatography (ERCP) during follow-up

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    Need for ERCP due to choledocholithiasis or acute cholangitis

  12. Need for gallbladder endoscopic or percutaneous drainage during follow-up

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    Need for gallbladder endoscopic or percutaneous drainage due to acute cholecystitis or cholangitis

  13. Need for drainage of collections and abscesses

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    Need for drainage of collections and abscesses (liver abscess, symtomatic pancreatic or peripancreatic collections not related to the index acute pancreatitis)

  14. Incidence of organ failure during follow-up

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    Organ failure definition (revised Atlanta classification): PaO2/FIO2<300, Creatinine >=1.9 mg/dl and/or systolic blood pressure <90mmHg despite fluid resuscitation

  15. Mortality

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    Death during follow-up

  16. Need for urgent cholecystectomy

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    Need for urgent cholecystectomy for acute gallbladder complication, mainly acute cholecystitis

  17. Need for surgical necrosectomy

    Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

    Need for surgical necrosectomy, mainly after infection of pancreatic necrosis (not related to the index acute pancreatitis)

Study contacts

Contact information is provided by the study sponsor or research team.

Alicia Vaillo

CONTACT

[email protected]

(+34) 661302932

Sponsors and collaborators

Lead sponsor

Hospital General Universitario de Alicante

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: OSOPOLAR

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 14, 2021
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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