A Phase 3 interventional study of Ursodeoxycholic Acid and Placebo in Acute Pancreatitis Due to Gallstones, sponsored by Hospital General Universitario de Alicante. Recruiting at 18 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Hospital General Universitario de Alicante · Phase 3, Interventional, and Prevention
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.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 332 is above the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Hospital General Universitario de Alicante is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Clinically significant
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Patients receiving Ursodeoxycholic Acid, capsules containing 300 mg, 10 mg/Kg per day: Patients 40 to 70 kg: 2 capsules/day \>70 to 100 Kg: 3 capsules/day \>100 kg: 4 capsules/day
Drug: Ursodeoxycholic Acid
Capsules containing placebo, indistinguishable from active treatment.
Drug: Placebo
Ursodeoxycholic Acid will be administered to patients in the UDCA group as a prophylactic measure of future complications associated to gallstones
Placebo: composition per 100g: colloidal silica 1.95g and cellulose microcrystalline 98.05g.
Complication due to gallstones
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"
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Relapse of acute pancreatitis
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
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Incidence of acute cholangitis
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
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Incidence of acute cholecystitis
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
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Incidence of biliary colic, with or without choledocholithiasis
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
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Effectiveness of ursodeoxycholic acid in treating gallstones
Decrease or elimination of gallstones according to ultrasonography
Time frame: Abdominal ultrasonography will be performed at 6 and 12 months after recruitment unless cholecystectomy is performed
EORTC-QLQ C30 questionnaire
EORTC-QLQ C30 questionnaire as a measure of Quality of Life
Time frame: Measurement at 1, 3, 6, 9 and 12 months after recruitment
Hospital stay during follow-up
Number of days admitted due to symptomatic gallstone disease
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Intensive care unit stay during follow-up
Number of days admitted in the intensive care unit due to symptomatic gallstone disease
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Adverse events
Adverse events due to ursodeoxycolic acid or placebo
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
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
Need for endoscopic retrograde cholangio-pancreatography (ERCP) during follow-up
Need for ERCP due to choledocholithiasis or acute cholangitis
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 during follow-up
Need for gallbladder endoscopic or percutaneous drainage due to acute cholecystitis or cholangitis
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
Need for drainage of collections and abscesses (liver abscess, symtomatic pancreatic or peripancreatic collections not related to the index acute pancreatitis)
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Incidence of organ failure during follow-up
Organ failure definition (revised Atlanta classification): PaO2/FIO2\<300, Creatinine \>=1.9 mg/dl and/or systolic blood pressure \<90mmHg despite fluid resuscitation
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Mortality
Death during follow-up
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Need for urgent cholecystectomy
Need for urgent cholecystectomy for acute gallbladder complication, mainly acute cholecystitis
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Need for surgical necrosectomy
Need for surgical necrosectomy, mainly after infection of pancreatic necrosis (not related to the index acute pancreatitis)
Time frame: From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed
Plan to share: No
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Studies of the drug tested here: Ursodeoxycholic Acid
Hospital General Universitario de Alicante