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Prevention study for Acute Pancreatitis Due to Gallstones
Official title Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis
ClinicalTrials.gov ID: NCT04924868
What this study is testing
What is Ursodeoxycholic Acid?
Ursodeoxycholic Acid is an investigational medicine, being studied as a potential treatment for acute pancreatitis due to gallstones.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Presence of gallstones according to any imaging technique
- Patient informed consent
You likely can't join 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...
See the full eligibility 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...
- Presence of gallstones according to any imaging technique
- Patient informed consent
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Santiago de Compostela, A coruña, Spain
- Alicante, Alicante, Spain
- Elche, Alicante, Spain
- Barcelona, Barcelona, Spain
- L'Hospitalet de Llobregat, Barcelona, Spain
- Sabadell, Barcelona, Spain
- Santander, Cantabria, Spain
- Granada, Granada, Spain
- Madrid, Madrid, Spain
- Marbella, Málaga, Spain
- Pamplona, Navarre, Spain
- Ourense, Ourense, Spain
- Oviedo, Principality of Asturias, Spain
- Alicante, Valencia, Spain
- Valladolid, Valladolid, Spain
- Bilbao, Vizcaya, Spain
- Zaragoza, Zaragoza, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santiago de Compostela, A coruña, Spain; Alicante, Alicante, Spain; Elche, Alicante, Spain; Barcelona, Barcelona, Spain; L'Hospitalet de Llobregat, Barcelona, Spain; Sabadell, Barcelona, Spain and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.