Actively Recruiting
Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis
Led by Hospital General Universitario de Alicante · Updated on 2025-03-20
332
Participants Needed
18
Research Sites
294 weeks
Total Duration
On this page
Sponsors
H
Hospital General Universitario de Alicante
Lead Sponsor
I
Instituto de Salud Carlos III
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Hospital admission due to acute pancreatitis with at least 2 of the following: typical pancreatitis pain, amylase and/or lipase over 3 times the normal upper limit, imaging showing acute pancreatitis
- Presence of gallstones confirmed by any imaging technique
- Patient provides informed consent
You will not qualify if you...
- Previous gallbladder removal surgery or endoscopic procedures related to biliary tract before recruitment
- History of recurrent acute pancreatitis from any cause
- Waiting list for cholecystectomy less than 30 days at the enrolling center
- Randomization more than 3 days after hospital discharge for acute pancreatitis
- UDCA use in the last 5 years or previous UDCA failure to dissolve gallstones
- Allergy, intolerance, or contraindications to UDCA including active gastric or duodenal ulcers, liver or intestinal disorders affecting bile salt circulation, and lactation
- Presence of common bile duct stones diagnosed before randomization
- Active alcoholism defined as 5 or more daily drinks in men or 3 or more in women, or suspicion of significant alcoholism
- Recent significant non-compliance or social problems affecting follow-up
- Hypertriglyceridemia over 400 mg/dL during admission or history of severe poorly controlled hypertriglyceridemia
- Chronic pancreatitis with pancreatic calcifications or Wirsung duct 4 mm or more
- Pancreatic cystic lesions not caused by pancreatitis
- Wirsung duct stenosis
- Primary hyperparathyroidism
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 18 locations
1
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A coruña, Spain, 15706
Not Yet Recruiting
2
Hospital General Universitario de Alicante
Alicante, Alicante, Spain, 03010
Actively Recruiting
3
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Not Yet Recruiting
4
Hospital Univerisitario Vall D´Hebron
Barcelona, Barcelona, Spain, 08035
Not Yet Recruiting
5
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Not Yet Recruiting
6
Consorci Corporació Sanitària Parc Taulí de Sabadell
Sabadell, Barcelona, Spain, 08208
Not Yet Recruiting
7
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Not Yet Recruiting
8
Hospital Clínio San Cecilio
Granada, Granada, Spain, 18016
Not Yet Recruiting
9
Hospital Ramon y Cajal
Madrid, Madrid, Spain
Actively Recruiting
10
Hospital Costa del Sol,
Marbella, Málaga, Spain, 29603
Actively Recruiting
11
Clinica Unversidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
12
Complejo Hospitalario de Ourense
Ourense, Ourense, Spain, 32005
Not Yet Recruiting
13
Hospital Universitario Central de Asturias.
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
14
Hospital Clínico Universitario de Valencia
Alicante, Valencia, Spain, 46010
Actively Recruiting
15
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain, 47003
Actively Recruiting
16
Hospital Universitario de Cruces
Bilbao, Vizcaya, Spain, 48903
Actively Recruiting
17
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, Spain, 50009
Actively Recruiting
18
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, Spain, 50009
Not Yet Recruiting
Research Team
A
Alicia Vaillo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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