Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT04924868

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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