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

NCT ID: NCT04924868

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-10

Study Completion Date

2027-07-01

Brief Summary

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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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Detailed Description

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Conditions

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Acute Pancreatitis Due to Gallstones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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UDCA (Ursodeoxycholic Acid) group

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

Group Type ACTIVE_COMPARATOR

Ursodeoxycholic Acid

Intervention Type DRUG

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

Placebo group

Capsules containing placebo, indistinguishable from active treatment.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Ursodeoxycholic Acid

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Hospital General Universitario de Alicante

OTHER

Sponsor Role lead

Responsible Party

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Enrique de-Madaria

Coordinator of Biliary-Pancreatic Unit.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enrique De Madaria, Medicine

Role: PRINCIPAL_INVESTIGATOR

Alicante General University Hospital

Locations

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Hospital Clínico Universitario de Santiago

Santiago de Compostela, A coruña, Spain

Site Status NOT_YET_RECRUITING

Hospital General Universitario de Alicante

Alicante, Alicante, Spain

Site Status RECRUITING

Hospital General Universitario de Elche

Elche, Alicante, Spain

Site Status NOT_YET_RECRUITING

Hospital Univerisitario Vall D´Hebron

Barcelona, Barcelona, Spain

Site Status NOT_YET_RECRUITING

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status NOT_YET_RECRUITING

Consorci Corporació Sanitària Parc Taulí de Sabadell

Sabadell, Barcelona, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Site Status NOT_YET_RECRUITING

Hospital Clínio San Cecilio

Granada, Granada, Spain

Site Status NOT_YET_RECRUITING

Hospital Ramon y Cajal

Madrid, Madrid, Spain

Site Status RECRUITING

Hospital Costa del Sol,

Marbella, Málaga, Spain

Site Status RECRUITING

Clinica Unversidad de Navarra

Pamplona, Navarre, Spain

Site Status RECRUITING

Complejo Hospitalario de Ourense

Ourense, Ourense, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Central de Asturias.

Oviedo, Principality of Asturias, Spain

Site Status RECRUITING

Hospital Clínico Universitario de Valencia

Alicante, Valencia, Spain

Site Status RECRUITING

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, Spain

Site Status RECRUITING

Hospital Universitario de Cruces

Bilbao, Vizcaya, Spain

Site Status RECRUITING

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, Spain

Site Status RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, Spain

Site Status NOT_YET_RECRUITING

Countries

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Spain

Central Contacts

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Alicia Vaillo

Role: CONTACT

[email protected]
(+34) 661302932

Facility Contacts

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Juan En Domínguez Muñoz, Medicine

Role: primary

[email protected]

Alicia Vaillo

Role: primary

[email protected]
0034 661302932

Irene Pascual Sánchez

Role: primary

[email protected]

Francesc Xa Molero Richard, Medicine

Role: primary

[email protected]

Silvia Salord Vila, Medicine

Role: primary

[email protected]

Laura Pa Llovet Soto, Medicine

Role: primary

[email protected]

Claudia Sánchez Marín

Role: primary

[email protected]

Antonio M Caballero, Medicine

Role: primary

[email protected]

Ana García García De Paredes, Medicine

Role: primary

[email protected]

Robin Rivera Irigoin, Medicine

Role: primary

[email protected]

Cristina Carretero Ribón, Medicine

Role: primary

[email protected]

Maria Francisco González

Role: primary

[email protected]

Maria Eu Lauret Braña

Role: primary

[email protected]

Isabel Pascual Moreno, Medicine

Role: primary

[email protected]

Maria Lo Ruíz Rebollo

Role: primary

[email protected]
983 42 00 00

Emma Martínez Moneo

Role: primary

[email protected]

Guillermo García Rayado, Medicine

Role: primary

[email protected]

Vanesa Bernal Monterde

Role: primary

[email protected]

Other Identifiers

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2020-005901-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2020/159

Identifier Type: -

Identifier Source: org_study_id

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