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

NCT04924868 | Recruiting Phase 3

• 2 other identifiers: 2020/1592020-005901-16
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 18

Brief Summary

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

Acute Pancreatitis Due to Gallstones

Keywords

Acute pancreatitis; Gallstones; Ursodeoxycholic Acid; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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"

  From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

Secondary Outcomes (17)

• Relapse of acute pancreatitis

  From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

• Incidence of acute cholangitis

  From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

• Incidence of acute cholecystitis

  From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

• Incidence of biliary colic, with or without choledocholithiasis

  From recruitment to cholecystectomy or up to 1 year after recruitment if cholecystectomy is not performed

• Effectiveness of ursodeoxycholic acid in treating gallstones

  Abdominal ultrasonography will be performed at 6 and 12 months after recruitment unless cholecystectomy is performed

Study Arms (2)

UDCA (Ursodeoxycholic Acid) group

ACTIVE COMPARATOR

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

Placebo group

PLACEBO COMPARATOR

Capsules containing placebo, indistinguishable from active treatment.

Drug: Placebo

Interventions

Ursodeoxycholic Acid DRUG

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

UDCA (Ursodeoxycholic Acid) group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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 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

Sponsors & Collaborators

• Hospital General Universitario de Alicante: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (18)

Hospital Clínico Universitario de Santiago

Santiago de Compostela, A coruña, 15706, Spain

NOT YET RECRUITING

Hospital General Universitario de Alicante

Alicante, Alicante, 03010, Spain

RECRUITING

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

NOT YET RECRUITING

Hospital Univerisitario Vall D´Hebron

Barcelona, Barcelona, 08035, Spain

NOT YET RECRUITING

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

NOT YET RECRUITING

Consorci Corporació Sanitària Parc Taulí de Sabadell

Sabadell, Barcelona, 08208, Spain

NOT YET RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

NOT YET RECRUITING

Hospital Clínio San Cecilio

Granada, Granada, 18016, Spain

NOT YET RECRUITING

Hospital Ramon y Cajal

Madrid, Madrid, Spain

RECRUITING

Hospital Costa del Sol,

Marbella, Málaga, 29603, Spain

RECRUITING

Clinica Unversidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Complejo Hospitalario de Ourense

Ourense, Ourense, 32005, Spain

NOT YET RECRUITING

Hospital Universitario Central de Asturias.

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Alicante, Valencia, 46010, Spain

RECRUITING

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, 47003, Spain

RECRUITING

Hospital Universitario de Cruces

Bilbao, Vizcaya, 48903, Spain

RECRUITING

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Pancreatitis; Gallstones

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Cholelithiasis; Biliary Tract Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Enrique De Madaria, Medicine

  Alicante General University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia Vaillo

CONTACT

(+34) 661302932; vailloalicia@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of Biliary-Pancreatic Unit.

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 14, 2021
• Study Start: November 10, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (18)