Ursodeoxycolic acid for the prevention of relapsing complications after gallstone acute pancreatitis, a double-blind multicenter randomized-controlled trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital General Universitario Dr. Balmis

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2024-12-04

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518237-28-00

EudraCT number

2020-005901-16

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To assess the incidence during follow-up of patients who have had a first episode of PAB, of the main variable of the study: death or complication associated with gallstones (acute pancreatitis, biliary colic, cholecystitis, cholangitis or choledocholithiasis), until have cholecystectomy performed or up to one year after the initial PAB.

Secondary objectives 1

1. to assess the individual incidence of each of the biliary complications that make up the main variable. Value consumption of resources. Perform a survival analysis of the main variable (death or biliary complication during follow-up), using the Kaplan Meier statistic. Assess the effectiveness of the treatment in dissolving the lithiasis. Assess the quality of life.

Conditions and MedDRA coding

recurrence of acute biliary pancreatitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Adulthood (18 years or older)
2. Income from PAB (will meet conditions 1 and 2): 1. Diagnosis of acute pancreatitis, at least 2 of the following 3 criteria (2) i) Acute abdominal pain in upper hemiabdomen or mesogastrium ii) Amylasemia or lipasemia greater than 3 times the upper limit of normal iii) Imaging test compatible with acute pancreatitis 2. Diagnosis of biliary etiology: cholelithiasis, microlithiasis or gallbladder sludge diagnosed by ultrasound, CT, MRI or endoscopic ultrasound.
3. Signature of the informed consent.

Exclusion criteria 15

1. Endoscopic cholecystectomy and / or sphincterotomy prior to recruitment
2. Recurrent acute pancreatitis (1 or more previous episodes of pancreatitis of any origin)
3. Current waiting list at your center for cholecystectomy for PAB less than 30 days
4. Randomization more than 3 days after discharge from hospital for PAB
5. UDCA consumption in the last 5 years
6. Allergy, intolerance or presence of contraindications to UDCA (contraindicated in patients with gastric or duodenal ulcer, liver or intestinal disorders that interfere with the enterohepatic circulation of bile salts and lactation).
7. Presence of choledocholithiasis diagnosed by imaging tests prior to randomization.
8. Active alcoholism greater than or equal to 5 alcoholic drinks per day or high clinical suspicion of clinically significant alcoholism
9. Recent history of significant therapeutic non-compliance or social problem that makes follow-up difficult
10. Hypertriglyceridemia greater than 400 mg / dL during admission or a history of poorly controlled severe hypertriglyceridemia.
11. Chronic pancreatitis (pancreatic calcifications and / or Wirsung duct of 4 or more mm)
12. Pancreatic cystic lesions not attributed to the PAB itself
13. Wirsung duct stenosis.
14. Primary hyperparathyroidism
15. Pregnancy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Death and / or complication associated with gallstones (new episode of PAB, cholangitis, cholecystitis, choledocholithiasis or biliary colic, variable based on the primary endpoint of the PONCHO clinical trial (1)), until cholecystectomy is performed or until 1 year.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital General Universitario Dr. Balmis

Sponsor organisation

Hospital General Universitario Dr. Balmis

Address

Avinguda Del Pintor Baeza 12

City

Alicante

Postcode

03010

Country

Spain

Scientific contact point

Organisation

Hospital General Universitario Dr. Balmis

Contact name

Alicia Vaillo

Public contact point

Organisation

Hospital General Universitario Dr. Balmis

Contact name

Alicia Vaillo

Locations

1 EU/EEA country · 21 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications