Secondary prophylaxis after pancreatitis

• Conditions: Gallstone Dissolution; MedDRA version: 15.1Level: LLTClassification code 10050844Term: Pancreatitis due to gallstonesSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-003174-89-ES
• Lead Sponsor: Enrique De Madaria Pascual

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-29
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients over 18 years.
Patients with first episode of acute biliary pancreatitis without previous cholecystectomy

• Diagnosis of acute pancreatitis: at least 2 of these criteria: a) abdominal pain b) or lipasemia amylase greater than 3 times the upper limit of normal c) test image compatible with acute pancreatitis
• Diagnosis of biliary etiology: gallstones / microlithiasis / biliary sludge gallbladder diagnosed by ultrasound, CT, MRI or EUS

3. Free to participate in clinical trial, with written informed consent from the patient.
4. Ability to properly complete rating scales

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Ability to perform cholecystectomy within two months.
Presence choledocholithiasis.
Previous surgical or endoscopic sphincterotomy.
Pancreatic cystic lesions not attributable to the very acute gallstone pancreatitis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified