Gallstone Dissolution MedDRA version: 15.1 Level: LLT Classification code 10050844 Term: Pancreatitis due to gallstones System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Ursobilane
Pharmaceutical Form: Capsule
INN or Proposed INN: -
CAS Number: -
Current Sponsor code: -
Other descriptive name: URSODEOXYCHOLIC ACID
Concentration unit: IU/mg international un
Sponsors
Enrique De Madaria Pascual
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the incidence during follow-up of the composite variable"biliary complication or acute pancreatitis" in patients randomized to receive UDCA or placebo after acute biliary pancreatitis;Secondary Objective: To evaluate the incidence of complications during follow-up bile (biliary colic, acute cholecystitis, choledocholithiasis de novo and cholangitis acute) and acute pancreatitis. To evaluate the frequency of total dissolution of gallstones.;Primary end point(s): Biliary complication or acute pancreatitis.;Timepoint(s) of evaluation of this end point: 1,2,3,6,9,12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence of any of the following variables: biliary colic, acute cholecystitis, acute cholangitis, choledocholithiasis and / or acute pancreatitis;Timepoint(s) of evaluation of this end point: 1,2,3,6,9,12 months | — |
Countries
Spain
Contacts
Public ContactHospital Grl. Univ. de Alicante
Enrique de Madaria Pascual
Outcome results
None listed