UDCA for Symptomatic Gallstone Disease

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

Summary

We conduct a randomized, double-blind, placebo-controlled trial on effects of UDCA on biliary pain and complications in highly symptomatic gallstone patients scheduled for cholecystectomy. We also evaluate potential beneficial effects of impaired gallbladder motility

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborators: Agis Zorgverzekeringen; Dr. Falk Pharma GmbH; Dutch Digestive Diseases Foundation; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• Patients between 18 and 75 years of age study are upon admission to the waiting list for elective cholecystectomy for symptomatic cholecystolithiasis defined as:

• presence of gallbladder stones or sludge, without bile duct stones or bile duct dilatation at ultrasonography;\

• at least one episode of severe right upper quadrant or midline epigastric pain of at least 30 min. duration, with radiation and/or movement urge, or at least three episodes of severe right upper quadrant or midline epigastric pain of at least 30 min. duration without such radiation or movement urge, in the previous 12 months

Exclusion Criteria:

• Contra-indication for general anaesthesia or surgery

• Current or previous acute cholecystitis, obstructive jaundice or pancreatitis

• Previous papillotomy, because of preferential flow of UDCA-enriched bile to the intestine rather than to the gallbladder

• Pregnancy or lactation

• Current or previous use of UDCA

• Participation in another study

• Inability to speak Dutch or English or mental disability