UDCA for Symptomatic Gallstone Disease (NCT00161083) | Clinical Trial Compass
CompletedPhase 4
UDCA for Symptomatic Gallstone Disease
Netherlands180 participantsStarted 2001-11
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
incidence severe right upper quadrant or midline epigastric pain (> 30 min)and colic-free intervals