UDCA for Symptomatic Gallstone Disease
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|ClinicalTrials.gov Identifier: NCT00161083|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 27, 2006
|Condition or disease||Intervention/treatment||Phase|
|Cholecystolithiasis||Drug: ursodeoxycholic acid||Phase 4|
Gallstone disease is very common with an estimated prevalence of 10-15% in the adult Western population. Approximately 90% of gallstone carriers are asymptomatic. The annual risk of biliary colic in asymptomatic gallstone carriers has been suggested to be approximately 1%. Also, asymptomatic gallstone carriers are at risk for acute pancreatitis, choledocholithiasis and acute cholecystitis. Although accurate prospective data are lacking, annual incidences of these potentially lethal complications are estimated to be approximately 0.2%, 0.2% and 0.3%, respectively.
One can easily imagine that migration of gallbladder stones into the common bile duct may lead to biliary pain. How gallbladder stones remaining in the gallbladder lead to biliary symptoms is not entirely clear. Strong gallbladder contraction, with temporary impaction of the stone in the orifice of the cystic duct might cause biliary pain. Although impaired gallbladder motility could therefore theoretically protect against colics, symptomatic gallbladder stone patients often have complaints despite coexistent impaired gallbladder emptying.
Ursodeoxycholic acid (UDCA) has been claimed to reduce the risk of biliary pain, regardless of gallstone dissolution. In a large study by Tomida et al., risks of biliary pain or gallstone complications (acute cholecystitis) were reduced in both symptomatic and asymptomatic gallstone carriers, although gallstones were generally not dissolved. Also, biliary pancreatitis might be prevented by long-term UDCA treatment. Increased fasting and residual postprandial gallbladder volumes during UDCA treatment, less cholesterol crystals or decreased mucin contents in bile could be the underlying mechanisms for these beneficial effects. However, prospective studies on effects of UDCA on symptoms or complications in highly symptomatic patients are lacking.
In the Netherlands symptomatic gallstone patients are admitted to a waiting list for elective cholecystectomy by general surgeons. The waiting period may last several months because of logistic reasons. During this waiting period gallstone patients are at risk for biliary pain and complications. Therefore, we conducted 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 evaluated potential beneficial effects of impaired gallbladder motility
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Studie Naar De Effectiviteit Van Ursodeoxycholzuur Ter Preventie Van Galsteen-Gerelateerde Klachten Bij patiënten in Afwachting Van Een Cholecystectomie|
|Study Start Date :||November 2001|
|Study Completion Date :||November 2004|
- incidence severe right upper quadrant or midline epigastric pain (> 30 min)and colic-free intervals
- nr gallstone complications (acute cholecystitis, choledocholithiasis or acute pancreatitis) and non-severe right upper quadrant or midline epigastric pain and nr aalgesics taken
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161083
|Utrecht, Netherlands, 3508 GA|
|Principal Investigator:||Niels G Venneman, MD||UMC Utrecht|
|Study Director:||Karel J van Erpecum, MD, PhD||UMC Utrecht|