UDCA for Symptomatic Gallstone Disease
Condition: Cholecystolithiasis
MeSH terms: Gallstones; Cholecystolithiasis; Cholelithiasis
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      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
    

Intervention name(s): ursodeoxycholic acid
Intervention type(s): Drug
Intervention MeSH terms: Ursodeoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ursodeoxycholic acid; gallstone; complications; pancreatitis; gallbladder motility; colic