UDCA for Symptomatic Gallstone Disease
UDCA for Symptomatic Gallstone Disease
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
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
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