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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
Sponsor:
Collaborators:
Dr. Falk Pharma GmbH
Dutch Digestive Diseases Foundation
ZonMw: The Netherlands Organisation for Health Research and Development
Agis Zorgverzekeringen
Information provided by:
UMC Utrecht

Brief 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

Condition or disease Intervention/treatment Phase
Cholecystolithiasis Drug: ursodeoxycholic acid Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones
Drug Information available for: Ursodiol




Primary Outcome Measures :
  1. incidence severe right upper quadrant or midline epigastric pain (> 30 min)and colic-free intervals

Secondary Outcome Measures :
  1. nr gallstone complications (acute cholecystitis, choledocholithiasis or acute pancreatitis) and non-severe right upper quadrant or midline epigastric pain and nr aalgesics taken


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161083


Locations
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Netherlands
UMC Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
Dr. Falk Pharma GmbH
Dutch Digestive Diseases Foundation
ZonMw: The Netherlands Organisation for Health Research and Development
Agis Zorgverzekeringen
Investigators
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Principal Investigator: Niels G Venneman, MD UMC Utrecht
Study Director: Karel J van Erpecum, MD, PhD UMC Utrecht

Publications of Results:
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ClinicalTrials.gov Identifier: NCT00161083     History of Changes
Other Study ID Numbers: MLDS WS 00-08
MLDS WS 00-08
ZonMw: 920-03-232
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 27, 2006
Last Verified: September 2005
Keywords provided by UMC Utrecht:
ursodeoxycholic acid
gallstone
complications
pancreatitis
gallbladder motility
colic
Additional relevant MeSH terms:
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Gallstones
Cholecystolithiasis
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents