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UDCA for Symptomatic Gallstone Disease

Primary Purpose

Cholecystolithiasis

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
ursodeoxycholic acid
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystolithiasis focused on measuring ursodeoxycholic acid, gallstone, complications, pancreatitis, gallbladder motility, colic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMC Utrecht

Outcomes

Primary Outcome Measures

incidence severe right upper quadrant or midline epigastric pain (> 30 min)and colic-free intervals

Secondary Outcome Measures

nr gallstone complications (acute cholecystitis, choledocholithiasis or acute pancreatitis) and non-severe right upper quadrant or midline epigastric pain and nr aalgesics taken

Full Information

First Posted
September 7, 2005
Last Updated
July 26, 2006
Sponsor
UMC Utrecht
Collaborators
Dr. Falk Pharma GmbH, Dutch Digestive Diseases Foundation, ZonMw: The Netherlands Organisation for Health Research and Development, Agis Zorgverzekeringen
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1. Study Identification

Unique Protocol Identification Number
NCT00161083
Brief Title
UDCA for Symptomatic Gallstone Disease
Official Title
Studie Naar De Effectiviteit Van Ursodeoxycholzuur Ter Preventie Van Galsteen-Gerelateerde Klachten Bij patiënten in Afwachting Van Een Cholecystectomie
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
UMC Utrecht
Collaborators
Dr. Falk Pharma GmbH, Dutch Digestive Diseases Foundation, ZonMw: The Netherlands Organisation for Health Research and Development, Agis Zorgverzekeringen

4. Oversight

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystolithiasis
Keywords
ursodeoxycholic acid, gallstone, complications, pancreatitis, gallbladder motility, colic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ursodeoxycholic acid
Primary Outcome Measure Information:
Title
incidence severe right upper quadrant or midline epigastric pain (> 30 min)and colic-free intervals
Secondary Outcome Measure Information:
Title
nr gallstone complications (acute cholecystitis, choledocholithiasis or acute pancreatitis) and non-severe right upper quadrant or midline epigastric pain and nr aalgesics taken

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels G Venneman, MD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karel J van Erpecum, MD, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Study Director
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
16729326
Citation
Venneman NG, Besselink MG, Keulemans YC, Vanberge-Henegouwen GP, Boermeester MA, Broeders IA, Go PM, van Erpecum KJ. Ursodeoxycholic acid exerts no beneficial effect in patients with symptomatic gallstones awaiting cholecystectomy. Hepatology. 2006 Jun;43(6):1276-83. doi: 10.1002/hep.21182.
Results Reference
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UDCA for Symptomatic Gallstone Disease

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