Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161083
Status:
COMPLETED
Last Update Posted:
2006-07-27
First Post:
2005-09-07
Brief Title:
UDCA for Symptomatic Gallstone Disease
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Studie Naar De Effectiviteit Van Ursodeoxycholzuur Ter Preventie Van Galsteen-Gerelateerde Klachten Bij patiënten in Afwachting Van Een Cholecystectomie
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 02 02 and 03 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MLDS WS 00-08 | None | None | None |
| ZonMw 920-03-232 | None | None | None |