Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0192090461
Study information
Scientific title
Acronym
Study hypothesis
To determine the diagnostic accuracy of magnetic resonance cholangiopancreatography versus endoscopic cholangiopancreatography (ERCP) detection of choledocholithiasis in patients undergoing laparoscopic cholecystectomy.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Cholelithiasis
Intervention
Patients were randomised to:
1. Endoscopic retrograde cholangiopancreatography
2. Magnetic resonance cholangiopancreatography
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Laparoscopic cholecystectomy and on table cholangiogram to confirm that the common bile duct is clear of stones.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
27/07/2001
Overall trial end date
01/01/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Total number of subjects = 168.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
168
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
27/07/2001
Recruitment end date
01/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Surgery
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Queens Medical Centre University Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/12811312
Publication citations
-
Results
Griffin N, Wastle ML, Dunn WK, Ryder SD, Beckingham IJ, Magnetic resonance cholangiopancreatography versus endoscopic retrograde cholangiopancreatography in the diagnosis of choledocholithiasis., Eur J Gastroenterol Hepatol, 2003, 15, 7, 809-813, doi: 10.1097/01.meg.0000059156.68845.46.