A prospective randomised trial of magnetic resonance imaging versus endoscopic retrograde cholangiopancreatography evaluation of patients with suspected cholelithiasis

ISRCTN ISRCTN89479536
DOI https://doi.org/10.1186/ISRCTN89479536
Protocol serial number N0192090461
Sponsor Department of Health (UK)
Funder Queens Medical Centre University Hospital NHS Trust (UK)
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
22/04/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr IJ Beckingham
Scientific

Department of Surgery
E Floor West Block
University Hospital
Nottingham
NG7 2UH
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo determine the diagnostic accuracy of magnetic resonance cholangiopancreatography versus endoscopic cholangiopancreatography (ERCP) detection of choledocholithiasis in patients undergoing laparoscopic cholecystectomy.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCholelithiasis
InterventionPatients were randomised to:
1. Endoscopic retrograde cholangiopancreatography
2. Magnetic resonance cholangiopancreatography
Intervention typeOther
Primary outcome measure(s)

Laparoscopic cholecystectomy and on table cholangiogram to confirm that the common bile duct is clear of stones.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/01/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration168
Key inclusion criteriaTotal number of subjects = 168.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment27/07/2001
Date of final enrolment01/01/2004

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Department of Surgery
Nottingham
NG7 2UH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/07/2003 Yes No