Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0199129927
Study information
Scientific title
Cost effectiveness, safety and efficiency of using a cannulatome versus a cannula for initial cannulation at endoscopic retro-grade cholangiopancreatography (ERCP) in suspected choledocolithiasis
Acronym
Study hypothesis
Is the initial use of a cannulatome more cost effective than the initial use of a diagnostic cannula in patients with suspected choledocolithiasis?
Ethics approval
Not provided at time of registration
Study design
Single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Digestive System: Choledocholithiasis
Intervention
Cannulatome vs diagnostic cannula
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Success of cannulation, time to cannulation and sphincterotomy and complication rates
Secondary outcome measures
Not provided at time of registration
Overall trial start date
11/06/2003
Overall trial end date
27/02/2006
Reason abandoned
Eligibility
Participant inclusion criteria
50 patients who require endoscopic retro-grade cholangiopancreatography (ERCP) for suspected choledocolithiasis
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
50
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
11/06/2003
Recruitment end date
27/02/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Berkshire & Battle Hospitals NHS Trust
Reading
RG1 5AN
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Berkshire and Battle Hospitals 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