Cost effectiveness, safety and efficiency of using a cannulatome versus a cannula for initial cannulation at endoscopic retro-grade cholangiopancreatography (ERCP) in suspected choledocolithiasis

ISRCTN ISRCTN54340540
DOI https://doi.org/10.1186/ISRCTN54340540
Secondary identifying numbers N0199129927
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
15/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A S Mee
Scientific

Gastroenterology Department
Royal Berkshire & Battle Hospitals NHS Trust
London Road
Reading
RG1 5AN
United Kingdom

Study information

Study designSingle centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Scientific titleCost effectiveness, safety and efficiency of using a cannulatome versus a cannula for initial cannulation at endoscopic retro-grade cholangiopancreatography (ERCP) in suspected choledocolithiasis
Study objectivesIs the initial use of a cannulatome more cost effective than the initial use of a diagnostic cannula in patients with suspected choledocolithiasis?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedDigestive System: Choledocholithiasis
InterventionCannulatome vs diagnostic cannula
Intervention typeOther
Primary outcome measureSuccess of cannulation, time to cannulation and sphincterotomy and complication rates
Secondary outcome measuresNot provided at time of registration
Overall study start date11/06/2003
Completion date27/02/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants50
Key inclusion criteria50 patients who require endoscopic retro-grade cholangiopancreatography (ERCP) for suspected choledocolithiasis
Key exclusion criteriaNot provided at time of registration
Date of first enrolment11/06/2003
Date of final enrolment27/02/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Berkshire & Battle Hospitals NHS Trust
Reading
RG1 5AN
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Royal Berkshire and Battle Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan