Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14399
Study information
Scientific title
A multi-centre randomised trial comparing EUS guided fine needle aspiration cytology (FNAC) with fine needle aspiration biopsy (FNAB) in sampling solid pancreatic mass lesions
Acronym
The ProCore Study
Study hypothesis
The aim of this study is to investigate the diagnostic accuracy of the standard FNAC needle compared with the new FNAB needle in the sampling of solid pancreatic lesions.
Ethics approval
12/EM/0189
Study design
Randomised interventional diagnostic accuracy trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Gastrointestinal
Intervention
Complications, Immediate complications, if any, will be recorded after the procedure. Patients will be contacted 30 days after the procedure to record any late complication.; Tissue Sampling, On the day of the procedure the patient will be consented for the procedure and for the study and will be randomised to either to obtain biopsy using 22G/25G FNAC needle citology or to obtain biopsy using 22G/25G FNAB needle. Linear and/or Radial EUS scopes will be used to identify and to take biopsy from the suspected lesion. Samples will be obtained according to the standard protocol.
According to the published data we have assumed a diagnostic accuracy of 70% using EUS-FNAC, and this to be increased to 85% using EUS-FNAB needle. To detect the difference with a p value of 0.05 (two tailed) in the two groups with 80% power we will need to recruit 134 in each group.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Diagnostic accuracy of the standard FNAC needle compared with the new FNAB needle
Secondary outcome measures
1. Adequacy of the sample obtained with the FNAC needle compared with the new FNAB needle
2. Cost analysis using the FNAC needle compared with the FNAB needle
3. Number of passes needed in obtaining adequate sample using FNAC needle compared with the FNAB needle 4. Time taken in obtaining adequate sample using the FNAC needle compared with the FNAB needle
Overall trial start date
01/09/2012
Overall trial end date
01/03/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult patients 18 years and above with a solid pancreatic mass of any size, needing to undergo EUS examination to collect sample for diagnosis. Definition of a solid pancreatic mass will be based on an ultrasound, CT scan or on the findings of a prior EUS.
2. Patients should have the ability and be willing to give informed consent.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 268; UK Sample Size: 268
Participant exclusion criteria
1. Cystic lesions of the pancreas.
2. Patients known to be intolerant to endoscopy.
3. Patients not clinically fit for endoscopy as judged by their cariong team.
4. Patients on anticoagulation therapy.
5. Patients already participating in another trial.
Recruitment start date
01/09/2012
Recruitment end date
01/03/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
Wolfson Digestive Diseases Centre
South Block
C-Floor
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Cook Medical
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