Endoscopic Ultrasound Guided Tissue Sampling (The ProCore Study)

ISRCTN	ISRCTN99035319
DOI	https://doi.org/10.1186/ISRCTN99035319
Secondary identifying numbers	14399

Submission date: 28/06/2013
Registration date: 28/06/2013
Last edited: 15/07/2016

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

Ms Denise Norris
Scientific

Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Study information

Study design	Randomised interventional diagnostic accuracy trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Diagnostic
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
Study acronym	The ProCore Study
Study objectives	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(s)	12/EM/0189
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2012
Completion date	01/03/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 268; UK Sample Size: 268
Key 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.
Key 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.
Date of first enrolment	01/09/2012
Date of final enrolment	01/03/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Queens Medical Centre

Nottingham
NG7 2UH
United Kingdom

Sponsor information

University of Nottingham (UK)
University/education

Wolfson Digestive Diseases Centre
South Block
C-Floor, Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom

Website	http://www.nottingham.ac.uk/
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Industry

Cook Medical

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

15/07/2016: No publications found, verifying study status with principal investigator.