Condition category
Digestive System
Date applied
28/06/2013
Date assigned
28/06/2013
Last edited
15/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Denise Norris

ORCID ID

Contact details

Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

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

http://www.nottingham.ac.uk/

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

Publication citations

Additional files

Editorial Notes

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