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Endoscopic Ultrasound Guided Tissue Sampling (The ProCore Study)

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN99035319
Enrollment
268
Registered
2013-06-28
Start date
2012-09-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Oral and Gastrointestinal

Interventions

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 t

Sponsors

University of Nottingham (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of the standard FNAC needle compared with the new FNAB needle

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026