Endoscopic Ultrasound Guided Tissue Sampling (The ProCore Study)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2013
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. CONDITION: Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Gastrointestinal ; Digestive System PRIMARY OUTCOME: Diagnostic accuracy of the standard FNAC needle compared with the new FNAB needle SECONDARY OUTCOME: 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 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.
Epistemonikos ID: e1ab1e87283458590558cde4ad4d944f2ff43c5d
First added on: Aug 22, 2024