Clinical trialNACompleted
Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle
Pilot-Feasibility Trial of EUS Guided Pancreas Fine Needle Core Biopsy for Whole Exome Sequencing and Genomic Profiling
- Outcome
- Outcome unknown
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- 16 May 2016
- Expected end
- 10 November 2018
- Enrollment
- 50 participants
- Sites
- 1
- Primary outcomes
- Total DNA Yield of Adenocarcinoma
- Sponsor
- Other
- Results posted
- 2020-01-06
- Last update
- 6 January 2020
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Brief summary public domain (ClinicalTrials.gov)
This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.
Detailed description public domain (ClinicalTrials.gov)
This is a single-blinded randomized controlled trial with paired evaluation of conventional FNA needle versus FNB needle stratified by lesion location (pancreas head tumor versus pancreas body/tail). A minimum of 4 passes ( 2 with each needle) will be performed from all the lesions. After each pass of needle, the on-site cytopathologists will evaluate the adequacy and the degree of the pathological changes in the obtained material. Based on the information provided by the onsite cytopathologists, the endosonographer will repeat the FNA until enough histological material is obtained to confirm a diagnosis. Patients will be assessed immediately after procedure and during the first 30 days with a follow-up.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Total DNA Yield of Adenocarcinoma [Baseline]. Mean, ng/µL (Standard Deviation). Fine Needle Biopsy (FNB) (n=37): 5930.10 (881); Fine Needle Aspiration (FNA) (n=37): 3365.22 (788). Analysis, Fine Needle Biopsy (FNB) vs Fine Needle Aspiration (FNA): p=0.01; t-test, 2 sided; superiority.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis [Baseline]. Median, needle passes (Full Range). Fine Needle Biopsy (FNB) (n=50): 5 (0 to 5); Fine Needle Aspiration (FNA) (n=50): 2 (0 to 5).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Core Tissue Length [Baseline]. Median, centimeters (Full Range). Fine Needle Biopsy (FNB) (n=50): 6 (0 to 20); Fine Needle Aspiration (FNA) (n=50): 2 (0 to 7). Analysis, Fine Needle Biopsy (FNB) vs Fine Needle Aspiration (FNA): p=0.001; Wilcoxon (Mann-Whitney); superiority.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Concentration of DNA Yield of Adenocarcinoma [Baseline]. Mean, µg/mL (Standard Deviation). Fine Needle Biopsy (FNB) (n=37): 65.00 (8.6); Fine Needle Aspiration (FNA) (n=37): 37.21 (8.3). Analysis, Fine Needle Biopsy (FNB) vs Fine Needle Aspiration (FNA): p=0.02; t-test, 2 sided; superiority.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Percentage of Tumor Cellularity [Baseline]. Median, percentage of tumor cellularity (Full Range). Fine Needle Biopsy (FNB) (n=50): 40 (0 to 90); Fine Needle Aspiration (FNA) (n=50): 10 (0 to 100). Analysis, Fine Needle Biopsy (FNB) vs Fine Needle Aspiration (FNA): p=.001; Wilcoxon (Mann-Whitney); superiority.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation [Baseline]. Count Of Participants, Participants. Fine Needle Biopsy (FNB) (n=50): 3; Fine Needle Aspiration (FNA) (n=50): 18.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation [Baseline]. Count Of Participants, Participants. Fine Needle Biopsy (FNB) (n=50): 33; Fine Needle Aspiration (FNA) (n=50): 4.