Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle

Pancreatic Cancer Clinical Trial

Official title:

Pilot-Feasibility Trial of EUS Guided Pancreas Fine Needle Core Biopsy for Whole Exome Sequencing and Genomic Profiling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678442
• Other study ID #: 15-007801
• Status: Completed
• Phase: N/A
• Start date: May 16, 2016
• Est. completion date: November 10, 2018

Study information

• Verified date: December 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 10, 2018
• Est. primary completion date: November 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Male and female patients who are 18 years old or older and are referred for the evaluation of pancreatic mass lesion.

• International Normalized Ratio (INR) less than 1.5 and platelet count of more than 50,000.

• Medically stable to undergo sedation for EUS.

• Signed informed consent

Exclusion Criteria:

• Medical condition that preclude the patient from having a therapeutic procedure regardless of the EUS finding

• Pregnant patients

Related Conditions & MeSH terms

• Pancreatic Cancer

Intervention

Device:
• Fine Needle Biopsy (FNB)
The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.
• Fine Needle Aspiration (FNA)
Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds.

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total DNA Yield of Adenocarcinoma	Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.	Baseline
Secondary	Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis	The total number of passes required to obtain adequate tissue sample for cytology/histology processing and interpretation.	Baseline
Secondary	Core Tissue Length	The length of the tissue core sample acquired, on the first needle pass, measured in centimeters.	Baseline
Secondary	Concentration of DNA Yield of Adenocarcinoma	The concentration of the DNA from the adenocarcinoma on the first needle pass, measured in micrograms per microliter.	Baseline
Secondary	Percentage of Tumor Cellularity	Percent of tumor cellularity with first pass of adenocarcinoma	Baseline
Secondary	Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation	The total number of subjects whose first-pass biopsy contained adequate material for cytologic interpretation, as determined by a cytopathologist.	Baseline
Secondary	Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation	The number of subjects whose first pass biopsy contained adequate material for high quality histologic interpretation, as determined by a cytopathologist. High quality is defined as being greater than 10 power field in length.	Baseline

External Links

•   Mayo Clinic Clinical Trials