Skip to main content
OpenTrials
Completed

NCT Number: NCT02678442

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fine Needle Biopsy (FNB)

Device

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.

Other names: Shark Core Fine Needle Biopsy

Fine Needle Aspiration (FNA)

Device

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.

Primary outcomes

  1. Total DNA Yield of Adenocarcinoma

    Time frame: Baseline

    Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.

Secondary outcomes

  1. Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis

    Time frame: Baseline

    The total number of passes required to obtain adequate tissue sample for cytology/histology processing and interpretation.

  2. Core Tissue Length

    Time frame: Baseline

    The length of the tissue core sample acquired, on the first needle pass, measured in centimeters.

  3. Concentration of DNA Yield of Adenocarcinoma

    Time frame: Baseline

    The concentration of the DNA from the adenocarcinoma on the first needle pass, measured in micrograms per microliter.

  4. Percentage of Tumor Cellularity

    Time frame: Baseline

    Percent of tumor cellularity with first pass of adenocarcinoma

  5. Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation

    Time frame: Baseline

    The total number of subjects whose first-pass biopsy contained adequate material for cytologic interpretation, as determined by a cytopathologist.

  6. Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 9, 2016
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.