Clinical trial NCT02678442: Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle
Official title: Pilot-Feasibility Trial of EUS Guided Pancreas Fine Needle Core Biopsy for Whole Exome Sequencing and Genomic Profiling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-02-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total DNA Yield of Adenocarcinoma
timeFrame: Baseline
Secondary outcomes:
measure: Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis
timeFrame: Baseline
measure: Core Tissue Length
timeFrame: Baseline
measure: Concentration of DNA Yield of Adenocarcinoma
timeFrame: Baseline
measure: Percentage of Tumor Cellularity
timeFrame: Baseline
measure: Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation
timeFrame: Baseline
measure: Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation
timeFrame: Baseline
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Michael B. Wallace, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: