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

NCT02678442 | Completed Results

• 1 other identifier: 15-007801
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Total DNA Yield of Adenocarcinoma

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

  Baseline

Secondary Outcomes (6)

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

  Baseline

• Core Tissue Length

  Baseline

• Concentration of DNA Yield of Adenocarcinoma

  Baseline

• Percentage of Tumor Cellularity

  Baseline

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

  Baseline

Study Arms (2)

FNB first, then FNA

ACTIVE COMPARATOR

In an endoscopic ultrasound-guided procedure, Shark Core Fine Needle Biopsy (FNB) will be performed first, followed by Fine Needle Aspiration (FNA).

Device: Fine Needle Biopsy (FNB); Device: Fine Needle Aspiration (FNA)

FNA first, then FNB

ACTIVE COMPARATOR

In an endoscopic ultrasound-guided procedure, Fine Needle Aspiration (FNA) will be performed first, followed by Shark Core Fine Needle Biopsy (FNB).

Device: Fine Needle Biopsy (FNB); Device: Fine Needle Aspiration (FNA)

Interventions

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.

Also known as: Shark Core Fine Needle Biopsy

FNA first, then FNB; FNB first, then FNA

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.

FNA first, then FNB; FNB first, then FNA

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• Medtronic: collaborator

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Results Point of Contact

• Title: Dr. Michael B. Wallace
• Organization: Mayo Clinic

wallace.michael@mayo.edu

904-953-2222

Study Officials

• Michael B. Wallace, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, MPH, Professor of Medicine

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 9, 2016
• Study Start: May 16, 2016
• Primary Completion: November 10, 2018
• Study Completion: November 10, 2018
• Last Updated: January 6, 2020
• Results First Posted: January 6, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)