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

Mayo Clinic

Status: Completed

Conditions: Pancreatic Cancer

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02678442

15-007801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

FNB first, then FNA

Active Comparator group

Description:

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

Treatment:

Device: Fine Needle Aspiration (FNA)

Device: Fine Needle Biopsy (FNB)

FNA first, then FNB

Active Comparator group

Description:

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

Treatment:

Device: Fine Needle Aspiration (FNA)

Device: Fine Needle Biopsy (FNB)