Fine Needle Biopsy of Solid Pancreatic Mass Lesions

AdventHealth

Status: Unknown

Conditions: Pancreatic Neoplasms

Treatments: Diagnostic Test: Solid pancreatic mass lesion biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04085055

1469116

Details and patient eligibility

About

This is a randomized trial to evaluate and directly compare the tissue quality, diagnostic sucess and safety profile of four different Fine Needle Biopsy needles.

Full description

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is currently the standard method for sampling solid pancreatic masses, with reported sensitivity for malignant cytology of 85-95%, specificity of 95-98% and diagnostic accuracy of 78-95%. Diagnostic failure of EUS-FNA can be due to inadequate targeting, inexperience of the endoscopist/pathologist, or necrotic or fibrotic tumors in which viable cells are difficult to obtain. The cellularity and architectural representation of the sample can also be determined by the needle used and its specific features. Recently, new needles known as "fine needle biopsy (FNB)" needles have become available that are specially designed to promote the collection of core tissue by unique designs of their needle tips. The advantages of FNB over FNA needles are that (a) the quality of tissue procured is superior: FNA needles yield cytology whereas FNB needles yield histology (b) molecular marker analysis can be performed more reliably on histology samples than cytology aspirates and (c) as histological tissue is greater in quantity than cytological aspirates, a quicker diagnosis with fewer passes can be established by histology than cytology.

Four different types of FNB needles are currently available - reverse-bevel tip (EchoTip ProCore HD Ultrasound Biopsy Needle, Cook Medical, Bloomington, IN), Menghini-tip (EZ shot, Olympus America, Center Valley, PA), Franseen tip (Acquire, Boston Scientific Corporation, Natick, MA) and fork-tip (SharkCore, Medtronic Corporation/Covidien, Newton, MA) needles, each with unique tip designs to facilitate procurement of histological core tissue. Although we have previously compared in randomized trials the diagnostic yield of Franseen and fork-tip FNB needles and have shown the two needles to be equivalent, there are currently no randomized trials directly comparing all four FNB needle types. EUS-guided tissue acquisition can also be performed using different techniques, including the use of suction, no use of suction and the stylet retraction technique. There are currently no studies comparing these different tissue acquisition techniques using the different FNB needles and no study has demonstrated the best technique for FNB.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. All patients referred for EUS-guided tissue acquisition of suspected or confirmed solid pancreatic mass lesions visualized on any radiological imaging
2. Able and willing to provide written or verbal consent
3. ≥ 18 years old
4. Able to undergo conscious sedation for EUS procedure

Exclusion criteria

1. <18 years old
2. Unable to obtain informed consent from the patient
3. Medically unfit for sedation
4. Pregnant patients
5. No pancreatic mass lesions visualized on EUS
6. Irreversible coagulopathy as determined by platelet count < 50,000/microL or International Normalized Ratio (INR) > 1.5
7. Unable to stop anti-platelet agents prior to the procedure

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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130 participants in 4 patient groups

22 Gauge FNB Needle - ProCore

Active Comparator group

Description:

The 22 Gauge FNB Needle - ProCore will be used to biopsy solid pancreatic mass lesions.

Treatment:

Diagnostic Test: Solid pancreatic mass lesion biopsy

22 Gauge FNB Needle - Acquire

Active Comparator group

Description:

The 22 Gauge FNB Needle - Acquire will be used to biopsy solid pancreatic mass lesions.

Treatment:

Diagnostic Test: Solid pancreatic mass lesion biopsy

22 Gauge FNB Needle - SharkCore

Active Comparator group

Description:

The 22 Gauge FNB Needle - SharkCore will be used to biopsy solid pancreatic mass lesions.

Treatment:

Diagnostic Test: Solid pancreatic mass lesion biopsy

22 Gauge FNB needle - EZ Shot 3 Plus

Active Comparator group

Description:

The 22 Gauge FNB Needle - EZ Shot 3 Plus will be used to biopsy solid pancreatic mass lesions.

Treatment:

Diagnostic Test: Solid pancreatic mass lesion biopsy