Comparing the Diagnostic Adequacy of 25-gauge Fork-tip, Franseen and Reverse-bevel Type Needles in Endoscopic Ultrasound Guided Tissue Acquisition

A Prospective Randomized Study Comparing the Diagnostic Adequacy of 25-gauge Fork-tip, Franseen and Reverse-bevel Type Needles in Endoscopic Ultrasound Guided Tissue Acquisition

Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) and fine needle biopsy (EUS-FNB) are well established techniques for the acquisition of tissue to classify a number of lesions of the gastrointestinal tract and surrounding organs. These include pancreatic, lymphoid, subepithelial and other abdominal lesions. Historically, FNA was the sole available modality used to obtain cytological samples for analysis. The major shortcoming of this technique is the lack of a histological tissue core.

In recent years attention has turned to optimizing needle design to improve sample quality. New needles have been developed which aim to obtain a core of tissue with preserved architecture.

These needles include the first generation Reverse-bevel Echo Tip® HD ProCore™ (Wilson-Cook Medical Inc., Winston-Salem, NC, United States), and the second generation Fork-tip SharkCore™ (Medtronic Inc., Sunnyvale, CA, United States) and Franseen Acquire™ (Boston Scientific, Marlborough, MA, United States).

Currently there are a paucity of studies comparing the performance of these needles, and only two of these are prospective randomized controlled trials. Real world performance of these needles has seldom been reported, with only one RCT including non-pancreatic masses in their analysis.

The investigators hypothesize that second generation needles have equivalent or better diagnostic performance than the prior first-generation needle.

To test this, the investigators aim to conduct a prospective randomized controlled study comparing the performance of Fork-tip and Franseen needles for the sampling of pancreatic, subepithelial, lymphoid and other abdominal or mediastinal lesions. They also aim to include a retrospective control arm of consecutive cases using the first-generation Reverse-bevel needle.

The investigatora aim to assess the diagnostic yield of each needle, as well as number of needle passes used, and specimen quality.

Study Overview

• Status: Completed
• Conditions: Biopsy, Needle
• Intervention / Treatment: Device: Needle choice

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4102
      • Princess Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any solid tissue biopsy performed at the time of endoscopic ultrasound

Exclusion Criteria:

• Fluid samples were excluded.
• Cases where biopsy was not deemed necessary by the proceduralist based on endosonographic findings
• Cases where biopsy was deemed unsafe

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Reverse-bevel ProCore™; Historical comparator group of biopsies taken using Echo Tip® HD ProCore™ (Wilson-Cook Medical Inc., Winston-Salem, NC, United States) biopsy needle. Slow pull stylet technique with rapid on site evaluation in all cases.	Device: Needle choice; The type of needle use was the only intervention
Experimental: Fork-tip SharkCore™; Experimental group of biopsies using SharkCore™ (Medtronic Inc., Sunnyvale, CA, United States) biopsy needle. Slow pull stylet technique with rapid on site evaluation in all cases.	Device: Needle choice; The type of needle use was the only intervention
Experimental: Franseen Acquire™; Experimental group of biopsies using Acquire™ (Boston Scientific, Marlborough, MA, United States) biopsy needle. Slow pull stylet technique with rapid on site evaluation in all cases.	Device: Needle choice; The type of needle use was the only intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield	The percentage of lesions sampled for which a tissue diagnosis was obtained	At study completion, approximately 1 year after final subject enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of needle passes		At study completion, approximately 1 year after final subject enrolled
Sample bloodiness	A subjective assessment of the amount of blood seen on histopathological specimens (1 = no interference with interpretation, 2 = interference with interpretation but diagnosis can still be made, 3 = excessive blood makes assessment impossible)	At study completion, approximately 1 year after final subject enrolled
Target tissue cellularity	Subjective assessment by histopathologist of the cellularity of the sample (consisting of cells from the target lesion) - low, medium or high.	At study completion, approximately 1 year after final subject enrolled

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events	At end of study medical record review, approximately 1 year after final subject enrolled

Collaborators and Investigators

• Sponsor: Princess Alexandra Hospital, Brisbane, Australia
• Investigators: Study Director: Alexander Huelsen, MD, QLD Health

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: March 19, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Endoscopic ultrasound, Fine Needle Biopsy
• Other Study ID Numbers: LNR/QMS/44303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes