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

NCT05434247 | Completed FDA Device

• 1 other identifier: LNR/QMS/44303
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Biopsy, Needle

Keywords

Endoscopic ultrasound, Fine Needle Biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of needle passes

  At study completion, approximately 1 year after final subject enrolled

• Sample bloodiness

  At study completion, approximately 1 year after final subject enrolled

• Target tissue cellularity

  At study completion, approximately 1 year after final subject enrolled

Other Outcomes (1)

• Adverse events

  At end of study medical record review, approximately 1 year after final subject enrolled

Study Arms (3)

Reverse-bevel ProCore™

OTHER

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

Fork-tip SharkCore™

EXPERIMENTAL

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

Franseen Acquire™

EXPERIMENTAL

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

Interventions

Needle choice DEVICE

The type of needle use was the only intervention

Fork-tip SharkCore™; Franseen Acquire™; Reverse-bevel ProCore™

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Princess Alexandra Hospital, Brisbane, Australia: lead

Study Sites (1)

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Study Officials

• Alexander Huelsen, MD

  QLD Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology Staff Specialist

Model Details: Randomized trial with retrospective comparator group

Study Record Dates

• First Submitted: March 19, 2022
• First Posted: June 27, 2022
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2020
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)