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Completed

NCT Number: NCT05434247

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.

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Key information

Conditions

Biopsy, Needle

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Needle choice

Device

The type of needle use was the only intervention

Primary outcomes

  1. Diagnostic yield

    Time frame: At study completion, approximately 1 year after final subject enrolled

    The percentage of lesions sampled for which a tissue diagnosis was obtained

Secondary outcomes

  1. Number of needle passes

    Time frame: At study completion, approximately 1 year after final subject enrolled

  2. Sample bloodiness

    Time frame: At study completion, approximately 1 year after final subject enrolled

    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)

  3. Target tissue cellularity

    Time frame: At study completion, approximately 1 year after final subject enrolled

    Subjective assessment by histopathologist of the cellularity of the sample (consisting of cells from the target lesion) - low, medium or high.

Other outcomes

  1. Adverse events

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

Sponsors and collaborators

Lead sponsor

Princess Alexandra Hospital, Brisbane, Australia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 27, 2022
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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