Clinical trial NCT05434247: Comparing the Diagnostic Adequacy of 25-gauge Fork-tip, Franseen and Reverse-bevel Type Needles in Endoscopic Ultrasound Guided Tissue Acquisition
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biopsy, Needle
Keywords: Endoscopic ultrasound, Fine Needle Biopsy
Lead sponsor: Princess Alexandra Hospital, Brisbane, Australia
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 178
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial with retrospective comparator group
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic yield
timeFrame: At study completion, approximately 1 year after final subject enrolled
Secondary outcomes:
measure: Number of needle passes
timeFrame: At study completion, approximately 1 year after final subject enrolled
measure: Sample bloodiness
timeFrame: At study completion, approximately 1 year after final subject enrolled
measure: Target tissue cellularity
timeFrame: At study completion, approximately 1 year after final subject enrolled
Other outcomes:
measure: Adverse events
timeFrame: At end of study medical record review, approximately 1 year after final subject enrolled
Locations:
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
Study officials:
affiliation: QLD Health
name: Alexander Huelsen, MD
role: STUDY_DIRECTOR
References: