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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Biopsy, Needle

Intervention / Treatment
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* Device: Needle choice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized trial with retrospective comparator group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Reverse-bevel ProCore™<br>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<br>* The type of needle use was the only intervention<br>|
| Experimental: Fork-tip SharkCore™<br>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<br>* The type of needle use was the only intervention<br>|
| Experimental: Franseen Acquire™<br>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<br>* The type of needle use was the only intervention<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic ultrasound, Fine Needle Biopsy