Biopsy, Needle
Conditions
Keywords
Endoscopic ultrasound, Fine Needle Biopsy
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.
Interventions
DEVICENeedle choice
The type of needle use was the only intervention
Sponsors
Princess Alexandra Hospital, Brisbane, Australia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Randomized trial with retrospective comparator group
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | At study completion, approximately 1 year after final subject enrolled | The percentage of lesions sampled for which a tissue diagnosis was obtained |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) |
| Target tissue cellularity | 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
| Measure | Time frame |
|---|---|
| Adverse events | At end of study medical record review, approximately 1 year after final subject enrolled |
Countries
Australia
Outcome results
None listed