Lymph Nodes, Pancreatic Masses
Conditions
Keywords
Diagnostic accuracy, Endoscopic Ultrasound-Guided Fine Needle Aspiration, EUS-FNA, Endoscopic Ultrasound-Guided Fine Needle Biopsy, EUS-FNB, Pancreatic mass, Lymph node
Brief summary
The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue acquisition devices; the 25G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device.
Detailed description
Endoscopic ultrasound (EUS)-guided tissue acquisition has emerged as a valuable method to diagnose and stage malignancies. During Endoscopic Ultrasound (EUS), tissue samples can be obtained for pathological evaluation with different devices. Fine needle aspiration (FNA) provides a cytological specimen. Unfortunately, in a cytological specimen, inflammatory changes may be undistinguishable from well-differentiated dysplasia. Moreover, for neoplasms such as lymphomas and stromal tumors, tissue architecture and cell morphology are essential for accurate pathological assessment. Therefore, pathologists generally prefer a histological specimen. Fine needle biopsy (FNB) has the advantage of obtaining a histological specimen, which may lead to better diagnostic performance. However, FNB needles are stiffer and more difficult to handle, which can complicate tissue acquisition. In addition, the superiority of histology over cytology in EUS-guided tissue sampling has not been proven yet. For instance, tissue, obtained by FNA and processed with the new cell-block technique, may equal the diagnostic yield of histological tissue cores. A recent meta-analysis suggested that 25G is the optimal FNA needle size to obtain an adequate cytological specimen. In this study, we aim to compare the properties and merits of a newly designed, more flexible, 20G EUS ProCore FNB device to a conventional 25G EUS-FNA device.
Interventions
DEVICE25G FNA needle
DEVICE20G ProCore FNB needle
Sponsors
Cook Ireland, Ltd.
Foundation for Liver Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients referred for EUS-guided tissue acquisition because of a (I) pancreatic mass lesion or (II) lymph node * Age \> 18 years * Written informed consent * Lesion can be visualized with EUS and is ≥1 cm in size
Exclusion criteria
* Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP) * Use of anticoagulants that cannot be discontinued in order to guarantee an INR below 1.5 * Purely cystic lesions * Previous inclusion in the current study * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy | 27 months | Diagnostic accuracy is the number of correctly diagnosed cases as compared to gold standard diagnosis Gold standard diagnosis is defined as; 1. in operated patients; based on the surgical resection specimen 2. in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of tissue sampling and imaging studies), and confirmed by a compatible clinical disease course of at least 9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Whom Target Lesion Was Sampled | 1 day | records if a target lesion was reached during the procedure using the randomised needle or not |
| Presence of Vital Target Cells Per Case, Per Needle Type | after 27 months | Presence of sufficient vital target cells, as in, target organ cells to provide a diagnosis (yes or no) |
| Number of Patients With Adverse Events Per Needle Type | 27 months after procedure | adverse events per needle type, up to 27 months after procedure |
| Diagnostic Yield of the First Needle Pass | after 27 months | Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not |
| On-site Pathological Evaluation Performed | 27 months | Presence of pathologist on site during procedure |
Countries
Australia, Belgium, France, Israel, Italy, Japan, Netherlands, Spain, Sweden, United States
Participant flow
Pre-assignment details
3 patients were included but met exclusion criteria 4 patients were lost to follow-up
Participants by arm
| Arm | Count |
|---|---|
| 25G FNA Needle Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).
25G FNA needle | 306 |
| 20G ProCore FNB Needle Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).
20G ProCore FNB needle | 302 |
| Total | 608 |
Baseline characteristics
| Characteristic | 25G FNA Needle | 20G ProCore FNB Needle | Total |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 0.7 | 66 years STANDARD_DEVIATION 0.7 | 66 years STANDARD_DEVIATION 0.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 124 Participants | 140 Participants | 264 Participants |
| Sex: Female, Male Male | 182 Participants | 162 Participants | 344 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 306 | 0 / 302 |
| other Total, other adverse events | 3 / 306 | 2 / 302 |
| serious Total, serious adverse events | 0 / 306 | 0 / 302 |
Outcome results
Primary
Diagnostic Accuracy
Diagnostic accuracy is the number of correctly diagnosed cases as compared to gold standard diagnosis Gold standard diagnosis is defined as; 1. in operated patients; based on the surgical resection specimen 2. in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of tissue sampling and imaging studies), and confirmed by a compatible clinical disease course of at least 9 months
Time frame: 27 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 25G FNA Needle | Diagnostic Accuracy | 237 Participants |
| 20G ProCore FNB Needle | Diagnostic Accuracy | 263 Participants |
Secondary
Diagnostic Yield of the First Needle Pass
Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not
Time frame: after 27 months
Population: Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 25G FNA Needle | Diagnostic Yield of the First Needle Pass | 206 Participants |
| 20G ProCore FNB Needle | Diagnostic Yield of the First Needle Pass | 209 Participants |
Secondary
Number of Participants in Whom Target Lesion Was Sampled
records if a target lesion was reached during the procedure using the randomised needle or not
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 25G FNA Needle | Number of Participants in Whom Target Lesion Was Sampled | 306 Participants |
| 20G ProCore FNB Needle | Number of Participants in Whom Target Lesion Was Sampled | 298 Participants |
Secondary
Number of Patients With Adverse Events Per Needle Type
adverse events per needle type, up to 27 months after procedure
Time frame: 27 months after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 25G FNA Needle | Number of Patients With Adverse Events Per Needle Type | 3 Participants |
| 20G ProCore FNB Needle | Number of Patients With Adverse Events Per Needle Type | 2 Participants |
Secondary
On-site Pathological Evaluation Performed
Presence of pathologist on site during procedure
Time frame: 27 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 25G FNA Needle | On-site Pathological Evaluation Performed | 74 participants |
| 20G ProCore FNB Needle | On-site Pathological Evaluation Performed | 26 participants |
Secondary
Presence of Vital Target Cells Per Case, Per Needle Type
Presence of sufficient vital target cells, as in, target organ cells to provide a diagnosis (yes or no)
Time frame: after 27 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 25G FNA Needle | Presence of Vital Target Cells Per Case, Per Needle Type | 248 Participants |
| 20G ProCore FNB Needle | Presence of Vital Target Cells Per Case, Per Needle Type | 263 Participants |
p-value: <0.05Chi-squared