Fine Needle Aspiration, Pancreatic Mass
Conditions
Brief summary
The objective of this paired cohort study is to evaluate the diagnostic accuracy of Endoscopic Ultrasound-fine needle aspiration (EUS-FNA) with rapid onsite evaluation (ROSE) compared to EUS-fine needle biopsy (EUS-FNB) without ROSE. If EUS-FNB without ROSE is shown to be non-inferior to the current standard of care of EUS-FNA with ROSE in pancreatic lesions, this study has the potential to make EUS-guided tissue acquisition more economical (with elimination for the need for cytopathology staff onsite) as well as provide core histological specimen without sacrificing the overall diagnostic yield.
Detailed description
Endoscopic ultrasound (EUS) guided fine needle aspiration (EUS-FNA) is the primary technique for tissue acquisition for pancreatic lesions. Despite widespread adoption of the techniques, the diagnostic yield of EUS-FNA for pancreatic lesion is highly variable, with sensitivities ranging from 64-95%, specificities ranging from 75-100% and overall diagnostic accuracy ranging from 78-95%. Despite its mainstay as the primary technique for tissue acquisition, EUS-FNA has several limitations. The standard EUS-FNA does not routinely provide core biopsy specimen with preserved tissue architecture, which is required for immunohistochemical staining and for definitive diagnosis of conditions, such as lymphoma, gastrointestinal stromal tumors, Immunoglobulin G (IgG)-4-associated lymphoplasmacytic sclerosing pancreatitis. Furthermore, the diagnostic yield of EUS-FNA is highly dependent on the availability of bedside cytotechnologist or cytopathologist for rapid onsite evaluation (ROSE), which increases the overall cost required to perform EUS-FNA. Recently, multiple dedicated EUS fine needle biopsy (FNB) needles have been developed to obtain core specimens. Early small studies have shown promising results with these EUS-FNB needles. The objective of this paired cohort study is to evaluate the diagnostic accuracy of EUS-FNA with ROSE compared to EUS-FNA with ROSE. Participants will be assigned to the arms. If EUS-FNB without ROSE is shown to be non-inferior to the current standard of care of EUS-FNA with ROSE in pancreatic lesions, this study has the potential to make EUS-guided tissue acquisition more economical (with elimination for the need for cytopathology staff onsite) as well as provide core histological specimen without sacrificing the overall diagnostic yield.
Interventions
DIAGNOSTIC_TESTEUS-FNA with ROSE
EUS-FNA with ROSE vs EUS-FNB without ROSE
DIAGNOSTIC_TESTEUS-FNB without ROSE
EUS-FNA with ROSE vs EUS-FNB without ROSE
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient ≥ 18 years of age referred for EUS-guided biopsy for pancreatic mass lesions
Exclusion criteria
* Refusal to consent form * Uncorrectable coagulopathy (INR \> 1.5) * Uncorrectable thrombocytopenia (platelet \< 50,000) * Uncooperative patients * Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures) * Medically unstable for sedation * Entirely cystic lesions * Lesions inaccessible to EUS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Diagnostic Accuracy of Fine-needle Biopsy (FNB) Sampling Without Rapid Onsite Evaluation (ROSE) and the Fine Needle Aspiration (FNA) With ROSE in Pancreatic Mass Lesions | 6 months from the initial biopsy | Diagnostic accuracy will be defined as (true positive + true negative)/all participants in the arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specimen Adequacy | Post-procedure one week | Number of Specimens with Final Histopathological Diagnosis |
| Number of Histology Cores Obtained | Post-procedure one week | Number of Samples with Visible Histology Core Biopsy |
| Median Number of Passes | 6 months from the initial biopsy | Median number of passes required for accurate diagnosis |
| Number of Technical Failures | After the procedure, an average of 1 hour | Technical failure was defined as the inability to perform the procedure, including the need to change the needle |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EUS-FNA With ROSE EUS/FNA with ROSE will be performed using standard techniques via 22-g FNA needle (Cook Medical EchoTip Ultra or Boston Scientific Expect or Medtronic Beacon). Lesions will be identified using EUS and punctured with the FNA needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNA specimens will be processed for ROSE using standard techniques with bedside smear slide evaluation and liquid-based cytology and cell-block preparation.
EUS-FNA with ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE | 23 |
| EUS-FNB Without ROSE EUS/FNB without ROSE will be performed using similar techniques for tissue acquisition as FNA using 22-g FNB needle (Medtronic SharkCore or Boston Scientific Acquire). Lesions will be identified using EUS and punctured with the 22-g FNB needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNB samples will be placed directly into formalin containers and sent to be processed by surgical pathology.
EUS-FNB without ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE | 17 |
| Total | 40 |
Baseline characteristics
| Characteristic | EUS-FNB Without ROSE | Total | EUS-FNA With ROSE |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 25 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 15 Participants | 10 Participants |
| Age, Continuous | 69.94 years STANDARD_DEVIATION 8.41 | 67.32 years STANDARD_DEVIATION 9.59 | 65.39 years STANDARD_DEVIATION 9.95 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 30 Participants | 18 Participants |
| Region of Enrollment United States | 17 Participants | 40 Participants | 23 Participants |
| Sex: Female, Male Female | 10 Participants | 24 Participants | 14 Participants |
| Sex: Female, Male Male | 7 Participants | 16 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 17 |
| other Total, other adverse events | 0 / 23 | 0 / 17 |
| serious Total, serious adverse events | 0 / 23 | 0 / 17 |
Outcome results
Primary
The Diagnostic Accuracy of Fine-needle Biopsy (FNB) Sampling Without Rapid Onsite Evaluation (ROSE) and the Fine Needle Aspiration (FNA) With ROSE in Pancreatic Mass Lesions
Diagnostic accuracy will be defined as (true positive + true negative)/all participants in the arm.
Time frame: 6 months from the initial biopsy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EUS-FNA With ROSE | The Diagnostic Accuracy of Fine-needle Biopsy (FNB) Sampling Without Rapid Onsite Evaluation (ROSE) and the Fine Needle Aspiration (FNA) With ROSE in Pancreatic Mass Lesions | 91.3 percentage of true cases |
| EUS-FNB Without ROSE | The Diagnostic Accuracy of Fine-needle Biopsy (FNB) Sampling Without Rapid Onsite Evaluation (ROSE) and the Fine Needle Aspiration (FNA) With ROSE in Pancreatic Mass Lesions | 94.1 percentage of true cases |
Secondary
Median Number of Passes
Median number of passes required for accurate diagnosis
Time frame: 6 months from the initial biopsy
Population: Participants with accurate diagnosis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EUS-FNA With ROSE | Median Number of Passes | 2 passes |
| EUS-FNB Without ROSE | Median Number of Passes | 1 passes |
Secondary
Number of Histology Cores Obtained
Number of Samples with Visible Histology Core Biopsy
Time frame: Post-procedure one week
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| EUS-FNA With ROSE | Number of Histology Cores Obtained | 3 Samples |
| EUS-FNB Without ROSE | Number of Histology Cores Obtained | 46 Samples |
Secondary
Number of Technical Failures
Technical failure was defined as the inability to perform the procedure, including the need to change the needle
Time frame: After the procedure, an average of 1 hour
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| EUS-FNA With ROSE | Number of Technical Failures | 0 Procedures |
| EUS-FNB Without ROSE | Number of Technical Failures | 0 Procedures |
Secondary
Specimen Adequacy
Number of Specimens with Final Histopathological Diagnosis
Time frame: Post-procedure one week
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| EUS-FNA With ROSE | Specimen Adequacy | 35 Samples |
| EUS-FNB Without ROSE | Specimen Adequacy | 47 Samples |