Pancreatic Cancer
Conditions
Brief summary
This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.
Detailed description
This is a single-blinded randomized controlled trial with paired evaluation of conventional FNA needle versus FNB needle stratified by lesion location (pancreas head tumor versus pancreas body/tail). A minimum of 4 passes ( 2 with each needle) will be performed from all the lesions. After each pass of needle, the on-site cytopathologists will evaluate the adequacy and the degree of the pathological changes in the obtained material. Based on the information provided by the onsite cytopathologists, the endosonographer will repeat the FNA until enough histological material is obtained to confirm a diagnosis. Patients will be assessed immediately after procedure and during the first 30 days with a follow-up.
Interventions
DEVICEFine Needle Biopsy (FNB)
The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.
Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds.
Sponsors
Medtronic
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients who are 18 years old or older and are referred for the evaluation of pancreatic mass lesion. * International Normalized Ratio (INR) less than 1.5 and platelet count of more than 50,000. * Medically stable to undergo sedation for EUS. * Signed informed consent
Exclusion criteria
* Medical condition that preclude the patient from having a therapeutic procedure regardless of the EUS finding * Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total DNA Yield of Adenocarcinoma | Baseline | Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Core Tissue Length | Baseline | The length of the tissue core sample acquired, on the first needle pass, measured in centimeters. |
| Concentration of DNA Yield of Adenocarcinoma | Baseline | The concentration of the DNA from the adenocarcinoma on the first needle pass, measured in micrograms per microliter. |
| Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis | Baseline | The total number of passes required to obtain adequate tissue sample for cytology/histology processing and interpretation. |
| Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation | Baseline | The total number of subjects whose first-pass biopsy contained adequate material for cytologic interpretation, as determined by a cytopathologist. |
| Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation | Baseline | The number of subjects whose first pass biopsy contained adequate material for high quality histologic interpretation, as determined by a cytopathologist. High quality is defined as being greater than 10 power field in length. |
| Percentage of Tumor Cellularity | Baseline | Percent of tumor cellularity with first pass of adenocarcinoma |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FNB First, Then FNA In an endoscopic ultrasound-guided procedure, Shark Core Fine Needle Biopsy (FNB) will be performed first, followed by Fine Needle Aspiration (FNA).
Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.
Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds. | 25 |
| FNA First, Then FNB In an endoscopic ultrasound-guided procedure, Fine Needle Aspiration (FNA) will be performed first, followed by Shark Core Fine Needle Biopsy (FNB).
Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.
Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | FNB First, Then FNA | Total | FNA First, Then FNB |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 14.1 | 69 years STANDARD_DEVIATION 11.8 | 70 years STANDARD_DEVIATION 9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 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 | 22 Participants | 44 Participants | 22 Participants |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 12 Participants | 24 Participants | 12 Participants |
| Sex: Female, Male Male | 13 Participants | 26 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 2 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Total DNA Yield of Adenocarcinoma
Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fine Needle Biopsy (FNB) | Total DNA Yield of Adenocarcinoma | 5930.10 ng/µL | Standard Deviation 881 |
| Fine Needle Aspiration (FNA) | Total DNA Yield of Adenocarcinoma | 3365.22 ng/µL | Standard Deviation 788 |
p-value: 0.01t-test, 2 sided
Secondary
Concentration of DNA Yield of Adenocarcinoma
The concentration of the DNA from the adenocarcinoma on the first needle pass, measured in micrograms per microliter.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fine Needle Biopsy (FNB) | Concentration of DNA Yield of Adenocarcinoma | 65.00 µg/mL | Standard Deviation 8.6 |
| Fine Needle Aspiration (FNA) | Concentration of DNA Yield of Adenocarcinoma | 37.21 µg/mL | Standard Deviation 8.3 |
p-value: 0.02t-test, 2 sided
Secondary
Core Tissue Length
The length of the tissue core sample acquired, on the first needle pass, measured in centimeters.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fine Needle Biopsy (FNB) | Core Tissue Length | 6 centimeters |
| Fine Needle Aspiration (FNA) | Core Tissue Length | 2 centimeters |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Percentage of Tumor Cellularity
Percent of tumor cellularity with first pass of adenocarcinoma
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fine Needle Biopsy (FNB) | Percentage of Tumor Cellularity | 40 percentage of tumor cellularity |
| Fine Needle Aspiration (FNA) | Percentage of Tumor Cellularity | 10 percentage of tumor cellularity |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis
The total number of passes required to obtain adequate tissue sample for cytology/histology processing and interpretation.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fine Needle Biopsy (FNB) | Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis | 5 needle passes |
| Fine Needle Aspiration (FNA) | Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis | 2 needle passes |
Secondary
Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation
The total number of subjects whose first-pass biopsy contained adequate material for cytologic interpretation, as determined by a cytopathologist.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fine Needle Biopsy (FNB) | Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation | 3 Participants |
| Fine Needle Aspiration (FNA) | Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation | 18 Participants |
Secondary
Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation
The number of subjects whose first pass biopsy contained adequate material for high quality histologic interpretation, as determined by a cytopathologist. High quality is defined as being greater than 10 power field in length.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fine Needle Biopsy (FNB) | Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation | 33 Participants |
| Fine Needle Aspiration (FNA) | Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation | 4 Participants |