Trial Outcomes & Findings for Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle (NCT NCT02678442)
NCT ID: NCT02678442
Last Updated: 2020-01-06
Results Overview
Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline
Results posted on
2020-01-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention
STARTED
|
25
|
25
|
|
First Intervention
COMPLETED
|
25
|
25
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
25
|
25
|
|
Second Intervention
COMPLETED
|
23
|
23
|
|
Second Intervention
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle
Baseline characteristics by cohort
| Measure |
FNB First, Then FNA
n=25 Participants
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.
|
FNA First, Then FNB
n=25 Participants
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
70 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
69 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineTotal quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.
Outcome measures
| Measure |
Fine Needle Biopsy (FNB)
n=37 Participants
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)
n=37 Participants
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.
|
|---|---|---|
|
Total DNA Yield of Adenocarcinoma
|
5930.10 ng/µL
Standard Deviation 881
|
3365.22 ng/µL
Standard Deviation 788
|
SECONDARY outcome
Timeframe: BaselineThe total number of passes required to obtain adequate tissue sample for cytology/histology processing and interpretation.
Outcome measures
| Measure |
Fine Needle Biopsy (FNB)
n=50 Participants
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)
n=50 Participants
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.
|
|---|---|---|
|
Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis
|
5 needle passes
Interval 0.0 to 5.0
|
2 needle passes
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: BaselineThe length of the tissue core sample acquired, on the first needle pass, measured in centimeters.
Outcome measures
| Measure |
Fine Needle Biopsy (FNB)
n=50 Participants
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)
n=50 Participants
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.
|
|---|---|---|
|
Core Tissue Length
|
6 centimeters
Interval 0.0 to 20.0
|
2 centimeters
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: BaselineThe concentration of the DNA from the adenocarcinoma on the first needle pass, measured in micrograms per microliter.
Outcome measures
| Measure |
Fine Needle Biopsy (FNB)
n=37 Participants
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)
n=37 Participants
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.
|
|---|---|---|
|
Concentration of DNA Yield of Adenocarcinoma
|
65.00 µg/mL
Standard Deviation 8.6
|
37.21 µg/mL
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: BaselinePercent of tumor cellularity with first pass of adenocarcinoma
Outcome measures
| Measure |
Fine Needle Biopsy (FNB)
n=50 Participants
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)
n=50 Participants
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.
|
|---|---|---|
|
Percentage of Tumor Cellularity
|
40 percentage of tumor cellularity
Interval 0.0 to 90.0
|
10 percentage of tumor cellularity
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: BaselineThe total number of subjects whose first-pass biopsy contained adequate material for cytologic interpretation, as determined by a cytopathologist.
Outcome measures
| Measure |
Fine Needle Biopsy (FNB)
n=50 Participants
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)
n=50 Participants
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.
|
|---|---|---|
|
Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation
|
3 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
Fine Needle Biopsy (FNB)
n=50 Participants
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)
n=50 Participants
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.
|
|---|---|---|
|
Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation
|
33 Participants
|
4 Participants
|
Adverse Events
Fine Needle Biopsy (FNB)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Fine Needle Aspiration (FNA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fine Needle Biopsy (FNB)
n=50 participants at risk
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)
n=50 participants at risk
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.
|
|---|---|---|
|
General disorders
Pancreatitis
|
4.0%
2/50 • Number of events 2 • Adverse events were assessed immediately after the procedure and during the first 30 days with a follow-up telephone call or clinical visit for each subject, for a total of approximately two and a half years.
|
0.00%
0/50 • Adverse events were assessed immediately after the procedure and during the first 30 days with a follow-up telephone call or clinical visit for each subject, for a total of approximately two and a half years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place