Trial Outcomes & Findings for Trial Comparing 19 and 25-gauge EUS-FNA Needles (NCT NCT01677312)
NCT ID: NCT01677312
Last Updated: 2020-03-17
Results Overview
To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
5 months
Results posted on
2020-03-17
Participant Flow
Participant milestones
| Measure |
19G FNA Needle
19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
|
25G FNA Needle
25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Comparing 19 and 25-gauge EUS-FNA Needles
Baseline characteristics by cohort
| Measure |
19G FNA Needle
n=36 Participants
Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.
Pancreatic Biopsy: A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.
Histological Samples: The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.
|
25G FNA Needle
n=36 Participants
Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.
Pancreatic Biopsy: A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.
Histological Samples: The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
67.1 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
67.3 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
36 participants
n=7 Participants
|
72 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 monthsTo compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types.
Outcome measures
| Measure |
19G FNA Needle
n=36 Participants
19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
|
25G FNA Needle
n=36 Participants
25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
|
|---|---|---|
|
Median Number of Passes to Establish Diagnosis
|
1 No. of passes
Interval 1.0 to 1.0
|
1 No. of passes
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: 30 daysThe ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined.
Outcome measures
| Measure |
19G FNA Needle
n=36 Participants
19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
|
25G FNA Needle
n=36 Participants
25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
|
|---|---|---|
|
Procurement of Histological Samples
|
86.1 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hoursThe percentage of cases in which needle dysfunction occurs will be compared between the 19G and 25G needle types. Needle dysfunction will be defined as the need to use more than one FNA needle per lesion in an individual patient.
Outcome measures
| Measure |
19G FNA Needle
n=36 Participants
19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
|
25G FNA Needle
n=36 Participants
25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
|
|---|---|---|
|
Needle Dysfunction
|
0 percentage of participants
|
2.8 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysThe safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation.
Outcome measures
| Measure |
19G FNA Needle
n=36 Participants
19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
|
25G FNA Needle
n=36 Participants
25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
|
|---|---|---|
|
Complications
|
2.8 percentage of participants
|
0 percentage of participants
|
Adverse Events
19G FNA Needle
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
25G FNA Needle
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 |
19G FNA Needle
n=36 participants at risk
19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
|
25G FNA Needle
n=36 participants at risk
25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures
|
|---|---|---|
|
General disorders
Bleeding and fever
|
2.8%
1/36 • Number of events 1 • 10 days
Telephone follow up conducted at 24 hours and 10 days post-procedure
|
0.00%
0/36 • 10 days
Telephone follow up conducted at 24 hours and 10 days post-procedure
|
Additional Information
Dr. Shyam Varadarajulu, MD
Center for Interventional Endoscopy, Florida Hospital
Phone: 407-303-2570
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place