Trial Outcomes & Findings for Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions (NCT NCT01936467)
NCT ID: NCT01936467
Last Updated: 2017-04-13
Results Overview
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
121 participants
Primary outcome timeframe
up to 6 months
Results posted on
2017-04-13
Participant Flow
Patients were enrolled between September 2013 and December 2014 in two tertiary academic centers
Patients were excluded from the study because a predominantly cystic lesion was found; the lack of an appreciable mass at EUS, unavailable on-site pathology and respiratory distress precluding completion of the examination
Participant milestones
| Measure |
Suction Technique
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
|
Capillary Technique
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
61
|
|
Overall Study
COMPLETED
|
60
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions
Baseline characteristics by cohort
| Measure |
Suction Technique
n=60 Participants
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
|
Capillary Technique
n=61 Participants
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
64.15 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Prior History
Chronic Pancreatitis
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Prior History
Chemotherapy
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Prior History
Radiation therapy
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Prior non-diagnostic FNA
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Antiplatelet therapy
|
6 participants
n=5 Participants
|
14 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Pancreatic mass Location
Uncinate/Head
|
31 participants
n=5 Participants
|
42 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Pancreatic mass Location
Neck
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Pancreatic mass Location
Body
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Pancreatic mass Location
Tail
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Pancreatic mass size
|
2.86 Centimeter
STANDARD_DEVIATION 1.23 • n=5 Participants
|
3.2 Centimeter
STANDARD_DEVIATION 1.63 • n=7 Participants
|
3.03 Centimeter
STANDARD_DEVIATION 1.43 • n=5 Participants
|
|
Echogeicity of the lesion
Hypoecho
|
52 participants
n=5 Participants
|
55 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Echogeicity of the lesion
Isoecho
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Echogeicity of the lesion
Hyperecho
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Cystic Component
|
12 mass
n=5 Participants
|
10 mass
n=7 Participants
|
22 mass
n=5 Participants
|
|
Vascular involvement
Arterial
|
28 mass
n=5 Participants
|
21 mass
n=7 Participants
|
49 mass
n=5 Participants
|
|
Vascular involvement
Venous
|
28 mass
n=5 Participants
|
32 mass
n=7 Participants
|
60 mass
n=5 Participants
|
|
Vascular involvement
Arterial and Venous
|
19 mass
n=5 Participants
|
14 mass
n=7 Participants
|
33 mass
n=5 Participants
|
|
EUS features of chronic pancreatitis
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Biliary stent present
Metal stent
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Biliary stent present
Plastic stent
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsDiagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Outcome measures
| Measure |
Capillary Technique
n=61 Participants
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously
|
Patients With Negative Gold Standard
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
|
|---|---|---|
|
Diagnostic Yield of Capillary Technique
|
75.4 percentage of specimen
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsDiagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Outcome measures
| Measure |
Capillary Technique
n=60 Participants
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously
|
Patients With Negative Gold Standard
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
|
|---|---|---|
|
Diagnostic Yield of Standard Technique
|
65 percentage of specimen
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.
Sensitivity of the EUS-FNA with Capillary technique
Outcome measures
| Measure |
Capillary Technique
n=48 Participants
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously
|
Patients With Negative Gold Standard
n=4 Participants
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
|
|---|---|---|
|
Sensitivity of EUS-FNA With Capillary Technique
Positive EUS-FNA
|
45 participants
|
0 participants
|
|
Sensitivity of EUS-FNA With Capillary Technique
Negative EUS-FNA
|
3 participants
|
4 participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.
Sensitivity of the EUS-FNA with Capillary technique
Outcome measures
| Measure |
Capillary Technique
n=44 Participants
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously
|
Patients With Negative Gold Standard
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
|
|---|---|---|
|
Sensitivity of EUS-FNA With StandardTechnique
Positive EUS-FNA
|
39 Participants
|
—
|
|
Sensitivity of EUS-FNA With StandardTechnique
Negative EUS-FNA
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.
Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions
Outcome measures
| Measure |
Capillary Technique
n=44 Participants
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously
|
Patients With Negative Gold Standard
n=52 Participants
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
|
|---|---|---|
|
Sensitivity of EUS-FNA
|
88.6 percentage of positive gold standard
|
93.7 percentage of positive gold standard
|
SECONDARY outcome
Timeframe: immediateThe rate of aquiring diagnostic pancreatic mass tissue with first FNA pass
Outcome measures
| Measure |
Capillary Technique
n=60 Participants
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously
|
Patients With Negative Gold Standard
n=61 Participants
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
|
|---|---|---|
|
First Pass Diagnostic Rate
|
23 participants
|
26 participants
|
SECONDARY outcome
Timeframe: immediateThe rate of acquiring core tissue of the pancreatic mass through EUS-FNA
Outcome measures
| Measure |
Capillary Technique
n=60 Participants
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously
|
Patients With Negative Gold Standard
n=61 Participants
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
|
|---|---|---|
|
Acquisition of Core Tissue
|
28 participants
|
37 participants
|
SECONDARY outcome
Timeframe: 6 monthsThe proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease
Outcome measures
| Measure |
Capillary Technique
n=60 Participants
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously
|
Patients With Negative Gold Standard
n=61 Participants
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
|
|---|---|---|
|
Diagnostic Accuracy of EUS-FNA
|
88 percent accurate
|
93.8 percent accurate
|
Adverse Events
Suction Technique
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Capillary Technique
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place