Trial Outcomes & Findings for EUS-guided Fine Needle Aspiration (FNA) With and Without the Use of a Stylet (NCT NCT01316614)
NCT ID: NCT01316614
Last Updated: 2014-12-03
Results Overview
The number of passes was determined by the lesion site and mirrored clinical practice (6 passes for pancreatic/other lesions and 4 passes for lymph nodes). The order of these passes was determined by a preprinted randomization sequence kept in an opaque sealed envelope that was opened by the research coordinator or EUS technologist after enrollment. Each participant had an equal number of passes with stylet and without stylet. There was no communication between the endosonographer and the cytopathologist regarding the adequacy of the specimen or diagnosis until all passes had been completed. The on-site evaluation of smears was performed to assess cellular adequacy and to assess the need for any additional passes. Additional passes were made at the discretion of the endosonographer as clinically indicated but were not included in the final analysis. The cytology slides were evaluated by 3 experienced cytopathologists who were all blinded to the stylet status of the passes.
COMPLETED
NA
137 participants
At the time of EUS-FNA procedure (Day 1)
2014-12-03
Participant Flow
The study opened to participant enrollment on 07/21/2010 and closed to participant enrollment on 02/07/2012.
Participant milestones
| Measure |
With Stylet & Without Stylet
There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet. Only the order of the passes were randomized.
|
|---|---|
|
Overall Study
STARTED
|
137
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
With Stylet & Without Stylet
There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet. Only the order of the passes were randomized.
|
|---|---|
|
Overall Study
No solid lesion and FNA not indicated
|
25
|
|
Overall Study
Cytology slides not available for review
|
4
|
|
Overall Study
Cystic lesion
|
5
|
|
Overall Study
Inadequate number of passes
|
2
|
|
Overall Study
Medically unstable
|
1
|
Baseline Characteristics
EUS-guided Fine Needle Aspiration (FNA) With and Without the Use of a Stylet
Baseline characteristics by cohort
| Measure |
With Stylet & Without Stylet
n=100 Participants
There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet.
|
|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
|
Lesions that underwent EUS-FNA
Pancreatic masses
|
58 participants
n=5 Participants
|
|
Lesions that underwent EUS-FNA
Lymph nodes
|
25 participants
n=5 Participants
|
|
Lesions that underwent EUS-FNA
Gastric subepithelial lesion
|
6 participants
n=5 Participants
|
|
Lesions that underwent EUS-FNA
Esophageal subepithelial lesion
|
2 participants
n=5 Participants
|
|
Lesions that underwent EUS-FNA
Biliary stricture
|
3 participants
n=5 Participants
|
|
Lesions that underwent EUS-FNA
Hilar mass
|
1 participants
n=5 Participants
|
|
Lesions that underwent EUS-FNA
Liver
|
1 participants
n=5 Participants
|
|
Lesions that underwent EUS-FNA
Ampulla
|
1 participants
n=5 Participants
|
|
Lesions that underwent EUS-FNA
Left adrenal gland
|
1 participants
n=5 Participants
|
|
Lesions that underwent EUS-FNA
Mediastinal mass
|
2 participants
n=5 Participants
|
|
Size of lesions
All lesions
|
2.95 centimeters (cm)
STANDARD_DEVIATION 21.8 • n=5 Participants
|
|
Size of lesions
Pancreas
|
3.18 centimeters (cm)
STANDARD_DEVIATION 1.53 • n=5 Participants
|
|
Size of lesions
Lymph node
|
2.08 centimeters (cm)
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Size of lesions
All other lesions
|
3.35 centimeters (cm)
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Tissue echogenecity
Hypoechoic
|
86 participants
n=5 Participants
|
|
Tissue echogenecity
Mixed echogenicity
|
14 participants
n=5 Participants
|
|
Needle gauge used
22-gauge
|
77 participants
n=5 Participants
|
|
Needle gauge used
25-gauge
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the time of EUS-FNA procedure (Day 1)Population: 100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 overall passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.
The number of passes was determined by the lesion site and mirrored clinical practice (6 passes for pancreatic/other lesions and 4 passes for lymph nodes). The order of these passes was determined by a preprinted randomization sequence kept in an opaque sealed envelope that was opened by the research coordinator or EUS technologist after enrollment. Each participant had an equal number of passes with stylet and without stylet. There was no communication between the endosonographer and the cytopathologist regarding the adequacy of the specimen or diagnosis until all passes had been completed. The on-site evaluation of smears was performed to assess cellular adequacy and to assess the need for any additional passes. Additional passes were made at the discretion of the endosonographer as clinically indicated but were not included in the final analysis. The cytology slides were evaluated by 3 experienced cytopathologists who were all blinded to the stylet status of the passes.
Outcome measures
| Measure |
With Stylet
n=100 Participants
Each participant had half of their passes performed with a stylet.
|
Without Stylet
n=100 Participants
Each participant had half of their passes performed without a stylet.
|
|---|---|---|
|
Compare Adequacy of Diagnoses in Passes With and Without a Stylet
Benign or negative for malignancy
|
80 passes
|
68 passes
|
|
Compare Adequacy of Diagnoses in Passes With and Without a Stylet
Atypical
|
21 passes
|
18 passes
|
|
Compare Adequacy of Diagnoses in Passes With and Without a Stylet
Suspicious
|
23 passes
|
15 passes
|
|
Compare Adequacy of Diagnoses in Passes With and Without a Stylet
Malignant
|
94 passes
|
110 passes
|
|
Compare Adequacy of Diagnoses in Passes With and Without a Stylet
Inadequate for reporting
|
57 passes
|
64 passes
|
SECONDARY outcome
Timeframe: At the time of EUS-FNA procedure (Day 1)Population: 100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.
Percentage of area of slide that contains cells of the representative lesion
Outcome measures
| Measure |
With Stylet
n=100 Participants
Each participant had half of their passes performed with a stylet.
|
Without Stylet
n=100 Participants
Each participant had half of their passes performed without a stylet.
|
|---|---|---|
|
Degree of Cellularity
No representative cells present
|
66 passes
|
72 passes
|
|
Degree of Cellularity
Representative cells present in <25%
|
58 passes
|
46 passes
|
|
Degree of Cellularity
Representative cells present in <25-50% slide
|
97 passes
|
99 passes
|
|
Degree of Cellularity
Representative cells present in >50% of the slide
|
54 passes
|
58 passes
|
SECONDARY outcome
Timeframe: At the time of EUS-FNA procedure (Day 1)Population: 100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.
Number of cells per slide
Outcome measures
| Measure |
With Stylet
n=100 Participants
Each participant had half of their passes performed with a stylet.
|
Without Stylet
n=100 Participants
Each participant had half of their passes performed without a stylet.
|
|---|---|---|
|
Degree of Cellularity
Fair (<100 cells/slide)
|
127 passes
|
120 passes
|
|
Degree of Cellularity
Good (100-1000 cells/slide)
|
70 passes
|
82 passes
|
|
Degree of Cellularity
Excellent (>1000 cells/slide)
|
78 passes
|
73 passes
|
SECONDARY outcome
Timeframe: At the time of EUS-FNA procedure (Day 1)Population: 100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.
Outcome measures
| Measure |
With Stylet
n=100 Participants
Each participant had half of their passes performed with a stylet.
|
Without Stylet
n=100 Participants
Each participant had half of their passes performed without a stylet.
|
|---|---|---|
|
Adequacy of Specimen
Inadequate
|
87 passes
|
78 passes
|
|
Adequacy of Specimen
Adequate
|
188 passes
|
197 passes
|
SECONDARY outcome
Timeframe: At the time of EUS-FNA procedure (Day 1)Population: 100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.
Percentage of area of slide that represents GI contamination
Outcome measures
| Measure |
With Stylet
n=100 Participants
Each participant had half of their passes performed with a stylet.
|
Without Stylet
n=100 Participants
Each participant had half of their passes performed without a stylet.
|
|---|---|---|
|
Contamination
No contaminations seen
|
212 passes
|
220 passes
|
|
Contamination
Contamination present in <25% of the slide
|
52 passes
|
47 passes
|
|
Contamination
Contamination present in 25%-50% of the slide
|
7 passes
|
5 passes
|
|
Contamination
Contamination present in >50% of the slide
|
4 passes
|
3 passes
|
SECONDARY outcome
Timeframe: At the time of EUS-FNA procedure (Day 1)Population: 100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.
Outcome measures
| Measure |
With Stylet
n=100 Participants
Each participant had half of their passes performed with a stylet.
|
Without Stylet
n=100 Participants
Each participant had half of their passes performed without a stylet.
|
|---|---|---|
|
Amount of Blood
Minimal
|
126 passes
|
120 passes
|
|
Amount of Blood
Moderate
|
82 passes
|
86 passes
|
|
Amount of Blood
Significant
|
67 passes
|
69 passes
|
Adverse Events
With Stylet & Without Stylet
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Daniel K. Mullady, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place