Trial Outcomes & Findings for Evaluation of PCLs Using Three EUS-FNA Needles (NCT NCT01711294)
NCT ID: NCT01711294
Last Updated: 2021-01-15
Results Overview
Volume of aspirated cyst fluid as a function of estimated maximal volume, based on pre-aspiration EUS measure of cyst diameter (s) (% aspiration of total estimated volume)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
250 participants
Primary outcome timeframe
At procedure (Up to 1 hour)
Results posted on
2021-01-15
Participant Flow
Participant milestones
| Measure |
19G Flex Needle
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
121
|
65
|
64
|
|
Overall Study
COMPLETED
|
121
|
65
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
19G Flex Needle
n=121 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=65 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=64 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 14 • n=121 Participants
|
65 years
STANDARD_DEVIATION 16 • n=65 Participants
|
62 years
STANDARD_DEVIATION 15 • n=64 Participants
|
63 years
STANDARD_DEVIATION 15 • n=250 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=121 Participants
|
36 Participants
n=65 Participants
|
34 Participants
n=64 Participants
|
134 Participants
n=250 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=121 Participants
|
29 Participants
n=65 Participants
|
30 Participants
n=64 Participants
|
116 Participants
n=250 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Medical History
Diabetes Mellitus
|
25 Participants
n=121 Participants
|
13 Participants
n=65 Participants
|
12 Participants
n=64 Participants
|
50 Participants
n=250 Participants
|
|
Medical History
Chronic Pancreatitis
|
8 Participants
n=121 Participants
|
5 Participants
n=65 Participants
|
3 Participants
n=64 Participants
|
16 Participants
n=250 Participants
|
|
Medical History
Necrotizing Pancreatitis
|
0 Participants
n=121 Participants
|
1 Participants
n=65 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=250 Participants
|
|
Medical History
Symptomatic
|
41 Participants
n=121 Participants
|
28 Participants
n=65 Participants
|
21 Participants
n=64 Participants
|
90 Participants
n=250 Participants
|
|
Pancreatic Cystic Lesion (PCL) Location
Head/uncinate
|
53 Participants
n=121 Participants
|
30 Participants
n=65 Participants
|
26 Participants
n=64 Participants
|
109 Participants
n=250 Participants
|
|
Pancreatic Cystic Lesion (PCL) Location
Body
|
26 Participants
n=121 Participants
|
23 Participants
n=65 Participants
|
21 Participants
n=64 Participants
|
70 Participants
n=250 Participants
|
|
Pancreatic Cystic Lesion (PCL) Location
Tail
|
39 Participants
n=121 Participants
|
12 Participants
n=65 Participants
|
13 Participants
n=64 Participants
|
64 Participants
n=250 Participants
|
|
Pancreatic Cystic Lesion (PCL) Location
Neck
|
2 Participants
n=121 Participants
|
0 Participants
n=65 Participants
|
4 Participants
n=64 Participants
|
6 Participants
n=250 Participants
|
|
Pancreatic Cystic Lesion (PCL) Location
Junction of body and tail
|
1 Participants
n=121 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=250 Participants
|
PRIMARY outcome
Timeframe: At procedure (Up to 1 hour)Volume of aspirated cyst fluid as a function of estimated maximal volume, based on pre-aspiration EUS measure of cyst diameter (s) (% aspiration of total estimated volume)
Outcome measures
| Measure |
19G Flex Needle
n=121 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=65 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=64 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Volume of Aspirated Cyst Fluid as a Function of Estimated Maximal Volume
|
78 percentage of cyst volume aspirated
Standard Deviation 35
|
74 percentage of cyst volume aspirated
Standard Deviation 39
|
73 percentage of cyst volume aspirated
Standard Deviation 41
|
SECONDARY outcome
Timeframe: 30 daysAdverse events related to study procedure or study device were tabulated. Adverse events were assessed from the index procedure up to 30 days post procedure.
Outcome measures
| Measure |
19G Flex Needle
n=121 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=65 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=64 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Number of Patients With Related Adverse Events
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Procedure (Up to 1 hour)Change value is calculated as cyst volume measured after initial procedure (up to 1 hour) minus volume measured at the beginning of the initial procedure. Volume is measured using the standard geometric formula 4/3 πr³ where r is half the long axis. The volume unit is cc.
Outcome measures
| Measure |
19G Flex Needle
n=121 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=65 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=64 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Change in Volume of Cyst Post Initial Procedure Compared to Pre Procedure
|
16 cc
Standard Deviation 38
|
13 cc
Standard Deviation 35
|
22 cc
Standard Deviation 79
|
SECONDARY outcome
Timeframe: Procedure (up to 1 hour)Successful echoendoscopic fine needle aspiration of PCL, defined as complete cyst aspiration (final cyst maximal diameter of less than 5mm) or collection of aspirate adequate to perform two standard assays: cytology and carcinoembryonic antigen (CEA) (sample volume of 3 cc or more)
Outcome measures
| Measure |
19G Flex Needle
n=121 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=65 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=64 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Number of Participants With Successful Echoendoscopic Fine Needle Aspiration of PCL
|
108 Participants
|
53 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Procedure (Up to 1 hour)Patients whose pancreatic cyst lesion(s) can be reached and penetrated by the EUS-FNA needles.
Outcome measures
| Measure |
19G Flex Needle
n=121 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=65 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=64 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Number of Participants With PCL Reached/Penetrated
|
114 Participants
|
62 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Procedure (Up to 1 hour)Needle pass defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst.
Outcome measures
| Measure |
19G Flex Needle
n=121 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=65 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=64 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Number of EUS-FNA Needle Passes at Initial Procedure.
|
1 Needle passes
Standard Deviation 0
|
1 Needle passes
Standard Deviation 0
|
1 Needle passes
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Procedure (Up to 1 hour)Total number of EUS-FNA needles used across all participants at the initial procedure.
Outcome measures
| Measure |
19G Flex Needle
n=121 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=65 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=64 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Number of EUS-FNA Needles Used at Initial Procedure.
|
156 Needles used
|
81 Needles used
|
78 Needles used
|
SECONDARY outcome
Timeframe: Procedure (Up to 1 hour)Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst. Time of needle pass in is time of the first needle puncture into the cyst lumen. Needle pass out is time of removal of needle outside the cyst lumen, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst.
Outcome measures
| Measure |
19G Flex Needle
n=121 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=65 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=64 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Time Needed for Aspiration for Each Needle Pass at Initial Procedure.
|
86 seconds
Standard Deviation 115
|
145 seconds
Standard Deviation 188
|
106 seconds
Standard Deviation 163
|
SECONDARY outcome
Timeframe: Procedure (Up to 1 hour)Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst. Time of first needle pass in is time of the first needle puncture into the cyst lumen. Time of last needle pass out is time of removal of needle outside the cyst lumen at the end of the last fluid aspiration from a single or multi-loculated cyst, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst.
Outcome measures
| Measure |
19G Flex Needle
n=121 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=65 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=64 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Time From First Needle Pass in to Last Needle Pass Out at Initial Procedure.
|
210 seconds
Standard Deviation 225
|
198 seconds
Standard Deviation 161
|
238 seconds
Standard Deviation 205
|
SECONDARY outcome
Timeframe: Procedure (Up to 1 hour)Population: Ease of needle passage into the echoendoscope is evaluated per needle.
Number of needles rated either Excellent or Very good when inserted into the echoendoscope at the initial procedure.
Outcome measures
| Measure |
19G Flex Needle
n=137 Needles
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=72 Needles
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=70 Needles
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Number of Needles With Needle Insertion Rated as Excellent/Very Good
|
89 Needles
|
65 Needles
|
31 Needles
|
SECONDARY outcome
Timeframe: Procedure (Up to 1 hour)Population: Ease of needle passage out of the echoendoscope is evaluated per needle.
Number of needles rated either Excellent or Very good when removed from the echoendoscope at the initial procedure.
Outcome measures
| Measure |
19G Flex Needle
n=135 Needles
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=72 Needles
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=70 Needles
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Number of Needles With Needle Removal Rated as Excellent/Very Good
|
108 Needles
|
67 Needles
|
47 Needles
|
SECONDARY outcome
Timeframe: Procedure (Up to 1 hour)Population: Quality of needle visualization inside the cyst is evaluated per needle.
Number of needles rated either Excellent or Very good for visualization at the initial procedure.
Outcome measures
| Measure |
19G Flex Needle
n=131 Needle
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=69 Needle
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=64 Needle
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Number of Needles With Needle Visualization Rated as Excellent/Very Good
|
98 Needle
|
61 Needle
|
50 Needle
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: 3 patients excluded from analysis population in 19G Flex Arm due to histology diagnosis of neuroendocrine tumor (1), EUS diagnosis of neuroendocrine tumor (1), and solid cystic papillary neoplasm (1). 2 patients excluded from analysis population in 22G Arm due to missing EUS diagnosis (1) and EUS diagnosis of SPEN (1). 4 patients excluded from analysis population in 19G Arm due to missing EUS diagnosis (1) and EUS diagnosis of neuroendocrine tumor (3).
In order to assess the accuracy of EUS-FNA-based standard assays (cytology and CEA) as a diagnostic measure of disease state, the Disease State per EUS-FNA measure was compared to a reference diagnosis. The reference diagnostic standard was diagnosis from a surgical specimen histology, the true gold standard for cases that evolved to surgical resection within the follow-up of the study. For cases that did not progress to surgery within the follow-up period, the reference diagnostic standard was a composite diagnosis by a consensus board. The consensus board consisted of 3 experts who were blinded to the type of needle used. The consensus board diagnoses of disease state were based on baseline medical history, EUS and cross sectional imaging of the cyst, and aspirate characteristics (i.e. aspirate color and viscosity). If the EUS-FNA diagnosis matches with the histopathology or consensus board diagnosis, then the participant will be counted as having accurate diagnosis.
Outcome measures
| Measure |
19G Flex Needle
n=118 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=63 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=60 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Number of Participants With Accurate Diagnosis of the Disease State Using the EUS-FNA Needles
|
91 Participants
|
50 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 3 patients excluded from this analysis (1 patient in each Arm) due to missing data in post EUS-FNA patient management.
Post EUS-FNA patient management required (clinical and/or imaging surveillance, percutaneous drainage, surgical removal).
Outcome measures
| Measure |
19G Flex Needle
n=120 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=64 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=63 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Number of Participants Requiring Post EUS-FNA Patient Management
|
85 Participants
|
45 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Procedure - 30 days after procedurePopulation: 3 patients excluded from this analysis (1 patient in each Arm) due to missing data in patient management decision directly influenced by the EUS findings.
Patients whose Post EUS-FNA Management (clinical and/or imaging surveillance, percutaneous drainage, surgical removal) was Directly Influenced by the EUS-FNA findings.
Outcome measures
| Measure |
19G Flex Needle
n=120 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=64 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=63 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Number of Participants Whose Management Decision Was Directly Influenced by the EUS Findings
|
106 Participants
|
56 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: Procedure (Immediate)In the case of inability to access the pancreatic cystic lesion or to attain complete cyst aspiration, salvage aspiration procedure should be performed. Patients randomized to 19G Flex should undergo a salvage procedure with 22G or 19G needle (needle choice at discretion of physician); patients randomized to 22G or 19G should undergo salvage procedure with 19G Flex needle.
Outcome measures
| Measure |
19G Flex Needle
n=121 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=65 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=64 Participants
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Rate of Cross-over to Salvage Arm
|
8 Participants
|
8 Participants
|
11 Participants
|
Adverse Events
19G Flex Needle
Serious events: 3 serious events
Other events: 1 other events
Deaths: 1 deaths
22G Needle
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
19G Needle
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
19G Flex Needle
n=121 participants at risk
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=65 participants at risk
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=64 participants at risk
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.83%
1/121 • Number of events 1 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
1.5%
1/65 • Number of events 1 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
0.00%
0/64 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.83%
1/121 • Number of events 1 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
0.00%
0/65 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
0.00%
0/64 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
|
Infections and infestations
Gastroenteritis
|
0.83%
1/121 • Number of events 1 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
0.00%
0/65 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
0.00%
0/64 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.83%
1/121 • Number of events 1 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
0.00%
0/65 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
0.00%
0/64 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma metastatic
|
0.00%
0/121 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
1.5%
1/65 • Number of events 1 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
0.00%
0/64 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
Other adverse events
| Measure |
19G Flex Needle
n=121 participants at risk
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex)
19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle.
|
22G Needle
n=65 participants at risk
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G)
22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
19G Needle
n=64 participants at risk
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G)
19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle.
|
|---|---|---|---|
|
General disorders
Haemorrhagic cyst
|
0.00%
0/121 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
1.5%
1/65 • Number of events 1 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
0.00%
0/64 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/121 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
0.00%
0/65 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
1.6%
1/64 • Number of events 1 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.83%
1/121 • Number of events 1 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
0.00%
0/65 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
0.00%
0/64 • Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
|
Additional Information
Lina Ginnetti, Clinical Endoscopy Director
Boston Scientific Corporation
Phone: 508-683-4512
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60