Trial Outcomes & Findings for EUS FNB Versus FNA With On-Site Cytopathology in Solid Pancreatic Masses (NCT NCT03485924)
NCT ID: NCT03485924
Last Updated: 2024-09-19
Results Overview
Diagnostic accuracy will be defined as (true positive + true negative)/all participants in the arm.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
6 months from the initial biopsy
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
EUS-FNA With ROSE
EUS/FNA with ROSE will be performed using standard techniques via 22-g FNA needle (Cook Medical EchoTip Ultra or Boston Scientific Expect or Medtronic Beacon). Lesions will be identified using EUS and punctured with the FNA needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNA specimens will be processed for ROSE using standard techniques with bedside smear slide evaluation and liquid-based cytology and cell-block preparation. The first randomization assigned EUS sampling technique will be used until adequate specimen is achieved (up to 3 passes total). After 3 passes, the patient will undergo the other EUS sampling technique until adequate specimen is achieved (up to 3 passes total).
EUS-FNA with ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE
|
EUS-FNB Without ROSE
EUS/FNB without ROSE will be performed using similar techniques for tissue acquisition as FNA using 22-g FNB needle (Medtronic SharkCore or Boston Scientific Acquire). Lesions will be identified using EUS and punctured with the 22-g FNB needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNB samples will be placed directly into formalin containers and sent to be processed by surgical pathology. The first randomization assigned EUS sampling technique will be used until adequate specimen is achieved (up to 3 passes total). After 3 passes, the patient will undergo the other EUS sampling technique until adequate specimen is achieved (up to 3 passes total).
EUS-FNB without ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
17
|
|
Overall Study
COMPLETED
|
23
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EUS FNB Versus FNA With On-Site Cytopathology in Solid Pancreatic Masses
Baseline characteristics by cohort
| Measure |
EUS-FNA With ROSE
n=23 Participants
EUS/FNA with ROSE will be performed using standard techniques via 22-g FNA needle (Cook Medical EchoTip Ultra or Boston Scientific Expect or Medtronic Beacon). Lesions will be identified using EUS and punctured with the FNA needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNA specimens will be processed for ROSE using standard techniques with bedside smear slide evaluation and liquid-based cytology and cell-block preparation.
EUS-FNA with ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE
|
EUS-FNB Without ROSE
n=17 Participants
EUS/FNB without ROSE will be performed using similar techniques for tissue acquisition as FNA using 22-g FNB needle (Medtronic SharkCore or Boston Scientific Acquire). Lesions will be identified using EUS and punctured with the 22-g FNB needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNB samples will be placed directly into formalin containers and sent to be processed by surgical pathology.
EUS-FNB without ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Age, Continuous
|
65.39 years
STANDARD_DEVIATION 9.95 • n=99 Participants
|
69.94 years
STANDARD_DEVIATION 8.41 • n=107 Participants
|
67.32 years
STANDARD_DEVIATION 9.59 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 months from the initial biopsyDiagnostic accuracy will be defined as (true positive + true negative)/all participants in the arm.
Outcome measures
| Measure |
EUS-FNA With ROSE
n=23 Participants
EUS/FNA with ROSE will be performed using standard techniques via 22-g FNA needle (Cook Medical EchoTip Ultra or Boston Scientific Expect or Medtronic Beacon). Lesions will be identified using EUS and punctured with the FNA needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNA specimens will be processed for ROSE using standard techniques with bedside smear slide evaluation and liquid-based cytology and cell-block preparation.
EUS-FNA with ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE
|
EUS-FNB Without ROSE
n=17 Participants
EUS/FNB without ROSE will be performed using similar techniques for tissue acquisition as FNA using 22-g FNB needle (Medtronic SharkCore or Boston Scientific Acquire). Lesions will be identified using EUS and punctured with the 22-g FNB needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNB samples will be placed directly into formalin containers and sent to be processed by surgical pathology.
EUS-FNB without ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE
|
|---|---|---|
|
The Diagnostic Accuracy of Fine-needle Biopsy (FNB) Sampling Without Rapid Onsite Evaluation (ROSE) and the Fine Needle Aspiration (FNA) With ROSE in Pancreatic Mass Lesions
|
91.3 percentage of true cases
|
94.1 percentage of true cases
|
SECONDARY outcome
Timeframe: Post-procedure one weekNumber of Specimens with Final Histopathological Diagnosis
Outcome measures
| Measure |
EUS-FNA With ROSE
n=59 Samples
EUS/FNA with ROSE will be performed using standard techniques via 22-g FNA needle (Cook Medical EchoTip Ultra or Boston Scientific Expect or Medtronic Beacon). Lesions will be identified using EUS and punctured with the FNA needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNA specimens will be processed for ROSE using standard techniques with bedside smear slide evaluation and liquid-based cytology and cell-block preparation.
EUS-FNA with ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE
|
EUS-FNB Without ROSE
n=47 Samples
EUS/FNB without ROSE will be performed using similar techniques for tissue acquisition as FNA using 22-g FNB needle (Medtronic SharkCore or Boston Scientific Acquire). Lesions will be identified using EUS and punctured with the 22-g FNB needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNB samples will be placed directly into formalin containers and sent to be processed by surgical pathology.
EUS-FNB without ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE
|
|---|---|---|
|
Specimen Adequacy
|
35 Samples
|
47 Samples
|
SECONDARY outcome
Timeframe: Post-procedure one weekNumber of Samples with Visible Histology Core Biopsy
Outcome measures
| Measure |
EUS-FNA With ROSE
n=59 Samples
EUS/FNA with ROSE will be performed using standard techniques via 22-g FNA needle (Cook Medical EchoTip Ultra or Boston Scientific Expect or Medtronic Beacon). Lesions will be identified using EUS and punctured with the FNA needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNA specimens will be processed for ROSE using standard techniques with bedside smear slide evaluation and liquid-based cytology and cell-block preparation.
EUS-FNA with ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE
|
EUS-FNB Without ROSE
n=47 Samples
EUS/FNB without ROSE will be performed using similar techniques for tissue acquisition as FNA using 22-g FNB needle (Medtronic SharkCore or Boston Scientific Acquire). Lesions will be identified using EUS and punctured with the 22-g FNB needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNB samples will be placed directly into formalin containers and sent to be processed by surgical pathology.
EUS-FNB without ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE
|
|---|---|---|
|
Number of Histology Cores Obtained
|
3 Samples
|
46 Samples
|
SECONDARY outcome
Timeframe: 6 months from the initial biopsyPopulation: Participants with accurate diagnosis
Median number of passes required for accurate diagnosis
Outcome measures
| Measure |
EUS-FNA With ROSE
n=21 Participants
EUS/FNA with ROSE will be performed using standard techniques via 22-g FNA needle (Cook Medical EchoTip Ultra or Boston Scientific Expect or Medtronic Beacon). Lesions will be identified using EUS and punctured with the FNA needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNA specimens will be processed for ROSE using standard techniques with bedside smear slide evaluation and liquid-based cytology and cell-block preparation.
EUS-FNA with ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE
|
EUS-FNB Without ROSE
n=16 Participants
EUS/FNB without ROSE will be performed using similar techniques for tissue acquisition as FNA using 22-g FNB needle (Medtronic SharkCore or Boston Scientific Acquire). Lesions will be identified using EUS and punctured with the 22-g FNB needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNB samples will be placed directly into formalin containers and sent to be processed by surgical pathology.
EUS-FNB without ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE
|
|---|---|---|
|
Median Number of Passes
|
2 passes
Interval 1.0 to 3.0
|
1 passes
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: After the procedure, an average of 1 hourTechnical failure was defined as the inability to perform the procedure, including the need to change the needle
Outcome measures
| Measure |
EUS-FNA With ROSE
n=59 Procedures
EUS/FNA with ROSE will be performed using standard techniques via 22-g FNA needle (Cook Medical EchoTip Ultra or Boston Scientific Expect or Medtronic Beacon). Lesions will be identified using EUS and punctured with the FNA needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNA specimens will be processed for ROSE using standard techniques with bedside smear slide evaluation and liquid-based cytology and cell-block preparation.
EUS-FNA with ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE
|
EUS-FNB Without ROSE
n=47 Procedures
EUS/FNB without ROSE will be performed using similar techniques for tissue acquisition as FNA using 22-g FNB needle (Medtronic SharkCore or Boston Scientific Acquire). Lesions will be identified using EUS and punctured with the 22-g FNB needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNB samples will be placed directly into formalin containers and sent to be processed by surgical pathology.
EUS-FNB without ROSE: EUS-FNA with ROSE vs EUS-FNB without ROSE
|
|---|---|---|
|
Number of Technical Failures
|
0 Procedures
|
0 Procedures
|
Adverse Events
EUS-FNA With ROSE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EUS-FNB Without ROSE
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