Trial Outcomes & Findings for Core Biopsy Endo Sonography Study Evaluation of the Significance of the Pro-core® Needle (NCT NCT02181140)
NCT ID: NCT02181140
Last Updated: 2019-06-18
Results Overview
Diagnostic accuracy of Pro-core needle (22 G) will be compared to conventional fine needle aspiration (22 G). Therefore EUS-FNA with both needles is undertaken in a random order in each lesion. For Pro-core needle, a histological / cytological diagnosis and quality assessment will be made by pathologists.For Echotip aspiration needle, reference cytology evaluation is done by cytology experts. The histopathological diagnosis after surgery or the clinical follow up of at least one year after EUS FNA is current standard.
COMPLETED
NA
56 participants
up to 1 year
2019-06-18
Participant Flow
Participant milestones
| Measure |
EUS Guided FNA and Fine Needle Punction
punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order
EUS guided FNA and fine needle punction: punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Core Biopsy Endo Sonography Study Evaluation of the Significance of the Pro-core® Needle
Baseline characteristics by cohort
| Measure |
EUS Guided FNA and Fine Needle Punction
n=56 Participants
punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order
EUS guided FNA and fine needle punction: punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics
|
|---|---|
|
Age, Continuous
|
67.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
56 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 1 yearDiagnostic accuracy of Pro-core needle (22 G) will be compared to conventional fine needle aspiration (22 G). Therefore EUS-FNA with both needles is undertaken in a random order in each lesion. For Pro-core needle, a histological / cytological diagnosis and quality assessment will be made by pathologists.For Echotip aspiration needle, reference cytology evaluation is done by cytology experts. The histopathological diagnosis after surgery or the clinical follow up of at least one year after EUS FNA is current standard.
Outcome measures
| Measure |
EUS Guided Pro Core FNA
n=56 Participants
EUS guided punction of a lesion by pro core fine needle to evacuate histology and smear biologics
|
|---|---|
|
Diagnostic Accuracy
|
84 Diagnostic accuracy (%)
|
SECONDARY outcome
Timeframe: day 0 and day 14Population: Histology (not cytology) samples for Pro-core Needle
Histology (not cytology) samples for Pro-core Needle: Number of adequately evaluable histology samples
Outcome measures
| Measure |
EUS Guided Pro Core FNA
n=56 Participants
EUS guided punction of a lesion by pro core fine needle to evacuate histology and smear biologics
|
|---|---|
|
EUS Pro Core FNA: Histology Samples
|
36 participants
|
SECONDARY outcome
Timeframe: day 0 and day 14Complication rates of EUS FNA
Outcome measures
| Measure |
EUS Guided Pro Core FNA
n=56 Participants
EUS guided punction of a lesion by pro core fine needle to evacuate histology and smear biologics
|
|---|---|
|
Complication Rates
|
0 participants
|
Adverse Events
EUS Guided FNA
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Dr. Thomas Rösch
Interdisciplinary Endoscopy Department and Clinic University Hospital Hamburg-Eppendorf
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place