Trial Outcomes & Findings for Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS (NCT NCT02167074)

NCT ID: NCT02167074

Last Updated: 2021-08-23

Results Overview

Diagnostic accuracy is the number of correctly diagnosed cases as compared to gold standard diagnosis Gold standard diagnosis is defined as; 1. in operated patients; based on the surgical resection specimen 2. in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of tissue sampling and imaging studies), and confirmed by a compatible clinical disease course of at least 9 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 615 participants
• Primary outcome timeframe: 27 months
• Results posted on: 2021-08-23

Participant Flow

3 patients were included but met exclusion criteria 4 patients were lost to follow-up

Participant milestones

Measure	25G FNA Needle Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 25G FNA needle	20G ProCore FNB Needle Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 20G ProCore FNB needle
Overall Study STARTED	306	302
Overall Study COMPLETED	306	302
Overall Study NOT COMPLETED	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	25G FNA Needle n=306 Participants Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 25G FNA needle	20G ProCore FNB Needle n=302 Participants Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 20G ProCore FNB needle	Total n=608 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 0.7 • n=306 Participants	66 years STANDARD_DEVIATION 0.7 • n=302 Participants	66 years STANDARD_DEVIATION 0.5 • n=608 Participants
Sex: Female, Male Female	124 Participants n=306 Participants	140 Participants n=302 Participants	264 Participants n=608 Participants
Sex: Female, Male Male	182 Participants n=306 Participants	162 Participants n=302 Participants	344 Participants n=608 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 27 months

Diagnostic accuracy is the number of correctly diagnosed cases as compared to gold standard diagnosis

Gold standard diagnosis is defined as;

1. in operated patients; based on the surgical resection specimen

2. in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of tissue sampling and imaging studies), and confirmed by a compatible clinical disease course of at least 9 months

Outcome measures

Measure	25G FNA Needle n=306 Participants Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 25G FNA needle	20G ProCore FNB Needle n=302 Participants Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 20G ProCore FNB needle
Diagnostic Accuracy	237 Participants	263 Participants

SECONDARY outcome

Timeframe: 1 day

records if a target lesion was reached during the procedure using the randomised needle or not

Outcome measures

Measure	25G FNA Needle n=306 Participants Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 25G FNA needle	20G ProCore FNB Needle n=302 Participants Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 20G ProCore FNB needle
Number of Participants in Whom Target Lesion Was Sampled	306 Participants	298 Participants

SECONDARY outcome

Timeframe: after 27 months

Presence of sufficient vital target cells, as in, target organ cells to provide a diagnosis (yes or no)

Outcome measures

Measure	25G FNA Needle n=306 Participants Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 25G FNA needle	20G ProCore FNB Needle n=302 Participants Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 20G ProCore FNB needle
Presence of Vital Target Cells Per Case, Per Needle Type	248 Participants	263 Participants

SECONDARY outcome

Timeframe: 27 months after procedure

adverse events per needle type, up to 27 months after procedure

Outcome measures

Measure	25G FNA Needle n=306 Participants Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 25G FNA needle	20G ProCore FNB Needle n=302 Participants Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 20G ProCore FNB needle
Number of Patients With Adverse Events Per Needle Type	3 Participants	2 Participants

SECONDARY outcome

Timeframe: after 27 months

Population: Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not

Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not

Outcome measures

Measure	25G FNA Needle n=306 Participants Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 25G FNA needle	20G ProCore FNB Needle n=302 Participants Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 20G ProCore FNB needle
Diagnostic Yield of the First Needle Pass	206 Participants	209 Participants

SECONDARY outcome

Timeframe: 27 months

Presence of pathologist on site during procedure

Outcome measures

Measure	25G FNA Needle n=306 Participants Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 25G FNA needle	20G ProCore FNB Needle n=302 Participants Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 20G ProCore FNB needle
On-site Pathological Evaluation Performed	74 participants	26 participants

Adverse Events

25G FNA Needle

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

20G ProCore FNB Needle

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	25G FNA Needle n=306 participants at risk Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 25G FNA needle	20G ProCore FNB Needle n=302 participants at risk Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 20G ProCore FNB needle
Gastrointestinal disorders pancreatitis	0.65% 2/306 • 27 months it does not differ, 5 adverse events	0.33% 1/302 • 27 months it does not differ, 5 adverse events
General disorders pain	0.33% 1/306 • 27 months it does not differ, 5 adverse events	0.33% 1/302 • 27 months it does not differ, 5 adverse events

Additional Information

Dr. P. van Riet

Erasmusm MC University Medical Center Rotterdam

Phone: 0031648237608

Email: p.vanriet@erasmusmc.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place