Trial Outcomes & Findings for Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle (NCT NCT01769248)

Results Overview

The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

140 participants

Primary outcome timeframe

1 year

Results posted on

2018-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Fine Needle Aspiration (FNA) fine needle aspiration Fine needle aspiration: Fine needle aspiration using endoscopic ultrasound-FNA needles. This was the standard of care arm	Fine Needle Biopsy (FNB) Fine Needle biopsy Fine Needle biopsy: FNB, test arm for core biopsies, endoscopic ultrasound-FNB
Overall Study STARTED	70	70
Overall Study Participants Who Crossed-over	28	12
Overall Study COMPLETED	42	58
Overall Study NOT COMPLETED	28	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fine Needle Aspiration n=70 Participants fine needle aspiration Fine needle aspiration: Fine needle aspiration	Fine Needle Biopsy n=70 Participants Fine needle biopsy Fine needle biopsy: FNB	Total n=140 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	57 Participants n=7 Participants	107 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	13 Participants n=7 Participants	33 Participants n=5 Participants
Age, Continuous	63.7 years STANDARD_DEVIATION 14.4 • n=5 Participants	64.1 years STANDARD_DEVIATION 14.4 • n=7 Participants	63.8 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	30 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	40 Participants n=7 Participants	74 Participants n=5 Participants
Region of Enrollment United States	70 participants n=5 Participants	70 participants n=7 Participants	140 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage.

Outcome measures

Outcome measures
Measure	Fine Needle Aspiration n=70 Participants fine needle aspiration Fine needle aspiration: Fine needle aspiration	Fine Needle Biopsy n=70 Participants Fine needle biopsy Fine needle biopsy: FNB
Diagnostic Yield of EUS-FNB and EUS-FNA	67.1 percentage of patients	90 percentage of patients

SECONDARY outcome

Timeframe: 1 year

Population: Patients with pancreatic and non-pancreatic lesions receiving EUS-FNA and EUS-FNB.

The investigators' secondary outcome will assess the ability to obtain an adequate specimen for in room cytologic evaluation as determined by our cytopathologist. This will be defined as a sample that is representative (not necessarily diagnostic) of the lesion in question. This will be expressed as a percentage and compared between FNA and FNB

Outcome measures

Outcome measures
Measure	Fine Needle Aspiration n=70 Participants fine needle aspiration Fine needle aspiration: Fine needle aspiration	Fine Needle Biopsy n=70 Participants Fine needle biopsy Fine needle biopsy: FNB
Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB	60.0 percentage of participants	82.8 percentage of participants

SECONDARY outcome

Timeframe: 1 yr

Population: Participants receiving alternative tissue acquisition method when initial three passes with either EUS-FNA or EUS-FNB failed to provide an adequate specimen.

As above. Crossover to FNA or FNB occurs after 3 passes without adequate material

Outcome measures

Outcome measures
Measure	Fine Needle Aspiration n=28 Participants fine needle aspiration Fine needle aspiration: Fine needle aspiration	Fine Needle Biopsy n=12 Participants Fine needle biopsy Fine needle biopsy: FNB
Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%)	96.4 percentage of participants	41.7 percentage of participants

Adverse Events

Fine Needle Aspiration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fine Needle Biopsy

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

Srinadh Komanduri

Northwestern University

Phone: 312-695-0484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place