Trial Outcomes & Findings for 19 Versus 22-Gauge Needle for EUS-LB (NCT NCT02967991)

Results Overview

Defined by total portal structures \> 5 or length of the longest piece \> 15 mm) Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB. FNA-fine needle aspiration FNB-fine needle biopsy

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

7 days

Results posted on

2019-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	19G EUS-FNA Needle First, Then 22G FNB Needle EUS-guided liver biopsy EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy First Intervention: 10 minutes Washout: 1 minute Second Intervention: 10 minutes	22G FNB Needle First, Then 19G EUS-FNA Needle EUS-guided liver biopsy EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy First Intervention: 10 minutes Washout: 1 minute Second Intervention: 10 minutes
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

19 Versus 22-Gauge Needle for EUS-LB

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=20 Participants EUS-guided liver biopsy using a 19-gauge FNA then 22-gauge liver biopsy needle EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNA-fine needle aspiration
Age, Continuous	50.5 mean years total population STANDARD_DEVIATION 18.4 • n=99 Participants
Sex/Gender, Customized Sex of Particpants : Male	5 Participants n=99 Participants
Sex/Gender, Customized Sex of Particpants : Female	15 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	20 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 7 days

Population: specimens not particpants

Defined by total portal structures \> 5 or length of the longest piece \> 15 mm) Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB. FNA-fine needle aspiration FNB-fine needle biopsy

Outcome measures

Outcome measures
Measure	19 Gauge FNA n=20 specimens EUS-guided liver biopsy using a19-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNA-fine needle aspiration	22 Gauge FNB n=20 specimens EUS-guided liver biopsy using a 22-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNB-fine needle biopsy
Number of Specimens for Which a Histologic Diagnosis Could be Made Based Upon the Amount of Tissue Obtained With the Needle	17 specimens	14 specimens

SECONDARY outcome

Timeframe: Day of Procedure

Population: specimens not particpants

Presence of a visible core specimen (yes/no) Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB. FNA-fine needle aspiration FNB-fine needle biopsy

Outcome measures

Outcome measures
Measure	19 Gauge FNA n=20 specimens EUS-guided liver biopsy using a19-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNA-fine needle aspiration	22 Gauge FNB n=20 specimens EUS-guided liver biopsy using a 22-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNB-fine needle biopsy
The Number of Specimens With a Visible Core After Needle Biopsy	20 specimens	19 specimens

SECONDARY outcome

Timeframe: Day of Procedure

Population: specimens not participants

Presence of visible clots in specimen (yes/no) Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB. FNA-fine needle aspiration FNB-fine needle biopsy

Outcome measures

Outcome measures
Measure	19 Gauge FNA n=20 specimens EUS-guided liver biopsy using a19-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNA-fine needle aspiration	22 Gauge FNB n=20 specimens EUS-guided liver biopsy using a 22-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNB-fine needle biopsy
The Number of Specimens With a Visible Clot After Needle Biopsy	4 specimens	1 specimens

SECONDARY outcome

Timeframe: 7 days

Patient with blood visible from patient's mouth, rectum with a 2 gram drop in hemoglobin Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB. FNA-fine needle aspiration FNB-fine needle biopsy

Outcome measures

Outcome measures
Measure	19 Gauge FNA n=20 Participants EUS-guided liver biopsy using a19-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNA-fine needle aspiration	22 Gauge FNB EUS-guided liver biopsy using a 22-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNB-fine needle biopsy
The Number of Patients With Visible Bleeding After Needle Biopsy	0 Participants	—

SECONDARY outcome

Timeframe: 1 days

Pain using Likert score 0-10 (10 worst) Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB. FNA-fine needle aspiration FNB-fine needle biopsy

Outcome measures

Outcome measures
Measure	19 Gauge FNA n=20 Participants EUS-guided liver biopsy using a19-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNA-fine needle aspiration	22 Gauge FNB EUS-guided liver biopsy using a 22-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNB-fine needle biopsy
The Number of Patients With Pain 1 Day After Needle Biopsy	0 Participants	—

SECONDARY outcome

Timeframe: 7 days

Pain using Likert score 0-10 (10 worst) Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB. FNA-fine needle aspiration FNB-fine needle biopsy

Outcome measures

Outcome measures
Measure	19 Gauge FNA n=20 Participants EUS-guided liver biopsy using a19-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNA-fine needle aspiration	22 Gauge FNB EUS-guided liver biopsy using a 22-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNB-fine needle biopsy
The Number of Patients With Pain 7 Day After Needle Biopsy	1 Participants	—

SECONDARY outcome

Timeframe: 7 Days

Patient requiring visit to healthcare center (emergency room, hospital, call to service) within time 7 days Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB. FNA-fine needle aspiration FNB-fine needle biopsy

Outcome measures

Outcome measures
Measure	19 Gauge FNA n=20 Participants EUS-guided liver biopsy using a19-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNA-fine needle aspiration	22 Gauge FNB EUS-guided liver biopsy using a 22-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNB-fine needle biopsy
The Number of Patients Requiring Medical Care After Needle Biopsy	1 Participants	—

SECONDARY outcome

Timeframe: 7 days

Population: specimens not participants

Number of portal tracts (PT) in the specimen (total) under histologic examination Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB. FNA-fine needle aspiration FNB-fine needle biopsy

Outcome measures

Outcome measures
Measure	19 Gauge FNA n=20 specimens EUS-guided liver biopsy using a19-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNA-fine needle aspiration	22 Gauge FNB n=20 specimens EUS-guided liver biopsy using a 22-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNB-fine needle biopsy
Number of Portal Tracts (PT) in the Specimen (Total) Under Histologic Examination	7.4 mean portal tracts Standard Deviation 5.9	6.1 mean portal tracts Standard Deviation 7.2

SECONDARY outcome

Timeframe: 7 days

Population: specimens not participants

Length of all the tissue (centimeters) by adding the sum of all pieces Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB. FNA-fine needle aspiration FNB-fine needle biopsy

Outcome measures

Outcome measures
Measure	19 Gauge FNA n=20 specimens EUS-guided liver biopsy using a19-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNA-fine needle aspiration	22 Gauge FNB n=20 specimens EUS-guided liver biopsy using a 22-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNB-fine needle biopsy
Aggregate Specimen Length Under Histologic Examination	76.5 cm for portal tracts of specimens Standard Deviation 35.4	66.9 cm for portal tracts of specimens Standard Deviation 47.8

SECONDARY outcome

Timeframe: 7 days

Population: specimens not participants

length of the longest tissue biopsy piece (centimeters) as measured by pathology Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB. FNA-fine needle aspiration FNB-fine needle biopsy

Outcome measures

Outcome measures
Measure	19 Gauge FNA n=20 specimens EUS-guided liver biopsy using a19-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNA-fine needle aspiration	22 Gauge FNB n=20 specimens EUS-guided liver biopsy using a 22-gauge liver biopsy in the left lobe EUS-guided liver biopsy: Endoscopic ultrasound guided liver biopsy FNB-fine needle biopsy
Length of the Longest Piece Under Histologic Examination	13.2 mean cm for portal tracts of specimens Standard Deviation 5.1	10.8 mean cm for portal tracts of specimens Standard Deviation 6.8

Adverse Events

Total Population

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

Shaffer Mok

University Hospitals Case Western Reserve

Phone: 4404065500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place