UMIN-CTR Clinical Trial

Public title

Single pass, 1 needle actuation versus single pass, 3 actuations with fanning technique for endoscopic ultrasound guided liver biopsy (EUS-LB): a randomized prospective trial.

Acronym

EUS-liver biopsy: 1 vs 3 passes

Scientific Title

Modified 1 pass, 1 actuation wet suction Versus 1 pass, 3 to-and-fro needle motions fanning technique for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Randomized Prospective Trial.

Scientific Title:Acronym

EUS-liver biopsy: 1 vs 3 passes,a Randomized Prospective Trial.

Region

North America

Condition

Abnormal liver enzymes, hepatitis, NASH, alcohol related liver disease

Classification by specialty

Gastroenterology

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess whether the diagnostic ability of 1 pass 1 actuation is inferior to 1 pass 3 actuation during EUS guided liver biopsy using FNB needle. The primary endpoint was number of complete portal tracts.

Basic objectives2

Others

Basic objectives -Others

To verify the adequacy and safety of both liver biopsy technique

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary endpoint was number of complete portal tracts.

Key secondary outcomes

Secondary endpoints were sample adequacy for the pathologic diagnosis, length of longest piece, aggregate specimen length, and adverse events.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

One pass 1 actuation (to-and-fro movement) technique was defined as single puncture with a single needle movement into the liver

Interventions/Control_2

A 1:3 technique was defined as a single puncture and then 3 to-and-fro needle motions with the fanning technique into the liver

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

18 years of age with elevation of liver biochemistry tests of uncertain etiology, or the need to grade and stage autoimmune, viral, or metabolic liver disease.

Key exclusion criteria

Pregnancy
Platelet count less than 50,000 per microliter of blood.
INR > 1.5
Unable to provide informed consent
Ptients who could not discontinue anticoagulation or antiplatelet agents
Hemophilia
Decompensated liver cirrhosis
Those unable to safely undergo the EUS for any reason.

Target sample size

40

Name of lead principal investigator

1st name	David
Middle name	Lawrence
Last name	Diehl

Organization

Geisinger Medical Center

Division name

Department of Gastroenterology and Nutrition

Zip code

17822

Address

100 N. Academy Ave, Mail Code 21-11, Danville, PA

TEL

570-271-6856

Email

dldiehl@geisinger.edu

Name of contact person

1st name	Kelly
Middle name
Last name	Haddock

Organization

Geisinger Medical Center

Division name

Department of Gastroenterology and Nutrition

Zip code

17822

Address

100 N. Academy Ave, Mail Code 21-11, Danville, PA

TEL

570-271-6856

Homepage URL

Email

kmhaddock@geisinger.edu

Institute

Geisinger Medical Center
Department of Gastroenterology and Nutrition

Institute

Department

Personal name

Organization

Geisinger clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

USA

Co-sponsor

Name of secondary funder(s)

Organization

Geisinger Institutional Review Board

Address

100 N. Academy Ave., Mail Code 30-69, Danville, PA 17821

Tel

5702141635

Email

bcook@geisinger.edu

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Geisinger Medical Center
Department of Gastroenterology and Nutrition
100 N. Academy Ave
Danville, PA 17821

Date of disclosure of the study information

2020

Year

04

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

https://insights.ovid.com/american-gastroenterology/ajgast/2018/10/001/one-versus-three-needle-actua

Number of participants that the trial has enrolled

40

Results

EUS-LB using 1:3 technique produced longer parenchymal liver core tissue with more CPTs than the 1:1 technique with equivalent safety profile.

Results date posted

2020

Year

03

Month

07

Day

Results Delayed

Results Delay Reason

N/A

Date of the first journal publication of results

2018

Year

10

Month

01

Day

Baseline Characteristics

Forty individuals were recruited for the study from March 2018 to June 2018. The indication for LB in the majority (72.5%) was evaluation of abnormal liver biochemical tests. Patient demographics and procedural indications are presented in Table 1 and 2. Thirty-five (87.5%) were Caucasians, 21 (52.5%) were female, mean BMI was 32.7, six (15%) were alcoholic, average platelet count was 225. Of the 20 patients undergoing EUS-LB with the 1:1 technique, mean age was 55.2 years (SD 16.9), mean body mass index was 32.35 (SD 5.0); for the 20 patients with the 1:3 technique, mean age was 51.5 years (12.4), and mean BMI 33.1(6.7). Pathological diagnoses included alcoholic and non-alcoholic liver disease, viral hepatitis, primary biliary cholangitis, autoimmune hepatitis, and secondary iron overload.

Participant flow

All individuals undergoing EUS-LB received
propofol anesthesia during the entire procedure, with applicable cardiorespiratory monitoring either by a certified registered anesthetist and/or anesthesiologist as per routine protocol in our facility. The endosonographic examination was done with a curved linear-array echoendoscopes (GF-UC140-AL5 or GF-UCT180; Olympus America, Center Valley, Pennsylvania, United States

Adverse events

Of the 40 patients who underwent EUS-LB, 15 (37.5%) patients complained of abdominal pain, 7 (35%) in the 1:1 group vs 8 (40%) in the 1:3 group; P=0.744. Abdominal pain was classified as mild, moderate and severe using the Numeric Rating Scale (NRS). Four (20%) patients in the 1:1 group reported moderate abdominal pain vs 3 (15%) in the 1:3 group, P=0.838. Two (10%) patients in the 1:1 group reported severe pain vs 4 (20%) in the 1:3 group, P=0.838. No serious procedure or anesthesia related adverse events were reported with either technique. No patients were lost to follow-up.

Outcome measures

The primary endpoint was number of complete portal tracts. Secondary endpoints were sample adequacy for the pathologic diagnosis, length of longest piece, aggregate specimen length, and AEs. Results for continuous variables are expressed by using mean standard deviation, median and interquartile range (IQR). Categorical variables were expressed as simple proportions.

Plan to share IPD

IPD sharing Plan description

Submit for publication

Recruitment status

Completed

Date of protocol fixation

2018

Year

03

Month

01

Day

Date of IRB

2018

Year

03

Month

15

Day

Anticipated trial start date

2018

Year

03

Month

25

Day

Last follow-up date

2020

Year

03

Month

03

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

04

Month

08

Day

Last modified on

2020

Year

10

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045318