UMIN-CTR Clinical Trial

Basic information
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
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

Objectives
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

Assessment
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.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Geisinger Medical Center Department of Gastroenterology and Nutrition
Institute
Department

Funding Source
Organization	Geisinger clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	USA

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

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

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date	2020 Year 04 Month 08 Day
Last modified on	2020 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045318

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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