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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040101
Receipt No. R000045318
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.
Date of disclosure of the study information 2020/04/08
Last modified on 2020/10/13

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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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