UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046965 |
|---|---|
| Receipt number | R000052899 |
| Scientific Title | Randomized controlled trial of endoscopic ultrasound-guided liver biopsy versus percutaneous liver biopsy for adequate liver biopsy specimen |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2025/03/19 07:58:46 |
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Basic information
Public title
Randomized controlled trial of endoscopic ultrasound-guided liver biopsy versus percutaneous liver biopsy for adequate liver biopsy specimen
Acronym
RCT of EUS-LB versus P-LB for adequate liver biopsy specimen
Scientific Title
Randomized controlled trial of endoscopic ultrasound-guided liver biopsy versus percutaneous liver biopsy for adequate liver biopsy specimen
Scientific Title:Acronym
RCT of EUS-LB versus P-LB for adequate liver biopsy specimen
Region
| Japan |
Condition
Condition
Chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the two technique in a prospective study comparing between patients, who requiring liver biopsy, randomly assigned to either EUS-LB or P-LB.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acquisition rate of adequate liver biopsy specimen
Key secondary outcomes
1) number of needle passes needed to obtain adequate sample
2) number of complete portal tract obtained in a liver biopsy specimen
3) post-fix aggregate liver biopsy specimen length
4) post-fix longest liver biopsy specimen length
5) pain score
6) time for hospital stay per patient
7) adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic ultrasound-guided liver biopsy
Interventions/Control_2
Percutaneous liver biopsy
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
1) patients =or >18 years of age
2) patients who are judged by a specialist of the Japanese Society of Gastroenterology to require a liver biopsy
3) providing written informed consent
Key exclusion criteria
1) coagulopathy (INR of =or >1.5 and/or platelet count =or <50,000)
2) patients who are unable to discontinue anticoagulant and/or antiplatelet medication (excluding aspirin alone)
3) patients with liver cirrhosis
4) presence of clinically detectable ascites around the liver
5) presence of gastric varices
6) post-esophagogastric surgery (excluding distal gastrectomy)
7) pregnancy
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Okuwaki |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa
TEL
+81-42-778-8111
kokuwaki@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Okuwaki |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa
TEL
+81-42-778-8111
Homepage URL
kokuwaki@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine, Department of Gastroenterology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Ethics Committee of Kitasato University Hospital
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
Tel
+81-42-778-7756
rinri@med.kitasato-u.ac.jp
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
北里大学病院（神奈川）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 22 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052899
