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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000033250
Receipt No. R000037755
Scientific Title Single-center, prospective comparative study for detection ability of hepatocellular carcinoma between abdominal ultrasonography and endoscopic ultrasonography
Date of disclosure of the study information 2018/07/03
Last modified on 2019/06/17

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Basic information
Public title Single-center, prospective comparative study for detection ability of hepatocellular carcinoma between abdominal ultrasonography and endoscopic ultrasonography
Acronym Single-center, prospective comparative study for detection ability of hepatocellular carcinoma between abdominal ultrasonography and endoscopic ultrasonography
Scientific Title Single-center, prospective comparative study for detection ability of hepatocellular carcinoma between abdominal ultrasonography and endoscopic ultrasonography
Scientific Title:Acronym Single-center, prospective comparative study for detection ability of hepatocellular carcinoma between abdominal ultrasonography and endoscopic ultrasonography
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Comparative for detection ability of hepatocellular carcinoma between abdominal ultrasonography and endoscopic ultrasonography
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Difference of detection rate of hepatocellular carcinoma between contrast-enhanced abdominal ultrasonography and contrast-enhanced endoscopic ultrasonography
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Abdominal ultrasonography (including contrast-enhanced abdominal ultrasonography) 1 time.
Endoscopic ultrasonography (including contrast-enhanced endoscopic ultrasonography) 1 time.
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Diagnosed with hepatocellular carcinoma using contrast-enhanced CT and/or Gd-EOB-MRI.
Within 3 tumors.
Informed consent must be obtained from patients themselves.
Eastern Cooperative Oncology Group performance status 0-2.
Key exclusion criteria Difficult to endoscopic ultrasonography.
Difficult to gastrointestinal endoscopy.
Presence of esophageal varices with F2, F3 and/or red color sign.
Presence of sever organopathy.
Difficult to obtain informed consent.
Ineligible cases are judged by researchers.

Target sample size 147

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Kitano
Organization Wakayama Medical University
Division name Second Department of Internal Medicine
Zip code 641-0012
Address 811-1 Kimiidera, Wakayama, Wakayama Prefecture
TEL +81-73-447-2300
Email kitano@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Shimizu
Organization Wakayama Medical University
Division name Second Department of Internal Medicine
Zip code 641-0012
Address 811-1 Kimiidera, Wakayama, Wakayama Prefecture
TEL +81-73-447-2300
Homepage URL
Email rshimizu@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Research Ethics Committee of Wakayama Medical University
Address 811-1 Kimiidera, Wakayama
Tel 0734472300
Email wa-rinri@wakayama-med.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

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 03 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 Terminated
Date of protocol fixation
2018 Year 04 Month 27 Day
Date of IRB
2018 Year 07 Month 17 Day
Anticipated trial start date
2018 Year 07 Month 18 Day
Last follow-up date
2023 Year 04 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 02 Day
Last modified on
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037755

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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