UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033250 |
|---|---|
| Receipt number | 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 21:29:33 |
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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
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
rshimizu@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037755
