UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017701 |
|---|---|
| Receipt number | R000020229 |
| Scientific Title | Usefulness of radiofrequency ablation with infusing the contrast medium into bile duct for hepatocellular carcinoma located near the intrahepatic bile duct |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2015/05/27 15:01:20 |
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Basic information
Public title
Usefulness of radiofrequency ablation with infusing the contrast medium into bile duct for hepatocellular carcinoma located near the intrahepatic bile duct
Acronym
Usefulness of radiofrequency ablation with infusing the contrast medium into bile duct
Scientific Title
Usefulness of radiofrequency ablation with infusing the contrast medium into bile duct for hepatocellular carcinoma located near the intrahepatic bile duct
Scientific Title:Acronym
Usefulness of radiofrequency ablation with infusing the contrast medium into bile duct
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the usefulness of radiofrequency ablation with infusing the contrast medium into bile duct
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of bile duct injury after radiofrequency ablation
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
In the intervention group, radiofrequency ablationis are performed with infusing the contrast medium into bile duct .
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
1. Patients with liver cacer. Maximum tumor size of 3-10 cm with a tumor number of 3 or less.
2. Informed consent from the patient.
Key exclusion criteria
1.Pregnant women and those with
possibility of pregnancy.
2.Patients expected liver transplantation within a year.
3.Total serum bilirubin <= 3 mg/dl.
4.Severe ascites.
5.Child-Pugh grade C liver profile.
6.Egg and egg products allergy.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Hiasa |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5308
hiasa@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Hirooka |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5308
Homepage URL
b447004U@mails.cc.ehime-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine
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
Address
Tel
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
| 2015 | Year | 07 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2015 | Year | 05 | Month | 27 | Day |
Last modified on
| 2015 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020229
