UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035394 |
|---|---|
| Receipt number | R000040330 |
| Scientific Title | Efficacy and safety of the endoscopic radiofrequency ablation for unresectable cholangiocarcinoma: the pilot study |
| Date of disclosure of the study information | 2018/12/28 |
| Last modified on | 2018/12/28 17:09:35 |
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Basic information
Public title
Efficacy and safety of the endoscopic radiofrequency ablation for unresectable cholangiocarcinoma: the pilot study
Acronym
Efficacy and safety of the endoscopic radiofrequency ablation for unresectable cholangiocarcinoma: the pilot study
Scientific Title
Efficacy and safety of the endoscopic radiofrequency ablation for unresectable cholangiocarcinoma: the pilot study
Scientific Title:Acronym
Efficacy and safety of the endoscopic radiofrequency ablation for unresectable cholangiocarcinoma: the pilot study
Region
| Japan |
Condition
Condition
cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of endoscopic RFA using Habib on unresectable cholangiocarcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
technical success
Key secondary outcomes
survival time
time to RBO
complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
endoscopic radiofrequency ablation
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
unresectable cholangiocarcinoma
written
written informed consent
Key exclusion criteria
immpossible to endoscopic approach
bad general condition
pregnant
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahisa Ogawa |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL
022-252-1111
t-ogawa@openhp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahisa Ogawa |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL
022-252-1111
Homepage URL
t-ogawa@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
Funding Source
Organization
N/A
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
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
仙台市医療センター仙台オープン病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 28 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 21 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 21 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 21 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 28 | Day |
Last modified on
| 2018 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040330
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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