UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017178 |
|---|---|
| Receipt number | R000019932 |
| Scientific Title | A safety and efficacy of endoscopic biliary drainage for patients with hilar cholangiocarcinoma |
| Date of disclosure of the study information | 2015/04/20 |
| Last modified on | 2016/10/27 12:30:35 |
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Basic information
Public title
A safety and efficacy of endoscopic biliary drainage for patients with hilar cholangiocarcinoma
Acronym
Endoscopic biliary drainage for hilar cholangiocarinoma
Scientific Title
A safety and efficacy of endoscopic biliary drainage for patients with hilar cholangiocarcinoma
Scientific Title:Acronym
Endoscopic biliary drainage for hilar cholangiocarinoma
Region
| Japan |
Condition
Condition
Hilar cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of endoscopic biliary drainage
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A rate of complications
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hilar cholangiocarcinoma who underwent endoscopic biliary drainage
Key exclusion criteria
Patients who underwent PTBD or SEMS placement as an initial treatment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazumichi Kawakubo |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kita15, NIshi7, Kita-ku, Sapporo
TEL
0117161161
kkawakubo-gi@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumichi Kawakubo |
Organization
Hokkaido Univ. Graduate School of Medicine, Dept. Gastroenterology & Hepatology
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kita15, NIshi7, Kita-ku, Sapporo
TEL
0117161161
Homepage URL
kkawakubo-gi@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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 | 04 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
CONCLUSION: The endoscopic management of hilar cholangiocarcinoma is challenging. ENBD should be selected as a temporary drainage method because of its low risk of complications.
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
Main results already published
Date of protocol fixation
| 2015 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2015 | Year | 04 | Month | 20 | Day |
Last modified on
| 2016 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019932
