UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016593 |
|---|---|
| Receipt number | R000019254 |
| Scientific Title | Safety and efficacy of endoscopic and percutaneous preoperative biliary drainage in patients with malignant hilar biliary obstruction: A multicenter retrospective analysis |
| Date of disclosure of the study information | 2015/02/21 |
| Last modified on | 2017/05/31 18:31:42 |
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Basic information
Public title
Safety and efficacy of endoscopic and percutaneous preoperative biliary drainage
in patients with malignant hilar biliary obstruction: A multicenter retrospective analysis
Acronym
E-POD hilar
Scientific Title
Safety and efficacy of endoscopic and percutaneous preoperative biliary drainage
in patients with malignant hilar biliary obstruction: A multicenter retrospective analysis
Scientific Title:Acronym
E-POD hilar
Region
| Japan |
Condition
Condition
Malignant hilar biliary obstruction by biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of preoperative biliary drainage in patients with malignant hilar biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The necessity and the cause of additional biliary drainage procedure
Key secondary outcomes
Total number of biliary drainage procedures, time to resolution of jaundice, preoperative pathological diagnosis, preoperative complications
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 malignant biliary obstruction due to biliary tract cancer who underwent surgical resection
Key exclusion criteria
1)patients who underwent preoperative biliary drainage at the referring hospitals
2)patients with unresectable biliary tract cancer
3)patients who refused to participate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
The University of Tokyo
Division name
Gastroenterology
Zip code
Address
7-3-1, Hongo Bunkyo-ku Tokyo
TEL
03-3815-5411
isayama-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yousuke Nakai |
Organization
The University of Tokyo
Division name
Gastroenterology
Zip code
Address
7-3-1, Hongo Bunkyo-ku Tokyo
TEL
03-3815-5411
Homepage URL
ynakai-tky@umin.ac.jp
Sponsor or person
Institute
E-POD study group
Institute
Department
Personal name
Funding Source
Organization
No
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 | 02 | Month | 21 | 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
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
| 2014 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter retrospective study
Management information
Registered date
| 2015 | Year | 02 | Month | 20 | Day |
Last modified on
| 2017 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019254
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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