UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008492 |
|---|---|
| Receipt number | R000009982 |
| Scientific Title | Multicenter study for Endoscopic Pre-Operative Biliary Drainage in Patients with Malignant Distal Biliary Obstruction |
| Date of disclosure of the study information | 2012/07/22 |
| Last modified on | 2013/09/16 10:17:38 |
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Basic information
Public title
Multicenter study for Endoscopic Pre-Operative Biliary Drainage in Patients with Malignant Distal Biliary Obstruction
Acronym
Multicenter E-POD study
Scientific Title
Multicenter study for Endoscopic Pre-Operative Biliary Drainage in Patients with Malignant Distal Biliary Obstruction
Scientific Title:Acronym
Multicenter E-POD study
Region
| Japan |
Condition
Condition
Pancreas head ca, extrahepatic bile duct ca
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of endoscopic preoperative biliary drainage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Additional endoscopic biliary drainage
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases with pancreatic head cancer or extrahepatic bile duct cancer accompanied with obstructive jaundice and underwent endoscopic biliary drainage followed by resection
Key exclusion criteria
endoscopic biliary drainage in other hospital
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Sasahira |
Organization
Sempo Tokyo Takanawa Hospital
Division name
Gastroenterology
Zip code
Address
3-10-11, Takanawa, Minato-Ku
TEL
03-3443-9191
sasahira-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Sasahira |
Organization
E-POD study group
Division name
E-POD study group
Zip code
Address
3-10-11, Takanawa, Minato-Ku
TEL
03-3443-9191
Homepage URL
sasahira-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
| 2012 | Year | 07 | Month | 22 | 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
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 31 | Day |
Other
Other related information
Observation Study
Management information
Registered date
| 2012 | Year | 07 | Month | 22 | Day |
Last modified on
| 2013 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009982
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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