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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008492
Receipt No. 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

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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
Email 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
Email sasahira-tky@umin.ac.jp

Sponsor
Institute E-POD study group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009982

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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