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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016593
Receipt No. 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

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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
Email 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
Email ynakai-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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019254

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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