UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of endoscopic and percutaneous preoperative biliary drainage in patients with malignant hilar biliary obstruction: A multicenter retrospective analysis
Title of the study (Brief title)	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	Hiroyuki Isayama
Organization	The University of Tokyo
Division name	Gastroenterology
Address	7-3-1, Hongo Bunkyo-ku Tokyo
TEL	03-3815-5411
Email	isayama-tky@umin.ac.jp

Public contact
Name of contact person	Yousuke Nakai
Organization	The University of Tokyo
Division name	Gastroenterology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 12 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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