UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of appropriate access route for endoscopic ultrasonography-guided biliary drainage in patients with malignant distal biliary obstruction after failed transpapillary drainage: a randomized multicenter study
Title of the study (Brief title)	A randomized multicenter study for EUS-guided biliary drainage
Region	Japan

Condition
Condition	Obstructive jaundice
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare feasibility of EUS-guided choledochoduodenostomy and hepaticogastrostomy in patients with distal biliary obstruction due to unresectable malignant tumors.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Technical success rate: to assess non-inferiority of EUS-HGS to EUS-CDS.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	EUS-guided choledochoduodenostomy
Interventions/Control_2	EUS-guided hepaticogastrostomy
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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	# Unresectable advanced cancer # Requirement of biliary drainage due to # lignant biliary stricutre # Failure or inability of biliary drainage by ERCP. # Written informed consent
Key exclusion criteria	# Inability to perform endoscopy # Performance status = 4 # Failure of other organs # Inability to obtain informed consent
Target sample size	60

Research contact person
Name of lead principal investigator	Masayuki Kitano
Organization	Kinki UNiversity Faculuty of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL	072-366-0221
Email	m-kitano@med.kindai.ac.jp

Public contact
Name of contact person	Masayuki Kitano
Organization	Kinki University Faculty of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL	072-366-0221
Homepage URL
Email	m-kitano@med.kindai.ac.jp

Sponsor
Institute	Study Group for EUS-guided Biliary Drainage
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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	2013 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 08 Day
Anticipated trial start date	2013 Year 09 Month 09 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 08 Month 11 Day
Last modified on	2017 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013408