UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endoscopic ultrasound-guided hepaticogastrostomy with a covered metal stent for malignant biliary obstruction: a prospective feasibility study
Title of the study (Brief title)	EUS-HGS for malignant biliary obstruction
Region	Japan

Condition
Condition	Malignant biliary obstruction
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate a safety and utility of EUS-HGS
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A rate of stent dysfunction
Key secondary outcomes	Complication

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	EUS-HGS
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1,Age>20 2,Patient without previous biliary drainage 3,Expected prognosis > 2 months 4,Performance status <2 5,Patients with written informed consent
Key exclusion criteria	1,Patients wihout intrahepatic bile duct dilation 2,Massive ascites 3,Severe comorbidity 4,Contraindications for upper GI endoscope 5,Severe biliary obstruction extending into secondary branch of left intrahepatic duct. 6,Bleeding diathesis
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroshi Kawakami
Organization	Hokkaido University Hospital
Division name	Department of Gastroenterology
Address	Kita14 Nishi5, Kita-ku, Sapporo
TEL
Email

Public contact
Name of contact person
Organization	Hokkaido University Hospital
Division name	Clinical Research Support Center
Address
TEL
Homepage URL
Email	crjimu@huhp.hokudai.ac.jp

Sponsor
Institute	Department of Gastroenterology, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
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	2012 Year 09 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 08 Month 15 Day
Anticipated trial start date	2012 Year 09 Month 01 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	2012 Year 09 Month 01 Day
Last modified on	2018 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010375