UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study of endoscopic ultrasound-guided hepaticogastrostomy combined with antegrade stenting using novel metal stent
Acronym	Prospective study of endoscopic ultrasound-guided hepaticogastrostomy with antegrade stenting using novel stent
Scientific Title	Prospective study of endoscopic ultrasound-guided hepaticogastrostomy combined with antegrade stenting using novel metal stent
Scientific Title:Acronym	Prospective study of endoscopic ultrasound-guided hepaticogastrostomy with antegrade stenting using novel stent
Region	Japan

Condition
Condition	Obstructive Jaundice
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the EUS-HGAS procedure success rate for unresectable malignant biliary obstructive cases using novel metal stent
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	EUS-HGAS procedure success rate
Key secondary outcomes	Type, frequency of adverse events. 3 months after EUS - HGAS stent patency. Clinical efficacy rate.

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 with EUS-AS using novet metal stent(Zilver type 2)
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	nonresectable advanced malignant tumor case Cases requiring biliary duct drainage due to malignant bile duct obstruction Difficult cases of biliary drainage via Vater papilla approach Cases in which survival is expected for more than 3 months
Key exclusion criteria	Difficult cases of endoscopic approach Perfomance status 4 case Cases with serious complications in other organs Informed consent case not available
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Kazuhide Middle name Last name Higuchi
Organization	Osaka Medical College Hospital
Division name	Gastrointestinal Division
Zip code	569-8686
Address	2-7 Daigakumachi, Takatsuki, Osaka
TEL	+81726831221
Email	higuchi@osaka-med.ac.jp

Public contact
Name of contact person	1st name Saori Middle name Last name Ueno
Organization	Osaka Medical College Hospital
Division name	Gastrointestinal Division
Zip code	569-8686
Address	2-7 Daigakumachi, Takatsuki, Osaka
TEL	+81726831221
Homepage URL
Email	onchannopasocon@yahoo.co.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Osaka Medical College
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka Medical College
Address	2-7 Daigakumachi, Takatsuki, Osaka
Tel	0726-83-1221
Email	rinri@osaka-med.ac.jp

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	大阪医科大学付属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 31 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	Open public recruiting
Date of protocol fixation	2018 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date	2019 Year 01 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 30 Day
Last modified on	2019 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040677