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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014605
Receipt No. R000016994
Scientific Title Evaluation of endoscopic ultrasound-guided hepaticogastrostomy combined with antegrade stenting: a prospective multicenter registration study.
Date of disclosure of the study information 2014/07/31
Last modified on 2017/02/10

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Basic information
Public title Evaluation of endoscopic ultrasound-guided hepaticogastrostomy combined with antegrade stenting: a prospective multicenter registration study.
Acronym Evaluation of endoscopic ultrasound-guided hepaticogastrostomy combined with antegrade stenting: a prospective multicenter registration study.
Scientific Title Evaluation of endoscopic ultrasound-guided hepaticogastrostomy combined with antegrade stenting: a prospective multicenter registration study.
Scientific Title:Acronym Evaluation of endoscopic ultrasound-guided hepaticogastrostomy combined with antegrade stenting: a prospective multicenter registration study.
Region
Japan

Condition
Condition Obstructive jaundice
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the stent patency duration and complication rates of EUS-HGAS in patients with obstructive jaundice due to unresectable malignant biliary obstruction after failure of transpapillary drainage and EUS guided choledochoduodenostomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The stent patency rate 3 months after EUS-HGAS
Key secondary outcomes

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 guided hepaticogastrostomy nd antegrade stenting
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
100 years-old >
Gender Male and Female
Key inclusion criteria # Unresectable malignant disease
# Malignant biliary obstruction to be required biliary drainage
# Unsuccessful transpapillary drainage and EUS-guided choledochoduodenostomy
# Written informed consent
# Survival for 3 months or longer
Key exclusion criteria # Iability to perform endoscopy
# Performance status = 4
# Serious failure of other organs
# Inability to obtain informed consent
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Kitano
Organization Kinki University Facluty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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
1st name
Middle name
Last name Masayuki Kitano
Organization Kinki University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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)

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 近畿大学医学部附属病院(大阪府)、大阪医科大学附属病院(大阪府)、神戸大学医学部附属病院(兵庫県)、日本赤十字和歌山医療センター(和歌山県)、ベルランド総合病院(大阪府)、川崎医科大学川崎病院(岡山県)、岡山大学医学部附属病院(岡山県)、香川大学医学部附属病院(香川県)、北野病院(大阪府)、佐久総合病院(長野県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 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 Completed
Date of protocol fixation
2014 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 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
2014 Year 07 Month 22 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=R000016994

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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