UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014605 |
|---|---|
| Receipt number | 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 17:51:37 |
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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
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
m-kitano@med.kindai.ac.jp
Sponsor or person
Institute
Study Group for EUS-guided Biliary Drainage
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016994
