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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044441
Receipt No. R000050764
Scientific Title The prospective study to evaluate the technical feasibility and clinical effectiveness of endoscopic ultrasounds-guided hepaticogastrotomy with small diameter guide wire.
Date of disclosure of the study information 2021/06/07
Last modified on 2021/06/05

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Basic information
Public title The prospective study to evaluate the technical feasibility and clinical effectiveness of endoscopic ultrasounds-guided hepaticogastrotomy with small diameter guide wire.
Acronym The prospective study to evaluate the technical feasibility and clinical effectiveness of endoscopic ultrasounds-guided hepaticogastrotomy with small diameter guide wire.
Scientific Title The prospective study to evaluate the technical feasibility and clinical effectiveness of endoscopic ultrasounds-guided hepaticogastrotomy with small diameter guide wire.
Scientific Title:Acronym The prospective study to evaluate the technical feasibility and clinical effectiveness of endoscopic ultrasounds-guided hepaticogastrotomy with small diameter guide wire.
Region
Japan

Condition
Condition Obstructive jaundice
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of usefulness and safety of EUS-HGS using a guide wire with a smaller diameter than the conventional one
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes technical success
Key secondary outcomes early/rate adverse event
clinical effect improvement rate
stent patency
time to stent dysfunction
survival rate

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The cases of EUS-HGS using 0.018 inch guidewire
The number of procedure is 1
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
95 years-old >=
Gender Male and Female
Key inclusion criteria 1.20 years old and over
2.Cases with obstructive jaundice for which transpapillary biliary drainage is difficult
3.Cases of biliary calculus with difficult transpapillary biliary drainage
4.Intrahepatic bile duct is 1.5 mm or less
5.ECOG (Eastern Cooperative Oncology Group) performance status 0-3
Key exclusion criteria 1.Cases with serious complications in other organs: 3 or more in ASA classification (excluding dialysis patients)
2.ECOG performance status 4
3.When the prognosis for life is judged to be less than 3 months due to poor general condition
4.Other patients who are judged by the research-responsible (sharing) doctor to be inappropriate as subjects
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Okuda
Organization Osaka Medical and Pharmaceutical University
Division name 2nd Department of Internal Medicine
Zip code 5698686
Address 2-7,Daigakummachi,Takatsuki city,Osaka
TEL 0726831221
Email atsushi.okuda@ompu.ac.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Okuda
Organization Osaka Medical and Pharmaceutical University
Division name 2nd Department of Internal Medicine
Zip code 5698686
Address 2-7,Daigakummachi,Takatsuki city,Osaka
TEL 0726831221
Homepage URL
Email atsushi.okuda@ompu.ac.jp

Sponsor
Institute Osaka Medical and Pharmaceutical University
Institute
Department

Funding Source
Organization Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Osaka Medical and Pharmaceutical University
Address 2-7,Daigakummachi,Takatsuki city,Osaka
Tel 0726831221
Email atsushi.okuda@ompu.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

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 07 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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 07 Day
Date of IRB
2021 Year 05 Month 28 Day
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 05 Day
Last modified on
2021 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050764

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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