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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034036
Receipt No. R000038800
Scientific Title Randomized control trial of inside stenting using plastic stent and side by side stenting using 6mm full-covered self expandable metallic stent for endoscopic bilateral biliary drainage to malignant hilar biliary obstruction
Date of disclosure of the study information 2018/09/10
Last modified on 2019/09/06

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Basic information
Public title Randomized control trial of inside stenting using plastic stent and side by side stenting using 6mm full-covered self expandable metallic stent for endoscopic bilateral biliary drainage to malignant hilar biliary obstruction
Acronym RCT of IS and MS-SBS for MHBO
Scientific Title Randomized control trial of inside stenting using plastic stent and side by side stenting using 6mm full-covered self expandable metallic stent for endoscopic bilateral biliary drainage to malignant hilar biliary obstruction
Scientific Title:Acronym RCT of IS and MS-SBS for MHBO
Region
Japan

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

Objectives
Narrative objectives1 To compare the technical success, time to recurrent biliary obstruction, or re-intervention after recurrent biliary obstruction between inside stenting using plastic stent and side by side stenting using full-covered self expandable metallic stent
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to Recurrent Biliary Obstruction
Key secondary outcomes technical success rate, procedure time, functional success rate, adverse event, time of possible biliary drainage including re-intervention, survival time

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 side by side stenting using 6mm full-covered self expandable metallic stent
Interventions/Control_2 inside stenting using plastic stent
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. Untreated unresectable malignant hilar biliary obstruction
2. Type 2/3/4 in Bismuth classification
3. More than 3mg/dl of serum bilirubin
4. More than 20 years old
5. More than 30 days of expected survival period
6. Written informed consent obtained
Key exclusion criteria 1. Patients with surgical altered anatomy or post-hepatectomy
2. Endoscopic approach to the biliary system is impossible
3. Prior biliary drainage (transient naso-biliary drainage can be included)
4. biliary obstruction to 3rd branch of bilateral bile duct
5. Pregnant women or those suspected of pregnancy
6. Patients considered ineligible by attending physicians
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Toshifumi
Middle name
Last name Kin
Organization Teine-Keijinkai Hospital
Division name Center for Gastroenterology
Zip code 006-8555
Address 1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, 006-8555 Japan
TEL 011-681-8111
Email kin_toshifumi@yahoo.co.jp

Public contact
Name of contact person
1st name Toshifumi
Middle name
Last name Kin
Organization Teine-Keijinkai Hospital
Division name Center for Gastroenterology
Zip code 006-8555
Address 1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, 006-8555 Japan
TEL 011-681-8111
Homepage URL
Email kin_toshifumi@yahoo.co.jp

Sponsor
Institute Center for Gastroenterology, Teine-Keijinkai Hospital
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)

IRB Contact (For public release)
Organization Teine-Keijinkai Hospital
Address 1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, 006-8555 Japan
Tel 011-681-8111
Email teine@keijinkai.or.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
2018 Year 09 Month 10 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 08 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 10 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
2018 Year 09 Month 05 Day
Last modified on
2019 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038800

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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