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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021428
Receipt No. R000024719
Scientific Title Triple-branched stent-in-stent placement for inoperable high-grade malignant hilar biliary strictures for which bilateral metal stenting has failed
Date of disclosure of the study information 2016/03/10
Last modified on 2016/03/10

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Basic information
Public title Triple-branched stent-in-stent placement for inoperable high-grade malignant hilar biliary strictures for which bilateral metal stenting has failed
Acronym Triple metallic stent-in-stenting for malignant hilar strictures
Scientific Title Triple-branched stent-in-stent placement for inoperable high-grade malignant hilar biliary strictures for which bilateral metal stenting has failed
Scientific Title:Acronym Triple metallic stent-in-stenting for malignant hilar strictures
Region
Asia(except Japan)

Condition
Condition high-grade malignant hilar biliary strictures
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the technical feasibility and efficacy of endoscopic triple-branched cross-wired metal stent-in-stent placement in patients with inoperable high-grade malignant hilar biliary strictures in whom bilateral stent-in-stent had failed clinically.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The technical success rate of triple-branched stent-in-stent placement: appropriate placement of third metal stent through prior-placed metal stents in bilaterally stent-in-stent fashion.
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
Device,equipment
Interventions/Control_1 Endoscopic biliary metal 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
17 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Histologically proven inoperable malignant hilar biliary strictures
2. Disease of Bismuth class type III or IV
3. Unresolved or recurrent cholangitis after bilateral metallic stenting
4. Karnofsky index more than 30%
5. No serious or uncontrolled medical illness.
Key exclusion criteria 1. Malignant hilar biliary strictures caused by metastatic lesions
2. Atrophic liver lobe
3. Uncontrolled coagulopathy
4. Patient's refusal
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jong Ho Moon
Organization SoonChunHyang University School of Medicine
Division name Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
Address 170 Jomaru-ro, Wonmi-gu, Bucheon 14584
TEL +82-32-621-5094
Email jhmoon@schmc.ac.kr

Public contact
Name of contact person
1st name
Middle name
Last name Hyun Jong Choi
Organization SoonChunHyang University School of Medicine
Division name Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
Address 170 Jomaru-ro, Wonmi-gu, Bucheon 14584
TEL +82-32-621-5211
Homepage URL
Email joseph@schmc.ac.kr

Sponsor
Institute SoonChunHyang University School of Medicine
Institute
Department

Funding Source
Organization No specific funding source
Organization
Division
Category of Funding Organization Outside Japan
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

Other administrative information
Date of disclosure of the study information
2016 Year 03 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 Enrolling by invitation
Date of protocol fixation
2011 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 01 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
2016 Year 03 Month 10 Day
Last modified on
2016 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024719

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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