UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021428 |
|---|---|
| Receipt number | 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 22:57:08 |
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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
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
joseph@schmc.ac.kr
Sponsor or person
Institute
SoonChunHyang University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024719
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
