UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012734 |
|---|---|
| Receipt number | R000014878 |
| Scientific Title | A prospective randomized comparative study of a novel anti-reflux metal stent versus partial covered metal stent in patients with inoperable distal malignant biliary strictures |
| Date of disclosure of the study information | 2013/12/31 |
| Last modified on | 2015/01/17 17:46:58 |
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Basic information
Public title
A prospective randomized comparative study of a novel anti-reflux metal stent versus partial covered metal stent in patients with inoperable distal malignant biliary strictures
Acronym
Comparision of a novel anti-reflux metal stent with partial covered metal stent for distal malignant biliary strictures
Scientific Title
A prospective randomized comparative study of a novel anti-reflux metal stent versus partial covered metal stent in patients with inoperable distal malignant biliary strictures
Scientific Title:Acronym
Comparision of a novel anti-reflux metal stent with partial covered metal stent for distal malignant biliary strictures
Region
| Asia(except Japan) |
Condition
Condition
Inoperable distal malignant biliary stircutres
1) Common bile duct cancer
2) Pancreatic head cancer
3) Gallbladder cancer
4) Other metastatic malignant biliary strictures
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the role of a innovative anti-reflux valve in biliary metallic stents by comparision of a novel anti-reflux metal stent versus partial covered metal stent in patients with inoperable distal malignant biliary strictures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Stent occlusion
Key secondary outcomes
Clinical success
Complications
Stent patency
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Biliary drainage with a novel anti-reflux metal stent
Interventions/Control_2
Biliary drainage with a conventional partial covered metal 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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Providing informed consent
2) Inoperable distal malignant biliary strictures
3) Distal malignant biliary strictures with high operative risk
4) Distal malignant biliary strictures on imaging studies
5) Histopathologically confirmed as malignancy
6) Stricture in distance above 2 cm from the bifurcation of bile duct
Key exclusion criteria
1) Refusal of this study
2) Plan for curative or palliative surgery
3) Stricture in distance within 2 cm from the bifurcation of bile duct
4) Risk of bleeding: PT-INR > 1.5, normal 0.85-1.25 or platelet count < 80,000/mm3, normal 150,000-450,000/mm3
5) Pregnant or breast-feeding women
6) Performance status < 3 (scales of the Eastern Cooperative Oncology Group)
Target sample size
132
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
Zip code
Address
1174 Jung-Dong, Wonmi-Ku, Bucheon 420-767, Korea
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
Zip code
Address
1174 Jung-Dong, Wonmi-Ku, Bucheon 420-767, Korea
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
SoonChunHyang University School of Medicien
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Korea
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
SoonChunHyang University School of Medicine, Buchoen Hospital, Korea
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 03 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 31 | Day |
Last modified on
| 2015 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014878
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