UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009893 |
|---|---|
| Receipt number | R000011592 |
| Scientific Title | Re-intervention for occluded biliary metal stent for patients with malignant distal biliary stricture -a multicenter prospective randomized controlled trial |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2019/08/05 09:05:55 |
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Basic information
Public title
Re-intervention for occluded biliary metal stent for patients with malignant distal biliary stricture -a multicenter prospective randomized controlled trial
Acronym
Re-intervention for occluded biliary metal stent for patients with malignant distal biliary stricture -a multicenter prospective randomized controlled trial
Scientific Title
Re-intervention for occluded biliary metal stent for patients with malignant distal biliary stricture -a multicenter prospective randomized controlled trial
Scientific Title:Acronym
Re-intervention for occluded biliary metal stent for patients with malignant distal biliary stricture -a multicenter prospective randomized controlled trial
Region
| Japan |
Condition
Condition
malignant biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish adequate re-intervention for occluded meta l stent in patients with malignant distal biliary stricture by a multicenter prospective randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to stent re-occlusion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
metal stent placement
Interventions/Control_2
plastic stent placement
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. age >/= 20
2. malignant biliary stricture
3. unresectable
4. those who had undergone biliary metal stent placement
5. total bilirubin >/= 3.0 mg/dL or dilation of intrahepatic biliary duct
6. those who attempt to undergo transpapillary biliary drainage
7. those who give IC
Key exclusion criteria
1. hilar stricture
2. inaccessible to transpapillary approach
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Ito |
Organization
Sendai City Medical Center
Division name
Gastroenterology
Zip code
Address
5-22-1, Tsurugaya, Sendai, Miyagi
TEL
+81-22-252-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Ito |
Organization
Sendai City Medical Center
Division name
Gastroenterology
Zip code
Address
5-22-1, Tsurugaya, Sendai, Miyagi
TEL
Homepage URL
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
Funding Source
Organization
Sendai City Medical Center
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2013 | Year | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 29 | Day |
Last modified on
| 2019 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011592
