UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009779 |
|---|---|
| Receipt number | R000002159 |
| Scientific Title | A prospective randomized study of "covered" vs "uncovered" metallic stets for the management of biliary stricture by unresectable lower to middle bile duct cancer |
| Date of disclosure of the study information | 2013/01/14 |
| Last modified on | 2014/02/19 09:18:21 |
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Basic information
Public title
A prospective randomized study of "covered" vs "uncovered" metallic stets for the management of biliary stricture by unresectable lower to middle bile duct cancer
Acronym
"Covered" vs "uncovered" metallic stents for biliary stricture by unresectable middle to lower bile duct cancer.
Scientific Title
A prospective randomized study of "covered" vs "uncovered" metallic stets for the management of biliary stricture by unresectable lower to middle bile duct cancer
Scientific Title:Acronym
"Covered" vs "uncovered" metallic stents for biliary stricture by unresectable middle to lower bile duct cancer.
Region
| Japan |
Condition
Condition
Biliary stricture caused by unresectable middle to lower bile duct cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaaluate the efficacy of covered metallic stent (CMS) and uncovered metallic stent (UMS)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
duration until stent dysfunction
Key secondary outcomes
1) overall survival
2) incedence of side effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Covered metallic stent (CMS)
Interventions/Control_2
Uncovered metallic stent (UMS)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Unresectable middle to lower bile duct cancer.
2) Pathological confirmation is essential.
3) Stricuture is located to middle to lower bile duct.
4) Clinical stage (UICC) is more than stage 2b.
5) Informed consent is essential.
Key exclusion criteria
1) PS>4
2) Severe complication of another organ.
3) A patient who gives no written IC.
4) A participating doctor thinks the patient is not proper for this study.
5) Prognosis will be within 3 months.
6) Initial drainage worsen the status of the patient.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidekazu Mukai |
Organization
Yodogawa Chiristian Hospital
Division name
Department of Gastroenterology
Zip code
Address
Awaji 2-9-26 Higasiyodogawa-Ku, Osaka
TEL
06-6322-2250
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyohito Tanaka |
Organization
Kyoto Secind Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
Address
TEL
075-231-5171
Homepage URL
Sponsor or person
Institute
Kansai Endoscopic Device Selection (EDS) Working Group
Institute
Department
Personal name
Funding Source
Organization
Kansai Endoscopic Device Selection (EDS) Working Group
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
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 | 01 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Reintervention was performed for recurrent biliary obstruction in 18 of 72 covered SEMSs (25%) and 28 of 71 uncovered SEMSs (39%). Median stent patency times were 552 days and 314 days for the covered and uncovered SEMSs groups, respectively. The log-rank test revealed that the stent patency time in the covered SEMSs group was significantly longer than that in the uncovered SEMSs group (P=0.041). Stent dysfunction developed in 17 (23%) patients in the covered SEMSs group and in 23 (38%) patients in the uncovered SEMSs group, respectively.
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
Completed
Date of protocol fixation
| 2009 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2012 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 14 | Day |
Last modified on
| 2014 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002159
