UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024832 |
|---|---|
| Receipt number | R000028568 |
| Scientific Title | A Multicenter Prospective Randomized Study of Fully Covered Metallic Stent versus Tube Stent in Patients with Borderline Resectable Pancreatic Carcinoma |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2024/11/20 10:45:42 |
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Basic information
Public title
A Multicenter Prospective Randomized Study of Fully Covered Metallic Stent versus Tube Stent in Patients with Borderline Resectable Pancreatic Carcinoma
Acronym
TOBIP-01/NUPAT-04
Scientific Title
A Multicenter Prospective Randomized Study of Fully Covered Metallic Stent versus Tube Stent in Patients with Borderline Resectable Pancreatic Carcinoma
Scientific Title:Acronym
TOBIP-01/NUPAT-04
Region
| Japan |
Condition
Condition
Pancreatic carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Compare of stent patency between tube stent and fully covered metallic stent for BR pancreatic carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of cases who do not need stent exchange until surgical operation or diagnosis of inoperation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
tube stent (more than 8.5 Fr)
Interventions/Control_2
Fully covered metallic stent (more than 8 mm)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Borderline resectable Pancreatic ductal carcinoma case with bile duct stenosis (image diagnosis)
Cases planed NAC(R)T more than 2 month
PS(ECOG) 0 or 1
Adequate oral intake
Estimated life expectancy more than 3 months
Without another malignant disease
With informed concent
Key exclusion criteria
Severe neurologic impairment or mental disorder
With severe other organ disorder
Pregnant or lactating women,
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirooka |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
4668550
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
0527442166
h-kawa@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kawashima |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
4668550
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
0527442166
Homepage URL
h-kawa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Boards of Nagoya University Hospital
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Japan
Tel
0527442061
ethics@med.nagoya-u.ac.jp
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
| 2017 | Year | 01 | 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
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 14 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028568
