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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024832
Receipt No. 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 2019/05/19

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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
Email 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
Email h-kawa@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

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
Email 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 Open public recruiting
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
2019 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028568

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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