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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030473
Receipt No. R000032249
Scientific Title A prospective randomised study of covered self-expandable metal stents with an anti-migration system versus plastic stent for the borderline resctable pancreatic cancer
Date of disclosure of the study information 2017/12/20
Last modified on 2019/06/24

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Basic information
Public title A prospective randomised study of covered self-expandable metal stents with an anti-migration system versus plastic stent for the borderline resctable pancreatic cancer
Acronym FCMS versus PS for the borderline resctable pancreatic cancer
Scientific Title A prospective randomised study of covered self-expandable metal stents with an anti-migration system versus plastic stent for the borderline resctable pancreatic cancer
Scientific Title:Acronym FCMS versus PS for the borderline resctable pancreatic cancer
Region
Japan

Condition
Condition borderline resectable pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of randomized study was to assess the advantage of plastic stent vs. covered SEMS with an anti-migration system in term of rate of reintervention and postoperative complication
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes rate of reintervention
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Intervetions is to place a full covered self-expanable metal stent with anti-migration system to resectable borderline pancreatic cancer with bile duct obstruction
Interventions/Control_2 Control is to place a plastic stent to resectable borderline pancreatic cancer with bile duct obstruction
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

Not applicable
Gender Male and Female
Key inclusion criteria graphically diagnosed borderline resectable pancreatic cancer
malignant distal biliary obstruction
schedueled for neo adjvant chemotherapy
Key exclusion criteria the anterior intestinal stricture of the nipple
sever dysfunction in other organs
difficult of endoscopic approach
hilar biliary obstruction
with distant metastasis
without pathological diagnosisa
history of EST
a doctor judged inappropriate as a study
Target sample size 22

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Kitano
Organization wakayama medical university
Division name Second Department of Internal Medicine
Zip code 6410012
Address 811-1 Kimiidera wakayama city wakayama
TEL 073-447-2300
Email kitano@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Tamura
Middle name
Last name Takashi
Organization wakayama medical university
Division name Second Department of Internal Medicine
Zip code 6410012
Address 811-1 Kimiidera wakayama city wakayama
TEL 073-447-2300
Homepage URL
Email ttakashi28@gmail.com

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Rearch Reveiw Commitee of Wakayama Medical University
Address 811-1 Kimidera Wakayama-shi
Tel 0734410714
Email wa-riniri@wakayama-med.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 12 Month 20 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 05 Month 31 Day
Date of IRB
2017 Year 05 Month 30 Day
Anticipated trial start date
2017 Year 05 Month 31 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 19 Day
Last modified on
2019 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032249

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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