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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044211
Receipt No. R000050486
Scientific Title A multicenter observational study of a new metal stent with Anti-Reflux valve in patients with resectable or borderline resectable pancreatic cancer and obstructive jaundice during neoadjuvant treatment.
Date of disclosure of the study information 2021/05/14
Last modified on 2021/05/14

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Basic information
Public title A multicenter observational study of a new metal stent with Anti-Reflux valve in patients with resectable or borderline resectable pancreatic cancer and obstructive jaundice during neoadjuvant treatment.
Acronym A multicenter observational study of a new metal stent with Anti-Reflux valve in patients with resectable or borderline resectable pancreatic cancer and obstructive jaundice during neoadjuvant treatment.
Scientific Title A multicenter observational study of a new metal stent with Anti-Reflux valve in patients with resectable or borderline resectable pancreatic cancer and obstructive jaundice during neoadjuvant treatment.
Scientific Title:Acronym A multicenter observational study of a new metal stent with Anti-Reflux valve in patients with resectable or borderline resectable pancreatic cancer and obstructive jaundice during neoadjuvant treatment.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the patency and safety of a new coverd metal stent with Anti-Reflux valve during neoadjuvant chemotherapy for resectable and resectable borderline pancreatic cancer patients with biliary obstruction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stent patency rate
Key secondary outcomes Cholangitis incidence
tecnical success rate
Adverse event

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 Resectable or borderline resectable pancreatic ductal carcinoma case with bile duct stenosis (image diagnosis)
Cases planed NAC(R)T
Key exclusion criteria Patients with performance status 4
Severe neurologic impairment or mental disorder
with severe other organ disorder
Pregnant or lactating women,
Cases in which endoscopic biliary drainage is impossible
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Honokuchi
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Digestive and Lifestyle Diseases
Zip code 890-8520
Address 8-35-1 Sakuragaoka, Kagoshima
TEL 0992755326
Email m-hino@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Hinokuchi
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Digestive and Lifestyle Diseases
Zip code 890-8520
Address 8-35-1 Sakuragaoka, Kagoshima
TEL 0992755326
Homepage URL
Email m-hino@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization Kagoshima University Graduate School of Medical and Dental Sciences
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 Kagoshima University Graduate School of Medical and Dental Sciences
Address 8-35-1 Sakuragaoka, Kagoshima
Tel 099-275-6624
Email crmc@m2.kufm.kagoshima-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
2021 Year 05 Month 14 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
2019 Year 01 Month 01 Day
Date of IRB
2020 Year 01 Month 24 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information n this study, a new coverd metal stent with Anti-Reflux valve was placed during preoperative adjuvant treatment for patient with resectable and resectable borderline pancreatic cancer and obstructive jaundice. We observe the stent occlusion rate until the operation.

Management information
Registered date
2021 Year 05 Month 14 Day
Last modified on
2021 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050486

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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