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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040398
Receipt No. R000046099
Scientific Title Surgical outcomes in each vascular resection range and reconstruction method in patients with portal vein and superior mesenteric vein resection for pancreatic head cancer Japan-Korea Cooperative Project
Date of disclosure of the study information 2020/05/14
Last modified on 2020/05/14

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Basic information
Public title Surgical outcomes in each vascular resection range and reconstruction method in patients with portal vein and superior mesenteric vein resection for pancreatic head cancer Japan-Korea Cooperative Project
Acronym Surgical outcomes of patients with portal vein and superior mesenteric vein resection for pancreatic head cancer
Scientific Title Surgical outcomes in each vascular resection range and reconstruction method in patients with portal vein and superior mesenteric vein resection for pancreatic head cancer Japan-Korea Cooperative Project
Scientific Title:Acronym Surgical outcomes of patients with portal vein and superior mesenteric vein resection for pancreatic head cancer
Region
Japan Asia(except Japan)

Condition
Condition Pancreatic cancer
Classification by specialty
Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify the appropriate range of PV / SMV / SV / JV resection and these reconstruction method in analyzing short- and long-term surgical results that contributes to safety and prognosis in multicenter collaborative study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Overall survival
Key secondary outcomes Morbidity and mortality
Disease-free survival
R0 resection rate
histological invasion rate of the resected PV/SMV
Morbidity and mortality
Initial recurrence patterns

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Pancreatic head adenocarcinoma (PDAC) patients with PV/SMV resection for tumor involvement
Key exclusion criteria Unresectable PDAC with distant metastasis
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Yuichi
Middle name
Last name Nagakawa
Organization Tokyo Medical University
Division name Department of Gastrointestinal and Pediatric Surgery
Zip code 1600023
Address 6-7-1, Nishishinjuku, Shinjyuku-ku, Tokyo 160-0023 Japan
TEL 03-3342-6111
Email naga@tokyo-med.ac.jp

Public contact
Name of contact person
1st name Yuichi
Middle name
Last name Nagakawa
Organization Tokyo Medical University
Division name Department of Gastrointestinal and Pediatric Surgery
Zip code 1600023
Address 6-7-1, Nishishinjuku, Shinjyuku-ku, Tokyo 160-0023 Japan
TEL 03-3342-6111
Homepage URL
Email naga@tokyo-med.ac.jp

Sponsor
Institute Department of Gastrointestinal and Pediatric Surgery,Tokyo Medical University
Institute
Department

Funding Source
Organization Japanese Society of Hepato-Biliary-Pancreatic Surgery
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 Tokyo Medical University institutional review board
Address Department of Gastrointestinal and Pediatric Surgery,Tokyo Medical University
Tel 03-3342-6111
Email IRB@tokyo-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 日本肝胆膵外科学会の高度技能専門医 認定修練施設(A、B)242施設

Other administrative information
Date of disclosure of the study information
2020 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 252
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 Enrolling by invitation
Date of protocol fixation
2020 Year 01 Month 09 Day
Date of IRB
2020 Year 02 Month 12 Day
Anticipated trial start date
2020 Year 05 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Surgical data is collected from the facilities associated to the Japanese Society of Hepatobiliary and Pancreatic Surgery and Korean Society of Hepatobiliary and Pancreatic Surgery.

Management information
Registered date
2020 Year 05 Month 14 Day
Last modified on
2020 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=R000046099

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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