UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040398
Receipt number 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 16:11:30

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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 or person

Institute

Department of Gastrointestinal and Pediatric Surgery,Tokyo Medical University

Institute

Department

Personal name



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

Value
https://center6.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