UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041642
Receipt No. R000047358
Scientific Title Prognostic Analysis of Distal Pancreatectomy for Pancreatic Body and/or Tail Cancer
Date of disclosure of the study information 2020/10/01
Last modified on 2021/03/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prognostic Analysis of Distal Pancreatectomy for Pancreatic Body and/or Tail Cancer
Acronym Prognostic Analysis of Distal Pancreatectomy for Pancreatic Body and/or Tail Cancer
Scientific Title Prognostic Analysis of Distal Pancreatectomy for Pancreatic Body and/or Tail Cancer
Scientific Title:Acronym Prognostic Analysis of Distal Pancreatectomy for Pancreatic Body and/or Tail Cancer
Region
Japan

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

Objectives
Narrative objectives1 In this study, we examined the prognostic impact of distal pancreatectomy (DP) or distal pancreatectomy with celiac axis resection (DP-CAR) in patients with portal vein contact of pancreatic body and/or tail cancer, which was evaluated via preoperative computed tomography. Moreover, we consider the appropriate resectability status for the patients with pancreatic body and/or tail cancer involving portal vein and eligible candidates for DP or DP-CAR.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The relationship between overall survival and portal vein resection and/or the portal vein contact of pancreatic body and/or tail cancer, which was evaluated via preoperative computed tomography in the patients of eligible candidates for DP or DP-CAR
Key secondary outcomes The relationship between overall survival and preoperative chemo or chemoradiotherapy

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 Patients with pancreatic body and/or tail cancer who underwent DP or DP-CAR between 2002 and 2017

Invasive ductal carcinoma was confirmed by pathological examination
Key exclusion criteria Histologic type was other than invasive ductal carcinoma

Multiple or asynchronic carcinoma
Target sample size 3531

Research contact person
Name of lead principal investigator
1st name Yusuke
Middle name
Last name Yamamoto
Organization Kyoto Prefectural University of Medicine
Division name Digestive Surgery
Zip code 602-8566
Address Kajii-cho 465, Kamigyo-ku, Kyoto
TEL 075-251-5111
Email yamayu-1@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Yusuke
Middle name
Last name Yamamoto
Organization Kyoto Prefectural University of Medicine
Division name Digestive Surgery
Zip code 602-8566
Address Kajii-cho 465, Kamigyo-ku, Kyoto
TEL 075-251-5111
Homepage URL
Email yamayu-1@koto.kpu-m.ac.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

Funding Source
Organization Japanese Society of Hepato-Biliary-Pancreatic Surgery
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Shizuoka Cancer Center
Address 1007, Shimo-Nagakubo, Sunto-Nagaizumi, Shizuoka
Tel 055-989-5222
Email yamayu-1@koto.kpu-m.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 長野県厚生農業協同組合連合会 佐久総合病院 佐久医療センター
杏林大学付属病院
愛知県がんセンター
JA北海道厚生連札幌厚生病院
自治医科大学附属さいたま医療センター
金沢大学医学部附属病院
東京女子医科大学病院
順天堂大学医学部附属順天堂医院
九州大学病院
東北大学病院
奈良県立医科大学附属病院
宮崎大学医学部附属病院
広島大学病院
大阪大学医学部附属病院
東京慈恵会医科大学附属病院
富山県立中央病院
静岡県立静岡がんセンター
東京医科歯科大学医学部附属病院
福島県立医科大学附属病院
北海道大学病院
千葉大学医学部附属病院
東京医科大学病院
福山市民病院
京都第二赤十字病院
京都府立医科大学付属病院
岐阜大学医学部附属病院
富山大学附属病院
滋賀医科大学医学部附属病院
新潟県立中央病院
福井大学医学部附属病院
独立行政法人 国立病院機構 岩国医療センター
山形県立中央病院
琉球大学医学部附属病院
社会医療法人仁愛会 浦添総合病院
北海道勤労者医療協会 勤医協中央病院
新潟厚生連長岡中央綜合病院
市立函館病院
日本赤十字社和歌山医療センター
和歌山県立医科大学附属病院

Other administrative information
Date of disclosure of the study information
2020 Year 10 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 22 Day
Date of IRB
2020 Year 05 Month 29 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicenter Retrospective study

Management information
Registered date
2020 Year 09 Month 02 Day
Last modified on
2021 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047358

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.