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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016468
Receipt No. R000019128
Scientific Title The Impact of Postoperative Complications on Survivals after Esophagectomy for Esophageal Cancer
Date of disclosure of the study information 2015/02/07
Last modified on 2018/08/30

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Basic information
Public title The Impact of Postoperative Complications on Survivals after Esophagectomy for Esophageal Cancer
Acronym The Impact of Postoperative Complications on Survivals after Esophagectomy for Esophageal Cancer
Scientific Title The Impact of Postoperative Complications on Survivals after Esophagectomy for Esophageal Cancer
Scientific Title:Acronym The Impact of Postoperative Complications on Survivals after Esophagectomy for Esophageal Cancer
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the impact of postoperative complications after esophagectomy on survivals
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Disease free survival rate, overall survival rate
Key secondary outcomes

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 esophageal cancer who underwent esophagectomy with thoracotomy and laparotomy, with R0 or R1 resection between January 1997 and December 2012 at Keio University Hospital, Tokyo, Japan.
Key exclusion criteria Patients whose doctor judged to be ineligible for this study.
Target sample size 402

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Kitagawa
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Email kitagawa@a3.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroya Takeuchi
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email htakeuchi@a6.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 02 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2015 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To assess the impact of postoperative complications after esophagectomy on survivals

Management information
Registered date
2015 Year 02 Month 07 Day
Last modified on
2018 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019128

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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