UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016468 |
|---|---|
| Receipt number | 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 10:47:12 |
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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
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
htakeuchi@a6.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019128
