UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047458 |
|---|---|
| Receipt number | R000054117 |
| Scientific Title | Risk factors for operative morbidity and mortality after esophagectomy for esophageal cancer |
| Date of disclosure of the study information | 2022/04/11 |
| Last modified on | 2022/04/11 12:55:02 |
* 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
Impact of diabetes control status on anastomotic leakage after esophagectomy for esophageal cancer
Acronym
Impact of diabetes control status on anastomotic leakage after esophagectomy for esophageal cancer
Scientific Title
Risk factors for operative morbidity and mortality after esophagectomy for esophageal cancer
Scientific Title:Acronym
Risk factors for operative morbidity and mortality after esophagectomy for esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the impact of diabetes control status on anastomotic leakage after esophagectomy for esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the occurrence of anastomotic leakage
Key secondary outcomes
surgical site infection, respiratory complications, cardiovascular complications, operative morbidity, operative mortality, and length of hospital stay after surgery
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
A two-center database (2011-2019) was retrospectively reviewed to identify patients with esophageal cancer who underwent esophagectomy.
Key exclusion criteria
Patients who underwent two-stage reconstruction or who were missing HbA1c values were excluded from the study.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Daiko |
Organization
National Cancer Center Hospital
Division name
Division of Esophageal Surgery
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
+81-3-3542-2511
hdaiko@ncc.go.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Oguma |
Organization
National Cancer Center Hospital
Division name
Division of Esophageal Surgery
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
+81-3-3542-2511
Homepage URL
https://www.ncc.go.jp/jp/about/research_promotion/study/list/2020-303.pdf
joguma@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
International University of Health and Welfare School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee at National Cancer Center
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
+81-3-3542-2511
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-303
Org. issuing International ID_1
the Ethics Committee at National Cancer Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立がん研究センター中央病院（東京都）、国立がん研究センター東病院（千葉県）、国際医療福祉大学医学部（千葉県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.ncc.go.jp/jp/about/research_promotion/study/list/2020-303.pdf
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
2154
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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 11 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 11 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 11 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 11 | Day |
Other
Other related information
This study aimed to evaluate the impact of diabetes control status on anastomotic leakage after esophagectomy for esophageal cancer.
Management information
Registered date
| 2022 | Year | 04 | Month | 11 | Day |
Last modified on
| 2022 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054117
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
