UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049208 |
|---|---|
| Receipt number | R000056046 |
| Scientific Title | Association of weight loss during neoadjuvant therapy with failure to rescue and in-hospital mortality after esophagectomy for esophageal cancer |
| Date of disclosure of the study information | 2022/10/13 |
| Last modified on | 2022/10/13 16:34:11 |
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Basic information
Public title
Association of weight loss during neoadjuvant therapy with failure to rescue and in-hospital mortality after esophagectomy for esophageal cancer
Acronym
Association of weight loss during neoadjuvant therapy with failure to rescue and in-hospital mortality after esophagectomy for esophageal cancer
Scientific Title
Association of weight loss during neoadjuvant therapy with failure to rescue and in-hospital mortality after esophagectomy for esophageal cancer
Scientific Title:Acronym
Association of weight loss during neoadjuvant therapy with failure to rescue and in-hospital 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 retrospective study assessed the effect of weight loss during neoadjuvant therapy on failure to rescue after esophagectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
in-hospital mortality, failure to rescue
Key secondary outcomes
major complications, respiratory complications, anastomotic leakage, length of stay after surgery, total hospitalization costs
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent esophagectomy after neoadjuvant therapy between July 2010 and March 2019 were identified from a Japanese nationwide inpatient database.
Key exclusion criteria
The exclusion criteria were as follows:patients who underwent combined surgery for laryngeal or hypopharyngeal cancer; and patients who were outliers for height (<100 or >200 cm), weight (<20 or >200 kg), body mass index (BMI) (<12.5 or >60 kg/m2), or weight change during neoadjuvant therapy (>30% gain or >30% loss). We also excluded patients who underwent neoadjuvant therapy and esophagectomy during the same hospitalization.
Target sample size
15000
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Hirano |
Organization
International University of Health and Welfare School of Medicine
Division name
Department of Hepatobiliary-Pancreatic and Gastrointestinal Surgery
Zip code
2868520
Address
852 Hatakeda, Narita, Chiba, Japan
TEL
0476355600
yukihirano@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Hirano |
Organization
International University of Health and Welfare School of Medicine
Division name
Department of Hepatobiliary-Pancreatic and Gastrointestinal Surgery
Zip code
2868520
Address
852 Hatakeda, Narita, Chiba, Japan
TEL
0476355600
Homepage URL
yukihirano@iuhw.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 13 | 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
15159
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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This retrospective cohort study was conducted using the Diagnosis Procedure Combination database, a Japanese nationwide inpatient database More than 8 million hospital administrative claims data and discharge abstracts from more than 1200 hospitals are collected annually in this database. All university hospitals are required to participate in the database, while other hospitals participate on a voluntary basis.
Management information
Registered date
| 2022 | Year | 10 | Month | 13 | Day |
Last modified on
| 2022 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056046
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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