UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061751 |
|---|---|
| Receipt number | R000069568 |
| Scientific Title | Impact of Preoperative Sarcopenia on Postoperative Outcomes in Patients Undergoing Esophagectomy for Esophageal Cancer: A Retrospective Observational Study |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/31 11:46:03 |
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Basic information
Public title
Impact of Preoperative Sarcopenia on Postoperative Outcomes in Patients Undergoing Esophagectomy for Esophageal Cancer: A Retrospective Observational Study
Acronym
Impact of Preoperative Sarcopenia on Postoperative Outcomes in Patients Undergoing Esophagectomy for Esophageal Cancer: A Retrospective Observational Study
Scientific Title
Impact of Preoperative Sarcopenia on Postoperative Outcomes in Patients Undergoing Esophagectomy for Esophageal Cancer: A Retrospective Observational Study
Scientific Title:Acronym
Impact of Preoperative Sarcopenia on Postoperative Outcomes in Patients Undergoing Esophagectomy for Esophageal Cancer: A Retrospective Observational Study
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Esophagectomy for esophageal cancer is a highly invasive procedure, and appropriate perioperative management is essential to ensure surgical safety. The aim of this retrospective observational study is to investigate the association between preoperative sarcopenia and sarcopenic obesity and perioperative outcomes in patients undergoing surgery for esophageal cancer, and to evaluate their utility as risk assessment indicators in perioperative management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative Complication
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
| 30 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We included 450 consecutive patients who underwent esophagectomy for esophageal cancer at our department between January 2008 and December 2019.
Key exclusion criteria
Patients with unavailable or incomplete follow-up data for survival outcomes.
Patients who declined participation through the opt-out consent process.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Goda |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama
TEL
073-447-2300
go-da@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Goda |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama
TEL
0734472300
Homepage URL
go-da@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Taro Goda
Funding Source
Organization
Wakayama Medical University
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
Wakayama Medical University
Address
811-1 Kimiidera, Wakayama
Tel
0734472300
go-da@wakayama-med.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
和歌山県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | 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
450
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 | 03 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 01 | Day |
Other
Other related information
This is a single-center retrospective observational study of patients who underwent esophagectomy for esophageal cancer between January 2008 and December 2019. Patient enrollment has already been completed, and data collection and statistical analyses will be performed using existing clinical records.
Management information
Registered date
| 2026 | Year | 05 | Month | 31 | Day |
Last modified on
| 2026 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069568
