UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057371 |
|---|---|
| Receipt number | R000064780 |
| Scientific Title | A retrospective study to analyze predictors of complications in elderly patients undergoing esophageal cancer surgery |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/24 10:11:38 |
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Basic information
Public title
A retrospective study to analyze predictors of complications in elderly patients undergoing esophageal cancer surgery
Acronym
A retrospective study to analyze predictors of complications in elderly patients undergoing esophageal cancer surgery
Scientific Title
A retrospective study to analyze predictors of complications in elderly patients undergoing esophageal cancer surgery
Scientific Title:Acronym
A retrospective study to analyze predictors of complications in elderly patients undergoing esophageal cancer surgery
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Although radical esophageal cancer surgery is a highly invasive procedure, it is currently regarded as the standard treatment for curative esophageal cancer. In recent years, radical esophageal cancer surgery has been increasingly performed in elderly patients.
Recently, radical esophageal cancer surgery has been increasingly performed in elderly patients, but postoperative complications are reported to be more frequent in elderly patients. The purpose of this study was to identify predictive factors for postoperative complications in elderly patients who have undergone surgery in the past.
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
| 75 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
50 elderly patients over 75 years old who underwent esophageal cancer surgery between April 2019 and March 2024 in our department
1) A definite diagnosis of esophageal cancer has been obtained by histological examination. Histological type is not specified.
2) Patients must be 75 years of age or older.
3) Previous chemotherapy, radiation therapy, or endoscopic treatment for esophageal cancer is not specified.
Key exclusion criteria
1) Cases in which opt-out consent was not obtained
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Kitadani |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama
TEL
073-447-2300
nakai@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Nakai |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama
TEL
0734472300
Homepage URL
nakai@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-447-2300
wa-rinri@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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | 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
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study subjects will be 50 elderly patients aged 75 years or older who underwent esophageal cancer surgery at our department between April 2019 and March 2024. The following evaluation items will be entered using electronic medical records and existing databases. There are no items that require direct inquiry of the patient.
Management information
Registered date
| 2025 | Year | 03 | Month | 24 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064780
