UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059375 |
|---|---|
| Receipt number | R000067910 |
| Scientific Title | A Retrospective Observational Study for Identifying Prognostic Factors in Patients Undergoing Surgery for Esophageal Cancer |
| Date of disclosure of the study information | 2025/10/11 |
| Last modified on | 2025/10/11 21:04:18 |
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Basic information
Public title
A Retrospective Observational Study for Identifying Prognostic Factors in Patients Undergoing Surgery for Esophageal Cancer
Acronym
A Retrospective Observational Study for Identifying Prognostic Factors in Patients Undergoing Surgery for Esophageal Cancer
Scientific Title
A Retrospective Observational Study for Identifying Prognostic Factors in Patients Undergoing Surgery for Esophageal Cancer
Scientific Title:Acronym
A Retrospective Observational Study for Identifying Prognostic Factors in Patients Undergoing Surgery for Esophageal Cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Radical esophagectomy is an invasive procedure but remains the standard treatment for achieving curative intent in patients with esophageal cancer. However, some patients do not benefit from surgery, such as those who undergo non-curative resection or experience early recurrence. To improve outcomes through multidisciplinary treatment including surgery, this study aims to identify prognostic factors associated with poor outcomes by analyzing cases that have previously undergone esophagectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Operative course (operative time, blood loss), postoperative course (day of water intake initiation, day of oral intake initiation, postoperative hospital stay, inflammatory findings, incidence of postoperative complications, nutritional status), and postoperative recurrence-free survival rate
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A histopathological diagnosis confirming esophageal cancer has been obtained; histological type is not restricted.
2) Patients aged 20 years or older; no upper age limit is specified.
3) Prior chemotherapy, radiotherapy, or endoscopic treatment for esophageal cancer is not restricted.
Key exclusion criteria
1) Patients who could not be followed up for prognosis.
2) Patients who did not provide consent through the opt-out process.
Target sample size
890
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 Sugery
Zip code
641-8510
Address
811-1, Kimiidera,Wakayama 641-8510, JAPAN
TEL
0734410613
kitadani@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Kitadani |
Organization
Wakayama Medical University
Division name
Second Department of Sugery
Zip code
641-8510
Address
811-1, Kimiidera, Wakayama 641-8510,JAPAN
TEL
0734410613
Homepage URL
kitadani@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
self-procured
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 641-8510,JAPAN
Tel
0734472300
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 | 10 | Month | 11 | 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
| 2021 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2030 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preoperative Evaluation
Age, sex, height, weight, medical history, medications, alcohol, smoking, prior surgery; tumor size, location, macroscopic type, biopsy, cStage (TNM 8th ed); labs: RBC, Hb, Ht, WBC, lymphocytes, platelets, TP, Alb, T.Bil, ALP, AST, ALT, LDH, BUN, Cr, glucose, Fe, T-chol, TG, ChoE, NLR, SCC, p53, CK19; neoadjuvant therapy; aortic/tracheal invasion by dynamic CT and PET-CT.
Intraoperative Evaluation
Operative time, blood loss, procedure, lymphadenectomy extent, reconstructed organ blood flow, recurrent laryngeal nerve monitoring, reconstruction route, anastomosis, conduit diameter, curative resection status.
Postoperative Evaluation
Early (in-hospital): complications >= Grade II (Clavien-Dindo), surgery-related death; labs on POD1 (RBC, Hb, Ht, WBC, lymphocytes, platelets, TP, Alb, T.Bil, ALP, AST, ALT, LDH, BUN, Cr, amylase, glucose, CRP), max temp, first flatus, water/oral intake day, hospital stay, discharge weight; pathology: qualitative diagnosis, 12th ed Japanese Classification, histologic response.
Late (post-discharge): complications >= Grade II, surgery-related death, adjuvant therapy, recurrence date, post-recurrence treatment, death (cancer/other), 5-year survival follow-up.
Management information
Registered date
| 2025 | Year | 10 | Month | 11 | Day |
Last modified on
| 2025 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067910
