UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011658 |
|---|---|
| Receipt number | R000013608 |
| Scientific Title | Correlation between coagulation factor XIII and perioperative complication in esophageal cancer patients who underwent transthoracic esophagectomy |
| Date of disclosure of the study information | 2013/09/09 |
| Last modified on | 2025/03/17 10:42:59 |
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Basic information
Public title
Correlation between coagulation factor XIII and perioperative complication in esophageal cancer patients who underwent transthoracic esophagectomy
Acronym
Cagulation factor XIII and perioperative complication in esophageal cancer patients who underwent transthoracic esophagectomy
Scientific Title
Correlation between coagulation factor XIII and perioperative complication in esophageal cancer patients who underwent transthoracic esophagectomy
Scientific Title:Acronym
Cagulation factor XIII and perioperative complication in esophageal cancer patients who underwent transthoracic esophagectomy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the correlation between Factor XIII and perioperative complication in esophageal cancer patients who underwent transthoracic esophagectomy.
Basic objectives2
Others
Basic objectives -Others
To investigate the clinical significance of Factor XIII as a biomarker
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of perioperative 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Histologically diagnosed as esophageal cancer
Older than 20 years old
Key exclusion criteria
Diadnoses as esophageal cancer with distant metastasis
Disalbe to consent by himself
Have congenital or acquired coagulation disorder
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Kawakubo |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
hkawakubo@z3.keio.jp
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Fukuda |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
fukudak@z6.keio.jp
Sponsor or person
Institute
Department of Surgery, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Keio University School of Medicine
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
Keio University School of Medicine, Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2013 | Year | 09 | Month | 09 | 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
113
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
| 2013 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To observe the correlation between preoperative FXIII and postoperative complication
Management information
Registered date
| 2013 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013608
