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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011658
Receipt No. 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 2020/09/11

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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
Email 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
Email fukudak@z6.keio.jp

Sponsor
Institute Department of Surgery, Keio University School of Medicine
Institute
Department

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
Email 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 No longer recruiting
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
2020 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013608

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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