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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000024436
Receipt No. R000028125
Scientific Title Predict factors of the major complications related to gastric conduit in thoracoscopic esophagectomy
Date of disclosure of the study information 2016/11/30
Last modified on 2018/02/15

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Basic information
Public title Predict factors of the major complications related to gastric conduit in thoracoscopic esophagectomy
Acronym Predict factors of the major complications related to gastric conduit in TE
Scientific Title Predict factors of the major complications related to gastric conduit in thoracoscopic esophagectomy
Scientific Title:Acronym Predict factors of the major complications related to gastric conduit in TE
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastrointestinal surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the predictive factors about the postoperative complications related to gastric conduit.
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of the postoperative complications related to gastric conduit.
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
85 years-old >
Gender Male and Female
Key inclusion criteria Thoracic esophagectomy with gastric conduit reconstructions are performed
Key exclusion criteria None
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Eguchi
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Surgery
Zip code
Address sakamoto 1-7-1
TEL 095-819-7316
Email sueguchi@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Kobayashi
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Surgery
Zip code
Address sakamoto 1-7-1
TEL 095-819-7316
Homepage URL
Email shinichirokobayashi@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization This study was supported by a Grant-in-Aid for Scientific Research (17K16569 Shinichiro Kobayashi).
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
Address
Tel
Email

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
2016 Year 11 Month 30 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 Main results already published
Date of protocol fixation
2015 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
2015 Year 11 Month 01 Day
Date of closure to data entry
2017 Year 10 Month 01 Day
Date trial data considered complete
2017 Year 10 Month 31 Day
Date analysis concluded
2018 Year 02 Month 15 Day

Other
Other related information From 2006 to 2015, 75 patients who underwent thoracic esophagectomy for esophageal cancer cancer at Department of Surgery in Nagasaki University Hospital were enrolled retrospectively in this study.

Management information
Registered date
2016 Year 10 Month 17 Day
Last modified on
2018 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028125

Research Plan
Registered date File name
2018/02/15 胸腔鏡下食道癌手術における胃管関連合併症発症の周術期因子の解析 公開文書.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/02/15 外科学会1.xlsx


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