UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024436 |
|---|---|
| Receipt number | 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 04:11:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
shinichirokobayashi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
