UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000557 |
|---|---|
| Receipt number | R000000670 |
| Scientific Title | Evaluation of effect of sivelestat administration on postoperative course of patients with thoracic esophageal cancer who underwent trans-thoracic esophagectomy. |
| Date of disclosure of the study information | 2007/01/01 |
| Last modified on | 2007/12/26 16:06:39 |
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Basic information
Public title
Evaluation of effect of sivelestat administration on postoperative course of patients with thoracic esophageal cancer who underwent trans-thoracic esophagectomy.
Acronym
Sivelestat on esophageal cancer
Scientific Title
Evaluation of effect of sivelestat administration on postoperative course of patients with thoracic esophageal cancer who underwent trans-thoracic esophagectomy.
Scientific Title:Acronym
Sivelestat on esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of sivelestat administration on postoperative course of patients with thoracic esophageal cancer who underwent trans-thoracic esophagectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
*Postoperative complication
*Postoperative inflammatory parameters
*Recurrent disease
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Post operative administrations of sivelestat (day 0- day 4)
Interventions/Control_2
Control
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Thoracic esophageal cancer.
Trans-thoracic esophagectomy along with lymphadenectomy.
Key exclusion criteria
None
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takenori Ochiai |
Organization
Chiba University Graduate School of Medicine
Division name
Frontier Surgery
Zip code
Address
1-8-1 Inohana Chuo-ku Chiba-city Chiba
TEL
043-226-2110
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Shimada |
Organization
Chiba University Graduate School of Medicine
Division name
Frontier Surgery
Zip code
Address
1-8-1 Inohana Chuo-ku Chiba-city Chiba
TEL
043-226-2110
Homepage URL
Sponsor or person
Institute
Gastrointestinal Surgery, Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Graduate School of Medicine, Frontier Surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2007 | Year | 01 | Month | 01 | 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
Completed
Date of protocol fixation
| 2006 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 12 | Month | 25 | Day |
Last modified on
| 2007 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000670
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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