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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000557
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Gastrointestinal Surgery, Chiba University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000670

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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