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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011942
Receipt No. R000013943
Scientific Title Effects of protective one-lung ventilation during esophagectomy on postoperative pulmonary complication and acute kidney injury
Date of disclosure of the study information 2013/10/15
Last modified on 2013/10/02

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Basic information
Public title Effects of protective one-lung ventilation during esophagectomy on postoperative pulmonary complication and acute kidney injury
Acronym Protective one-lung ventilation during esophagectomy
Scientific Title Effects of protective one-lung ventilation during esophagectomy on postoperative pulmonary complication and acute kidney injury
Scientific Title:Acronym Protective one-lung ventilation during esophagectomy
Region
Japan

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

Objectives
Narrative objectives1 To test the hypothesis that protective one-lung ventilation prevents the occurrence of postoperative pulmonary complication and acute kidney injury through suppression of inflammatory response in patients undergoing esophagectomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative pulmonary complication
Postoperative acute kidney injury
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 One group receives protective one-lung ventilation during thoracic part of esophagectomy.
Interventions/Control_2 The other group receives conventional one-lung ventilation.
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 Patients with esophageal cancer who require one-lung ventilation during esophagectomy with right thoracotomy.
Key exclusion criteria Patients who undergo dialysis preoperativey, who have allergy to anesthesia-related agents, who have impaired cognitive function, and who have pulmonary diseases such as giant bullae and interstitial pneumonia are excluded.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiji Ishikawa
Organization Tokyo Medical and Dental University
Division name Anesthesiology
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL 03-5803-5325
Email ishikawa.mane@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiji Ishikawa
Organization Tokyo Medical and Dental University
Division name Anesthesiology
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8519
TEL 81-3-5803-5325
Homepage URL
Email ishikawa.mane@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research from Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization
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
2013 Year 10 Month 15 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 Preinitiation
Date of protocol fixation
2013 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 10 Month 02 Day
Last modified on
2013 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013943

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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