UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011942 |
|---|---|
| Receipt number | 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 13:58:03 |
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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
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
ishikawa.mane@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013943
