UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045319 |
|---|---|
| Receipt number | R000051612 |
| Scientific Title | Effects of different mechanical ventilation on lung protection in patients undergoing minimally invasive esophagectomy in the prone position: A single-blind randomized study |
| Date of disclosure of the study information | 2021/09/05 |
| Last modified on | 2022/01/14 15:15:34 |
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Basic information
Public title
Effects of different mechanical ventilation on lung protection in patients undergoing minimally invasive esophagectomy in the prone position: A single-blind randomized study
Acronym
Effects of different mechanical ventilation on lung protection in patients undergoing minimally invasive esophagectomy in the prone position: A single-blind randomized study
Scientific Title
Effects of different mechanical ventilation on lung protection in patients undergoing minimally invasive esophagectomy in the prone position: A single-blind randomized study
Scientific Title:Acronym
Effects of different mechanical ventilation on lung protection in patients undergoing minimally invasive esophagectomy in the prone position: A single-blind randomized study
Region
| Japan |
Condition
Condition
Esophageal cancer
Esophagogastric junction cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prove the hypothesis that two-lung ventilation during the thoracic part of minimally invasive esophagectomy in the prone position is more lung protective than one-lung ventilation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum interleukin-6 concentration at the end of thoracic part of minimally invasive esophagectomy
Key secondary outcomes
The secondary outcomes include postoperative pulmonary complication, reintubation, days in the intensive care unit, and days under mechanical ventilation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Patients are randomized into two groups. One of the groups receives two-lung ventilation during the thoracic part of minimally invasive esophagectomy.
Interventions/Control_2
The other group receives 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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Participants should consent to receive the combination of epidural and general anesthesia.
2) Participants should give written informed consent after receiving enough information on the study.
3) Close member of the family may give consent in case participants have trouble understanding the information on the study.
Key exclusion criteria
1) Morbidly obese
2) Severe chronic obstructive lung disease
3) Interstitial pneumonia
4) Giant lung cyst
5) Those who have tracheostomy
6) Those in whom hypercapnia cannot be accepted (e.g., pulmonary hypertension, intracranial hypertension)
7) Those whom researchers consider as not appropriate for participants
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Ishikawa |
Organization
Juntendo University, School of Medicine
Division name
Department of Anesthesiology and Pain Clinic
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
81-3-3813-3111
seiji.ishikawa.juntendo@gmail.com
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Ishikawa |
Organization
Juntendo University, School of Medicine
Division name
Department of Anesthesiology and Pain Clinic
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
81-3-3813-3111
Homepage URL
seiji.ishikawa.juntendo@gmail.com
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo Clinical Research and Trial Center
Address
3-1-3, Hongo, Bunkyo-ku, 113-0033 Tokyo, Japan
Tel
03-5802-1584
hongo-rinri@juntendo.ac.jp
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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 31 | Day |
Last modified on
| 2022 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051612
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/02/26 | 研究計画書.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/02/26 | Bimarkers_MIE data.pdf |
