UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060233 |
|---|---|
| Receipt number | R000068892 |
| Scientific Title | Study on the effect of individualized positive end-expiratory pressure on lung and kidney protection during minimally invasive esophagectomy in the prone position (single-blind, randomized controlled trial) |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2025/12/30 09:31:42 |
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Basic information
Public title
Study on the effect of individualized positive end-expiratory pressure on lung and kidney protection during minimally invasive esophagectomy in the prone position (single-blind, randomized controlled trial)
Acronym
Study on the effect of individualized positive end-expiratory pressure on lung and kidney protection during minimally invasive esophagectomy in the prone position (single-blind, randomized controlled trial)
Scientific Title
Study on the effect of individualized positive end-expiratory pressure on lung and kidney protection during minimally invasive esophagectomy in the prone position (single-blind, randomized controlled trial)
Scientific Title:Acronym
Study on the effect of individualized positive end-expiratory pressure on lung and kidney protection during minimally invasive esophagectomy in the prone position (single-blind, randomized controlled trial)
Region
| Japan |
Condition
Condition
Esophageal or gastroesophageal junction cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to demonstrate that individualized PEEP provides a stronger protective effect on the lungs than uniformly applied PEEP. The secondary objective is to clarify the mechanisms by which different PEEP settings affect outcomes, particularly the involvement of interorgan crosstalk between the lungs and kidneys.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum interleukin-6 (IL-6) concentrations after chest manipulation
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
To determine the optimal PEEP level, the individualized group increases the PEEP level by 2 cmH2O per minute from 0 to 16 cmH2O during one-lung ventilation without changing the tidal volume or ventilation rate. The PEEP level at which the drive pressure is minimized is defined as the optimal PEEP level for that patient. The optimal PEEP level is used during one-lung ventilation in the individualized group.
Interventions/Control_2
The fixed group has the PEEP level fixed at 5 cmH2O during one-lung ventilaiton.
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. Subjects aged 20 to 80 years at the time of consent.
2. Subjects undergoing minimally invasive esophagectomy in the prone position using thoracoscopic or robotic assistance.
3. Subjects who agree to undergo combined epidural anesthesia.
4. Subjects who have received a thorough explanation of this study and fully understood the requirements, and who have provided their own voluntary written consent.
Key exclusion criteria
1. Patients undergoing gastrointestinal reconstruction using intrathoracic anastomosis
2. Patients with severe obesity (body mass index 35 kg/m2 or greater)
3. Patients with severe chronic obstructive pulmonary disease (FEV1% < 50%)
4. Patients with interstitial pneumonia (including patients suspected of having interstitial pneumonia based on diagnostic imaging)
5. Patients with giant lung cysts (emphysematous lung cysts occupying one-third or more of one thoracic cavity)
6. Patients with a tracheostomy
7. Patients with pulmonary hypertension or intracranial hypertension, even if mild, who are considered to be unable to tolerate hypercapnia
8. Other subjects deemed inappropriate by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shihoko |
| Middle name | |
| Last name | Iwata |
Organization
Juntendo University Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
81-3-3813-3111
s.iwata.st@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shihoko |
| Middle name | |
| Last name | Iwata |
Organization
Juntendo University Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
81-3-3813-3111
Homepage URL
s.iwata.st@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology, Japan.
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
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
81-3-3814-5672
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 31 | 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
| 2025 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2031 | 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
| 2025 | Year | 12 | Month | 30 | Day |
Last modified on
| 2025 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068892
