UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061831 |
|---|---|
| Receipt number | R000070753 |
| Scientific Title | Evaluation of optimal ventilator settings during esophageal endoscopic submucosal dissection under general anesthesia |
| Date of disclosure of the study information | 2026/06/08 |
| Last modified on | 2026/06/08 17:51:32 |
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Basic information
Public title
Evaluation of optimal ventilator settings during esophageal endoscopic submucosal dissection under general anesthesia
Acronym
PEEP-ESD Study
Scientific Title
Evaluation of optimal ventilator settings during esophageal endoscopic submucosal dissection under general anesthesia
Scientific Title:Acronym
PEEP-ESD
Region
| Japan |
Condition
Condition
Early esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the operability and safety of esophageal endoscopic submucosal dissection (ESD) with and without positive end-expiratory pressure (PEEP).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resection speed (mm2/min)(calculated as specimen area divided by resection time)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
No PEEP group (PEEP 0 cmH2O)
Interventions/Control_2
PEEP group (PEEP 5-10 cmH2O)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients undergoing esophageal ESD under general anesthesia
2.Adults aged 18 years or older
3.Patients who provide written informed consent for participation in this study
Key exclusion criteria
1.Patients with clinically significant chronic respiratory disease (e.g., COPD or interstitial lung disease)
2.Patients requiring home oxygen therapy
3.Patients with severe obesity (BMI >= 35 kg/m2)
4.Patients with severe heart failure or unstable hemodynamic status
5.Patients with active respiratory infection
6.Patients considered unsuitable for study participation by the principal investigator or sub-investigators
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | TOMOHIRO |
| Middle name | |
| Last name | YAMAZAKI |
Organization
St. Luke's International Hospital
Division name
Department of Gastroenterology
Zip code
104-8560
Address
9-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan
TEL
03-3541-5151
yamazaki.tomohiro.2e@luke.ac.jp
Public contact
Name of contact person
| 1st name | TOMOHIRO |
| Middle name | |
| Last name | YAMAZAKI |
Organization
St. Luke's International Hospital
Division name
Department of Gastroenterology
Zip code
1700002
Address
9-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan
TEL
08054967905
Homepage URL
yamazaki.tomohiro.2e@luke.ac.jp
Sponsor or person
Institute
St. Luke's International Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, St. Luke's International University
Address
9-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan
Tel
03-3541-5151
yamazaki.tomohiro.2e@luke.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
--- Select One ---
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 08 | 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
| 2026 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 06 | Month | 08 | Day |
Last modified on
| 2026 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070753
