UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062650 |
|---|---|
| Receipt number | R000071712 |
| Scientific Title | Positive-pressure ventilation under general anesthesia narrows the endoscopic field during esophageal endoscopic submucosal dissection: a blinded paired image analysis |
| Date of disclosure of the study information | 2026/08/21 |
| Last modified on | 2026/08/21 17:28:30 |
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Basic information
Public title
Positive-pressure ventilation under general anesthesia narrows the endoscopic field during esophageal endoscopic submucosal dissection: a blinded paired image analysis
Acronym
Positive-pressure ventilation under general anesthesia narrows the endoscopic field during esophageal endoscopic submucosal dissection: a blinded paired image analysis
Scientific Title
Positive-pressure ventilation under general anesthesia narrows the endoscopic field during esophageal endoscopic submucosal dissection: a blinded paired image analysis
Scientific Title:Acronym
Positive-pressure ventilation under general anesthesia narrows the endoscopic field during esophageal endoscopic submucosal dissection: a blinded paired image analysis
Region
| Japan |
Condition
Condition
Superficial esophageal cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
General anesthesia with positive-pressure ventilation may narrow the esophageal lumen during ESD compared with intravenous sedation. This study investigated whether this perceived narrowing reflects an actual change in the endoscopic field.
Basic objectives2
Others
Basic objectives -Others
General anesthesia (GA) with positive-pressure ventilation (PPV) is increasingly used for esophageal endoscopic submucosal dissection (ESD), yet many operators perceive that the esophageal lumen appears narrower under PPV than under intravenous sedation with preserved spontaneous breathing; we examined whether this reflects a real change in the endoscopic field.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of cases in which the GA set was judged narrower
Key secondary outcomes
Inter-rater agreement between the two readers' selections was measured by Cohen kappa
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
It included consecutive patients who underwent esophageal ESD under GA between August 2023 and December 2025
Key exclusion criteria
A patient was eligible when the same lesion had also been examined at a preceding outpatient surveillance endoscopy performed under intravenous sedation with the same endoscope model, and when at least four consecutive images were available at each examination from the moment the lesion first entered the field; patients not meeting these criteria were excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Furuhashi |
Organization
St Luke's International Hospital
Division name
Department of Gastroenterology
Zip code
1048660
Address
9-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
+81-03-3541-5151
ms04furuhashi@gmail.com
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Furuhashi |
Organization
St Luke's International Hospital
Division name
Department of Gastroenterology
Zip code
1048660
Address
9-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
+81-03-3541-5151
Homepage URL
ms04furuhashi@gmail.com
Sponsor or person
Institute
St Luke's International Hospital
Institute
Department
Personal name
Funding Source
Organization
St Luke's International Hospital
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
Institutional Review Board of
Address
9-1 Akashi-cho, Chuo-ku, Tokyo, Japan
Tel
+81-03-3541-5151
ms04furuhashi@gmail.com
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
| 2026 | Year | 08 | Month | 21 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No specific findings
Management information
Registered date
| 2026 | Year | 08 | Month | 21 | Day |
Last modified on
| 2026 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071712
