UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052774 |
|---|---|
| Receipt number | R000060221 |
| Scientific Title | Airway management during general anesthesia for endoscopic submucosal dissection of oropharyngeal and hypopharyngeal cancers at Showa Medical University Northern Yokohama Hospital |
| Date of disclosure of the study information | 2023/11/12 |
| Last modified on | 2026/09/08 22:22:18 |
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Basic information
Public title
Airway management during general anesthesia for endoscopic submucosal dissection of oropharyngeal and hypopharyngeal cancers at Showa Medical University Northern Yokohama Hospital
Acronym
Airway management during general anesthesia for endoscopic submucosal dissection of oropharyngeal and hypopharyngeal cancers at Showa Medical University Northern Yokohama Hospital
Scientific Title
Airway management during general anesthesia for endoscopic submucosal dissection of oropharyngeal and hypopharyngeal cancers at Showa Medical University Northern Yokohama Hospital
Scientific Title:Acronym
Airway management during general anesthesia for endoscopic submucosal dissection of oropharyngeal and hypopharyngeal cancers at Showa Medical University Northern Yokohama Hospital
Region
| Japan |
Condition
Condition
Oropharyngeal and hypopharyngeal cancers
Classification by specialty
| Oto-rhino-laryngology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In endoscopic submucosal dissection for oropharyngeal and hypopharyngeal cancers (pharyngeal ESD), the tumor lesions are located close to the vocal cords.
Airway management by tracheostomy provides a good surgical field and endoscopic maneuverability and is very useful when postoperative laryngeal edema occurs. However, it is invasive, and there are concerns about dysphonia, dysphagia, and delayed wound closure in the medium to long term.
Airway management by tracheal intubation may interfere with the surgical field and endoscopic maneuverability. In addition, postoperative laryngeal edema may make immediate extubation difficult and necessitate reintubation or postoperative tracheostomy.
To improve the surgical field and endoscopic maneuverability and reduce the risk of postoperative upper airway obstruction, we have used an airway management technique involving a bronchial blocker and a cricothyrotomy kit (the Suzuki method; Suzuki T et al. Can J Anesth. 2014;61:39-45). After encountering a case in which airway management using this method was difficult, we retrospectively reviewed previous cases to examine potential improvements to the method, with the aim of improving its safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of intraoperative and postoperative airway-related events and adverse events associated with respiratory management.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent an endoscopic procedure related to oropharyngeal or hypopharyngeal cancer at Showa Medical University Northern Yokohama Hospital, with a bronchial blocker and a cricothyrotomy kit used as the planned airway management technique.
Key exclusion criteria
Cases with insufficient information on the anesthetic technique, lesion location, or other relevant variables.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Yamamura |
Organization
Showa Medical University Northern Yokohama Hospital
Division name
Department of Anesthesiology
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
045-949-7000
ayayamamura128@gmail.com
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Yamamura |
Organization
Showa Medical University Northern Yokohama Hospital
Division name
Department of Anesthesiology
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
045-949-7000
Homepage URL
ayayamamura128@gmail.com
Sponsor or person
Institute
Showa Medical University
Showa Medical University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa Medical University
Showa Medical University Northern Yokohama Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa Medical University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8000
m-rinri@ofc.showa-u.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
| 2023 | Year | 11 | Month | 12 | Day |
Related information
URL releasing protocol
No publicly accessible protocol is available.
Publication of results
Partially published
Result
URL related to results and publications
No public URL. Partial results were presented at the JSA 71st Annual Meeting on June 6, 2024.
Number of participants that the trial has enrolled
21
Results
Among 23 procedures managed with this technique, planned airway management was maintained in most procedures, and no airway obstruction occurred after catheter removal. Ventilation difficulty associated with catheter compression or kinking occurred in some procedures, and oral tracheal intubation was required in a small number.
Results date posted
| 2026 | Year | 09 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Detailed baseline characteristics were not reported in the conference presentation.
Participant flow
Twenty-three procedures in 21 patients were included in the interim analysis.
Adverse events
Ventilation difficulty associated with catheter compression or kinking was observed.
Outcome measures
Planned airway management was maintained in most procedures, and no airway obstruction occurred after catheter removal.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 13 | 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
The occurrence of intraoperative and postoperative airway-related events and adverse events associated with respiratory management will be analyzed.
Management information
Registered date
| 2023 | Year | 11 | Month | 12 | Day |
Last modified on
| 2026 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060221
