UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052774 |
|---|---|
| Receipt number | R000060221 |
| Scientific Title | Investigation of airway management methods for endoscopic mucosectomy for hypopharyngeal cancer under general anesthesia management. |
| Date of disclosure of the study information | 2023/11/12 |
| Last modified on | 2024/03/19 12:04:02 |
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Basic information
Public title
Investigation of airway management methods for endoscopic mucosectomy for hypopharyngeal cancer under general anesthesia management.
Acronym
Investigation of airway management methods for endoscopic mucosectomy for hypopharyngeal cancer under general anesthesia management.
Scientific Title
Investigation of airway management methods for endoscopic mucosectomy for hypopharyngeal cancer under general anesthesia management.
Scientific Title:Acronym
Investigation of airway management methods for endoscopic mucosectomy for hypopharyngeal cancer under general anesthesia management.
Region
| Japan |
Condition
Condition
pharyngeal cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In endoscopic mucosectomy for nasopharyngeal cancer (nasopharyngeal ESD), the tumor lesion is in close proximity to the vocal cords.
Airway management by tracheotomy provides good endoscopic maneuverability and is very useful when postoperative laryngeal edema occurs, but it is invasive, and there are concerns about patient dysphonia, dysphagia, and delayed closure of the incisional wound in the medium to long term.
In addition to the problems of obstructed operative vision and endoscopic maneuverability, postoperative laryngeal edema may make immediate extubation difficult, necessitating reintubation and postoperative tracheostomy.
To improve the operative field of view, endoscopic maneuverability, and reduce the risk of postoperative upper airway obstruction, we have been using a bronchial blocker and cricothyrotomy kit for airway management (Suzuki method, Suzuki T et al, Can J Anesth, 2014, 61:39-45). In this study, we experienced a case in which airway management using this method was difficult, so we reviewed past cases and discussed improvements to this method in order to improve the safety of this method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative and postoperative airway-related incidents and adverse events related to airway and 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
Endoscopic surgery for hypopharyngeal cancer performed under general anesthesia at Showa University Northern Yokohama Hospital
Key exclusion criteria
Non
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Yamamura |
Organization
Showa 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 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 University
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University
Showa 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 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
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 30 | 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
Intraoperative and postoperative airway-related incidents and adverse events related to respiratory management
Management information
Registered date
| 2023 | Year | 11 | Month | 12 | Day |
Last modified on
| 2024 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060221
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
