UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060614 |
|---|---|
| Receipt number | R000069315 |
| Scientific Title | A Study of Effective Pharyngeal Anesthesia in Upper Gastrointestinal Endoscopy (Innovative Use of Xylocaine Viscous: Efforts to Reduce Patient Discomfort) |
| Date of disclosure of the study information | 2026/02/08 |
| Last modified on | 2026/02/07 19:32:35 |
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Basic information
Public title
A Study of Effective Pharyngeal Anesthesia in Upper Gastrointestinal Endoscopy
(Innovative Use of Xylocaine Viscous: Efforts to Reduce Patient Discomfort)
Acronym
Effective Pharyngeal Anesthesia
Scientific Title
A Study of Effective Pharyngeal Anesthesia in Upper Gastrointestinal Endoscopy
(Innovative Use of Xylocaine Viscous: Efforts to Reduce Patient Discomfort)
Scientific Title:Acronym
Effective Pharyngeal Anesthesia
Region
| Japan |
Condition
Condition
upper gastrointestinal tract
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identifying the most effective application sites for pharyngeal anesthesia using xylocaine viscous as premedication for upper gastrointestinal endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of insertion resistance and pharyngeal contraction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
For participants who provide informed consent, a nurse will administer pharyngeal anesthesia using the conventional method, and the endoscopist will evaluate the effectiveness of the pharyngeal anesthesia.
Interventions/Control_2
Among participants who have given informed consent, pharyngeal anesthesia will be administered by a nurse using the soft palate technique, and its effectiveness will be assessed by the endoscopist.
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
Individuals who underwent a health checkup and upper gastrointestinal endoscopy at the Preventive Medicine Center.
Key exclusion criteria
When xylocaine spray is used in addition to the standard pharyngeal anesthesia.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | TOMOKO |
| Middle name | |
| Last name | KOTANI |
Organization
St.Lukes International Hospital
Division name
Center for Preventive Medicine
Zip code
104-8560
Address
9-1 akashi-cho chuo-ku Tokyo-to
TEL
03-3541-5151
okutomo@luke.ac.jp
Public contact
Name of contact person
| 1st name | TOMOKO |
| Middle name | |
| Last name | KOTANI |
Organization
St. Lukes International Hospital
Division name
Center for Preventive Medicine
Zip code
104-8560
Address
9-1 akashi-cho chuo-ku Tokyo-to
TEL
03-3541-5151
Homepage URL
okutomo@luke.ac.jp
Sponsor or person
Institute
St. Lukes International University
Institute
Department
Personal name
Funding Source
Organization
Others
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
St. Lukes International Hospital
Address
9-1 akashi-cho chuo-ku Tokyo-to
Tel
03-3541-511
okutomo@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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | 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 | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2027 | 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 | 02 | Month | 07 | Day |
Last modified on
| 2026 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069315
