UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063061 |
|---|---|
| Receipt number | R000072189 |
| Scientific Title | Evaluation of Pharyngeal Anesthesia for Unsedated Upper Gastrointestinal Endoscopy: A Comparison of the Conventional and Soft Palate Methods |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/26 13:26:11 |
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Basic information
Public title
Evaluation of Pharyngeal Anesthesia for Unsedated Upper Gastrointestinal Endoscopy: A Comparison of the Conventional and Soft Palate Methods
Acronym
Evaluation of Pharyngeal Anesthesia for Unsedated Upper Gastrointestinal Endoscopy: A Comparison of the Conventional and Soft Palate Methods
Scientific Title
Evaluation of Pharyngeal Anesthesia for Unsedated Upper Gastrointestinal Endoscopy: A Comparison of the Conventional and Soft Palate Methods
Scientific Title:Acronym
Evaluation of Pharyngeal Anesthesia for Unsedated Upper Gastrointestinal Endoscopy: A Comparison of the Conventional and Soft Palate Methods
Region
| Japan |
Condition
Condition
gastric cancer
esophageal cancer
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the soft palate method in patients undergoing unsedated upper gastrointestinal endoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resistance during insertion and pharyngeal contraction
Gag reflex during the examination (Gag Reflex Score: 0-3)
Procedural difficulty (5-point Likert scale)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Xylocaine Viscous was applied to the soft palate as a pretreatment for upper gastrointestinal endoscopy.
Interventions/Control_2
Application of Xylocaine Viscous to the base of the tongue before upper gastrointestinal endoscopy
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 Center for Preventive Medicine
Individuals who received pharyngeal anesthesia with Xylocaine Viscous applied by a nurse as a premedication
Individuals who did not receive sedatives or antispasmodic agents
Individuals who provided written informed consent to participate in this study
Key exclusion criteria
Individuals who received Xylocaine spray in addition to standard pharyngeal anesthesia
Individuals deemed unsuitable for participation by the principal investigator or co-investigators
Target sample size
560
Research contact person
Name of lead principal investigator
| 1st name | TOMOKO |
| Middle name | |
| Last name | KOTANI |
Organization
St. Luke's International Hospital
Division name
Center for Preventive Medicine, St. Luke's International Hospital
Zip code
1048560
Address
9-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
0335415151
okutomo@luke.ac.jp
Public contact
Name of contact person
| 1st name | TOMOKO |
| Middle name | |
| Last name | KOTANI |
Organization
St. Luke's International Hospital
Division name
Center for Preventive Medicine, St. Luke's International Hospital
Zip code
1048560
Address
9-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
03-3541-5151
Homepage URL
okutomo@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
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Luke's International Hospital
Address
9-1 Akashi-cho, Chuo-ku, Tokyo, Japan
Tel
0335415151
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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 01 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2027 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 | 09 | Month | 26 | Day |
Last modified on
| 2026 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072189
