UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050134 |
|---|---|
| Receipt number | R000056976 |
| Scientific Title | A prospective multicenter study of the effect of small caliber endoscope in reducing pain in upper endoscopy |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2025/01/26 10:01:00 |
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Basic information
Public title
A prospective multicenter study of the effect of small caliber endoscope in reducing pain in upper endoscopy
Acronym
The efficacy of small caliber endoscope
Scientific Title
A prospective multicenter study of the effect of small caliber endoscope in reducing pain in upper endoscopy
Scientific Title:Acronym
A prospective multicenter study of the effect of small caliber endoscope in reducing pain in upper endoscopy
Region
| Japan |
Condition
Condition
Upper gastrointestinal endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the degree of patient distress with narrow and normal diameter scopes in transoral endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient distress as measured by Visual analog scale (0-10)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Small-caliber endoscope
Interventions/Control_2
Conventional endoscope
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
For Patients undergoing upper gastrointestinal endoscopy scheduled between the date of approval and August 31, 2023
Key exclusion criteria
1:Subjects with resection of the stomach or duodenum
2:Subjects undergoing upper gastrointestinal endoscopy under sedation
3:Subjects whose physician considers it difficult to participate in this study
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Ryoji |
| Middle name | |
| Last name | Ichijima |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
173-8610
Address
30-1, Oyaguchi Kami-cho, Itabashi-ku, Tokyo
TEL
03-3972-8111
ryoji0331@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Takasu |
Organization
Nihon University Hospital
Division name
Division of gastroenterology
Zip code
1018309
Address
1-6 Kandasurugadai, Chiyoda-ku, Tokyo-to
TEL
0332931711
Homepage URL
ayakatakasumd@gmail.com
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
none
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
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1, Oyaguchi Kami-cho, Itabashi-ku, Tokyo
Tel
03-3972-8111
med.rinsyokenkyu@nihon-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
日本大学医学部附属板橋病院 (東京都)、日本大学病院 (東京都)、国際医療福祉大学市川病院 (千葉県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.nihon-u.ac.jp/hospital/outline/optout
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
239
Results
The standard-diameter endoscopy group (A) had 120 patients, and the ultra-thin endoscopy group (B) had 119. Male patients were 72 (60.0%) in A and 84 (70.6%) in B (p=0.086). Median age [IQR] was 66 [56-75] in A and 65 [54-74] in B. Patient discomfort (VAS score, 0-10) was significantly higher in A (5.0 [2.0-6.0]) than in B (3.0 [1.0-5.0], p=0.002).
Results date posted
| 2025 | Year | 01 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients undergoing standard upper gastrointestinal endoscopy.
Participant flow
After obtaining patient consent, participants were divided into a standard-diameter endoscopy group and an ultra-thin endoscopy group, and the examinations were performed. Subsequently, patients completed a questionnaire regarding their level of discomfort and satisfaction.
Adverse events
In this study, no adverse events were observed.
Outcome measures
The degree of patient discomfort measured using the Visual Analog Scale score.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2023 | Year | 01 | Month | 25 | Day |
Last modified on
| 2025 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056976
