UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043688 |
|---|---|
| Receipt number | R000049887 |
| Scientific Title | Prospective observational study on Patient's distress in Esophagogastroduodenoscopy |
| Date of disclosure of the study information | 2021/05/26 |
| Last modified on | 2025/03/24 19:15:08 |
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Basic information
Public title
Prospective observational study on Patient's distress in Esophagogastroduodenoscopy
Acronym
Prospective observational study on Patient's distress in Esophagogastroduodenoscopy
Scientific Title
Prospective observational study on Patient's distress in Esophagogastroduodenoscopy
Scientific Title:Acronym
Prospective observational study on Patient's distress in Esophagogastroduodenoscopy
Region
| Japan |
Condition
Condition
esophagogastroduodenoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the degree and circumstances of distress during esophagogastroduodenoscopy without sedation, and to clarify the data that can serve as a basis for the operation and development of endoscopes that reduce patient's distress.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The timing and degree of the distress that patients feel during esophagogastroduodenoscopy without sedation
Key secondary outcomes
-Factors associated with distress during esophagogastroduodenoscopy
-The relationship between blood pressure, pulse rate, and SpO2 and the timing and indegree of the distress.
-Differences in perceptions of distress between endoscopist and patients based on post-endoscopy questionnaires.
-Comparison of strongest distress level and distress frequency with the examining physician.
-Strongest pain level and pain frequency compared with endoscope type (small diameter and normal diameter).
-Comparison of exam distress with desire for next exam or sedation.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The esophagogastroduodenoscopy cases that seven endoscopists will be in charge of between May 2021 and March 2022 that meet the following selection criteria
(1) 10 cases of normal diameter endoscopy and 10 cases of small diameter endoscopy (whether normal diameter or small diameter will be determined clinically)
(2) The purpose of the examination is asymptomatic screening or post-treatment surveillance.
(3) Patients who can provide written consent for participation in the study of their own free will
(4) Patients whose age at the time of obtaining consent is between 20 and 80 years old.
Key exclusion criteria
(1) Women who are pregnant or may become pregnant
(2) Patients who wish to be sedated during endoscopy.
(3) Patients with PS of more than 3
(4) Patients with lesions that require treatment or detailed examination. However, follow-up observation of the size and shape of the lesion is acceptable.
(5) Patients for whom the examination time is expected to exceed 10 minutes.
(6) Endoscopic ultrasound examination.
(7) After treatment for pharyngeal, laryngeal, or esophageal cancer
(8) The patients who were remnant stomach or gastric tube.
(9) Other cases deemed unsuitable by the physician in charge.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Kanzaki |
Organization
Okayama University Hospital
Division name
Gastroenterology
Zip code
700-8558
Address
2-5-1 shikata-cho, kita-ku, Okayama city
TEL
086-235-7219
kanzaki@qc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Kanzaki |
Organization
Okayama University Hospital
Division name
Gastroenterology
Zip code
700-8558
Address
2-5-1 shikata-cho, kita-ku, Okayama city
TEL
086-235-7219
Homepage URL
kanzaki@qc4.so-net.ne.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Fuji film
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 shikata-cho, kita-ku, Okayama city
Tel
086-235-6938
mae6605@adm.okayama-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
| 2021 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f3.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
140
Results
The high incident situations of pain during EGD were esophageal insertion and duodenal observation, arising 59.3% and 40.7% respectively. The factors associated with pain during esophageal insertion were endoscopist experience. On the other hand, for pain during duodenal observation, the factors related were younger age and female gender. Factors related to patient discomfort were pain during esophageal insertion (odds 2.68, p=0.016) and past experiences of painful EGD.
Results date posted
| 2023 | Year | 09 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total number of 140 patiets who underwent esophagogastroduodenoscopy
Participant flow
We enrolled the patients who visited our hospital to be received EGD for the purpose of screening or surveillance without any symptoms. Prior to the EGD procedure, each patients provided written informed consent to this study.
Adverse events
none
Outcome measures
main; identify the situations and frequencies of pain during EGD
sedondary; factors associated with principal pain situation, factors associated with overall discomfort from survey,and the change of biological data before and during EGD,
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following data will be measured during the endoscopic examination, and questions will be asked to the endoscopist and the patient, and the data will be used for this study.
(1) Basic patient information: age, sex, diagnosis, PS, drinking history, smoking history, endoscopy history, previous examination pain level, purpose of endoscopy, drugs used during examination, endoscope type, etc.
(2) Stored video during the endoscopic examination, information on the pain judgment button during the examination, heart rate, blood pressure, SpO2, etc.
3) Questionnaire after the examination
Management information
Registered date
| 2021 | Year | 03 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049887
