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 2023/09/22 20:01:25

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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

Email

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


Email

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

Email

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

No longer recruiting

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

2023 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049887


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name