UMIN-ICDS Clinical Trial

Public title

A multicenter prospective cohort study for determining the optimal condition of observation for gastroesophageal junction (GOJ) in Upper esophagogastroduodenoscopy (EGD) under conscious situation

Acronym

GOJ-A

Scientific Title

A multicenter prospective cohort study for determining the optimal condition of observation for gastroesophageal junction (GOJ) in Upper esophagogastroduodenoscopy (EGD) under conscious situation

Scientific Title:Acronym

GOJ-A

Region

Japan

Condition

None

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the optimal condition of identification for the distal end of palisade vessels (DEPV) in upper EGD under conscious situation

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Rate of identification for DEPV visibility between under natural breathing and deep-inspirate breathing

Key secondary outcomes

Differences of identification of DEPV between patients with and without hiatal hernia in each with natural breathing and deep-inspirate breathing
Differences of identification of DEPV between patients with and without reflex esophagitis in each with natural breathing and deep-inspirate breathing
Differences of identification of DEPV between patients with and without Helicobacter pylori infection in each with natural breathing and deep-inspirate breathing
Differences of identification of DEPV depending on the degree of endoscopic gastric atrophy in each with natural breathing and under deep-inspirate breathing
Difference in DEPV visibility score between natural breathing and deep-inspirate breathing
Difference of PEGF visibility rate between natural breathing and deep-inspirate breathing
Concordance rate of DEPV and PEGF in each with natural breathing and deep-inspirate breathing
Intraobserver and interobserver agreement for visibility of DEPV
Factors associated with difficulties of identification of DEPV

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Patients in whom GOJ zone will be observed in upper EGD under conscious situation.
(2) Patients have received sufficient explanation about their participation in this study and have given informed consent written by themselves.

Key exclusion criteria

(1) Patients who refuse for participating in this study
(2) Patients with a history of surgical resection in upper gastrointestinal tract
(3) Patients who underwent endoscopic treatment in the GOJ zone (POEM, including balloon dilatation)
(4) Patients with suspected or present neoplastic lesions in the GOJ zone
(5) Patients with a confirmed diagnosis of esophageal motor dysfunction such as achalasia
(6) Patients who are judged as inappropriate for participating in this study by the researchers

Target sample size

500

Name of lead principal investigator

1st name	Yoshimasa
Middle name
Last name	Miura

Organization

Jichi Medical University

Division name

Department of Medicine, Division of Gastroenterology

Zip code

3290498

Address

3311-1, Yakushiji, Shimotsuke, Tochigi, Japan

TEL

+81285587348

Email

y-miura@jichi.ac.jp

Name of contact person

1st name	Takashi
Middle name
Last name	Ueno

Organization

Jichi Medical University

Division name

Department of Medicine, Division of Gastroenterology

Zip code

329-0498

Address

3311-1, Yakushiji, Shimotsuke, Tochigi, Japan

TEL

+81285587348

Homepage URL

Email

m05012tu@jichi.ac.jp

Institute

Jichi Medical University

Institute

Department

Personal name

Organization

JDDW GOJZ consortium

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

the Ethics Committee of Jichi Medical University

Address

3311-1. Yakushiji, Shimotsuke, Tochigi

Tel

0285588933

Email

rinri@jichi.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2023

Year

11

Month

15

Day

Date of IRB

2023

Year

11

Month

15

Day

Anticipated trial start date

2023

Year

11

Month

20

Day

Last follow-up date

2026

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is an exploratory study. Since there were no prior studies about this field, we decided the sample size from study period and the number of participating institutions. The sample size was set as 500.

Registered date

2023

Year

11

Month

17

Day

Last modified on

2023

Year

11

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060250