UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051868 |
|---|---|
| Receipt number | R000058991 |
| Scientific Title | A multicenter prospective cohort study for determining gastroesophageal junction (GOJ) in esophagogastroduodenoscopy (EGD) under sedation |
| Date of disclosure of the study information | 2023/08/09 |
| Last modified on | 2023/08/24 18:07:55 |
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Basic information
Public title
A multicenter prospective cohort study for determining gastroesophageal junction (GOJ) in esophagogastroduodenoscopy (EGD) under sedation
Acronym
GOJ-S
Scientific Title
A multicenter prospective cohort study for determining gastroesophageal junction (GOJ) in esophagogastroduodenoscopy (EGD) under sedation
Scientific Title:Acronym
GOJ-S
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the rate of identifying the distal end of the palisade vessels (DEPV) and discrepancy between DEPV and proximal end of the gastric folds (PEGF) in EGD under sedation, and to establish the method for identifying GOJ
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of identifying DEPV in white light imaging
Key secondary outcomes
1) Difference of the rates of identifying DEPV among each sedation type
2) Difference of the rates of identifying DEPV between patients with and without hiatal hernia
3) Difference of the rates of identifying DEPV in patients with and without reflux esophagitis (Los Angeles classification N, M, A, B, C, and D)
4) Difference of the rates of identifying DEPV between patients with and without Helicobacter pylori infection and among degree of endoscopic gastric atrophy
5) Difference of the rates of identifying DEPV among white light imaging and various type of image enhanced endoscopy (NBI, BLI, LCI, TXI, and RDI)
6) Difference of the rates of identifying DEPV between transoral and transnasal endoscopy and among various type of endoscope
7) The length of palisade vessels which can be seen underneath the columnar epithelium
8) Concordance rate between DEPV and PEGV (and condition of the concordance)
9) Intraobserver and interobserver agreement for visibility of DEPV
10) Factors associated with no identification of DEPV
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients in whom GOJ zone will be observed in EGD under sedation
(2) Informed consent for participating in this study is conducted after the explanation
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
(4) Patients with tumors in the GOJ zone
(5) Patients who are judged as inappropriate for participating in this study by the researchers
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Koike |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Gastroenterology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
0227177171
tkoike@rd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Waku |
| Middle name | |
| Last name | Hatta |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Gastroenterology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
0227177171
Homepage URL
waku-style@festa.ocn.ne.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JDDW GOJZ consortium
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
the Ethics Committee of Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2023 | Year | 08 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 09 | 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
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.
Management information
Registered date
| 2023 | Year | 08 | Month | 08 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058991
