UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048766 |
|---|---|
| Receipt number | R000055540 |
| Scientific Title | Multicenter randomized controlled trial comparing the diagnostic performance of the submucosal invasion between chromoendoscopy and endoscopic ultrasonography |
| Date of disclosure of the study information | 2022/08/29 |
| Last modified on | 2022/08/26 12:17:49 |
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Basic information
Public title
Multicenter randomized controlled trial comparing the diagnostic performance of the submucosal invasion between chromoendoscopy and endoscopic ultrasonography
Acronym
Multicenter randomized controlled trial comparing the diagnostic performance of the submucosal invasion between chromoendoscopy and endoscopic ultrasonography
Scientific Title
Multicenter randomized controlled trial comparing the diagnostic performance of the submucosal invasion between chromoendoscopy and endoscopic ultrasonography
Scientific Title:Acronym
NES vs EUS trial
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The object of this study is to verify the superiority of diagnosis of early gastric cancer submucosal invasion by chromoendoscopy using non-extension sign to early gastric cancer submucosal invasion diagnosis by endoscopic ultrasonography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endopoint of this study is the specificity of diagnosis of depth of invasion of early gastric cancer by chromoendoscopy using non-extension sign and diagnosis of depth of invasion of early gastric cancer using endoscopic ultrasonography for diagnosing cT1b or deeper in the protocol initial examination.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
In the chromoendoscopy group, diagnosis of depth of invasion of early gastric cancer was first performed using chromoendoscopy. Immediately after that, the same examiner diagnoses the depth of inavasion of early gastric cancer using endoscopic ultrasonography.
Interventions/Control_2
In the endoscopic ultrasonography group, diagnosis of depth of invasion of early gastric cancer was first performed using endoscopic ultrasonography. Immediately after that, the same examiner diagnoses the depth of inavasion of early gastric cancer using chromoendoscopy.
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
1 Patients diagnosed with early gastric cancer by endoscopic diagnosis and diagnosed as Category 4 or 5 of the Vienna classification
2 Patients with a tumor diameter of 10 mm or more, and in the case of multiple lesions, the lesion with the largest tumor diameter is targeted
3 Patients scheduled for endoscopic resection or surgical resection
4 Patients aged 20 years or older on the date of registration
Key exclusion criteria
1 Patients after gastrectomy
2 Pedunculated gastric cancer
3 Patients planning preoperative chemotherapy
4 Patients who are deemed unsuitable for this study by their attending physician or examination physician
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Endoscopy
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino city, Fukuoka prefecture, Japan
TEL
092-921-1011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Miyaoka |
Organization
Fukuoka University Chikushi Hospital
Division name
Endoscopy
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino city, Fukuoka prefecture, Japan
TEL
092-921-1011
Homepage URL
miyaoka1@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Gastroenterological Endoscopy Society
Fukuoka University Chikushi Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka internatinal Cancer Institute
Tobata Kyoritsu Hospital
Kochi Red Cross Hospital
Ishikawa Prefectural Central Hospital
Kyoto Prefectural University of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka university medical ethics committee
Address
7-45-1 Nanakuma, Jonanku, Fukuoka city, Fukuoka prefecture, Japan
Tel
092-801-1011
fumed-ethics@fukuoka-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
| 2022 | Year | 08 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 05 | Day |
Date trial data considered complete
| 2025 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 26 | Day |
Last modified on
| 2022 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055540
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| Registered date | File name |
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