UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046908 |
|---|---|
| Receipt number | R000053521 |
| Scientific Title | Establishment of a training system for the diagnosis of early gastric cancer by endoscopy in the Kingdom of Bhutan |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/02/14 17:36:53 |
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Basic information
Public title
Establishment of a training system for the diagnosis of early gastric cancer by endoscopy in the Kingdom of Bhutan
Acronym
Establishment of a training system for the diagnosis of early gastric cancer by endoscopy in the Kingdom of Bhutan
Scientific Title
Establishment of a training system for the diagnosis of early gastric cancer by endoscopy in the Kingdom of Bhutan
Scientific Title:Acronym
Establishment of a training system for the diagnosis of early gastric cancer by endoscopy in the Kingdom of Bhutan
Region
| Asia(except Japan) |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of a sustainable training system to improve the diagnosis of early gastric cancer by endoscopy in Bhutan and verification of the training effects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of early gastric cancer (detected EGC ratio) in all gastric cancers (early gastric cancer [EGC] + advanced gastric cancer [AGC]) found using endoscopy
Detected EGC ratio = Number of detected EGC/Number of detected total GC (EGC + advanced cancer)
Key secondary outcomes
1) EGC detection rate in the total number of endoscopy per endoscopist
EGC detection rate = Number of detected EGC/Number of endoscopic procedures
2) Clinicopathological characteristics of early gastric cancer detected
3) Learning curve showing the acquisition of the systematic observation method by the endoscopist
4) Correlation between the parameters indicating the quality of the examination (achievement rate of the systematic observation method, degree of removal of mucus and bubbles, and degree of extension of the gastric wall) and the EGC detection ratio will be determined.
5) When hands-on guidance for endoscopic technique is initiated on-site, the proficiency of individual endoscopic techniques will be evaluated using the assessment sheet.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Providing physicians who are currently examining patients by endoscopy in Bhutan with training that enables them to acquire techniques, knowledge, and experiences for endoscopically diagnosing early gastric cancer and determining the training effects. This training program is collectively called "Train the Trainer (TTT) course." The TTT course refers to the training activities to cultivate medical supervisors who can train other physicians in the future.
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) Inclusion criteria
(1) Nationally qualified physicians in Bhutan who are engaged in upper gastrointestinal endoscopy
(2) Physicians who have understood the explanation and consented to participate in this study
(3) Physicians who have reported that the permission of the head of the institution was obtained for the submission of the consent form to participate in this study
Key exclusion criteria
(1) Participants who failed to participate in the training program during the research period of this study
(2) Participants who failed to submit their data
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
8188502
Address
1-1-1 Zokumyoin, Chikushino-city, Fukuoka, Japan
TEL
+81929211011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
8188502
Address
1-1-1 Zokumyoin, Chikushino-city, Fukuoka, Japan
TEL
+81929211011
Homepage URL
yao@fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Environmental and Preventive Medicine, Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University-Medical Ethics Review Board
Address
7-45-1 Nanakuma,Jonan-ku,Fukuoka 814-0180, Japan
Tel
+81928011011
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 | 04 | Month | 01 | 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
| 2021 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | 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
Management information
Registered date
| 2022 | Year | 02 | Month | 14 | Day |
Last modified on
| 2022 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053521
