UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046113 |
|---|---|
| Receipt number | R000052637 |
| Scientific Title | Clinical effect of intragastric air quantity on the endoscopic diagnostic ability for gastric cancer after Helicobacter pylori-eradication therapy |
| Date of disclosure of the study information | 2021/11/18 |
| Last modified on | 2021/11/18 17:48:11 |
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Basic information
Public title
Clinical effect of intragastric air quantity on the endoscopic diagnostic ability for gastric cancer after Helicobacter pylori-eradication therapy
Acronym
intragastric air quantity
Scientific Title
Clinical effect of intragastric air quantity on the endoscopic diagnostic ability for gastric cancer after Helicobacter pylori-eradication therapy
Scientific Title:Acronym
intragastric air quantity
Region
| Japan |
Condition
Condition
early gastric cancer after Helicobacter pylori-eradication therapy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the effect of intragastric air quantity on endoscopic images in early gastric cancer after Helicobacter pylori-eradication therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visibility of demarcation line during insufflation and deaeration
Key secondary outcomes
Effect of intragastric air quantity on the color tone of endoscopic images, correct diagnosis rate of endoscopic range diagnosis for gastric cancer after Helicobacter pylori-eradication therapy
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
endoscopic observation and marking during gastric insufflation and degassing
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically diagnosed as differentiated gastric cancer.
2)Clinically stage IA is suspected.
3)The lesion has a tumor diameter of 2 cm or more, and the macroscopic type is 0-IIb or 0-IIc.
4)After H.pylori-eradication therapy.
5)Negative on two or more H. pylori infection tests (serum antibody, urea breath test, fecal antigen, etc.).
6)General status is expected to be tolerant of endoscopic exam and resection.
7)Prognosis is expected to be improved by endoscopic resection of the lesion.
8) The age at the time of consent is 20 years or older.6
9)Patient agree with the participation in the study.
Key exclusion criteria
1) Sufficient endoscopic observation is difficult.
2) Surgery was selected.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Shibagaki |
Organization
Shimane University Hospital
Division name
Endoscopy Unit
Zip code
6938501
Address
89-1 Enya, Izumo, Japan
TEL
+81-85320-2190
kotaro@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Watanabe |
Organization
Shimane University Hospital
Division name
Gastroenterology
Zip code
6938501
Address
89-1 Enya, Izumo, Japan
TEL
+81-85320-2190
Homepage URL
maki-w@med.shimane-u.ac.jp
Sponsor or person
Institute
Gastroenterology, Faculty of Medicine, Shimane University
Institute
Department
Personal name
Funding Source
Organization
No fund.
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
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1 Enya, Izumo, Japan
Tel
+81-85320-2515
kenkyu@med.shimane-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 | 11 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 18 | Day |
Last modified on
| 2021 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052637
