UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018049 |
|---|---|
| Receipt number | R000020809 |
| Scientific Title | Study of the image-enhanced magnifying endoscopic diagnosis in the demarcation of gastric tumors |
| Date of disclosure of the study information | 2015/06/23 |
| Last modified on | 2026/09/12 13:58:20 |
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Basic information
Public title
Study of the image-enhanced magnifying endoscopic diagnosis in the demarcation of gastric tumors
Acronym
Diagnosis of demarcation of gastric tumors
Scientific Title
Study of the image-enhanced magnifying endoscopic diagnosis in the demarcation of gastric tumors
Scientific Title:Acronym
Diagnosis of demarcation of gastric tumors
Region
| Japan |
Condition
Condition
gastric tumor
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare diagnostic ability of magnifying endoscopy and negative biopsy about demarcation of gastric tumors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of accurate diagnosis of demarcation of gastric tumors
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
diagnosis the demarcation of tumors
by magnifying endoscopy
Interventions/Control_2
diagnosis the demarcation of tumors
by negative biopsy
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients of gastric tumor who gave written informed consent
Key exclusion criteria
patients who cannot give written informed consent
patients of moderately differentiated cancer (hand-shaking type) and undifferentiated cancer(sig or por)
patients of cannot undergo negative biopsy by such as anti-thrombotic
patients who local recurrence after endoscopic therapy
patients who cannot undergo the magnifying endoscope observation
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto prefectural university of medicine
Division name
Department of Gastroenterology
Zip code
6028566
Address
465 kajii-cho kamigyo-ku kyoto-shi kyoto-fu
TEL
075-251-5519
syokanai@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Dohi |
Organization
Kyoto prefectural university of medicine
Division name
Department of Gastroenterology
Zip code
6028566
Address
465 kajii-cho kamigyo-ku kyoto-shi kyoto-fu
TEL
075-251-5519
Homepage URL
osamu-d@koto.kpu-m.ac.jp
Sponsor or person
Institute
kyoto prefectural university of medicine department of gastroenterology and hepatology
Institute
Department
Personal name
Funding Source
Organization
kyoto prefectural university of medicine department of gastroenterology and hepaology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medicine Institutional Review Board Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kyoto, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
| 2015 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
https://karger.com/ddi/article-abstract/39/2/156/95161/Efficacy-and-Feasibility-of-Magnifying-Blue-L
Publication of results
Published
Result
URL related to results and publications
https://karger.com/ddi/article-abstract/39/2/156/95161/Efficacy-and-Feasibility-of-Magnifying-Blue-L
Number of participants that the trial has enrolled
128
Results
Diagnostic accuracy was 100 percent with M BLI alone and 95.0 percent with biopsy confirmation. Complete resection was 100 percent in both groups. M BLI alone was noninferior and significantly faster.
Results date posted
| 2026 | Year | 09 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Analysis included 62 M BLI lesions and 60 biopsy confirmation lesions. Median age was 73 and 72 years. Men comprised 64.5 and 68.3 percent. Median lesion size was 10 and 14 mm. Most lesions were well differentiated cancers.
Participant flow
A total of 113 patients with 128 lesions were enrolled. Four lesions were excluded before randomization. The remaining 124 were assigned equally. Two lesions were later excluded from the biopsy group leaving 62 versus 60 for analysis.
Adverse events
Adverse events including perforation and postoperative bleeding did not differ significantly between groups. The article did not provide event counts.
Outcome measures
The primary endpoint tested noninferiority of M BLI alone for demarcation accuracy and complete resection. The secondary endpoint assessed lesion features associated with M BLI misdiagnosis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020809
