UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028401 |
|---|---|
| Receipt number | R000031901 |
| Scientific Title | Diagnostic usefulness of blue laser imaging with magnifying endoscopy for invasion depth of superficial esophageal squamous cell carcinoma. |
| Date of disclosure of the study information | 2017/07/27 |
| Last modified on | 2024/01/31 11:53:53 |
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Basic information
Public title
Diagnostic usefulness of blue laser imaging with magnifying endoscopy for invasion depth of superficial esophageal squamous cell carcinoma.
Acronym
Diagnostic usefulness of blue laser imaging with magnifying endoscopy for invasion depth of superficial esophageal squamous cell carcinoma.
Scientific Title
Diagnostic usefulness of blue laser imaging with magnifying endoscopy for invasion depth of superficial esophageal squamous cell carcinoma.
Scientific Title:Acronym
Diagnostic usefulness of blue laser imaging with magnifying endoscopy for invasion depth of superficial esophageal squamous cell carcinoma.
Region
| Japan |
Condition
Condition
superficial esophageal squamous cell carcinoma.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate the diagnostic value for invasion depth of superficial esophageal squamous cell carcinoma using magnifying endoscopy with blue laser imaging(BLI) by comparing that of narrow band imaging(NBI).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diagnostic accuracy for invasion depth of SESCC using BLI with magnifying endoscopy.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients with superficial esophageal squamous cell carcinoma which are underwent endoscopic submucosal dissection.
Key exclusion criteria
1)the patients with the lesion which is not detected both BLI and NBI
2)the patients with the lesion which is not assessed both BLI and NBI
3)the patients who have been underwent radiotherapy for esophagus
4)the patients with the lesion whose microvascular pattern was not identified by magnifying endoscopy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto prefectural university of medicine
Division name
Gastroenterology and Hepatology
Zip code
6028566
Address
465, Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
0752515519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ueda |
Organization
Kyoto prefectural university of medicine
Division name
Gastroenterology and Hepatology
Zip code
602-8566,
Address
465, Kajii-cho, Kamigyo-ku, Kyoto Japan
TEL
0752515519
Homepage URL
tm-ueda@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto prefectural university of medicine
Institute
Department
Personal name
Funding Source
Organization
Fujifilm Corporation
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
Kyoto prefectural university of medicine
Address
465, Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan
Tel
0752515111
tm-ueda@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
| 2017 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
https://academic.oup.com/dote/article/34/3/doaa078/5874034?login=false
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/dote/article/34/3/doaa078/5874034?login=false
Number of participants that the trial has enrolled
160
Results
A total of 160 consecutive patients with SESCCs who underwent endoscopic submucosal dissection were enrolled in this study.The overall diagnostic accuracy rates of WLI, M-BLI, M-NBI, WLI with M-BLI (WLI + M-BLI), and WLI with M-NBI (WLI + M-NBI) were 86.9, 91.2, 90.6, 95.6 and 94.4%, respectively. Significant differences were found between WLI and WLI + M-BLI or WLI + M-NBI (P = 0.006 and P = 0.021, respectively).
Results date posted
| 2024 | Year | 01 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with SESCCs who underwent endoscopic submucosal dissection
Participant flow
retrospective, single-center study
Adverse events
none
Outcome measures
diagnostic accuracy of the depth of invasion of SESCC
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Endoscopic images of superficial esophageal squamous cell carcinomas(SESCCs) were recorded by both magnifying endoscopy with narrow band imaging(M-NBI) and magnifying endoscopy with blue laser imaging(M-BLI) prior to ESD. SESCCs were pathologically diagnosed by ESD specimens. Three endoscopists with no information of the lesions evaluated invasion depth of SESCCs using M-BLI and M-NBI images according to JES classification. The diagnostic value of each procedure was evaluated.
Management information
Registered date
| 2017 | Year | 07 | Month | 27 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031901
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