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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000028401 |
Receipt No. | 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 | 2017/07/27 |
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 |
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Condition | ||
Condition | superficial esophageal squamous cell carcinoma. | |
Classification by specialty |
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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 | |
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Eligibility | ||||
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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. |
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Target sample size | 100 |
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Organization | Kyoto prefectural university of medicine | ||||||
Division name | Gastroenterology and Hepatology | ||||||
Zip code | |||||||
Address | 465, Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan | ||||||
TEL | 0752515519 | ||||||
ynaito@koto.kpu-m.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kyoto prefectural university of medicine | ||||||
Division name | Gastroenterology and Hepatology | ||||||
Zip code | |||||||
Address | 465, Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan | ||||||
TEL | 0752515519 | ||||||
Homepage URL | |||||||
osamu-d@koto.kpu-m.ac.jp |
Sponsor | |
Institute | Kyoto prefectural university of medicine |
Institute | |
Department |
Funding Source | |
Organization | Fujifilm Corporation |
Organization | |
Division | |
Category of Funding Organization | Other |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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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. |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031901 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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