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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000037383 |
Receipt No. | R000042614 |
Scientific Title | Optical biopsy for esophageal squamous cell neoplasia by using endocytoscopy |
Date of disclosure of the study information | 2019/07/25 |
Last modified on | 2019/07/15 |
Basic information | ||
Public title | Optical biopsy for esophageal squamous cell neoplasia by using endocytoscopy | |
Acronym | ENEC study | |
Scientific Title | Optical biopsy for esophageal squamous cell neoplasia by using endocytoscopy | |
Scientific Title:Acronym | ENEC study | |
Region |
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Condition | ||
Condition | early esophageal squamous cell carcinoma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Recently, diagnostic technology of gastrointestinal endoscopy, using image enhancement such as magnifying endoscopy, has developed. Accuracy of endoscopic diagnosis for early esophageal squamous cell carcinoma (ESCC) is reported as about 90%. Because endoscopic biopsy sometime causes scar and fibrosis which would make endoscopic resection difficult and because histological diagnosis of minute specimens obtained by biopsy is not always accurate, endoscopic resection for ESCC is now often performed without preoperative endoscopic biopsy in Japan. Accurate technology of endoscopic diagnosis is therefore required.
Recently, high-resolution and ultra-high magnifying (about 500x) videoendoscopy, known as endocytoscopy, that enables microscopic observation at the cellular level has been developed. However, diagnostic ability of endocytoscopy for early esophageal tumor (without biopsy) has not been reported. In this study, we will perform endoscopic surveillance for the patients with high risk of ESCC by using endocytoscopy. The aim of this study is to confirm the accuracy of optical biopsy for esophageal squamous cell neoplasia by using endocytoscopy. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Sensitivity of endoscopic diagnosis by using endocytoscopy. |
Key secondary outcomes | 1) Rate of evaluable ultra-high magnifying images.
2) Specificity of endoscopic diagnosis by using endocytoscopy. 3) Accuracy of endoscopic diagnosis by using endocytoscopy. |
Base | |
Study type | Observational |
Study design | |
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Randomization | |
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Blocking | |
Concealment |
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Eligibility | ||||
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Gender | Male and Female | |||
Key inclusion criteria | The study subjects included patients who underwent ER for ESCC or were treated for head and neck cancer at the Hokkaido University Hospital and Keiyukai daini hospital, or were refered to the 2 hospitals for the lesions suspicious for early ESCC. The inclusion criteria of this study were as follows: 1) who have background mucosa with multiple minute iodine unstained areas (high risk group for metachronous ESCC), and 2) written informed consent obtained from the patient. | |||
Key exclusion criteria | Exclusion criteria were as follows: 1) with histological diagnosis of SCC by prior endoscopic biopsy, 2) unsuitability as subjects, 3) age < 20 years, and 4) current pregnancy. | |||
Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hokkaido University Hospital | ||||||
Division name | Division of Endoscopy | ||||||
Zip code | 060-8648 | ||||||
Address | Kita 14 jo, Nishi 5 chome, Kitaku, Sapporo, Japan | ||||||
TEL | 011-716-1161 | ||||||
yshimizu@med.hokudai.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Hokkaido University Hospital | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | 060-8648 | ||||||
Address | Kita 14 jo, Nishi 5 chome, Kitaku, Sapporo, Japan | ||||||
TEL | 011-716-1161 | ||||||
Homepage URL | |||||||
mokomokomomon@gmail.com |
Sponsor | |
Institute | Hokkaido University Hospital |
Institute | |
Department |
Funding Source | |
Organization | Self funding |
Organization | |
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Category of Funding Organization | Self funding |
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IRB Contact (For public release) | |
Organization | Hokkaido University Hospital Institutional Review Board |
Address | Kita 14 jo, Nishi 5 chome, Kitaku, Sapporo, Japan |
Tel | 011-706-7924 |
crjimu@huhp.hokudai.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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Enrolling by invitation | ||||||
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Other related information | Patients who are included in this study undergo endoscopic surveillance by using endocytoscopy. If esophageal lesions suspicious for early squamous cell carcinoma (redness area in white light, brownish area in narrow band imaging or demarcated unstained area in iodin staining) are found, endoscopists immediately perform ultra-high magnifying observation (with dyeing of 1% methylene blue solution and 0.05% crystal violet solution) for the lesion. Patients who are diagnosed to have ESCC by using endocytoscopy will undergo endoscopic resection later. Patients who are diagnosed to have benign lesion by using endocytoscopy undergo ordinal endoscopic biopsy. All procedure will be performed by endoscopists who are examined for diagnosis of early ESCC.
Final histological diagnosis will be decided in Sapporo Kosei Hospital as the central review. All specimens will be diagnosed to squamous cell carcinoma (including high grade intraepithelial neoplasia), low grade dysplasia and non-tumor (inflammation, epithelial atrophy) according to WHO classification. |
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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=R000042614 |
Research Plan | |
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Research case data | |
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