Unique ID issued by UMIN | UMIN000014503 |
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Receipt number | R000016849 |
Scientific Title | Randomized controlled trial of the second generation Narrow Band Imaging compared with White Light Imaging for detection of early gastric cancer |
Date of disclosure of the study information | 2014/07/07 |
Last modified on | 2020/04/07 16:28:28 |
Randomized controlled trial of the second generation Narrow Band Imaging compared with White Light Imaging for detection of early gastric cancer
Randomized controlled trial of NBI compared with WLI for detection of early gastric cancer (EGC Detection trial)
Randomized controlled trial of the second generation Narrow Band Imaging compared with White Light Imaging for detection of early gastric cancer
Randomized controlled trial of NBI compared with WLI for detection of early gastric cancer (EGC Detection trial)
Japan |
Early gastric cancer
Gastroenterology |
Malignancy
NO
To investigate the efficacy of the second generation narrow band imaging (NBI) for detection of early gastric cancer in a randomized controlled trial comparing white light imaging (WLI)
Efficacy
Confirmatory
Proportion of patients whose early gastric cancer is detected newly by non-magnifying endoscopy
(1)Positive predictive value of non-magnifying endoscopy
(2)Sensitivity and specificity of non-magnifying endoscopy
(3)Examination time
(4)Assessment of lesions which are overlooked
(5)The number of biopsies which are needed to diagnose gastric cancer
(6)Sensitivity and specificity of Near-focus mode
(7)Proportion of adverse events
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
2
Diagnosis
Device,equipment |
NBI followed by WLI
WLI followed by NBI
20 | years-old | <= |
85 | years-old | > |
Male and Female
Patients who plan to undergo upper gastrointestinal endoscopy and who meet one of following (1)-(5)
(1)Patients who have history of the endoscopic resection for early gastric cancer or adenoma
(2)Patients whose endoscopy is performed for the present gastric cancer or adenoma
(3)Patients who have history of the endoscopic resection for early esophageal cancer
(4)Patients whose endoscopy is performed for the present esophageal cancer
(5)Patients who have history of chemotherapy or radiotherapy for esophageal cancer
(1)Gastrectomy patients
(2)Patients who have reconstructed gastric tube
(3)Patients with severe underlying disease
(4)Patients taking medicines which cause the trouble in obtaining a biopsy tissue
(5)Patients who undergo urgent endoscopy
(6)Patients who were enrolled in this trial within eight months
(7)Patients whom a researcher judges to be inappropriate as a subject
4520
1st name | |
Middle name | |
Last name | Manabu Muto, MD, PhD |
Graduate School of Medicine, Kyoto University
Department of Therapeutic Oncology
54 Kawaharacho, Shogoin, Sakyo, Kyoto, 606-8507, Japan
075-751-4592(81-75-751-4592)
mmuto@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Naohiro Yoshida, MD |
Ishikawa Prefectural Central Hospital
Department of Gastroenterology
2-1 Kuratukihigashi Kanazawa, Ishikawa, 920-8530, Japan
076-237-8211(81-76-237-8211)
ynaohiro@ipch.jp
Department of Gastroenterology, Ishikawa Prefectural Central Hospital
Olympus Medical Systems Corporation
Profit organization
NO
石川県立中央病院 (石川県)
大阪府立成人病センター (大阪府)
岡山大学病院 (岡山県)
北里大学病院 (神奈川県)
京都大学医学部付属病院 (京都府)
国立がん研究センター中央病院 (東京都)
国立がん研究センター東病院 (千葉県)
国立国際医療研究センター病院 (東京都)
四国がんセンター (愛媛県)
静岡がんセンター (静岡県)
兵庫県立がんセンター (兵庫県)
福岡大学筑紫病院 (福岡県)
NTT東日本関東病院 (東京都)
Ishikawa Prefectural Central Hospital (Ishikawa)
Osaka Medical Center for Cancer and Cardiovascular Disease (Osaka)
Okayama University Hospital (Okayama)
Kitasato University Hospital (Kanagawa)
Kyoto University Hospital (Kyoto)
National Cancer Center Hospital (Tokyo)
National Cancer Center Hospital East (Chiba)
National Center for Global Health and Medicine (Tokyo)
Shikoku Cancer Center (Ehime)
Shizuoka Cancer Center (Shizuoka)
Hyogo Cancer Center (Hyogo)
Fukuoka University Chikushi Hospital (Fukuoka)
NTT Medical Center Tokyo (Tokyo)
2014 | Year | 07 | Month | 07 | Day |
NA
Published
https://gut.bmj.com/content/early/2020/04/02/gutjnl-2019-319631
4523
Early gastric cancers were found in 44 (1.9%) and 53 (2.3%; p=0.412) patients in the WLI and 2G-NBI groups, respectively, during primary EGD.
2020 | Year | 04 | Month | 07 | Day |
The baseline characteristics of the two groups were well balanced. In both groups, approximately 80% of patients underwent endoscopic examination for surveillance after endoscopic resection for a gastric neoplasm.
Between September 2014 and September 2017, 4,575 patients were assessed for study eligibility. Fifty-two patients refused to participate (46 patients before randomisation, six patients after randomisation). The remaining 4523 patients were randomly assigned to the WLI group (2258 patients, primary WLI followed by secondary 2G-NBI) or the 2G-NBI group (2265 patients, primary 2G-NBI followed by secondary WLI).
The only adverse event observed in this study was bleeding from a target lesion after biopsy in the 2G-NBI group, which required haemostatic therapy
PPV for EGC in suspicious lesions was 13.5% and 20.9% in the WLI (50/371 target lesions) and 2G-NBI groups (59/282 target lesions), respectively (p=0.015).
Completed
2014 | Year | 07 | Month | 07 | Day |
2014 | Year | 09 | Month | 12 | Day |
2014 | Year | 09 | Month | 12 | Day |
2018 | Year | 12 | Month | 11 | Day |
2019 | Year | 03 | Month | 07 | Day |
2019 | Year | 03 | Month | 30 | Day |
2014 | Year | 07 | Month | 07 | Day |
2020 | Year | 04 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016849
Research Plan | |
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Registered date | File name |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |
2020/05/01 | EGC:プロトコール検査後発見胃癌.xlsx |