UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014503
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized controlled trial of the second generation Narrow Band Imaging compared with White Light Imaging for detection of early gastric cancer
Acronym Randomized controlled trial of NBI compared with WLI for detection of early gastric cancer (EGC Detection trial)
Scientific Title Randomized controlled trial of the second generation Narrow Band Imaging compared with White Light Imaging for detection of early gastric cancer
Scientific Title:Acronym Randomized controlled trial of NBI compared with WLI for detection of early gastric cancer (EGC Detection trial)
Region
Japan

Condition
Condition Early gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of patients whose early gastric cancer is detected newly by non-magnifying endoscopy
Key secondary outcomes (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

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 NBI followed by WLI
Interventions/Control_2 WLI followed by NBI
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
85 years-old >
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria (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
Target sample size 4520

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Muto, MD, PhD
Organization Graduate School of Medicine, Kyoto University
Division name Department of Therapeutic Oncology
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo, Kyoto, 606-8507, Japan
TEL 075-751-4592(81-75-751-4592)
Email mmuto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohiro Yoshida, MD
Organization Ishikawa Prefectural Central Hospital
Division name Department of Gastroenterology
Zip code
Address 2-1 Kuratukihigashi Kanazawa, Ishikawa, 920-8530, Japan
TEL 076-237-8211(81-76-237-8211)
Homepage URL
Email ynaohiro@ipch.jp

Sponsor
Institute Department of Gastroenterology, Ishikawa Prefectural Central Hospital
Institute
Department

Funding Source
Organization Olympus Medical Systems Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 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)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 07 Day

Related information
URL releasing protocol NA
Publication of results Published

Result
URL related to results and publications https://gut.bmj.com/content/early/2020/04/02/gutjnl-2019-319631
Number of participants that the trial has enrolled 4523
Results
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. 
Results date posted
2020 Year 04 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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.
Participant flow
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). 
Adverse events
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
Outcome measures
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).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 07 Month 07 Day
Date of IRB
2014 Year 09 Month 12 Day
Anticipated trial start date
2014 Year 09 Month 12 Day
Last follow-up date
2018 Year 12 Month 11 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 03 Month 07 Day
Date analysis concluded
2019 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 07 Day
Last modified on
2020 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016849

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/05/01 EGC:プロトコール検査後発見胃癌.xlsx


Contact us.