UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014628
Receipt No. R000017020
Scientific Title Multicenter randomized controlled study for delineating early gastric cancer by magnifying endoscopy with narrow-band imaging (M-NBI)
Date of disclosure of the study information 2014/08/01
Last modified on 2017/07/25

* 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 Multicenter randomized controlled study for delineating early gastric cancer by magnifying endoscopy with narrow-band imaging (M-NBI)
Acronym M-NBI delineation study
Scientific Title Multicenter randomized controlled study for delineating early gastric cancer by magnifying endoscopy with narrow-band imaging (M-NBI)
Scientific Title:Acronym M-NBI delineation study
Region
Japan

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

Objectives
Narrative objectives1 Comparison between success rates of conventional endoscopy plus chromoendoscopy and conventional endoscopy plus magnifying endoscopy with NBI in delineating early gastric cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison between success rates of conventional endoscopy plus chromoendoscopy and conventional endoscopy plus magnifying endoscopy with NBI in delineating early gastric cancer.
Key secondary outcomes It is intended to determine differences in limitations of conventional endoscopy plus chromoendoscopy and conventional endoscopy plus magnifying endoscopy with NBI in delineating early gastric cancer and to compare correct diagnosis rates of the two techiniques according to clinicopathological findings.
In addition, correct diagnosis rates will be compared according to the conditions with high- and low-confidence prediction.

Base
Study type Interventional

Study design
Basic design Parallel
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 NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 conventional endoscopy plus chromoendoscopy
Interventions/Control_2 conventional endoscopy plus narrow-band imaging with magnifying endoscopy
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 Candidate patients have to meet all the following inclusion criteria to participate in the study.
(a) Patients who are diagnosed as early gastric cancer of 10 mm and over in diameter
1) Histopathological investigation of the biopsy confirmed gastric cancer.
2) If the patient have multiple cancers, a lesion of the most oral side lesion should be included..
(b) The patients who will be scheduled for endoscopic or surgical resection in each facilitiy should be included.
(c) Patients should be 20 years-old and over.
Key exclusion criteria (a) Patients who had undergone gastrectomy.
(b) Patients who have the high risk for bleeding.
(c) Patients who do1 not give Informed concent.
Target sample size 340

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kenshi Yao
Organization Fukuoka University Chikushi Hospital
Division name Department of Endoscopy
Zip code
Address 1-1-1, Zokumyoin, Chikushino-city, Fukuoka, Japan
TEL 092-921-1011
Email yao@fukuoka-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takashi Nagahama
Organization Fukuoka university chikushi hospital
Division name Department of gastroenterology
Zip code
Address 1-1-1, Zokumyoin, Chikushino city, Fukuoka, Japan
TEL 092-921-1011
Homepage URL
Email nagahamagogo@gmail.com

Sponsor
Institute Central Research Institute for Endoscopy, Fukuoka University
Institute
Department

Funding Source
Organization The Japanese Gastroenterological Association
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 福岡大学筑紫病院内視鏡部(福岡県)、大阪府立成人病センター消化器内科(大阪府)、石川県立中央病院消化器内科(石川県)、大分赤十字病院消化器内科(大分県)、高知赤十字病院(高知県)

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2014 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2016 Year 04 Month 01 Day
Date of closure to data entry
2016 Year 04 Month 28 Day
Date trial data considered complete
2016 Year 05 Month 01 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 23 Day
Last modified on
2017 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017020

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2016/05/01 データ固定用160428.xlsx


Contact us.