UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter Randomized Controlled Trial for the usefulness of Dual Red Imaging in endoscopic submucosal dissection
Title of the study (Brief title)	DRI
Region	Japan

Condition
Condition	early esophageal cancer, early gastric cancer, colorectal adenoma, early colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We evaluated the efficacy of DRI that facilitate for hemostasis management and shorten the treatment timeshortness in patients undergoing ESD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Shortening the time required for hemostasis.
Key secondary outcomes	Shortening the treatment time Perforation rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The endoscopist commenced the ESD using WLI, switched to DRI immediately when bleeding was detected, then switched back to WLI upon obtaining hemostasis (DRI group).
Interventions/Control_2	The endoscopist underwent ESD using WLI throughout the entire intervention.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Early esophageal cancer, depth of cancer invasion is EP or LPM. 2.Early gastric cancer, depth of cancer invasion is mucosal layer or submucosal layer1. 3.Colorectal adenoma, en bloc resection is difficult. 4.Early colorectal cancer, depth of cancer invasion is M or SM1. 5.There is no previous treatment for organ to treat. 6.Blood examination Hemoglobin more than 8.0g/dL, platelet less than 100000 /mm3. 7.Age more than 20,less than 80 years old 8.PS, 0 or 1. 9. We get informed consent from a patient.
Key exclusion criteria	1.More than two lesion are going to be treated. 2.A patient with the bleeding tendency. 3.During dialysis. 4.Residual and reccurence lesion.
Target sample size	400

Research contact person
Name of lead principal investigator	Naohisa Yahagi
Organization	Keio University School of Medicine
Division name	Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan. 160-8582
TEL	03-5363-3437
Email	yahagi.keio@gmail.com

Public contact
Name of contact person	Ai Fujimoto
Organization	Keio University School of Medicine
Division name	Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan. 160-8582
TEL	03-5363-3437
Homepage URL
Email	ai-fujimoto@a8.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 04 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 05 Month 08 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 04 Day
Last modified on	2017 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028905