UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025134 |
|---|---|
| Receipt number | R000028905 |
| Scientific Title | Multicenter Randomized Controlled Trial for the usefulness of Dual Red Imaging in endoscopic submucosal dissection |
| Date of disclosure of the study information | 2016/12/04 |
| Last modified on | 2017/12/19 16:34:52 |
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Basic information
Public title
Multicenter Randomized Controlled Trial for the usefulness of Dual Red Imaging in endoscopic submucosal dissection
Acronym
DRI
Scientific Title
Multicenter Randomized Controlled Trial for the usefulness of Dual Red Imaging in endoscopic submucosal dissection
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Naohisa Yahagi |
Organization
Keio University School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan. 160-8582
TEL
03-5363-3437
yahagi.keio@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ai Fujimoto |
Organization
Keio University School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan. 160-8582
TEL
03-5363-3437
Homepage URL
ai-fujimoto@a8.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 05 | Month | 08 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028905
