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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018351
Receipt No. R000021245
Scientific Title Investigation for shortening of the time required , easiness and psychological stress for hemostasis using new endoscopic imaging technology (Dual Red Imaging)
Date of disclosure of the study information 2015/07/21
Last modified on 2015/07/23

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Basic information
Public title Investigation for shortening of the time required , easiness and psychological stress for hemostasis using new endoscopic imaging technology (Dual Red Imaging)
Acronym Investigation for shortening of the time required , easiness and psychological stress for hemostasis using Dual Red Imaging (DRI).
Scientific Title Investigation for shortening of the time required , easiness and psychological stress for hemostasis using new endoscopic imaging technology (Dual Red Imaging)
Scientific Title:Acronym Investigation for shortening of the time required , easiness and psychological stress for hemostasis using Dual Red Imaging (DRI).
Region
Japan

Condition
Condition Esophageal cancer, Esophageal intraepithelial neoplasia,gastric cancer, gastric adenoma, colorectal cancer, colorectal adenoma, Barrett's esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the clinical efficacy of Dual Red Imaging (DRI) for the hemostasis in comparison with White Light Imaging (WLI) in ESD, time requited for hemostasis, easiness of hemostasis as well as psychological stress on hemostasis for both technology were evaluated during actual human ESD procedures.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.The average time required for hemostasis by hemostatic forceps in DRI is shorter than that in WLI.
2.The easiness of hemostasis is better in DRI than in WLI.
3. The psychological stress for hemostasis in DRI is lower than that in WLI.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 30 cases
Period:From August 1 2012 until March 19 2014
DRI or WLI was used alternately in between each bleeding occasion until complete hemostasis was achieved. 3 endpoints were assessed for each bleeding occasion.
Interventions/Control_2
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 1. Patient for esophageal cancer, gastric cancer,gastric adenoma, colorectal cancer,colorectal adenoma, Barrett's esophageal cancer, and subjected to esophageal, gastric and colorectal ESD.
2. Patient that an agreement was obtained.
Key exclusion criteria 1. Patient who judged that we were inappropriate to perform examination safely.
2. Patient that an agreement was not obtained.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naohisa Yahagi
Organization Keio University
Division name Center for Research and Development of Minimally Invasive Treatment, Cancer Center
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-5363-3437
Email yahagi-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohisa Yahagi
Organization Keio University
Division name Center for Research and Development of Minimally Invasive Treatment, Cancer Center
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-5363-3437
Homepage URL
Email yahagi-tky@umin.ac.jp

Sponsor
Institute Center for Research and Development of Minimally Invasive Treatment, Cancer Center, Keio University
Institute
Department

Funding Source
Organization Center for Research and Development of Minimally Invasive Treatment, Cancer Center, Keio University
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
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

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Study1; The average time required for hemostasis by dual knife in DRI was statistically shorter than that in WLI (average time; DRI 21sec., WLI 38sec., p=0.01). The average time required for hemostasis by hemostatic forceps in DRI tends to be shorter than that in WLI (average time; Dual Red Imaging 85sec., WLI 101sec., p=0.33). 
Study2; The average score of the subjective easiness of hemostasis was significantly lower in WLI than in DRI(average score; DRI 4.3, WLI 3.7, p=0.0008). The easiness of hemostasis is better in DRI than in WLI. 
Study3; The average score of the psychological stress for hemostasis in DRI was significantly lower than that in WLI (average score; DRI 1.7, WLI 2.5, p<0.0001).The psychological stress for hemostasis in DRI is lower than that in WLI.

(Presentation at the congress of Digestive Disease Week, May 2014, USA and the 22th Japan Digestive Disease Week, October 2014, Kobe)
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 Main results already published
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 10 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
2015 Year 07 Month 19 Day
Last modified on
2015 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021245

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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