Unique ID issued by UMIN | UMIN000018351 |
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Receipt number | 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 15:15:29 |
Investigation for shortening of the time required , easiness and psychological stress for hemostasis using new endoscopic imaging technology (Dual Red Imaging)
Investigation for shortening of the time required , easiness and psychological stress for hemostasis using Dual Red Imaging (DRI).
Investigation for shortening of the time required , easiness and psychological stress for hemostasis using new endoscopic imaging technology (Dual Red Imaging)
Investigation for shortening of the time required , easiness and psychological stress for hemostasis using Dual Red Imaging (DRI).
Japan |
Esophageal cancer, Esophageal intraepithelial neoplasia,gastric cancer, gastric adenoma, colorectal cancer, colorectal adenoma, Barrett's esophageal cancer
Gastroenterology |
Malignancy
NO
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.
Efficacy
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Active
1
Treatment
Device,equipment |
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.
20 | years-old | <= |
Not applicable |
Male and Female
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.
1. Patient who judged that we were inappropriate to perform examination safely.
2. Patient that an agreement was not obtained.
60
1st name | |
Middle name | |
Last name | Naohisa Yahagi |
Keio University
Center for Research and Development of Minimally Invasive Treatment, Cancer Center
35 Shinanomachi, Shinjyuku-ku, Tokyo
03-5363-3437
yahagi-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Naohisa Yahagi |
Keio University
Center for Research and Development of Minimally Invasive Treatment, Cancer Center
35 Shinanomachi, Shinjyuku-ku, Tokyo
03-5363-3437
yahagi-tky@umin.ac.jp
Center for Research and Development of Minimally Invasive Treatment, Cancer Center, Keio University
Center for Research and Development of Minimally Invasive Treatment, Cancer Center, Keio University
Self funding
NO
2015 | Year | 07 | Month | 21 | Day |
Partially published
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)
Main results already published
2012 | Year | 04 | Month | 01 | Day |
2012 | Year | 08 | Month | 10 | Day |
2015 | Year | 07 | Month | 19 | Day |
2015 | Year | 07 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021245
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