Unique ID issued by UMIN | UMIN000011458 |
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Receipt number | R000012249 |
Scientific Title | The efficacy of modified hemostasis forceps for gastric ESD |
Date of disclosure of the study information | 2013/08/25 |
Last modified on | 2019/12/18 23:28:24 |
The efficacy of modified hemostasis forceps for gastric ESD
The efficacy of modified hemostasis forceps
The efficacy of modified hemostasis forceps for gastric ESD
The efficacy of modified hemostasis forceps
Japan |
early gastric cancer
Gastroenterology |
Malignancy
NO
To assess the efficasy of new hemostasis forceps for bleeding during gstric ESD
Efficacy
hemostatic time for initial bleeding
hemostatic time for all bleeding
procedure time
complication
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Device,equipment |
standard hemostasis forceps
modified hemostasis forceps
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1. early gastric cancer that meet the criteria for ESD proposed by Japanese Gastric Cancer Society(those with a preoperative diagnosis of differentiated type intramucosal cancer without ulcer findings; differentiated type intramucosal cancer that was no longer than 3cm in diameter with ulcer findings; differentiated-type minute invasive submucosal cancer (invasion less than 0.5mm below the muscularis mucosa) that was no longer than 3cm in diameter; and undifferentiated-type intramucosal cancer that was no longer than 2 cm in diameter without ulcer finding.)
2. tumor size less than 60mm in diameter
1. leison including ulcer
2. patient recieving antithrombotic medication
3. patients with severe liver cirrhosis
4. dialysis patient
5. patient with compromized blood clotting
66
1st name | |
Middle name | |
Last name | Shinwa Tanaka |
Kobe University Hospital
Endoscopy
7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan
078-382-5111
tanakas@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Shinwa Tanaka |
Kobe University Hospital
Endoscopy
7-5-1 Chu-o-ku, Kusunoki-Cho, Kobe, Hyogo 650-0017, Japan
078-382-5111
tanakas@med.kobe-u.ac.jp
Kobe University Hospital
none
Other
NO
2013 | Year | 08 | Month | 25 | Day |
https://www.ncbi.nlm.nih.gov/pubmed/27648821
Published
https://www.ncbi.nlm.nih.gov/pubmed/27648821
57
Hemostasis time for the first bleeding episode during ESD was 73.0 seconds for the Coagrasper and 21.5 seconds for the FD-Y0007 (p < 0.001). When all episodes of bleeding were included, hemostasis time was 56.8 seconds in the Coagrasper group and 25.5 seconds in FD-Y0007group (p < 0.0001). The frequency of adverse events (perforation: 3.4% vs. 7.1%; delayed bleeding: 0% vs. 0%) was not significantly different between the two groups.
2019 | Year | 12 | Month | 18 | Day |
Coagraspergroup:29patients
Median age: 72years old
Male/Female: 20/9
FD-Y0007group 28patients
Median age:71years old
Male/Female: 18/10
Sixty-six patients were enrolled. After randomization, 33 patients were assigned to each group. Four patients in the Coagrasper group and 5 patients in the FD-Y0007 group were excluded because there were no bleeding episodes that required use of the hemostatic forceps. A total of 29 patients in the Coagrasper group and 28 patients in the FD-Y0007 group were analyzed
Perforation:
Coagrasper group 3.4%
FD-Y0007 group 7.1%
Delayed bleeding:
Coagrasper group 0%
FD-Y0007 group 0%
The time required to obtain hemostasis, which was measured for the first episode of bleeding during ESD
The mean time to obtain hemostasis for all episodes of bleeding
The rate of achieving hemostasis in 2 or fewer grasping attempts
The procedure times
Adverse event
Completed
2013 | Year | 07 | Month | 25 | Day |
2013 | Year | 09 | Month | 01 | Day |
2014 | Year | 06 | Month | 30 | Day |
2014 | Year | 07 | Month | 30 | Day |
2014 | Year | 10 | Month | 31 | Day |
2014 | Year | 11 | Month | 30 | Day |
2013 | Year | 08 | Month | 12 | Day |
2019 | Year | 12 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012249
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