Unique ID issued by UMIN | UMIN000027115 |
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Receipt number | R000031071 |
Scientific Title | A randomized controlled trial to assess the effectiveness of clip and snare method using pre-looping technique(CSM-PLT) for gastric endoscopic submucosal dissection |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2022/01/15 15:16:29 |
A randomized controlled trial to assess the effectiveness of clip and snare method using pre-looping technique(CSM-PLT) for gastric endoscopic submucosal dissection
CSM-PLT trial
A randomized controlled trial to assess the effectiveness of clip and snare method using pre-looping technique(CSM-PLT) for gastric endoscopic submucosal dissection
CSM-PLT trial
Japan |
gastric adenoma or early gastric cancer
Gastroenterology |
Malignancy
NO
To evaluate the efficacy of ESD using CSM-PLT compared with conventional ESD in terms of procedure time for patients with gastric epithelial neoplasia
Safety,Efficacy
ESD procedure time
ESD procedure time according to
/1. the endoscopist experience(expert or non-expert)
/2. the location of the lesion
/3. size of the lesion
/4. presence of ulceration
/5. incision device
6. procedure time for submucosal dissection of the lesion
7. successful procedure rate of ESD non-expert
8. coagulation procedure, number of times, duration
9. en bloc resection rate
10. adverse events rate
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
Central registration
2
Treatment
Device,equipment |
A: Conventional ESD group
B: ESD using CSM-PLT group
20 | years-old | <= |
Not applicable |
Male and Female
1. Histologically proven gastric adenoma or cancer
2. early gastric cancer which is within the absolute or expanded indication of ESD according to Japanese gastric cancer treatment guideline(ver4)
3. With only one lesion which will be treated endoscopically
4. Aged 20 years old or over
5. PS(ECOG)0.1.2
6. Meet all of the following criteria without blood transfusion in the past 14 days
a.Hb >= 9g/dl
b.Plt>= 100,000/mm3
c.AST,ALT <= 100
d.Cr <= 2.0mg/dl
7. Patients with written informed consent of this study
1. Patient with registration history of this study
2. Patient who are pregnant, may be pregnant, or lactating woman
3. Patient with psychosis
400
1st name | |
Middle name | |
Last name | Kenkei Hasatani , MD |
Fukui Prefectural Hospital
Department of Gastroenterology
2-8-1Yotsui , Fukuii city, Fukui, 910-8526, Japan
0776-54-5151
hasatani9@yahoo.co.jp
1st name | |
Middle name | |
Last name | Naohiro Yoshida, MD |
Ishikawa Prefectural Central Hospital
Department of Gastroenterology
2-1 Kuratukihigashi Kanazawa, Ishikawa, 920-8530, Japan
076-237-8211
ynaohiro@ipch.jp
Fukui prefectural hospital
Fukui prefectural hospital
Self funding
NO
2017 | Year | 07 | Month | 01 | Day |
Unpublished
Completed
2017 | Year | 03 | Month | 08 | Day |
2017 | Year | 03 | Month | 08 | Day |
2017 | Year | 07 | Month | 01 | Day |
2020 | Year | 03 | Month | 01 | Day |
2017 | Year | 04 | Month | 24 | Day |
2022 | Year | 01 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031071
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