Unique ID issued by UMIN | UMIN000027031 |
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Receipt number | R000030927 |
Scientific Title | Randomized controlled trial of endoscopic closure vs. non-closure after colon ESD for preventing post-ESD coagulation syndrome and delayed perforation |
Date of disclosure of the study information | 2017/04/18 |
Last modified on | 2022/10/22 09:17:44 |
Randomized controlled trial of endoscopic closure vs. non-closure after colon ESD for preventing post-ESD coagulation syndrome and delayed perforation
CliPEC study (endoscopic Clipping closure for preventing Post-ESD Coagulation syndrome and delayed perforation)
Randomized controlled trial of endoscopic closure vs. non-closure after colon ESD for preventing post-ESD coagulation syndrome and delayed perforation
CliPEC study (endoscopic Clipping closure for preventing Post-ESD Coagulation syndrome and delayed perforation)
Japan |
colorectal adenoma, early colorectal cancer
Gastroenterology |
Malignancy
NO
Efficacy of endoscopic clipping closure after colon ESD for preventing PECS and delayed perforation
Efficacy
Confirmatory
Explanatory
Phase III
The rate of PECS and delayed perforation
The rate of PECS, delayed perforation, delayed bleeding and other complications.
Success rate and treatment time of endoscopic closure.
Elucidation for clinical features of PECS
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
No treatment
YES
NO
Institution is considered as a block.
NO
Central registration
2
Treatment
Maneuver |
Non-closure
Endoscopic closure
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1. Colorectal adenoma or eraly colorectal cancer =< 5cm that will be treated with ESD
2. Age from 20 to 85 years old
3. Agreement with signed informed consent
1. Tumor size > 5cm
2. Cutting line will be into appendix, ileo-cecal valve or anus
3. Severe dysfunction of heart, lung and kidney
4. Poor status: Performance Status(ECOG) 3 or 4
5. VAS>20mm, BT>37.0(celsius) or WBC>normal range
6. Administration of steroid or pain killer
7. Administration of anti-cogulant drugs
8. Pregnancy
9. Metalic allergy
10. Inappropriateness with physician's judgement
320
1st name | Takaya |
Middle name | |
Last name | Shimura |
Nagoya City University Graduate School of Medical Sciences
Department of Gastroenterology and Metabolism
467-8601
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
052-853-8211
tshimura@med.nagoya-cu.ac.jp
1st name | Takaya |
Middle name | |
Last name | Shimura |
Nagoya City University Graduate School of Medical Sciences
Department of Gastroenterology and Metabolism
467-8601
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
052-853-8211
tshimura@med.nagoya-cu.ac.jp
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Self funding
Japan
Nagoya City University Hospital, Nagoya City West Medical Center, Japanese Red Cross Nagoya Daini Hospital, Aichi Medical University Hospital, Gifu Prefectural Tajimi Hospital, Kasugai Municipal Hospital, Chukyo Hospital, Nagoya City East Medical Center, Nagoya Memorial Hospital, Toyokawa City Hospital
Clinical Research Management Center, Nagoya City University Hospital
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
052-858-7215
clinical_research@med.nagoya-cu.ac.jp
NO
名古屋市立大学病院(愛知県)、名古屋市立西部医療センター(愛知県)、名古屋第二赤十字病院(愛知県)、愛知医科大学病院(愛知県)、岐阜県立多治見病院(岐阜県)、春日井市民病院(愛知県)、中京病院(愛知県)、名古屋市立東部医療センター(愛知県)、名古屋記念病院(愛知県)、豊川市民病院(愛知県)
2017 | Year | 04 | Month | 18 | Day |
https://www.giejournal.org/article/S0016-5107(19)32480-0/fulltext
Published
https://www.giejournal.org/article/S0016-5107(19)32480-0/fulltext
181
https://www.giejournal.org/article/S0016-5107(19)32480-0/fulltext
2022 | Year | 10 | Month | 22 | Day |
2019 | Year | 11 | Month | 27 | Day |
https://www.giejournal.org/article/S0016-5107(19)32480-0/fulltext
https://www.giejournal.org/article/S0016-5107(19)32480-0/fulltext
https://www.giejournal.org/article/S0016-5107(19)32480-0/fulltext
https://www.giejournal.org/article/S0016-5107(19)32480-0/fulltext
Completed
2017 | Year | 03 | Month | 29 | Day |
2017 | Year | 04 | Month | 14 | Day |
2017 | Year | 04 | Month | 24 | Day |
2018 | Year | 09 | Month | 30 | Day |
2017 | Year | 04 | Month | 18 | Day |
2022 | Year | 10 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030927
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