Unique ID issued by UMIN | UMIN000037678 |
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Receipt number | R000042926 |
Scientific Title | Efficacy and safety of hot snare polypectomy with low power pure-cut current for 10-14mm flat and sessile colorectal adenomas |
Date of disclosure of the study information | 2019/08/19 |
Last modified on | 2020/06/10 18:36:51 |
Prospective evaluation of hot snare polypectomy with low power pure-cut current
Low-power hot snare polypectomy
Efficacy and safety of hot snare polypectomy with low power pure-cut current for 10-14mm flat and sessile colorectal adenomas
SHARP trial
Japan |
Colorectal adenoma
Gastroenterology |
Others
NO
To evaluate the efficacy and safety of hot snare polypectomy with low-power pure-cut current for 10-14mm colorectal adenomas
Safety,Efficacy
Exploratory
Phase II
En bloc R0 resection rate
1. Incidence of immediate bleeding and perforation
2. Incidence of delayed adverse events (bleeding, perforation, unscheduled consultation)
3. Technical success rate of the procedure
4. En bloc resection rate
5. Incidence of the white protrusion at the ulcer bed
6. Histology of the tissues at the ulcer bed
7. Presence of submucosal tissue within the resected specimen
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with at least a single, 10 14mm sized , flat elevated or sessile colorectal adenoma diagnosed by magnified Narrow band imaging (JNET Type2A) with a high confidence
2. Patients aged 20 yrs or more
3. Patients with informed consent
1. Cases with synchronous colorectal cancer indicated for surgical interventions
2. Cases with inflammatory bowel disease or polyposis syndrome
3. Cases with blood coagulation dysfunction
4. Cases with active infection disease
5. Cases with dialysis
6. Cases who can not interrupt anticoagulant agents
7. When reserchers consider to be inappropriate cases
70
1st name | Kenichiro |
Middle name | |
Last name | Imai |
Shizuoka Cancer Center
Division of Endoscopy
4118777
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
055-989-5222
ke.imai@scchr.jp
1st name | Kenichiro |
Middle name | |
Last name | Imai |
Shizuoka Cancer Center
Division of Endoscopy
4118777
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
055-989-5222
ke.imai@scchr.jp
Shizuoka Cancer Center
Self funding
Self funding
Shizuoka Cancer Center
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
055-989-5222
ke.imai@scchr.jp
NO
静岡がんセンター(静岡県)
2019 | Year | 08 | Month | 19 | Day |
Unpublished
2020 | Year | 06 | Month | 10 | Day |
Enrolling by invitation
2019 | Year | 07 | Month | 16 | Day |
2019 | Year | 08 | Month | 08 | Day |
2019 | Year | 08 | Month | 19 | Day |
2022 | Year | 12 | Month | 31 | Day |
Definitions of study measurements
1. Histological complete resection is defined when endoscopically en bloc resection is achieved and when neoplastic tissues are not confirmed in four biopsy specimens taken from edge of a mucosal defect.
2. Technical success of low-power pure-cut polypectomy is defined when polyps can cut by low-power pure-cut current only after snare-capturing.
3. Endoscopic en bloc resection by low-power pure-cut polypectomy is defined when no residual adenoma is found at the mucosal defect after en bloc removal.
4. Immediate bleeding is defined when endoscopic hemostasis requires for persistent bleeding from polypectomy site after a period of at least 30 seconds.
5. Delayed bleeding is defined when emergent endoscopy, endoscopic hemostasis, or hospitalization is needed for bleeding within 30 days after polypectomy.
6. Perforation is defined when defects of muscular layer at the polypectomy site
7. Delayed perforation is defined when intraperitoneal free air is found by image examinations such as radiography or computed tomography
8. White protrusion is defined as a whitish protruded tissue at the mucosal defect after polypectomy
9. Histology of the ulcer bed is defined as histological findings of the specimen taken from white protrusion when white protrusion is appeared or from tissues at the ulcer bed when white protrusion is not appeared.
10. The presence of submucosal tissue in the resected specimen is defined when submucosal tissues are histologically confirmed below the removed adenoma
2019 | Year | 08 | Month | 13 | Day |
2020 | Year | 06 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042926
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