UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053779 |
|---|---|
| Receipt number | R000061373 |
| Scientific Title | Safety of hot snare polypectomy with low power pure-cut current for 10-14mm nonpedunculated colorectal adenomas: a multicenter prospective study |
| Date of disclosure of the study information | 2024/03/05 |
| Last modified on | 2024/03/26 21:31:26 |
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Basic information
Public title
Prospective evaluation of hot snare polypectomy with low power pure-cut current
Acronym
hot snare polypectomy with low power pure-cut current
Scientific Title
Safety of hot snare polypectomy with low power pure-cut current for 10-14mm nonpedunculated colorectal adenomas: a multicenter prospective study
Scientific Title:Acronym
SECURE study
Region
| Japan |
Condition
Condition
Colorectal adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of hot snare polypectomy with low-power pure-cut current for 10-14mm nonpedunculated colorectal adenomas
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Delayed bleeding rate of LPPC HSP
Key secondary outcomes
1. Overall delayed bleeding rate
2. Incidence of delayed bleeding not requiring hemostasis
3. Incidence of intraprocedural bleeding and perforation of LPPC HSP
4. Incidence of delayed adverse events (such as delayed perforation or unscheduled visit) excluding delayed bleeding of LPPC HSP
5. Technical success rate of LPPC HSP
6. Procedure time
7. En bloc resection rate of LPPC HSP
8. En bloc R0 resection rate of LPPC HSP
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Low-Power Pure-Cut Hot snare polypectomy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with at least one 10-14 mm non-pedunculated colorectal adenoma
2. Patients aged 20 yrs or more
3. Patients with informed consent
Key exclusion criteria
1. Cases for which the course up to 28 days after treatment cannot be followed
2. Cases of inflammatory bowel disease and colorectal polyposis
3. Cases with blood coagulation dysfunction
4. Cases with systemic infections requiring treatment
5. Cases undergoing dialysis
6. Cases taking antithrombotic drugs for which cessation according to guidelines cannot be achieved during treatment
7. Other cases deemed inappropriate as study subjects by the researchers
Target sample size
770
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Imai |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
4118777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
ke.imai@scchr.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Takada |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
4118777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
Homepage URL
ka.takada@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Tel
055-989-5222
ke.imai@scchr.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
静岡がんセンター（静岡県）、交雄会新さっぽろ病院（北海道）、栃木県立がんセンター（栃木県）国立がん研究センター中央病院（東京都）、滋賀医科大学医学部附属病院（滋賀県）、神戸市立医療センター中央市民病院（兵庫県）、日本赤十字社和歌山医療センター（和歌山県）、岡山医療センター（岡山県）、福島県立医科大学会津医療センター（福島県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Definition of study measurements
1. Delayed bleeding of LPPC HSP: Bleeding observed clinically from after leaving the endoscopy room to the 28th day after LPPC HSP, requiring hemostasis due to active bleeding (Forrest classification Ia, Ib) or exposed vessel (Forrest classification IIa) at the ulcer site after LPPC HSP.
2. Overall delayed bleeding: Any bleeding requiring hemostatic treatment regardless of whether it was caused by LPPC HSP.
3. Bleeding not requiring hemostasis: Bleeding from after leaving the endoscopy room to the 28th day after LPPC HSP, where no hemostatic treatment was performed.
4. Intraoperative bleeding of LPPC HSP: Bleeding requiring hemostatis during or immediately after lesion resection by LPPC HSP, where bleeding from the ulcer base did not spontaneously stop for 30 seconds or more.
5. Intraoperative perforation of LPPC HSP: Endoscopic recognition of muscle layer defects during or immediately after lesion resection by LPPC HSP.
6. Delayed perforation of LPPC HSP: Presence of intraperitoneal free gas on imaging examination performed between 12 hours and the 28th day after treatment.
7. Unscheduled visit: Unscheduled Hospital visit for self-reported symptoms that cannot be denied as unrelated to LPPC HSP, regardless of severity.
8. Technical success of LPPC HSP: Successful removal of the lesion by LPPC HSP.
9. Procedure time: Time between a picture before opening the snare and a picture of the ulcer base after completing the resection by LPPC HSP. In cases where resection by LPPC HSP is not possible and alternative treatment is performed, the time until completion of resection by alternative treatment is measured.
10. En bloc resection rate of LPPC HSP: Successful endoscopic en bloc resection without residual lesion by LPPC HSP.
11. R0 resection rate of LPPC HSP: Endoscopic en bloc resection by LPPC HSP and histologically confirmed negative vertical and horizontal margins.
Management information
Registered date
| 2024 | Year | 03 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061373
| Research Plan | |
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| Registered date | File name |
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