UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037678 |
|---|---|
| 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 | 2025/02/21 18:25:39 |
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Basic information
Public title
Prospective evaluation of hot snare polypectomy with low power pure-cut current
Acronym
Low-power hot snare polypectomy
Scientific Title
Efficacy and safety of hot snare polypectomy with low power pure-cut current for 10-14mm flat and sessile colorectal adenomas
Scientific Title:Acronym
SHARP trial
Region
| Japan |
Condition
Condition
Colorectal adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of hot snare polypectomy with low-power pure-cut current for 10-14mm colorectal adenomas
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
En bloc R0 resection rate
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 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
Key exclusion criteria
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
Target sample size
70
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 | 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
Homepage URL
ke.imai@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）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 19 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/jgh.16452
Publication of results
Unpublished
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/jgh.16452
Number of participants that the trial has enrolled
90
Results
Low-power pure-cut hot polypectomy removed all 100 enrolled polyps. For 98 pathologically neoplastic polyps, complete resection was achieved in 84 (85.7%, 95% confidence interval, 77-92%). The lower limit of the 95% confidence interval was not more than 15% below the pre-defined threshold of 86.6%. No severe adverse events occurred.
Results date posted
| 2020 | Year | 06 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age of patients was 70 years (IQR, 64-77.3); 67 (70%) were men; and 12 (13.3%) took antithrombotic drugs. The median size of polyps was 12 mm (IQR, 10.3-14). Most polyps (64.0%) were located at the proximal colon, 55% had a slightly elevated morphology, and 13.0% were histologically diagnosed as intramucosal carcinoma. A non-neoplastic pathology was found in two polyps.
Participant flow
To assess the cutting ability of LPPC, between August 2019 and August 2020, 169 patients were assessed for eligibility, and 79 patients were excluded because 61 patients were indicated for surgery for another cancerous lesion, 4 patients had polyposis syndrome, 2 patients could not suspend antithrombotic drugs, and 12 patients were excluded by physicians' discretion such as prolonged examination due to magnified endoscopy or dedicated polyp resection for other large polyps or difficulties to obtain the informed consent from the patient due to higher age or mental disease. Finally, 90 patients with 100 polyps were enrolled.
Adverse events
Immediate bleeding requiring clip hemostasis occurred in a case. There was no delayed bleeding requiring hemostasis. Minor hematochezia, which stopped spontaneously without any intervention, was observed in two (2.2%) patients. Unscheduled physician visits were found in two (2.2%) patients, one of whom was emergently admitted to another hospital with a diagnosis of pneumonia. It was judged that there was no causal relationship between pneumonia and LPPC HSP. Another patient complained of abdominal pain and mild fever managed conservatively without hospitalization. The other two patients had abdominal discomfort without needing a hospital visit.
Outcome measures
All enrolled polyps were successfully removed by LPPC HSP, where a 15-mm-sized snare was used in 94 (95.9%) cases. Therefore, the technical success rate was 100%. For 98 neoplastic polyps, en bloc and complete resection rates by LPPC HSP were 87.8% (86/98) and 85.7% (84/98, 95% confidence interval [CI], 77-92%), respectively. The lower limit of the 95% CI was not more than 15% below the pre-defined threshold of 86.6%. Neoplastic tissue was found in the marginal biopsies of 4 (4.1%) lesions. The resected specimens included the submucosal tissue in 87 (88.8%) and showed an indeterminable vertical margin in 9 (9.2%). In two cases with pathologically invasive cancer, margin-free resection was achieved. Histological evaluation was appropriately performed and additional surgery was completed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
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
Management information
Registered date
| 2019 | Year | 08 | Month | 13 | Day |
Last modified on
| 2025 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042926
