UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051569 |
|---|---|
| Receipt number | R000058517 |
| Scientific Title | Histopathological vertical margin positivity of cold snare polypectomy and mucosal resection for sessile serrated lesions and long-term results. |
| Date of disclosure of the study information | 2023/07/10 |
| Last modified on | 2026/01/10 17:02:39 |
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Basic information
Public title
Histopathological vertical margin positivity of cold snare polypectomy and mucosal resection for sessile serrated lesions and long-term results.
Acronym
Margin Positivity in Cold Snare Polypectomy vs. Mucosal Resection for Sessile Serrated Lesions and long-term results.
Scientific Title
Histopathological vertical margin positivity of cold snare polypectomy and mucosal resection for sessile serrated lesions and long-term results.
Scientific Title:Acronym
Margin Positivity in CSP vs. EMR for SSLs and long-term results.
Region
| Japan |
Condition
Condition
Sessile serrated lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There is a lack of studies that have histopathologically examined the vertical margins of SSL specimens resected using CSP. Furthermore, the appropriateness of CSP for SSLs has yet to be determined. This is a prospective cohort study comparing the local recurrence rates of CSP and EMR for SSL. Since recurrence is caused by the residual tumor in resected area, we evaluate the incidence of positive vertical margins in histopathological examination in this interim analysis. If there is no significant difference in the rate of positive vertical margins, we determined that long-term observation was not warranted and this cohort study would be terminated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of histopathological positive vertical margin of CSP and EMR specimens.
Key secondary outcomes
Mucosal fragmentation, presence of lateral margin, histopathological positive lateral margin, presence of damage or thermal coagulation, presence of muscularis mucosae, presence of submucosa, and the recurrence rate associated with polyp resection methods.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Consecutive patients treated with CSP or EMR and histopathologically diagnosed with SSL at the Southern-Tohoku General Hospital in Fukushima, Japan, between January 2019 and December 2022 were included in this study. SSLs less than 10 mm in diameter by endoscopic measurement and achieved en-block resection were included in this study.
Key exclusion criteria
Exclusion criteria were as follows: cases with more than 6 resections; underwent piecemeal resection; advanced cancer coexistence; serious comorbidities; history of inflammatory bowel disease; difficulty obtaining consent due to psychiatric disorder.
Target sample size
332
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Hamada |
Organization
Southern-Tohoku General Hospital
Division name
Department of Gastroenterology
Zip code
9638563
Address
7-115, Yatsuyamada, Koriyama-shi, Fukushima 963-8563, Japan
TEL
810249345322
ag14072@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Hamada |
Organization
Southern-Tohoku General Hospital
Division name
Department of Gastroenterology
Zip code
9638563
Address
7-115, Yatsuyamada, Koriyama-shi, Fukushima 963-8563, Japan
TEL
0249345322
Homepage URL
ag14072@yahoo.co.jp
Sponsor or person
Institute
Southern-Tohoku General Hospital
Institute
Department
Personal name
Koichi Hamada
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Southern-Tohoku General Hospital
Address
7-115, Yatsuyamada, Koriyama-shi, Fukushima 963-8563, Japan
Tel
810249345322
koichi.hamada@mt.strins.or.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2029 | Year | 04 | Month | 05 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We conducted a cohort study to compare the incidence of positive vertical margins and long-term results of CSP and EMR for SSLs. We are currently in the process of planning a follow-up study regarding recurrence rates after resection. In this paper, we report the histological evaluation of resection specimens in this cohort.
Prospective observational study.
Management information
Registered date
| 2023 | Year | 07 | Month | 10 | Day |
Last modified on
| 2026 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058517
