UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028389 |
|---|---|
| Receipt number | R000032498 |
| Scientific Title | Histological evaluation of Mucosal Defect after Cold Snare Polypectomy |
| Date of disclosure of the study information | 2017/07/31 |
| Last modified on | 2021/12/14 17:14:55 |
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Basic information
Public title
Histological evaluation of Mucosal Defect after Cold Snare Polypectomy
Acronym
cold biopsy study
Scientific Title
Histological evaluation of Mucosal Defect after Cold Snare Polypectomy
Scientific Title:Acronym
cold biopsy study
Region
| Japan |
Condition
Condition
colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine if mucosal layer is completely resected by cold snare polypectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incomplete resection rate of mucosal layer by cold snare polypectomy
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
non-pedunculated colorectal polyps with a diameter of 4-9 mm
Key exclusion criteria
Inflammatory bowel disease
Polyposis
Antiplatelet or anticoaglant can not be stopped
Coagulopathy
Severe organ failure
Target sample size
221
Research contact person
Name of lead principal investigator
| 1st name | Yoji |
| Middle name | |
| Last name | Takeuchi |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
5418567
Address
3-1-69, Otemae, Chuo-ku, Osaka
TEL
06-6945-1181
takeuti-yo@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Satoki |
| Middle name | |
| Last name | Shichijo |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
5418567
Address
3-1-69, Otemae, Chuo-ku, Osaka
TEL
06-6945-1181
Homepage URL
7satoki@oici.jp
Sponsor or person
Institute
Osaka International Cancer Institute
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
Osaka International Cancer Institute
Address
3-1-69, Otemae, Chuo-ku, Osaka
Tel
06-6945-1181
rinri01@opho.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
| 2017 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/abs/10.1111/jgh.14824
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/abs/10.1111/jgh.14824
Number of participants that the trial has enrolled
188
Results
From August 2017 to October 2018, 188 patients were screened, and 357 polyps were included. CSDP was detected in 122/355 (34%) evaluated mucosal defects. Excluding five lesions requiring hemostasis immediately following CSP, 352 mucosal defects were biopsied. After excluding 102 biopsies containing normal mucosa, we evaluated 250 biopsies. The overall incidence of incomplete mucosal layer resection was 63% (159/250), 76% (68/90) with CSDP and 57% (91/159) without CSDP (P < 0.01).
Results date posted
| 2020 | Year | 01 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
From August 2017
to October 2018, 188 patients participated, and 357 polyps in 177 patients were resected by CSP.
Participant flow
We recruited patients who were scheduled to undergo colorectal polypectomy, and written informed consent was obtained for participation in this study. The exclusion criteria were inflammatory bowel disease, familial polyposis, antiplatelet drugs or anticoagulants that could not be discontinued according to the Japanese guidelines,10 abnormal coagulopathy, severe organ failure, and patients who were judged unsuitable by their primary doctors.
Adverse events
Postprocedural bleeding occurred in three patients and was managed endoscopically without blood transfusion. One bleeding incident originated from a study lesion, and the other two bleeding incidences followed endoscopic mucosal resection with electrocautery for polyps measuring 10 and 20 mm, respectively. No perforation or other adverse eventswere observed.
Outcome measures
The primary outcome was the incidence of incomplete mucosal layer resection (presence of muscularis mucosa or residual polyp in the biopsied specimen).
Secondary outcomes were the incidence of CSDP, residual polyp in biopsied specimens, and any adverse event.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 18 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 18 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 27 | Day |
Other
Other related information
The aim is to examine the rate of complete resection of mucosal layer.
Management information
Registered date
| 2017 | Year | 07 | Month | 26 | Day |
Last modified on
| 2021 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032498
