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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028389
Receipt No. 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 2020/01/27

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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
Email 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
Email 7satoki@oici.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

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
Email 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 Completed
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
2020 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032498

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name

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