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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | colorectal polyps | |
Classification by specialty |
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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 | |
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Stratification | |
Dynamic allocation | |
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Blocking | |
Concealment |
Intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Target sample size | 221 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Results Delayed | |||||||
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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. |
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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. |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
Other related information | The aim is to examine the rate of complete resection of mucosal layer. |
Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032498 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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