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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016824 |
Receipt No. | R000019530 |
Scientific Title | Analysis of pathological local recurrence after cold snare polypectomy for colorectal polyp |
Date of disclosure of the study information | 2015/03/17 |
Last modified on | 2018/03/18 |
Basic information | ||
Public title | Analysis of pathological local recurrence after cold snare polypectomy for colorectal polyp | |
Acronym | Local recurrence after cold polypectomy for colorectal polyp | |
Scientific Title | Analysis of pathological local recurrence after cold snare polypectomy for colorectal polyp | |
Scientific Title:Acronym | Local recurrence after cold polypectomy for colorectal polyp | |
Region |
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Condition | ||
Condition | Colorectal polyp | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To reveal the rate of pathological local recurrence after cold snare polypectomy (CSP) for colorectal polyp |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | The rate of pathological local recurrence at 3 weeks after CSP for colorectal polyp |
Key secondary outcomes | The rate of morphological local recurrence at 3 weeks after CSP for colorectal polyp |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Purpose of intervention | |
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Eligibility | ||||
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Gender | Male and Female | |||
Key inclusion criteria | Patients who underwent CSP for colorectal polyps | |||
Key exclusion criteria | Patients with severe renal failure or heart failure, or evaluated incompetent by doctors in attendance | |||
Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Chiba University Hospital | ||||||
Division name | Gastroenterology | ||||||
Zip code | |||||||
Address | Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University (K1), 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan | ||||||
TEL | 043-226-2083 | ||||||
araim-cib@umin.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Chiba University Hospital | ||||||
Division name | Gastroenterology | ||||||
Zip code | |||||||
Address | 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan | ||||||
TEL | 043-226-2083 | ||||||
Homepage URL | |||||||
maruoka-cib@umin.ac.jp |
Sponsor | |
Institute | Chiba University |
Institute | |
Department |
Funding Source | |
Organization | Chiba University |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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IRB Contact (For public release) | |
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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 | 千葉大学医学部附属病院(千葉県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | https://www.ncbi.nlm.nih.gov/pubmed/29415287 |
Number of participants that the trial has enrolled | |
Results | Overall, 126 lesions in 39 patients were removed and 125 (99.2?%) were resected en bloc using CSP. Pathologically, 111 lesions (88.1?%) were confirmed as adenomas (4.2 +- 1.5?mm), with 36 of these (32.4?%) determined to be R0 resections. No complications were observed. All 37 patients with pathologically confirmed adenomas underwent follow-up colonoscopy, and 102 of 111 scars were detected in 33 patients. One pathological residual adenoma (0.98?%, 95?% confidence interval 0.02?%?-?5.3?%) was identified. |
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Results Delayed | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
Other related information | Safety and efficacy of UCSP for colorectal polyps will be analyzed. |
Management information | |||||||
Registered date |
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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=R000019530 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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