UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030129 |
|---|---|
| Receipt number | R000034393 |
| Scientific Title | A retrospective study for the usefulness of cold polypectomy compared to conventional polypectomy for colorectal polyps |
| Date of disclosure of the study information | 2017/11/28 |
| Last modified on | 2024/12/02 09:45:35 |
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Basic information
Public title
A retrospective study for the usefulness of cold polypectomy compared to conventional polypectomy for colorectal polyps
Acronym
A retrospective study for the usefulness of cold polypectomy
Scientific Title
A retrospective study for the usefulness of cold polypectomy compared to conventional polypectomy for colorectal polyps
Scientific Title:Acronym
A retrospective study for the usefulness of cold polypectomy
Region
| Japan |
Condition
Condition
Colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness and recurrence of cold polypectomy for diminutive polyps compared to conventional polypectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of recurrence more than 1 year after cold polypectomy
Key secondary outcomes
Delayed bleeding, Immediate bleeding rate required hemostatic clipping, pathological investigation(complete resection rate, range of resection) and the rate of the patients with anticoagulant drug
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with non-pedunculated polyps<10mm
2)Written informed consent
Key exclusion criteria
1)polyps the size is more than 10mm
2)pedunculated polyps
3)previous chemotherapy and radiotherapy for colorectal cancer
4)others
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | TAKESHI |
| Middle name | |
| Last name | YAMAMURA |
Organization
Nagoya University Graduate school of medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
4668550
Address
Tsuruma-cho
TEL
0527442172
tyamamu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKESHI |
| Middle name | |
| Last name | YAMAMURA |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
4668550
Address
Tsuruma-cho
TEL
0527442172
Homepage URL
tyamamu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of Nagoya University
Address
65, Tsuruma-cho, Shouwa-ku, Nagoya
Tel
052-741-2111
ethics@med.nagoya-u.ac.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 | 11 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.wjgnet.com/1007-9327/full/v27/i47/8182.htm
Publication of results
Published
Result
URL related to results and publications
https://www.wjgnet.com/1007-9327/full/v27/i47/8182.htm
Number of participants that the trial has enrolled
275
Results
The local recurrence rate was 0.93% in the CP group and 0.93% in the HP group, without a significant difference (P = 0.688). Additionally, no differences were observed in the macroscopic en bloc resection rate, histopathological complete resection rate, and pathological results between the groups. Adverse events did not occur in either group.
Results date posted
| 2024 | Year | 12 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In the 206 patients included in the study, the mean age was 68.7　years, the use of antithrombotics was 19.4%, and the indications for colonoscopy included screening,　constipation, abdominal pain, anemia, and bloody stools
Participant flow
We identified 959 Lesions (275 patients), which were divided into the HP (253 Lesions) and CP groups (706 Lesions).
We performed propensity score matching based on the size and morphology (sessile or flat) of the lesions and the polypectomy device (biopsy forceps or snare), which could have an influence on the local recurrence. The CP (215 Lesions) and HP groups (215 Lesions) (total 206 patients) were compared after propensity score matching.
Adverse events
Adverse events did not occur in either group.
Outcome measures
The local recurrence rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is to evaluate the long-term prognosis of cold polypectomy by follow-up colonoscopy more than one year after.
Management information
Registered date
| 2017 | Year | 11 | Month | 27 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034393
