UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035687 |
|---|---|
| Receipt number | R000040465 |
| Scientific Title | Feasibility study investigating the efficacy and safety of cold snarepolypectomy for pedunculated polyp (0-Ip polyp) |
| Date of disclosure of the study information | 2019/01/27 |
| Last modified on | 2022/01/29 10:16:51 |
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Basic information
Public title
Feasibility study investigating the efficacy and safety of cold snarepolypectomy for pedunculated polyp (0-Ip polyp)
Acronym
Efficacy and safety of cold snare polypectomy for pedunculated polyp (0-Ip polyp)
Scientific Title
Feasibility study investigating the efficacy and safety of cold snarepolypectomy for pedunculated polyp (0-Ip polyp)
Scientific Title:Acronym
Efficacy and safety of cold snare polypectomy for pedunculated polyp (0-Ip polyp)
Region
| Japan |
Condition
Condition
Colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of cold snare polypectomy for colorectal pedunculated polyp (0-Ip polyp)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of delayed bleeding
Key secondary outcomes
The rate of immediate bleeding
The rate of perforation
The retrieval rate of the resected spiecemen
The pathological margin of the spiecemen
The rate of en bloc resection
The rate of curative resection
The rate of requiring additional electrocautery
The thickness of stalk
procedure time
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with colorectal polyps were consequentially enrolled in the present study.
Key exclusion criteria
Patients whose lesions were found to be outside the guideline or expanded criteria for CSP by the endoscopic characteristics.
When the thickness of the stalk is thicker than the sheath of the snare
Patients in disagreement with informed consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Arimoto |
Organization
Omori Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
143-8527
Address
4-30-1, Ohta-ku, Chuo, Tokyo
TEL
0337753111
junarimoto_junjun@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Arimoto |
Organization
Omori Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
143-8527
Address
4-30-1, Ohta-ku, Chuo, Tokyo
TEL
0337753111
Homepage URL
junarimoto_junjun@yahoo.co.jp
Sponsor or person
Institute
Omori Red Cross Hospital
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
This study do not need financial support
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Omori Red Cross Hospital
Address
4-30-1, Ohta-ku, Chuo, Tokyo
Tel
03-3775-3111
junarimoto_junjun@yahoo.co.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
| 2019 | Year | 01 | Month | 27 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34727817/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/
Number of participants that the trial has enrolled
89
Results
The en-bloc resection rate was 100%. The rate of DPPB after CSP was 0%, however, DPPB after conversion to HSP occurred in 1 case (33.3% (1/3)).
Results date posted
| 2022 | Year | 01 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The total number of patients was 89, with a mean age of 70.5 years. In all, 15 patients were receiving antithrombotic therapy
Participant flow
During the study period, 89 consecutive patients were prospectively enrolled.
Adverse events
There was no case of perforation. The rate of immediate bleeding during CSP was 28.9% (33/114), and all cases of immediate bleeding could be adequately controlled by hemostasis clipping.
The rate of DPPB after CSP was 0%; however, DPPB after conversion to HSP occurred in 1 case (33.3% (1/3)).
Outcome measures
The primary outcome measure was the incidence of bleeding (DPPB and immediate bleeding).The rate of DPPB after CSP was 0%. The rate of immediate bleeding during CSP was 28.9%.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 27 | Day |
Other
Other related information
Observational study about usefulness and safety of CSP for pedunculated polyp (0-Ip polyp)
This is a single arm study.
The target lesion is adaptive lesion for CSP
Management information
Registered date
| 2019 | Year | 01 | Month | 27 | Day |
Last modified on
| 2022 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040465
