UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026655 |
|---|---|
| Receipt number | R000030610 |
| Scientific Title | Efficacy and safety of underwater cold snare polypectomy (UCSP) for colorectal polyps |
| Date of disclosure of the study information | 2017/03/22 |
| Last modified on | 2019/09/22 10:42:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy and safety of underwater cold snare polypectomy (UCSP) for colorectal polyps
Acronym
UCSP for colorectal polyps
Scientific Title
Efficacy and safety of underwater cold snare polypectomy (UCSP) for colorectal polyps
Scientific Title:Acronym
UCSP for colorectal polyps
Region
| Japan |
Condition
Condition
Colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the efficacy and safety of underwater cold snare polypectomy (UCSP) for colorectal polyps
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The morphological and phathological residual rate of adenomas 3 weeks after CSP
Key secondary outcomes
The rate of pathological complete resection (R0 resection) of UCSP, and the relationship between this and outcome of conventional cold snare polypectomy (CSP). The rate of having muscularis mucosae in specimens, morphological local recurrence at 3 weeks after UCSP, patients' characteristics (e.g. age, gender), lesions' characteristics (e.g. location, diameter, macroscopic appearance), safety (e.g. complications), and the relationship between these and outcomes of conventional CSP
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
Patients who underwent UCSP for colorectal polyps
Key exclusion criteria
Polyposis syndromes such as familial adenomatous polyposis; inflammatory bowel disease; coagulation abnormalities; antithrombotic drug therapy; hemodialysis with a tendency to bleed; severe hepatic or renal disorders; pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Arai |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
260-8670
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
+81-43-226-2083
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Maruoka |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL
+81-43-226-2083
Homepage URL
maruoka-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Graduate School of Medicine, Chiba University
Address
1-8-1, Inohana, Chuo-ku, Chiba, 260-8670, Japan
Tel
+81-43-222-7171
igaku-rinri@office.chiba-u.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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/31038769
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/31038769
Number of participants that the trial has enrolled
65
Results
Overall, 224 lesions in 65 patients were prospectively resected by UCSP. Pathologically, 209 lesions were adenomas (4.5+-1.5 mm). Only one pathological residual adenoma was identified, but there was no significant difference between the UCSP and CSP groups (both 1.0%). No complications were observed. R0 resection rate and rate of area containing the muscularis mucosa in the UCSP group were significantly higher than those in the CSP group (80.2% vs 32.7%, P < 0.001; 50.0% vs 35.3%, P = 0.015).
Results date posted
| 2019 | Year | 09 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients aged over 20 years old diagnosed with colorectal adenomaswere recruited.
Exclusion criteria were as follows: (i) polyposis syndromes such as familial adenomatous polyposis; (ii) inflammatory bowel disease; (iii) coagulation abnormalities; (iv) antithrombotic drug therapy; (v) hemodialysis with a tendency to bleed; (vi) severe hepatic or renal disorders; and (vii) pregnancy.
Participant flow
The study protocol, which included earlier follow-up colonoscopy instead of routine medical examination, was clearly explained, and a written informed consent was obtained from all patients prior to their enrolment.
Adverse events
No adverse events.
Outcome measures
Primary endpoint: pathological residual tumors 3 weeks after UCSP.
Secondary outcomes: R0 resection, complete retrieval, and complication rates.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Safety and efficacy of UCSP for colorectal polyps will be analyzed.
Management information
Registered date
| 2017 | Year | 03 | Month | 22 | Day |
Last modified on
| 2019 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030610
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
