UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043191 |
|---|---|
| Receipt number | R000049119 |
| Scientific Title | Results of Endoscopic Treatment of Colorectal Polyps and Long-Term Postoperative Outcome |
| Date of disclosure of the study information | 2021/01/31 |
| Last modified on | 2021/01/31 08:19:12 |
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Basic information
Public title
Results of Endoscopic Treatment of Colorectal Polyps
and Long-Term Postoperative Outcome
Acronym
Prospective Colorectal Polypectomy Study
Scientific Title
Results of Endoscopic Treatment of Colorectal Polyps
and Long-Term Postoperative Outcome
Scientific Title:Acronym
Prospective Colorectal Polypectomy Study
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate and clarify the following points in the endoscopic treatment of colorectal adenoma and colorectal cancer from a forward perspective.
1) Risk factors for segmental resection in colorectal HSP/CSP/EMR/ESD
2) Postoperative recurrence rate and risk factors affecting recurrence in colorectal HSP/CSP/EMR/ESD.
To compare the en bloc resection rate of colorectal HSP/CSP/EMR/ESD according to the treatment outcome, patient background, and years of experience of the surgeon within the same treatment method and between different treatment methods. This study is expected to enable the selection of an appropriate treatment method for colorectal neoplastic lesions and the selection of an appropriate surgeon based on years of experience. By examining and clarifying the above, it will be possible to select a safer, less burdensome, and more effective treatment method for patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of endoscopic en bloc resection, rate of accidental segmental resections that may occur when en bloc resection is performed
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients undergoing endoscopic treatment for colorectal polyps at our hospital
Key exclusion criteria
Patients whose consent could not be obtained
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Matsumura |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
2608677
Address
1-8-1 Inohana, Chuo-ku, Chiba(260-8677)
TEL
0432227171
tsubasaishikawa19881212@gmail.com
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Ishikawa |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
2608677
Address
1-8-1 Inohana, Chuo-ku, Chiba(260-8677)
TEL
0432262083
Homepage URL
ishikawa.tsubasa@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba(260-8677)
Tel
0432227171
ishikawa.tsubasa@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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Methods
The data will be picked up by medical records.
1) Patient background: gender, race, height, weight, comorbidities, medical history, current medical history, previous treatment, etc.
(2) Confirmation of subjective symptoms: Confirm by interview, etc. 2) Confirmation of subjective symptoms: Check by interview, etc. If there is a symptom diary, refer to it.
3) Blood pressure and pulse rate
(4) Blood tests: Blood chemistry tests: AST/ALT, Bil, TP/Alb, etc., to evaluate liver function and nutritional status; UN/Cre, etc., to evaluate renal function; CEA/AC19-9, etc., to evaluate tumor markers; PT/APTT, etc., to evaluate coagulation function; and blood count. 5) Urinalysis
5) Urinalysis: general urine, urine sediment, etc.
5) Urinalysis: general urine, urine sediment, etc. 6) Endoscopic findings, comparison with gross system.
7) Lesion factors (localization, gross type, tumor diameter, pathological findings [atypia, R0 resection, other], etc.)
Survival time. Presence of disease recurrence
(9) Complications/contingencies caused by treatment.
(x) Number of years of experience of the surgeon.
Summary of analysis
To examine the relationship between the accidental segmental resection rate, complication rate, patient background factors (age, gender, comorbidities, lifestyle, number of treatments, etc.), lesion factors (localization, gross type, tumor diameter, pathological findings [atypia, R0 resection, other], etc.), and surgeon factors (years, years of experience) for endoscopic treatment of colorectal adenoma and colorectal cancer.
Main analysis methods
The unpaired t test or chi-square test will be used for each factor to test for significant differences. Univariate/multivariate analysis will be performed to detect factors that contribute to the risk of segmental resection. Propensity score matching will be used as needed.
Management information
Registered date
| 2021 | Year | 01 | Month | 31 | Day |
Last modified on
| 2021 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049119
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