UMIN-CTR Clinical Trial

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
Email	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
Email	ishikawa.tsubasa@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049119