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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010155
Receipt No. R000011892
Scientific Title Prospective cohort study to evaluate the effectiveness, safety and long prognosis of endoscopic submucosal dissection for colorectal tumor
Date of disclosure of the study information 2013/03/04
Last modified on 2019/09/09

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Basic information
Public title Prospective cohort study to evaluate the effectiveness, safety and long prognosis of endoscopic submucosal dissection for colorectal tumor
Acronym Prospective cohort study to evaluate the effectiveness, safety and long prognosis of ESD for colorectal tumor
Scientific Title Prospective cohort study to evaluate the effectiveness, safety and long prognosis of endoscopic submucosal dissection for colorectal tumor
Scientific Title:Acronym Prospective cohort study to evaluate the effectiveness, safety and long prognosis of ESD for colorectal tumor
Region
Japan

Condition
Condition colorectal tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the effectiveness, safety and long prognosis of ESD for colorectal tumo
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Prevalence of complete en bloc resection, complication and prognosis in patients with colorectal ESD
Key secondary outcomes Prevalence of local/metastatic recurrence and rate of metachronous colorectal lesion after ESD

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Eendoscopic submucosal dissection for colorectal tumor
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)Colorectal ESD cases
2)Early colorectal cancer (>20 mm in diameter) for which endoscopic treatment is indicative but for which en bloc resection by snare EMR would be difficult.
3) Adenoma with non-lifting sign (+) after injection during EMR procedures.
4)Local residual tumor after EMR (>10 mm in diameter) for which en bloc resection by snare EMR would be difficult.
Key exclusion criteria non
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Haruhiro
Middle name
Last name Inoue
Organization Japan Gastroenterological Endoscopy Society
Division name President
Zip code 101-0062
Address 3-2-1 Kanda surugadai, Chiyoda-ku, Tokyo
TEL 03-3542-4670
Email kaminishi.michio@gmail.com

Public contact
Name of contact person
1st name Hideki
Middle name
Last name Ishikawa
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular-Targeting Cancer Prevention
Zip code 541-0042
Address 3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL 06-6202-5444
Homepage URL
Email cancer@gol.com

Sponsor
Institute Japan Gastroenterological Endoscopy Society
Institute
Department

Funding Source
Organization Japan Gastroenterological Endoscopy Society
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japan Gastroenterological Endoscopy Society
Address Shin-ochanomizu Urban Trinity Bldg.4F, 3-2-1, Kandasurugadai, Chiyoda-ku,Tokyo, 101-0062, Japan
Tel 03-3291-4111
Email info@jges.or.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
2013 Year 03 Month 04 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 No longer recruiting
Date of protocol fixation
2012 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 04 Day
Last follow-up date
2022 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 03 Day
Last modified on
2019 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011892

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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