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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004040
Receipt No. R000004868
Scientific Title Prospective cohort study to evaluate the efficacy and safety of endoscopic submucosal dissection for colorectal tumor
Date of disclosure of the study information 2010/08/14
Last modified on 2010/08/14

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Basic information
Public title Prospective cohort study to evaluate the efficacy and safety of endoscopic submucosal dissection for colorectal tumor
Acronym Prospective cohort study to evaluate the efficacy and safety of ESD for colorectal tumor
Scientific Title Prospective cohort study to evaluate the efficacy and safety of endoscopic submucosal dissection for colorectal tumor
Scientific Title:Acronym Prospective cohort study to evaluate the efficacy and safety 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 efficacy and safety of ESD for colorectal tumor
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prevalence of complete en bloc resection and complication in colorectal ESD
Key secondary outcomes Prevalence of local/residual recurrence after ESD

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 Colorectal ESD cases

Early colorectal cancer (larger than 20 mm in diameter) for which endoscopic treatment is indicative but for which en bloc resection by snare EMR would be difficult.

Adenoma with non-lifting sign (+) after injection during EMR procedures.

Local residual tumor after EMR (larger than 10 mm in diameter) for which en bloc resection by snare EMR would be difficult.
Key exclusion criteria Excluding the sentences above
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michio Kaminishi
Organization Japan Gastroenterological Endoscopy Society (JGES)
Division name President
Zip code
Address 3-22 Kanda Ogawamachi, Chiyoda-ku, Tokyo, Japan
TEL 03-3291-4111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Ishikawa
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular-Targeting Cancer Prevention
Zip code
Address 3-1-2F Kyomachibori Nishi-ku 2-chome Osaka 550-0003, Japan
TEL 06-6445-5585
Homepage URL
Email cancer@gol.com

Sponsor
Institute Japan Gastroenterological Endoscopy Society (JGES)
Institute
Department

Funding Source
Organization Japan Gastroenterological Endoscopy Society (JGES)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2010 Year 08 Month 14 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 Open public recruiting
Date of protocol fixation
2010 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cohort study

Management information
Registered date
2010 Year 08 Month 14 Day
Last modified on
2010 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004868

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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