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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009112
Receipt No. R000010686
Scientific Title Examination of suturing of the wound using endoscopic clips which was made by endoscopic submucosal dissection (ESD) for the colorectal tumor to prevent the complications and accerarate the repair of the dissected area.
Date of disclosure of the study information 2012/10/15
Last modified on 2013/10/15

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Basic information
Public title Examination of suturing of the wound using endoscopic clips which was made by endoscopic submucosal dissection (ESD) for the colorectal tumor to prevent the complications and accerarate the repair of the dissected area.
Acronym Efficacy of suturing of the wound using endoscopic clips which was made by ESD for colorectal tumor.
Scientific Title Examination of suturing of the wound using endoscopic clips which was made by endoscopic submucosal dissection (ESD) for the colorectal tumor to prevent the complications and accerarate the repair of the dissected area.
Scientific Title:Acronym Efficacy of suturing of the wound using endoscopic clips which was made by ESD for colorectal tumor.
Region
Japan

Condition
Condition More than 20mm colorectal tumors which can be resected using endoscopy.
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to evaluate 1)preventing the complications and 2)accereration of wound healing of dissected area in patients with colorectal tumors after ESD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Check for complications and repair rate of dissecterd area after ESD.
Key secondary outcomes Residual rate of the endoscopic clips for sutured the wound after ESD.

Correlation between the size of wound area after ESD and period of complete repair.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 endoscopic clips
Interventions/Control_2 no endoscopic clips
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 A patient who is diagnosed colorectal tumor more than 20mm.
Key exclusion criteria 1. A patient who can not be gained agreement with our informed consent.
2. A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.
3. A patient who can not be resected endoscopic treatment.
4. A patient who is suffered major complications under the endoscopic treatment.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoto Sakamoto
Organization Juntendo University
Division name Gastroenterology
Zip code
Address Hongo 3-1-3, Bunkyo-ku,Tokyo 113-8421,Japan
TEL 03-3813-3111
Email sakamoto@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taro Osada
Organization Juntendo University
Division name Gastroenterology
Zip code
Address Hongo 3-1-3, Bunkyo-ku,Tokyo 113-8421,Japan
TEL 03-3813-3111
Homepage URL
Email otaro@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
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
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
2012 Year 10 Month 15 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 07 Month 02 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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

Management information
Registered date
2012 Year 10 Month 15 Day
Last modified on
2013 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010686

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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