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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027031
Receipt No. R000030927
Scientific Title Randomized controlled trial of endoscopic closure vs. non-closure after colon ESD for preventing post-ESD coagulation syndrome and delayed perforation
Date of disclosure of the study information 2017/04/18
Last modified on 2018/12/10

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Basic information
Public title Randomized controlled trial of endoscopic closure vs. non-closure after colon ESD for preventing post-ESD coagulation syndrome and delayed perforation
Acronym CliPEC study (endoscopic Clipping closure for preventing Post-ESD Coagulation syndrome and delayed perforation)
Scientific Title Randomized controlled trial of endoscopic closure vs. non-closure after colon ESD for preventing post-ESD coagulation syndrome and delayed perforation
Scientific Title:Acronym CliPEC study (endoscopic Clipping closure for preventing Post-ESD Coagulation syndrome and delayed perforation)
Region
Japan

Condition
Condition colorectal adenoma, early colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Efficacy of endoscopic clipping closure after colon ESD for preventing PECS and delayed perforation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes The rate of PECS and delayed perforation
Key secondary outcomes The rate of PECS, delayed perforation, delayed bleeding and other complications.
Success rate and treatment time of endoscopic closure.
Elucidation for clinical features of PECS

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Non-closure
Interventions/Control_2 Endoscopic closure
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. Colorectal adenoma or eraly colorectal cancer =< 5cm that will be treated with ESD
2. Age from 20 to 85 years old
3. Agreement with signed informed consent
Key exclusion criteria 1. Tumor size > 5cm
2. Cutting line will be into appendix, ileo-cecal valve or anus
3. Severe dysfunction of heart, lung and kidney
4. Poor status: Performance Status(ECOG) 3 or 4
5. VAS>20mm, BT>37.0(celsius) or WBC>normal range
6. Administration of steroid or pain killer
7. Administration of anti-cogulant drugs
8. Pregnancy
9. Metalic allergy
10. Inappropriateness with physician's judgement
Target sample size 320

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaya Shimura
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL 052-853-8211
Email tshimura@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Nomura, Takaya Shimura
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL 052-853-8211
Homepage URL
Email tshimura@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Nagoya City University Hospital, Nagoya City West Medical Center, Japanese Red Cross Nagoya Daini Hospital, Aichi Medical University Hospital, Gifu Prefectural Tajimi Hospital, Kasugai Municipal Hospital, Chukyo Hospital, Nagoya City East Medical Center, Nagoya Memorial Hospital, Toyokawa City Hospital
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 名古屋市立大学病院(愛知県)、名古屋市立西部医療センター(愛知県)、名古屋第二赤十字病院(愛知県)、愛知医科大学病院(愛知県)、岐阜県立多治見病院(岐阜県)、春日井市民病院(愛知県)、中京病院(愛知県)、名古屋市立東部医療センター(愛知県)、名古屋記念病院(愛知県)、豊川市民病院(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 18 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
2017 Year 03 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 24 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 18 Day
Last modified on
2018 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030927

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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