UMIN-CTR Clinical Trial

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 Takaya Middle name Last name Shimura
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Zip code	467-8601
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 Takaya Middle name Last name Shimura
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Zip code	467-8601
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	Clinical Research Management Center, Nagoya City University Hospital
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel	052-858-7215
Email	clinical_research@med.nagoya-cu.ac.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	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	https://www.giejournal.org/article/S0016-5107(19)32480-0/fulltext
Publication of results	Published

Result
URL related to results and publications	https://www.giejournal.org/article/S0016-5107(19)32480-0/fulltext
Number of participants that the trial has enrolled	181
Results	https://www.giejournal.org/article/S0016-5107(19)32480-0/fulltext
Results date posted	2022 Year 10 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 11 Month 27 Day
Baseline Characteristics	https://www.giejournal.org/article/S0016-5107(19)32480-0/fulltext
Participant flow	https://www.giejournal.org/article/S0016-5107(19)32480-0/fulltext
Adverse events	https://www.giejournal.org/article/S0016-5107(19)32480-0/fulltext
Outcome measures	https://www.giejournal.org/article/S0016-5107(19)32480-0/fulltext
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 29 Day
Date of IRB	2017 Year 04 Month 14 Day
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	2022 Year 10 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030927