UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027031
Receipt number 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 2022/10/22 09:17:44

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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