UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043675
Receipt number R000049205
Scientific Title Effects of prophylactic clip closure versus non-closure after colorectal endoscopic submucosal dissection on postoperative outcomes: A phase III prospective randomized controlled trial
Date of disclosure of the study information 2021/05/01
Last modified on 2022/11/30 22:52:46

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Basic information

Public title

Effects of prophylactic clip closure versus non-closure after colorectal endoscopic
submucosal dissection on postoperative outcomes: A phase III prospective randomized controlled trial

Acronym

EPOC Trial

Scientific Title

Effects of prophylactic clip closure versus non-closure after colorectal endoscopic
submucosal dissection on postoperative outcomes: A phase III prospective randomized controlled trial

Scientific Title:Acronym

EPOC Trial

Region

Japan


Condition

Condition

colorectal neoplasm

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of prophylactic clip closure versus non-closure after colorectal endoscopic submucosal dissection on postoperative outcomes

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

delayed bleeding rate (severe)
delayed bleeding rate (mild)

Key secondary outcomes

delayed perforation rate
Post-ESD coagulation syndrome rate
clip closure time
the number and type of clips for closure
pathological findings
procedure time
resection speed
en bloc resection rate
complete resection rate
curative resection rate
the number of antithrombotic medicine users


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

closure group

Interventions/Control_2

non-closure group

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Lesions for which en bloc resection with snare EMR is difficult to apply and tumor size is 20 to 50 mm
(2) Aged above 20 years old
(3) Performance status of 0, 1 or 2
(4) To obey the guidelines in patients undergoing antithrombotic treatment proposed by the Japan Gastroenterological Endoscopy Society
(5) Written informed consent

Key exclusion criteria

(1) Preoperative endoscopic diagnosis of tumor depth is cT1b(SM2)
(2) Lesions of local recurrence after endoscopic resection
(3) Familial adenomatous polyposis and inflammatory bowel disease
(4) Patients with thrombocytopenia and/or bleeding tendency
(5) Women during pregnancy
(6) Unsuitable patient for clinical trial judged by clinicians

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Miyakawa

Organization

Asahi General Hospital

Division name

Department of Gastroenterology

Zip code

289-2511

Address

1326, I, Asahi ,Chiba, Japan

TEL

+81479638111

Email

a292miyaka2007@yahoo.co.jp


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Miyakawa

Organization

Asahi General Hospital

Division name

Department of Gastroenterology

Zip code

289-2511

Address

1326, I, Asahi ,Chiba, Japan

TEL

+81479638111

Homepage URL


Email

a292miyaka2007@yahoo.co.jp


Sponsor or person

Institute

Asahi General Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Asahi General Hospital

Address

1326, I, Asahi ,Chiba, Japan

Tel

+81479638111

Email

tinoue@hospital.asahi.chiba.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

国保旭中央病院
呉医療センター・中国がんセンター
横浜労災病院
北九州市立医療センター


Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 01 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

2021 Year 02 Month 01 Day

Date of IRB

2021 Year 03 Month 17 Day

Anticipated trial start date

2021 Year 06 Month 01 Day

Last follow-up date

2024 Year 06 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

2021 Year 03 Month 19 Day

Last modified on

2022 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049205


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name