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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043675
Receipt No. 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 2021/05/15

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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
Institute Asahi General Hospital
Institute
Department

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

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 Preinitiation
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 05 Month 01 Day
Last follow-up date
2024 Year 05 Month 31 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
2021 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.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


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