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 | 2024/04/18 23:17:17 |
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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
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
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
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
No longer 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
| 2024 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049205
