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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031248
Receipt No. R000035679
Scientific Title The Efficacy and Safety of Cold Snare Endoscopic Mucosal Resection for 10-14mm Flat and Sessile Colorectal Adenomas
Date of disclosure of the study information 2018/02/19
Last modified on 2020/06/11

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Basic information
Public title The Efficacy and Safety of Cold Snare Endoscopic Mucosal Resection for 10-14mm Flat and Sessile Colorectal Adenomas
Acronym ECO trial
Scientific Title The Efficacy and Safety of Cold Snare Endoscopic Mucosal Resection for 10-14mm Flat and Sessile Colorectal Adenomas
Scientific Title:Acronym ECO trial
Region
Japan

Condition
Condition 10-14mm flat and sessile colorectal adenomas
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and efficacy of cold snare endoscopic mucosal resection for flat and sessile colorectal adenomas (10-14 mm in size).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes En-bloc complete resection rate by histological examination
Key secondary outcomes 1. Rate of immediate bleeding requiring endoscopic hemostasis
2. Rate of delayed adverse events (perforation, bleeding)
3. Rate of impossible resection
4. En-bloc complete resection rate by endoscopic examination
5. Rate of white protrusions within the cold snare defect
6. Rate of resected specimens containing submucosal layer

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Cold snare endoscopic mucosal resection
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Flat and sessile adenomas (10-14 mm in size)
2. 20 years old and more
3. Written informed consent
Key exclusion criteria 1. Synchronous colorectal cancer requiring surgery
2. Inflammatory bowel disease or familial adenomatous polyposis patients
3. Blood coagulation disorder
4. Infectious disease with systemic therapy indicated
5. Hemodialysis
6. Impossible to suspend anticoagulant or antiplatelet medications
7. Others
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kenichiro
Middle name
Last name Imai
Organization Shizuoka Cancer Center
Division name Division of Endoscopy
Zip code 411-8777
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL 055-989-5222
Email k.imai1977@gmail.com

Public contact
Name of contact person
1st name Yohei
Middle name
Last name Yabuuchi
Organization Shizuoka Cancer Center
Division name Division of Endoscopy
Zip code 411-8777
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL 055-989-5222
Homepage URL
Email y.yabuuchi@scchr.jp

Sponsor
Institute Division of Endoscopy, Shizuoka Cancer Center
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 Shizuoka Cancer Center
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
Tel 055-989-5222
Email tansaku_office@scchr.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 静岡県立静岡がんセンター

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 19 Day

Related information
URL releasing protocol https://doi.org/10.1016/j.gie.2020.05.019
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1016/j.gie.2020.05.019
Number of participants that the trial has enrolled 80
Results
CS-EMR failed in 11 lesions (13.8%), all of which were resected using high-frequency electric current. En bloc resection rate by CS-EMR and histological complete resection rate by CS-EMR were 82.5% (66/80) and 63.8% (51/80), respectively. 

Of all 80 lesions, white protrusion within the mucosal defect, and submucosal layer in the resected specimens were found in 43 (53.8%), and 20 lesions (25.0%), respectively.
Results date posted
2020 Year 06 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 05 Month 25 Day
Baseline Characteristics
72 patients with 80 polyps were included. The median patient age was 68.5 years. 47 (65.3%) were men and 12 (16.7%) took antithrombotic drugs. 
The median size of polyps was 12 mm. Most polyps (63.8%) were located at the right colon, 56.3% had a slightly elevated morphology.
Participant flow
During the study period, 75 patients were assessed for eligibility, and 3 were excluded because 2 patients met the exclusion criteria and one polyp in the other patient was diagnosed as non-neoplastic lesion prior to CS-EMR.
Adverse events
No immediate bleeding occurred during the CS-EMR procedure.
No serious adverse events occurred.
Minor postprocedural bleeding was observed in 12 patients (16.7%). Seven patients (9.7%) complained of abdominal symptoms, 
Outcome measures
The primary outcome was histological complete resection rate by CS-EMR, which was defined as en bloc resection, pathologically negative vertical margin, and no neoplastic tissue obtained from four quadrants of the mucosal defect margin. The secondary outcomes were en bloc resection rate by CS-EMR; failure rate of CS-EMR; the incidence of adverse events such as immediate bleeding, delayed bleeding, delayed perforation, minor postprocedural bleeding, and abdominal symptoms; the presence of white protrusions within the mucosal defect; and the presence of a submucosal layer and muscularis mucosal layer in the resected specimens.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 01 Month 28 Day
Date of IRB
2018 Year 02 Month 06 Day
Anticipated trial start date
2018 Year 02 Month 19 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 08 Month 31 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 02 Month 11 Day
Last modified on
2020 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035679

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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