UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031248 |
|---|---|
| Receipt number | 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 11:24:06 |
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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
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
y.yabuuchi@scchr.jp
Sponsor or person
Institute
Division of Endoscopy, Shizuoka Cancer Center
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
Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
Tel
055-989-5222
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035679
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