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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047558
Receipt No. R000053955
Scientific Title Evaluation of efficacy and safety of Non Injection EMR using Bipolar Soft coagulation mode; NIEBS for colonic polyps: a single-center retrospective study of 746 procedures
Date of disclosure of the study information 2022/05/10
Last modified on 2022/04/22

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Basic information
Public title Evaluation of efficacy and safety of Non Injection EMR using Bipolar Soft coagulation mode; NIEBS for colonic polyps: a single-center retrospective study of 746 procedures
Acronym Evaluation of efficacy and safety of Non Injection EMR using Bipolar Soft coagulation mode; NIEBS for colonic polyps: a single-center retrospective study of 746 procedures
Scientific Title Evaluation of efficacy and safety of Non Injection EMR using Bipolar Soft coagulation mode; NIEBS for colonic polyps: a single-center retrospective study of 746 procedures
Scientific Title:Acronym Evaluation of efficacy and safety of Non Injection EMR using Bipolar Soft coagulation mode; NIEBS for colonic polyps: a single-center retrospective study of 746 procedures
Region
Japan

Condition
Condition colorectal adenomatous lesion
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We developed a method which in order to shorten the procedure time and to make it easy, the injection into submucosal layer under the lesion was decided not to do, the lesion was grasped including surrounding the normal mucosa, sufficiently squeezed, and resected in a short time energization by the bipolar snare having weakness burn effect setting in soft coagulation mode for a purpose of resecting without tumor residuals and preventing of perforation and delayed bleeding. This method was named Non Injection EMR using Bipolar Soft coagulation mode; NIEBS, adapted for the colorectal tumors, and evaluated its effectiveness and safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Endoscopic complete resection rate and residual or recurrence rate of colorectal adenomatous lesions by NIEBS.
Key secondary outcomes Complication rate

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria are included.
1. Colorectal elevated lesion (polyp)
2. From adenomatous lesions to T1a cancer
Key exclusion criteria If any of the following applies
1. Colorectal polyps for which dividing resection is not acceptable.
2. Colorectal polyps that may be cancer that invades deeper than the submucosa when observed endoscopically.
3. Those who refused to participate in this study.
4. Others who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size 746

Research contact person
Name of lead principal investigator
1st name Mitsuo
Middle name
Last name Tokuhara
Organization Japan Community Healthcare Organization Hoshigaoka Medical Center
Division name Department of Gastroenterology
Zip code 573-8511
Address 4-8-1 Hoshigaoka, Hirakata, Osaka 573-8511, Japan.
TEL +81-72-840-2641
Email tokuhami@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name Mitsuo
Middle name
Last name Tokuhara
Organization Kansai Medical University
Division name Third Department of Internal Medicine, Division of Gastroenterology and Hepatology
Zip code 573-1010
Address 2-5-1 Shinmachi, Hirakata, Osaka 573-1010, Japan.
TEL +81-72-804-0101
Homepage URL
Email tokuhami@hirakata.kmu.ac.jp

Sponsor
Institute Third Department of Internal Medicine, Division of Gastroenterology and Hepatology, Kansai Medical University
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 Kansai Medical University
Address 2-5-1 Shinmachi, Hirakata, Osaka 573-1010, Japan.
Tel +81-72-804-0101
Email tokuhami@hirakata.kmu.ac.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
2022 Year 05 Month 10 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
2022 Year 03 Month 20 Day
Date of IRB
2022 Year 03 Month 23 Day
Anticipated trial start date
2022 Year 03 Month 23 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None.

Management information
Registered date
2022 Year 04 Month 22 Day
Last modified on
2022 Year 04 Month 22 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053955

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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