UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047558 |
|---|---|
| Receipt number | 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 | 2022/12/19 14:35:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tokuhami@hirakata.kmu.ac.jp
Sponsor or person
Institute
Third Department of Internal Medicine, Division of Gastroenterology and Hepatology, Kansai Medical University
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
Kansai Medical University
Address
2-5-1 Shinmachi, Hirakata, Osaka 573-1010, Japan.
Tel
+81-72-804-0101
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
7
Results
This research was accepted in Clinical Endoscopy on December 16, 2022.
Manuscript ID : CE-22-200
Title : Evaluation of a new method Noninjection Resection using Bipolar Soft coagulation mode; NIRBS for colonic adenomatous lesions
Results date posted
| 2022 | Year | 12 | Month | 19 | Day |
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
Completed
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
This research was accepted in Clinical Endoscopy on December 16, 2022.
Manuscript ID : CE-22-200
Title : Evaluation of a new method Noninjection Resection using Bipolar Soft coagulation mode; NIRBS for colonic adenomatous lesions
Management information
Registered date
| 2022 | Year | 04 | Month | 22 | Day |
Last modified on
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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 |
