UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034299 |
|---|---|
| Receipt number | R000038947 |
| Scientific Title | Feasibility study investigating the efficacy and safety of SOUTEN snare for colorectal endoscopic submucosal dissection |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2020/09/28 19:27:04 |
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Basic information
Public title
Feasibility study investigating the efficacy and safety of SOUTEN snare for colorectal endoscopic submucosal dissection
Acronym
Efficacy and safety of SOUTEN snare for colorectal endoscopic submucosal dissection
Scientific Title
Feasibility study investigating the efficacy and safety of SOUTEN snare for colorectal endoscopic submucosal dissection
Scientific Title:Acronym
Efficacy and safety of SOUTEN snare for colorectal endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
Colorectal adenoma/early colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of SOUTEN snare for Colorectal ESD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Complication rate
assessed after endoscopic treatment
Key secondary outcomes
Procedure time, The rate of adverse events (perforation, delayed bleeding)
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with colorectal adenoma/early cancer were consequentially enrolled in the present study.
Key exclusion criteria
Patients whose lesions were found to be outside the guideline or expanded criteria for ESD by the endoscopic characteristics and histological findings of biopsy specimens.
Patients in disagreement with informed consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Ohata |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastroenterology
Zip code
141-8625
Address
5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL
+81-3-3448-6111
ken.ohata1974@gmail.com
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Arimoto |
Organization
Omori Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
143-8527
Address
4-30-1, Ohta-ku, Chuo, Tokyo
TEL
+81-3-3775-3111
Homepage URL
junarimoto_junjun@yahoo.co.jp
Sponsor or person
Institute
NTT Medical Center Tokyo
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
This study do not need financial support
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Omori Red Cross Hospital
Address
4-30-1, Ohta-ku, Chuo, Tokyo
Tel
+81-3-3775-3111
junarimoto_junjun@yahoo.co.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
NTT東日本関東病院(東京都)、大森赤十字病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
119
Results
Among 137 neoplasms, SOUTEN-ESD was completed in all cases. No cases required conversion to hybrid ESD or to a dedicated ESD device. The mean procedure time was about 26 minutes. The en-bloc resection rate was 100% and the R0 resection rate was 100%. The rate of perforation was 0%, the rate of delayed bleeding was 2.2%, and the rate of post-ESD coagulation syndrome (PECS) was 2.9%.
Results date posted
| 2020 | Year | 09 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
From October 2018 to January 2019, 119 consecutive patients were prospectively enrolled and treated by SOUTEN-ESD.
Participant flow
Colorectal ESD was performed for 149 colorectal neoplasms at NTT Medical Center Tokyo and Omori Red Cross Hospital during the study period. We excluded 12 lesions (three lesions with huge polypoid growth, one lesion converging folds, four recurrent lesions after endoscopic treatment, and four lesions suspected of SM deeply invasive adenocarcinoma (SM deep invasion)) since we performed colorectal ESD with other knives.
Adverse events
The rate of perforation was 0%, the rate of delayed bleeding was 2.2% (3/137), and the rate of PECS was 2.9% (4/137).
Outcome measures
The rate of Failure of SOUTEN-ESD was 0% (The rate of complete SOUTEN-ESD was 100%).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 30 | Day |
Other
Other related information
Observational study about usefulness of SOUTEN snare for colorectal ESD
This is a single arm study.
The target lesion is adaptive lesion for conventional colorectal ESD
Management information
Registered date
| 2018 | Year | 09 | Month | 27 | Day |
Last modified on
| 2020 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038947
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| Research case data | |
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