UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000034299
Receipt No. 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 (Ver. 5)

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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
Email 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
Email junarimoto_junjun@yahoo.co.jp

Sponsor
Institute NTT Medical Center Tokyo
Department of Gastroenterology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038947