UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020158 |
|---|---|
| Receipt number | R000023285 |
| Scientific Title | Efficacy of the shortening procedure time and safety under sufficient counter traction using Endoscopic Ring Thread Technique (ERTT) |
| Date of disclosure of the study information | 2015/12/10 |
| Last modified on | 2018/12/11 16:21:13 |
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Basic information
Public title
Efficacy of the shortening procedure time and safety under sufficient counter traction using Endoscopic Ring Thread Technique (ERTT)
Acronym
Efficacy of the ERTT
Scientific Title
Efficacy of the shortening procedure time and safety under sufficient counter traction using Endoscopic Ring Thread Technique (ERTT)
Scientific Title:Acronym
Efficacy of the ERTT
Region
| Japan |
Condition
Condition
The inclusion criteria of this study's patients who satisfied the following expanded indication inclusion criteria for ESD according to the guidelines of the Japan Gastric Cancer Association
(JGCA) were included. In differentiated gastric cancers, intramucosal carcinoma has no size restriction, whereas intramucosal carcinoma accompanied by ulcer scar and SM1 carcinoma
(500 um from the muscularis mucosae) should be <30 mm. In undifferentiated carcinomas,
intramucosal carcinoma should be <20 mm. Included patients consented to the study
after receiving oral and written explanations.
Classification by specialty
| Medicine in general | Gastroenterology | Surgery in general |
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
During gastric endoscopic submucosal dissection, the clear surgical view is necessary to perform the procedure safely.Under clear view using ERTT enable us to perform ESD without bleeding and perforation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
The procedure time of ESD between ERTT group and conventionalgroup
Key secondary outcomes
1.Bleeding during ESD
2.The procerure time of creating ERTT
3.Evaluation of visibility of ERTT using VAS (visual analogue sysytem) score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Innovative endoscopic counter traction method called ERTT which was made of surgical thread like ring-shaped thread
Interventions/Control_2
Conventional ESD
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
| 89 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria of this study's patients who satisfied the following expanded indication inclusion criteria for ESD according to the guidelines of the Japan Gastric Cancer Association
(JGCA) were included. In differentiated gastric cancers, intramucosal carcinoma has no size restriction, whereas intramucosal carcinoma accompanied by ulcer scar and SM1 carcinoma
(500 um from the muscularis mucosae) should be <30 mm. In undifferentiated carcinomas,
intramucosal carcinoma should be <20 mm. Included patients consented to the study
after receiving oral and written explanations.
Key exclusion criteria
Patients who should be removed the lesion by operation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mori Hirohito |
Organization
Kagawa university
Division name
Department of Gastroenterology and Neurology
Zip code
Address
1750-1, Miki, Kida, Kagawa, Japan
TEL
087-891-1256
hiro4884@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hayashi Yukari |
Organization
Ehime Rousai Hospital
Division name
Medical Affairs Division
Zip code
Address
13-27, Minamikomatsubara, Niihama, Ehime 792-8550, Japan
TEL
0897-33-6191
Homepage URL
ijikachou@ehimerosai.jp
Sponsor or person
Institute
Kagawa university
Institute
Department
Personal name
Funding Source
Organization
Ehime rousai hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 12 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 19 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 10 | Day |
Last modified on
| 2018 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023285
