UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025125 |
|---|---|
| Receipt number | R000028889 |
| Scientific Title | A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia. |
| Date of disclosure of the study information | 2016/12/30 |
| Last modified on | 2019/06/09 09:36:52 |
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Basic information
Public title
A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia.
Acronym
A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia.
Scientific Title
A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia.
Scientific Title:Acronym
A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia.
Region
| Japan |
Condition
Condition
early gastric cancer/gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of traction ESD with the S-O clip compared with conventional ESD in terms of procedure time for patients with gastric epithelial neoplasia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
ESD procedure time
Key secondary outcomes
Adverse events(delayed bleeding/perforation), ESD procedure time according to the location of the lesion, the proficiency of the operator (trainee or expert)and the presence of ulcer findings; en bloc resection rate; complete en bloc resection rate; amount of submucosal injection
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A: traction ESD with the S-O clip group
Interventions/Control_2
B: Conventional ESD group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven gastric adenoma or cancer, which is within the absolute or expanded indication of ESD according to Japanese gastric cancer treatment guideline 2014.
2) No gastrectomy and no reconstructive surgery of gastric tube for esophageal cancer.
3) Aged 20 years old or more.
4) ECOG performance status of 0, 1 or 2.
5) Predicted line of mucosal incision is not on the EG junction.
6) Predicted line of mucosal incision is not on the pylorus.
7) Follow up for 60 days after ESD.
8) Written informed consent.
Key exclusion criteria
1) Patients who are disqualified for this study by physicians
2) Patients with the possibility of the pregnancy or the pregnancy
3) Patients who are lactating
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dai Hirasawa |
Organization
Sendai Kousei Hospital
Division name
Department of Gastroenterology
Zip code
Address
Hirose-cho 4-15, Aoba-ku, Sendai city, Miyagi, Japan
TEL
022-222-6181
hirasawa@sendai-kousei-hospital.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rintaro Hashimoto |
Organization
Sendai Kousei Hospital
Division name
Department of Gastroenterology
Zip code
Address
Hirose-cho 4-15, Aoba-ku, Sendai city, Miyagi, Japan
TEL
022-222-6181
Homepage URL
rhashimoto@sendai-kousei-hospital.jp
Sponsor or person
Institute
Sendai Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
Sendai Kousei Hospital
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
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
仙台厚生病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 30 | 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
| 2016 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 02 | Day |
Last modified on
| 2019 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028889
