UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041385 |
|---|---|
| Receipt number | R000047244 |
| Scientific Title | A randomized controlled trial comparing an S-O clip and a clip with line traction method of endoscopic submucosal dissection for gastric epithelial neoplasia |
| Date of disclosure of the study information | 2020/08/11 |
| Last modified on | 2024/02/14 00:15:28 |
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Basic information
Public title
A randomized controlled trial comparing an S-O clip and a clip with line traction method of endoscopic submucosal dissection for gastric epithelial neoplasia
Acronym
A randomized controlled trial comparing an S-O clip and a clip with line traction method of endoscopic submucosal dissection for gastric epithelial neoplasia
Scientific Title
A randomized controlled trial comparing an S-O clip and a clip with line traction method of endoscopic submucosal dissection for gastric epithelial neoplasia
Scientific Title:Acronym
A randomized controlled trial comparing an S-O clip and a clip with line traction method of endoscopic submucosal dissection 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
Comparing the ESD procedure-related effects of an S-O clip and a clip with line in the traction-assisted gastric ESD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastric ESD procedure time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
S-O clip-assisted ESD group
Interventions/Control_2
Clip with line-assisted 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
| 94 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Histopathologically proven gastric adenoma or cancer that meets the absolute or expanded indication of ESD according to the Japanese gastric cancer treatment guideline 2018 (5th edition)
2)No gastrectomy and reconstructive surgery of gastric tube for esophageal cancer
3)Eastern Cooperative Oncology Group Performance Status ranges from 0 to 2
4)Written informed consent by the patient
5)Patient age between 20 and 94 years
Key exclusion criteria
1)Pregnant patients or with the possibility of the pregnancy
2)Lactating patients
3)Patients disqualified for this study by the physician
4)Patients who have participated in this study
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Nagata |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Department of Endoscopy
Zip code
253-0041
Address
1-5-1 TUJIDOUKANDAI FUJISAWA-SHI KANAGAWA JAPAN
TEL
0466-35-1177
mitsuru10jp@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Nagata |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Department of Endoscopy
Zip code
253-0041
Address
1-5-1 TUJIDOUKANDAI FUJISAWA-SHI KANAGAWA JAPAN
TEL
0466-35-1177
Homepage URL
mitsuru10jp@yahoo.co.jp
Sponsor or person
Institute
Department of Endoscopy, Shonan Fujisawa Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Fujisawa Tokushukai 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
Mirai Iryo Research Center
Address
1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
Tel
03-3263-4801
shimizu@mirai-iryo.com
Secondary IDs
Secondary IDs
YES
Study ID_1
TGE01528-008
Org. issuing International ID_1
Mirai Iryo Research Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
湘南藤沢徳洲会病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 11 | 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
| 2020 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 11 | Day |
Last modified on
| 2024 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047244
