UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050282 |
|---|---|
| Receipt number | R000057256 |
| Scientific Title | New closure method using traction device for mucosal defects after endoscopic submucosal dissection of gastric neoplasms |
| Date of disclosure of the study information | 2023/02/09 |
| Last modified on | 2023/02/09 12:20:03 |
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Basic information
Public title
New closure method using traction device for mucosal defects after endoscopic submucosal dissection of gastric neoplasms
Acronym
New closure method using traction device for mucosal defects after endoscopic submucosal dissection of gastric neoplasms
Scientific Title
New closure method using traction device for mucosal defects after endoscopic submucosal dissection of gastric neoplasms
Scientific Title:Acronym
New closure method using traction device for mucosal defects after endoscopic submucosal dissection of gastric neoplasms
Region
| Japan |
Condition
Condition
gastric neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the feasibility and efficacy of a new and simple method using traction device for closing mucosal defects after gastric ESD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complete closure rate
Key secondary outcomes
procedure time, number of clips used, number of traction devices used, ulcer closure rate on postoperative day 3, incidence of post-ESD bleeding and delayed perforation, incidence of PECS, incidence of other adverse events, ulcer healing rate 1 month after closure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After the submucosal layer at the lateral side of the mucosal defect was undermined, the mucosal defect is closed with clips using traction devices.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for ESD for gastric neoplasms
Key exclusion criteria
cases in which informed consent was not obtained for the study, cases in which part of the lesion extends to either the cardia or the pyloric ring, cases in which ulceration after resection of the lesion extends to 1/2 circumferential of the stomach, cases with severe organ failure, cases with abnormal blood clotting function with high bleeding risk, cases in which perforation was evident at the time of lesion resection, cases during pregnancy, patients in a situation where an urgent and obvious life crisis has occurred for some reason, and other cases that the attending physician or surgeon deems inappropriate for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Sumiyama |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
105-8461
Address
3-19-18, Nishishimbashi, Minato-ku
TEL
+81334331111
kaz_sum@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Ono |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
105-0003
Address
3-19-18, Nishishimbashi, Minato-ku
TEL
09072447358
Homepage URL
onoshingo@mbe.nifty.com
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of the Jikei University School of Medicine
Address
3-19-18, Nishishimbashi, Minato-ku
Tel
+81334331111
rinri@jikei.ac.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | 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
| 2023 | Year | 02 | Month | 09 | Day |
Last modified on
| 2023 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057256
