UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038999 |
|---|---|
| Receipt number | R000044473 |
| Scientific Title | Second-look Endoscopy on Postoperative Day 7 Prevents Bleeding After Discharge Following Gastric Endoscopic Submucosal Dissection with High-risk of Bleeding Patients |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2020/06/30 11:16:43 |
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Basic information
Public title
Second-look Endoscopy on Postoperative Day 7 Prevents Bleeding After Discharge Following Gastric Endoscopic Submucosal Dissection with High-risk of Bleeding Patients
Acronym
SLE on POD7 for Postoperative Bleeding
Scientific Title
Second-look Endoscopy on Postoperative Day 7 Prevents Bleeding After Discharge Following Gastric Endoscopic Submucosal Dissection with High-risk of Bleeding Patients
Scientific Title:Acronym
SLE on POD7 for Postoperative Bleeding
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the efficacy of SLE on postoperative day (POD) 7 to prevent postoperative bleeding after gastric ESD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative bleeding rate
Key secondary outcomes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with the lesion including the absolute and expanded criteria based on Gastric Cancer Treatment Guideline of 5th edition.
Key exclusion criteria
Patients with previously undergone stomach surgery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Horikawa |
Organization
Hiraka General Hospital
Division name
Gastroenterology
Zip code
013-8610
Address
Maego Yastukuchi 3-1, Yokote city, Akita
TEL
0182325121
horikawa_01@me.com
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Horikawa |
Organization
Hiraka General Hospital
Division name
Gastroenterology
Zip code
013-8610
Address
Maego Yastukuchi 3-1, Yokote city, Akita
TEL
0182325121
Homepage URL
horikawa_01@me.com
Sponsor or person
Institute
Hiraka General Hospital
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
Hiraka General Hospital
Address
Maego Yastukuchi 3-1, Yokote city, Akita
Tel
0182325121
horikawa_01@me.com
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
| 2020 | Year | 01 | Month | 01 | 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
| 2019 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 12 | Month | 25 | Day |
Last modified on
| 2020 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044473
