UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052773 |
|---|---|
| Receipt number | R000060218 |
| Scientific Title | Hemostatic procedures in gastric endoscopic submucosal exfoliation (ESD) |
| Date of disclosure of the study information | 2023/11/13 |
| Last modified on | 2023/11/12 13:47:13 |
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Basic information
Public title
Hemostatic procedures in gastric endoscopic submucosal exfoliation (ESD)
Acronym
Hemostatic procedures in gastric endoscopic submucosal exfoliation (ESD)
Scientific Title
Hemostatic procedures in gastric endoscopic submucosal exfoliation (ESD)
Scientific Title:Acronym
Hemostatic procedures in gastric endoscopic submucosal exfoliation (ESD)
Region
| Japan |
Condition
Condition
All patients who underwent gastric ESD at our department during the eligible period
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Postprocedure bleeding requires emergency endoscopic treatment and sometimes surgery. The synthetic self-assembling peptide (PureStat) is an absorbent hemostatic agent used to reduce the number of cauterizations with hemostatic forceps. It is thought to be effective in preventing posterior hemorrhage and promoting wound healing, but there have been few reports to date. In this study, we will examine the effects of hemostatic procedures using coagulation hemostats and the effects of adding PureStat to prevent posterior hemorrhage and promote wound healing after ESD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the frequency of posterior hemorrhage.
Secondary endpoints are the number of coagulation hemostasis at second-look endoscopy and the size of the ulcer base of the posttreatment ulcer at 1 and 2 months after ESD.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
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 | Maneuver |
Interventions/Control_1
In the first half of the period, the effectiveness of the conventional hemostatic method using hemostatic forceps (number of coagulation hemostasis and size of ulcer base of post-treatment ulcer 1 and 2 months after ESD) will be examined, and in the second half of the period, the conventional hemostatic method will be combined with Purestat to compare its effectiveness with that of the conventional hemostatic method.
Interventions/Control_2
In the first half of the period, the effectiveness of the conventional hemostatic method using hemostatic forceps (number of coagulation hemostasis and size of ulcer base of post-treatment ulcer 1 and 2 months after ESD) will be examined, and in the second half of the period, the conventional hemostatic method will be combined with Purestat to compare its effectiveness with that of the conventional hemostatic method.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who underwent gastric ESD in our department from September 2023 (after Ethics Committee approval) to April 2024 will be included.
Key exclusion criteria
Patients who did not give consent for clinical research.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Nagata |
Organization
Department of Gastroenterology, Hiroshima City North Medical Center Asa Citizens Hospital, Hiroshima, Japan
Division name
Department of Gastroenterology
Zip code
731-0293
Address
1-2-1 Kameyamaminami Asakita-ku, Hiroshima-shi
TEL
082-815-5211
s-nagata@asa-hosp.city.hiroshima.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Aaayama |
Organization
Department of Gastroenterology, Hiroshima City North Medical Center Asa Citizens Hospital, Hiroshima
Division name
Department of Gastroenterology
Zip code
731-0293
Address
1-2-1 Kameyamaminami Asakita-ku, Hiroshima-shi
TEL
082-815-5211
Homepage URL
asayama0502@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima City North Medical Center Asa Citizens Hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima City North Medical Center Asa Citizens 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
Hiroshima City North Medical Center Asa Citizens Hospital
Address
1-2-1 Kameyamaminami Asakita-ku, Hiroshima-shi
Tel
082-815-5211
asayama0502@hiroshima-u.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 | 11 | Month | 13 | 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
| 2023 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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 | 11 | Month | 12 | Day |
Last modified on
| 2023 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060218
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
