UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056957 |
|---|---|
| Receipt number | R000065091 |
| Scientific Title | Retrospective observational study on the efficacy of PuraStat in preventing delayed bleeding after endoscopic treatment of the gastrointestinal tract |
| Date of disclosure of the study information | 2025/02/06 |
| Last modified on | 2025/02/06 16:56:53 |
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Basic information
Public title
Retrospective observational study on the efficacy of PuraStat in preventing delayed bleeding after endoscopic treatment of the gastrointestinal tract
Acronym
R-PPE
Scientific Title
Retrospective observational study on the efficacy of PuraStat in preventing delayed bleeding after endoscopic treatment of the gastrointestinal tract
Scientific Title:Acronym
R-PPE
Region
| Japan |
Condition
Condition
Cases in which PuraStat was used during endoscopic resection of gastrointestinal tumors with a particularly high risk of delayed bleeding (cases in which the patient was taking antithrombotic medication, cases in which endoscopic resection of the duodenal bulb was performed and suture was not performed), cases in which PuraStat was used for gastroduodenal ulcer bleeding, cases in which PuraStat was used for bleeding after endoscopic treatment PuraStat was used for delayed bleeding after endoscopic treatment.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether PuraStat can prevent delayed bleeding after endoscopic procedures
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of delayed bleeding will be calculated and compared with previously reported cases and cases without PuraStat under similar conditions at our hospital.
Key secondary outcomes
Rate of delayed perforation, difference in rate of delayed bleeding by treatment site (duodenal vs. other), postoperative course, medical costs (calculated from devices used, labor costs, hospitalization costs, etc.)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases in which PuraStat was used during endoscopic resection of gastrointestinal tumors with a particularly high risk of delayed bleeding (cases in which patients were taking antithrombotic medications, cases in which endoscopic resection of the duodenal bulb was performed and suture was not performed), cases in which PuraStat was used for gastroduodenal ulcer bleeding, cases in which PuraStat was used for bleeding after endoscopic treatment PurStat was used for delayed bleeding after endoscopic treatment.
Key exclusion criteria
Cases in which the use of PuraStat was discontinued due to allergic reaction to PuraStat, etc., cases in which other hemostatic agents were used concomitantly, cases with hematological diseases, and cases in which refusal to participate in the study was made by the patient or his/her representative.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University Hospital
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
1608582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakayama |
Organization
Keio University Hospital
Division name
Cancer Center
Zip code
1608582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
anakayama34@keio.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
Funding Source
Organization
3-D Matrix, Inc.
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 Keio university school of medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-ft_pt@adst.keio.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
| 2025 | Year | 02 | Month | 06 | 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
| 2024 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2025 | Year | 02 | Month | 06 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065091
