UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057700 |
|---|---|
| Receipt number | R000065823 |
| Scientific Title | A Prospective Observational Study on the Clinical Management of Gastrointestinal Bleeding |
| Date of disclosure of the study information | 2025/04/29 |
| Last modified on | 2025/10/25 21:00:51 |
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Basic information
Public title
A Prospective Observational Study on the Clinical Management of Gastrointestinal Bleeding
Acronym
A Prospective Observational Study on Gastrointestinal Bleeding
Scientific Title
A Prospective Observational Study on the Clinical Management of Gastrointestinal Bleeding
Scientific Title:Acronym
A Prospective Observational Study on Gastrointestinal Bleeding
Region
| Japan |
Condition
Condition
Gastrointestinal bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the therapeutic efficacy and rebleeding rate in patients diagnosed with, or suspected of having, gastrointestinal bleeding by performing clinical examinations and treatments as part of routine medical care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rebleeding rate over a three-year period following initial presentation
Key secondary outcomes
Underlying pathology, therapeutic approach, clinical outcomes (success rate of hemostasis, procedure duration, incidence of intraoperative adverse events), incidence of postoperative adverse events, and length of hospital stay
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
Patients who were diagnosed with or suspected of having gastrointestinal bleeding at Keio University Hospital, who were aged 20 years or older at the time of consent, and who are able to provide written informed consent to participate in this study
Key exclusion criteria
In cases where the attending physician determines that participation in the study is inappropriate, or if the participant declines to continue participation after enrollment.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University School of Medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633790
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Rei |
| Middle name | |
| Last name | Mizobe |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1600016
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633437
Homepage URL
rei.mizobe@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Toky
Tel
0333531211
med-rinri-jimu@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 | 04 | Month | 29 | 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
| 2025 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 29 | Day |
Last follow-up date
| 2030 | Year | 04 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the rebleeding rate within three years after initial presentation in patients diagnosed with, or suspected of having, gastrointestinal bleeding, through clinical examinations and treatments performed as part of standard medical care.
Management information
Registered date
| 2025 | Year | 04 | Month | 23 | Day |
Last modified on
| 2025 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065823
