UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021302 |
|---|---|
| Receipt number | R000023707 |
| Scientific Title | The validation of new simple scoring system to assess the need for an urgent endoscopy in suspected upper gastrointestinal bleeding:multiple prospective cohort study |
| Date of disclosure of the study information | 2016/03/02 |
| Last modified on | 2021/09/06 15:29:02 |
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Basic information
Public title
The validation of new simple scoring system to assess the need for an urgent endoscopy in suspected upper gastrointestinal bleeding:multiple prospective cohort study
Acronym
The validation of new simple scoring system to assess the need for an urgent endoscopy in suspected upper gastrointestinal bleeding:multiple prospective cohort study
Scientific Title
The validation of new simple scoring system to assess the need for an urgent endoscopy in suspected upper gastrointestinal bleeding:multiple prospective cohort study
Scientific Title:Acronym
The validation of new simple scoring system to assess the need for an urgent endoscopy in suspected upper gastrointestinal bleeding:multiple prospective cohort study
Region
| Japan |
Condition
Condition
upper gastrointestinal bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The validation of new simple scoring system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The need for an urgent endoscopy
Key secondary outcomes
The use of endoscopic therapy
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All consecutive patients with suspected UGIB based on the presence of hematemesis, coffee ground vomitemesis, nasogastric lavage with blood, or coffee grounds in the initial examination, or melena or tarry or black stool as determined by rectal examination or history
Key exclusion criteria
Patients with iatrogenic bleeding following endoscopic procedures
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Hosoe |
Organization
Keio University School of Medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
+81-3-5363-3790
hosenao@db3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Masayasu |
| Middle name | |
| Last name | Horibe |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology Department of Internal Medicine
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
+81-3-5363-3790
Homepage URL
masayasu-horibe@umin.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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 ethical committee
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
Tel
03-3353-1211
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
| 2016 | Year | 03 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: prospective cohort study
Study duration:March 2016 to March 2025
Objective:All consecutive patients with suspected UGIB based on the presence of hematemesis, coffee ground vomitemesis, nasogastric lavage with blood, or coffee grounds in the initial examination, or melena or tarry or black stool as determined by rectal examination or history
Investigation items: Gender, age, disease, admission, time until urgent endoscopy is performed, endoscopic findings, use of endoscopic therapy,Blood transfusion, interventional radiology, surgery,Rebleeding, death, past history(gastro-duodenal ulcer, varix, upper gastrointestinal bleeding, hepatic disease, cardiac failure, use of PPI, systolic blood pressure and corresponding heart rate, the conscious, syncope, melena, blood test(WBC, hemoglobin, albumin, urea[BUN], creatinine, PT-INR), use of nasal tube
Management information
Registered date
| 2016 | Year | 03 | Month | 02 | Day |
Last modified on
| 2021 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023707
