UMIN-CTR Clinical Trial

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
Email	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
Email	masayasu-horibe@umin.ac.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023707