UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Single center retrospective observational study for management of upper gastrointestinal bleeding between by emergency physician with endoscopy training and gastroenterologist or general surgeon
Title of the study (Brief title)	Retrospective study for management of upper gastrointestinal bleeding by emergency physician
Region	Japan

Condition
Condition	gastrointestinal bleeding
Classification by specialty	Gastroenterology Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clinical outcomes and safety of gastrointestinal bleeding cases between treated by an emergency physician (EP) and by gastroenterologist or general surgeon
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Mortality
Key secondary outcomes	Transfusion, rebleeding and 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	18 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Upper GI bleeding cases treated using endoscopy in the emergency department between 2012 and 2014
Key exclusion criteria	Patients transferred from other hospitals, or had GI bleeding during the hospital stay due to non-GI causes
Target sample size	50

Research contact person
Name of lead principal investigator	Yoshiro Kobe
Organization	Kuki General Hospital
Division name	Department of Emergency and Critical Care Medicine
Address	418-1, Kamihayami, Kuki, Saitama
TEL	81480260033
Email	y-kobe@umin.org

Public contact
Name of contact person	Yoichi Kobayashi
Organization	Shin-Kuki General Hospital
Division name	General Administration Department
Address	418-1, Kamihayami, Kuki, Saitama
TEL	81480260033
Homepage URL
Email	y-kobayashi@shinkuki-hp.jp

Sponsor
Institute	Kuki General Hospital
Institute
Department

Funding Source
Organization	Kuki General Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 05 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 20 Day
Anticipated trial start date	2016 Year 09 Month 20 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	A retrospective chart review was conducted on all patients admitted to the emergency department of the Kuki General Hospital between April 2012 and March 2014.

Management information
Registered date	2017 Year 05 Month 22 Day
Last modified on	2018 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031447