UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of non-anesthesiologist administrated propofol during endoscopic submucosal dissection of gastric epithelial tumors in patient with co-morbidity on American society of anaesthesiologists physical status classification
Title of the study (Brief title)	A study on the safety and efficacy of propofol sedation
Region	Japan

Condition
Condition	Gastric epithelial tumors
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the safety of propofol during endoscopic submucosal dissection of gastric epithelial tumors in patient with co-morbidity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the safety of sedation by non-anesthesiologist administrated propofol in patient with comorbidity during ESD
Key secondary outcomes	Adverse events related to ESD, Clinicopathological tumor characteristics, and Hospital stay

Base
Study type	Others,meta-analysis etc

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	All cases due to undergo gastric ESD was included in this study.
Key exclusion criteria	patient with allergy to soybeans
Target sample size	500

Research contact person
Name of lead principal investigator	Keiichiro Abe
Organization	Dokkyo medical University
Division name	Department of Gastroenterology
Address	880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL	0282861111
Email	abebe0319@gmail.com

Public contact
Name of contact person	Keiichiro Abe
Organization	Dokkyo medical University
Division name	Department of Gastroenterology
Address	880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
TEL	0282861111
Homepage URL
Email	abebe0319@gmail.com

Sponsor
Institute	Dokkyo medical University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	JPN

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	2018 Year 08 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 01 Day
Anticipated trial start date	2011 Year 04 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	none

Management information
Registered date	2018 Year 08 Month 23 Day
Last modified on	2018 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038638