UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the intravenous anesthesia using propofol plus dexmedetomidine in endoscopic submucosal dissection
Title of the study (Brief title)	Evaluation of the intravenous anesthesia using propofol plus dexmedetomidine in endoscopic submucosal dissection
Region	Japan

Condition
Condition	Superficial esophageal cancer or early gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Comparison of the effects in safety and ESD treatment results between propofol alone and propofol plus dexmedetomidine as the intravenous anesthesia in ESD
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient's hemodynamics during ESD
Key secondary outcomes	ESD performances

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Propofol plus dexmedetomidine
Interventions/Control_2	Propofol alone
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	The superficial esophageal cancer and early gastric cancer which plan to be resected by endoscopic submucosal dissection.
Key exclusion criteria	Patients with serious cardiovascular or pulmonary disease, renal dysfunction and liver dysfunction.
Target sample size	100

Research contact person
Name of lead principal investigator	Nonaka Takashi
Organization	Yokohama City University Hospital
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL	045-787-2640
Email	nonaka@yokohama-cu.ac.jp

Public contact
Name of contact person	Nonaka Takashi
Organization	Yokohama City University Hospital
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL	045-787-2640
Homepage URL
Email	nonaka@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Hospital, Department of Gastroenterology and Hepatology
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)

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	2014 Year 05 Month 09 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 04 Month 11 Day
Anticipated trial start date	2014 Year 05 Month 09 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 04 Month 16 Day
Last modified on	2016 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016038