UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study about efficacy of Dexmedetomidine as a novel sedative agent during ESD for esophageal cancer
Title of the study (Brief title)	Efficacy of Dexmedetomidine during esophageal ESD
Region	Japan

Condition
Condition	Esophageal cancer (SCC)
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of new sedation using Dexmedetomidine during ESD for esophageal cancer in prospective study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	The ratio of the cases with no body movement during ESD
Key secondary outcomes	1 The frequency of respiratory depression, hypotention and bradycardia 2 Patients' levels of conciousness and suffer 3 Endoscopists' satisfaction level for sedation 4 Efficacy of BIS 5 Total consumed amount of midazolam and pethidine hydrochloride

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Sadation by dexmedetomidine, midazolam and pethidine hydrochloride during esophageal ESD
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1 Histologically diagnosed squamous cell carcinoma by endoscopic biopsy 2 SM1 or less in tumor invasion by preoperative diagnosis 3 Located in Ut/Mt/Lt/Ae, and able to perform ESD without intubation 4 No lymph node or distant metastasis by preoperative CT 5 Age is 20-80 6 Performance status is 0-2 7 No severe organ dysfunction 8 Written informed consent are obtained
Key exclusion criteria	1 Uncontrollable hypertention 2 Uncontrollable heart disease or arrhythmia 3 Respiratory disease needed oxygen in rest 4 Unstable angina (newly occurred or worsened in these 3 weeks) or myocardial infarction within 6 months 5 Difficult to discontinue antithrombotic drugs during preoperative period 6 Severe infectious disease needed systemic treatment 7 Patients judged inappropriate by investigator or attending doctor
Target sample size	65

Research contact person
Name of lead principal investigator	Toshiyuki Yoshio
Organization	Cancer Institute Hospital
Division name	Gstroenterology
Address	3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL	03-3520-0111
Email	toshiyuki.yoshio@jfcr.or.jp

Public contact
Name of contact person	Toshiyuki Yoshio
Organization	Cancer Institute Hospital
Division name	Gastroenterology
Address	3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL	03-3520-0111
Homepage URL
Email	toshiyuki.yoshio@jfcr.or.jp

Sponsor
Institute	Department of Gastroenterology,Cancer Institute Hospital
Institute
Department

Funding Source
Organization	non
Organization
Division
Category of Funding Organization	Other
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	がん研有明病院(東京都)

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 18 Day
Anticipated trial start date	2014 Year 10 Month 20 Day
Last follow-up date	2015 Year 10 Month 23 Day
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

Management information
Registered date	2015 Year 04 Month 28 Day
Last modified on	2018 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020077