UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of dexmedetomidine in the prophylactic endoscopic injection sclerotherapy for esophageal varices: A study protocol for prospective interventional study
Title of the study (Brief title)	Effect of dexmedetomidine in the prophylactic endoscopic injection sclerotherapy for esophageal varices: A study protocol for prospective interventional study
Region	Japan

Condition
Condition	Esophageal varices
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aims of the current study are to prospectively examine the safety and usefulness of DEX on sedation during prophylactic EIS for patients with EVs.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(a)Decreasing rate in SpO2 during endoscopic procedures (b)Increasing or decreasing rates in blood pressure during endoscopic procedures (c)Pulse fluctuation during endoscopic procedures (d)The rate of complications including disturbance or others (e)Ramsey Sedation Scale values
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The aims of the current study are to prospectively examine the safety and usefulness of DEX on sedation during prophylactic EIS for patients with EVs as compared with midazolam.
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	1.Patients with liver cirrhosis (LC) (diagnosed by liver histology or radiologic findings) who will require prophylactic EIS for EVs. Presence or absence of past history for endoscopic treatments for EVs is not required. Causes of LC are not also limited. 2. Child 5 or 6 or 7 points.
Key exclusion criteria	Exclusion criteria 1.Poor liver function (Child-Pugh points of 8 or more) 2.Patients with severe comorbid diseases 3.Patients who were judged to be inappropriate for the study subjects
Target sample size	50

Research contact person
Name of lead principal investigator	Shuhei Nishiguchi
Organization	Hyogo college of medicine
Division name	Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Address	1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.
TEL	0798-45-6472
Email	nishiguc@hyo-med.ac.jp

Public contact
Name of contact person	Yoshinori Iwata
Organization	Hyogo college of medicine
Division name	Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Address	1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.
TEL	0798-45-6472
Homepage URL
Email	yo-iwata@hyo-med.ac.jp

Sponsor
Institute	Hyogo college of medicine
Institute
Department

Funding Source
Organization	Hyogo college of medicine
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 03 Month 25 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 09 Month 01 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

Management information
Registered date	2017 Year 03 Month 24 Day
Last modified on	2017 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030642