UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of sedation with propofol versus midazolam for endoscopic injection sclerotherapy in patients with liver cirrhosis: Randomized controlled trial.
Acronym	RCT of EIS with propofol versus midazolam.
Scientific Title	Evaluation of sedation with propofol versus midazolam for endoscopic injection sclerotherapy in patients with liver cirrhosis: Randomized controlled trial.
Scientific Title:Acronym	RCT of EIS with propofol versus midazolam.
Region	Japan

Condition
Condition	Esophageal varix
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the efficacy and safty of sedation with propofol and midazolam for endoscopic injection sclerotherapy for esophageal varices in patients with liver cirrhosis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	minimal hepatic encephalopathy after endoscopic injection sclerotherapy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Using propofol for sedation during endoscopic injection sclerotherapy
Interventions/Control_2	Using midazolam for sedation during endoscopic injection sclerotherapy
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
Key inclusion criteria	1.Patient with liver cirrhosis who will be prophylactically performed endoscopic injection sclerotherapy for esophageal varix. 2.ECOG-Performance Status is 0 or1. 3. Patient without overtminimal hepatic encephalopathy. 4. Patient must provide written consent to participate in the study. 5. Patient without allergy to propofol and midazolam.
Key exclusion criteria	1. Patients with an American Society of Anesthesiologists (ASA) physical status of class 3, 4, 5. 2. Patients with active variceal bleeding. or past variceal bleeding. 3. Recurrent case after the treatment for esopageal varices. 4. Patients with severe liver failure(T.bil 4mg/gl, Child-Pugh score C). 5. Patients with severe renal failure. 6. Patients with overtminimal hepatic encephalopathy. 7. Patients with dementia, psychiatric illness. 8. Patient with comsumption of neuroactive medication. 9. Patient with drug abuse. 10. Patient with ongoing alcohol comsumption 2 weeks before the tratment. 11. Patient with allergy to propofol and midazolam. 12. Patient who have been judged as psychotic manifestation.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Katsutoshi Obara
Organization	Fukushima Medical University Hospital
Division name	Department of Endoscopy
Zip code
Address	1 Hikarigaoka, Fukushima, Japan
TEL	024-547-1583
Email	k-obara@fmu.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Ko Watanabe
Organization	Fukushima Medical University Hospital
Division name	Department of Endoscopy
Zip code
Address	1Hikarigaoka, Fukushima, Japan
TEL	024-547-1583
Homepage URL
Email	ko-wtn@ya2.so-net.ne.jp

Sponsor
Institute	Department of Endoscopy, Fukushima Medical University Hospital
Institute
Department

Funding Source
Organization	Department of Endoscopy, Fukushima Medical University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2015 Year 04 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 10 Day
Date of IRB	2014 Year 09 Month 20 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 04 Month 19 Day
Last modified on	2019 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019927