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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017173
Receipt No. R000019927
Scientific Title Evaluation of sedation with propofol versus midazolam for endoscopic injection sclerotherapy in patients with liver cirrhosis: Randomized controlled trial.
Date of disclosure of the study information 2015/04/19
Last modified on 2019/04/29

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000019927

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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