UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017173 |
|---|---|
| Receipt number | 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 16:32:39 |
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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
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
ko-wtn@ya2.so-net.ne.jp
Sponsor or person
Institute
Department of Endoscopy, Fukushima Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019927
