UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026688 |
|---|---|
| Receipt number | R000030642 |
| Scientific Title | Effect of dexmedetomidine in the prophylactic endoscopic injection sclerotherapy for esophageal varices: A study protocol for prospective interventional study |
| Date of disclosure of the study information | 2017/03/25 |
| Last modified on | 2017/08/03 18:26:46 |
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Basic information
Public title
Effect of dexmedetomidine in the prophylactic endoscopic injection sclerotherapy for esophageal varices: A study protocol for prospective interventional study
Acronym
Effect of dexmedetomidine in the prophylactic endoscopic injection sclerotherapy for esophageal varices: A study protocol for prospective interventional study
Scientific Title
Effect of dexmedetomidine in the prophylactic endoscopic injection sclerotherapy for esophageal varices: A study protocol for prospective interventional study
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shuhei Nishiguchi |
Organization
Hyogo college of medicine
Division name
Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Zip code
Address
1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.
TEL
0798-45-6472
nishiguc@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Iwata |
Organization
Hyogo college of medicine
Division name
Division of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Zip code
Address
1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan.
TEL
0798-45-6472
Homepage URL
yo-iwata@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of medicine
Institute
Department
Personal name
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)
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
| 2017 | Year | 03 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030642
