UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003912 |
|---|---|
| Receipt number | R000004678 |
| Scientific Title | Randomized Controlled Trial of Carvedilol versus Rabeprazol Administration in the prevention of Esophageal Variceal Bleeding After Esophageal Variceal Ligation |
| Date of disclosure of the study information | 2010/07/15 |
| Last modified on | 2017/08/16 19:22:01 |
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Basic information
Public title
Randomized Controlled Trial of Carvedilol versus Rabeprazol Administration in the prevention of Esophageal Variceal Bleeding After Esophageal Variceal Ligation
Acronym
Post-EVL Trial
Scientific Title
Randomized Controlled Trial of Carvedilol versus Rabeprazol Administration in the prevention of Esophageal Variceal Bleeding After Esophageal Variceal Ligation
Scientific Title:Acronym
Post-EVL Trial
Region
| Japan |
Condition
Condition
Patients after esophageal variceal ligation (EVL)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the carvedilol therapy versus rabeprazol in the prevention of esophageal variceal bleeding after EVL.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Non-bleeding survival time
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Carbedilol
Interventions/Control_2
Rabeprazol
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 and Female
Key inclusion criteria
(1)Liver cirrhosis, Child A or B.
(2)Esophageal variceal ligation within three months.
(3)Systolic blood pressure is more than 130 mm Hg or dyastolic blood pressure in more than 80 mm Hg.
(4)Heart rate is more than 60 bpm.
Key exclusion criteria
(1)Hepatocellular carcinoma
(2)Refractory ascites and uncontrolled hepatic encephalopathy
(3)Active alcoholism before 3 months
(4)Portal thrombus
(5)Severe hypertension:Systolic pressure is more than 160 mm Hg or diastolic pressure is more than 100 mm Hg.
(6)Contraindication for B-blockers
(7)Pregnancy
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Hidaka |
Organization
Kitasato University East Hospital
Division name
Department of Gastroenterology, Internal Medicine
Zip code
Address
2-1-1 Asamizodai, Minami-ku, Sagamihara, Kanagawa 252-0380
TEL
81-42-748-9111
hisashi7@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidaka Hisashi |
Organization
Post-EVL Trial
Division name
Post-EVL Trial Office
Zip code
Address
2-1-1 Asamizodai, Minami-ku, Sagamihara, Kanagawa 252-0380
TEL
042-748-9111
Homepage URL
hisashi7@kitasato-u.ac.jp
Sponsor or person
Institute
Post-EVL Trial Office
Institute
Department
Personal name
Funding Source
Organization
The Japanese Fundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2010 | Year | 07 | Month | 15 | 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
| 2010 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 14 | Day |
Last modified on
| 2017 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004678
