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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003912
Receipt No. 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

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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
Email 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
Email hisashi7@kitasato-u.ac.jp

Sponsor
Institute Post-EVL Trial Office
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004678

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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