UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Controlled Trial of Carvedilol versus Rabeprazol Administration in the prevention of Esophageal Variceal Bleeding After Esophageal Variceal Ligation
Title of the study (Brief title)	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	Hisashi Hidaka
Organization	Kitasato University East Hospital
Division name	Department of Gastroenterology, Internal Medicine
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	Hidaka Hisashi
Organization	Post-EVL Trial
Division name	Post-EVL Trial Office
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000004678