UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	pH monitoring in the esophago-gastric junction and stomach beore and after esophageal variceal treatment
Title of the study (Brief title)	pH monitoring beore and after esophageal variceal treatment
Region	Japan

Condition
Condition	1) Patients between 20 and 80 years old. 2) Patients have esophageal varices which could be treated by EVL therapy. 3) Patients with liver cirrhosis are Child-Pugh Classification (A or B).
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess pH monitering in the esophago-gastric junction and stomach before and after EVL treatment
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Comparing of 24 hours under pH 4 holding time (%) between beore and after EVL therapy in the esophago-gastric junction
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Esophageal variceal ligation (EVL)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who had F2 esophageal varices or larger and can receive EVL treatment.
Key exclusion criteria	Ongoing pharmacological acid supressive therapy; Drinking alcohol within 3 months before the start of the study; Child-Pugh score Hepatocellular carcinoma (HCC); Portal thrombosis.
Target sample size	20

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, Japan
TEL	+81-42-748-9111
Email	hisashi7@kitasato-u.ac.jp

Public contact
Name of contact person	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, Japan
TEL	+81-42-748-9111
Homepage URL
Email	hisashi7@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University
Organization
Division
Category of Funding Organization	Self funding
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	Kitasato University East Hospital

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 31 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2014 Year 04 Month 01 Day
Date of closure to data entry
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	2012 Year 07 Month 04 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=R000009294