The Association With Peptic Ulcer Disease and Hepatic Vein Pressure Gradient

July 22, 2014 updated by: Chang Seok Bang, Chuncheon Sacred Heart Hospital

Retrospective Observational Study of Impact of Portal Hypertension for the Peptic Ulcer in Liver Cirrhosis and Chronic Hepatitis

The aim of this study is to assess the role of portal hypertension of peptic ulcer disease in liver cirrhosis and chronic hepatitis.

Study Overview

Status

Completed

Conditions

Detailed Description

Retrospective case-control study

  • Investigators will analyze the medical records of hepatic vein pressure gradient (HVPG) and esophagogastroduodenoscopy (EGD) cases who had liver cirrhosis (LC) or chronic hepatitis in a single tertiary hospital (Chuncheon Sacred Heart hospital, Korea) within 2008~2012.
  • Portal hypertension is assessed using HVPG measurement via transjugular approach.
  • Peptic ulcer is evaluated through EGD within 3 months of HVPG measurement
  • The association of Peptic ulcer with LC, chronic hepatitis and total population (LC or chronic hepatitis) will be assessed by univariate and multivariate analysis
  • There is no specific time frame, because this study is retrospective observational study, however EGD data is enrolled if it was done within 3 month from HVPG measurement.

Study Type

Observational

Enrollment (Actual)

455

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangwon-do
      • Chuncheon, Gangwon-do, Korea, Republic of, 200-704
        • Chuncheon Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Investigators will analyze the medical records of hepatic vein pressure gradient (HVPG) and esophagogastroduodenoscopy (EGD) cases who had LC or chronic hepatitis in single tertiary hospital of Korea.

Description

Inclusion Criteria:

  • The patients who underwent hepatic vein pressure gradient (HVPG) measurement and esophagogastroduodenoscopy (EGD) and also had LC or chronic hepatitis

Exclusion Criteria:

  • The patients who have missing or incomplete HVPG or EGD data
  • The patients who underwent gastrectomy
  • The patients who have systemic malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with chronic hepatitis
Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
Patients with liver cirrhosis
Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Association of HVPG and PUD in Patients With Liver Cirrhosis
Time Frame: Retrospective case-control study (from 2009 to 2012, up to 3 years)

The association of hepatic vein pressure gradient that reflects portal hypertension and peptic ulcer disease in patients with liver cirrhosis was assessed statistically.

(NO specific time frame, only confined to 2009 to 2012, when the HVPG measurement was done). The Mann-Whitney test was used to evaluate the association between PUD or not and HVPG degree, by SPSS software.
Retrospective case-control study (from 2009 to 2012, up to 3 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
The Association Between PUD and HVPG in Patients With Chronic Hepatitis
Time Frame: Retrospective case-control study (from 2009 to 2012, up to 3 years)
Retrospective case-control study (from 2009 to 2012, up to 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chuncheon Sacred Heart Hospital

Investigators

  • Principal Investigator: Chang Seok Bang, M.D, Department of Internal Medicine, Hallym University College of Medicine
  • Study Chair: Gwang Ho Baik, M.D, Department of Internal Medicine, Hallym University College of Internal Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 17, 2013

First Posted (Estimate)

September 18, 2013

Study Record Updates

Last Update Posted (Estimate)

July 24, 2014

Last Update Submitted That Met QC Criteria

July 22, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCS-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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