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The Association With Peptic Ulcer Disease and Hepatic Vein Pressure Gradient

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ClinicalTrials.gov Identifier: NCT01944878
Recruitment Status : Completed
First Posted : September 18, 2013
Results First Posted : July 24, 2014
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Chang Seok Bang, Chuncheon Sacred Heart Hospital

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

Condition or disease
Cirrhosis Chronic Liver Disease

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.

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Study Type : Observational
Actual Enrollment : 455 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Retrospective Observational Study of Impact of Portal Hypertension for the Peptic Ulcer in Liver Cirrhosis and Chronic Hepatitis
Study Start Date : May 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944878


Locations
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Korea, Republic of
Chuncheon Sacred Heart hospital
Chuncheon, Gangwon-do, Korea, Republic of, 200-704
Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
Investigators
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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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chang Seok Bang, Principal investigator, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT01944878     History of Changes
Other Study ID Numbers: BCS-1
First Posted: September 18, 2013    Key Record Dates
Results First Posted: July 24, 2014
Last Update Posted: July 24, 2014
Last Verified: July 2014
Keywords provided by Chang Seok Bang, Chuncheon Sacred Heart Hospital:
Peptic ulcer
Liver cirrhosis
Portal hypertension
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Peptic Ulcer
Fibrosis
Pathologic Processes
Digestive System Diseases
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Stomach Diseases