The Association With Peptic Ulcer Disease and Hepatic Vein Pressure Gradient

• 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: Chuncheon Sacred Heart Hospital
• Information provided by (Responsible Party): Chang Seok Bang, Chuncheon Sacred Heart Hospital

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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) ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

Korea, Republic of

Chuncheon Sacred Heart hospital

Chuncheon, Gangwon-do, Korea, Republic of, 200-704

Sponsors and Collaborators

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

More Information

Publications:

Siringo S, Burroughs AK, Bolondi L, Muia A, Di Febo G, Miglioli M, Cavalli G, Barbara L. Peptic ulcer and its course in cirrhosis: an endoscopic and clinical prospective study. J Hepatol. 1995 Jun;22(6):633-41.

Vergara M, Calvet X, Roqué M. Helicobacter pylori is a risk factor for peptic ulcer disease in cirrhotic patients. A meta-analysis. Eur J Gastroenterol Hepatol. 2002 Jul;14(7):717-22.

Kamalaporn P, Sobhonslidsuk A, Jatchavala J, Atisook K, Rattanasiri S, Pramoolsinsap C. Factors predisposing to peptic ulcer disease in asymptomatic cirrhotic patients. Aliment Pharmacol Ther. 2005 Jun 15;21(12):1459-65.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bang CS, Baik GH, Kim JH, Kim JB, Suk KT, Yoon JH, Kim YS, Kim DJ. Peptic ulcer disease in liver cirrhosis and chronic hepatitis: impact of portal hypertension. Scand J Gastroenterol. 2014 Sep;49(9):1051-7. doi: 10.3109/00365521.2014.923501. Epub 2014 Jun 5.

• Responsible Party: Chang Seok Bang, Principal investigator, Chuncheon Sacred Heart Hospital
• ClinicalTrials.gov Identifier: NCT01944878
• Other Study ID Numbers: BCS-1
• First Posted: September 18, 2013
• 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:

Liver Cirrhosis; Liver Diseases; Peptic Ulcer; Fibrosis; Pathologic Processes; Digestive System Diseases; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Stomach Diseases