Clinical trial NCT01944878: The Association With Peptic Ulcer Disease and Hepatic Vein Pressure Gradient
Official title: Retrospective Observational Study of Impact of Portal Hypertension for the Peptic Ulcer in Liver Cirrhosis and Chronic Hepatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Chronic Liver Disease
Keywords: Peptic ulcer
Liver cirrhosis
Portal hypertension
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: The Association of HVPG and PUD in Patients With Liver Cirrhosis
timeFrame: Retrospective case-control study (from 2009 to 2012, up to 3 years)
Secondary outcomes:
measure: The Association Between PUD and HVPG in Patients With Chronic Hepatitis
timeFrame: Retrospective case-control study (from 2009 to 2012, up to 3 years)
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart hospital
state: Gangwon-do
Study officials:
affiliation: Department of Internal Medicine, Hallym University College of Medicine
name: Chang Seok Bang, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine, Hallym University College of Internal Medicine
name: Gwang Ho Baik, M.D
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1016/0168-8278(95)80219-3.
citation: Vergara M, Calvet X, Roque 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. doi: 10.1097/00042737-200207000-00002.
citation: 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. doi: 10.1111/j.1365-2036.2005.02507.x.
citation: 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.