The Association With Peptic Ulcer Disease and Hepatic Vein Pressure Gradient

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944878
• Other study ID #: BCS-1
• Status: Completed
• Phase: N/A
• First received: September 6, 2013
• Last updated: July 22, 2014
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: July 2014
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Liver Disease
• Cirrhosis
• Hypertension, Portal
• Liver Cirrhosis
• Liver Diseases
• Peptic Ulcer

Locations

Country	Name	City	State
Korea, Republic of	Chuncheon Sacred Heart hospital	Chuncheon	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Association of HVPG and PUD in Patients With Liver Cirrhosis	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)	No
Secondary	The Association Between PUD and HVPG in Patients With Chronic Hepatitis		Retrospective case-control study (from 2009 to 2012, up to 3 years)	No