- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01944878
The Association With Peptic Ulcer Disease and Hepatic Vein Pressure Gradient
Retrospective Observational Study of Impact of Portal Hypertension for the Peptic Ulcer in Liver Cirrhosis and Chronic Hepatitis
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Gangwon-do
-
Chuncheon, Gangwon-do, Korea, republiek van, 200-704
- Chuncheon Sacred Heart Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
The Association of HVPG and PUD in Patients With Liver Cirrhosis
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
The Association Between PUD and HVPG in Patients With Chronic Hepatitis
Tijdsspanne: Retrospective case-control study (from 2009 to 2012, up to 3 years)
|
Retrospective case-control study (from 2009 to 2012, up to 3 years)
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Chang Seok Bang, M.D, Department of Internal Medicine, Hallym University College of Medicine
- Studie stoel: Gwang Ho Baik, M.D, Department of Internal Medicine, Hallym University College of Internal Medicine
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BCS-1
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .