- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Gangwon-do
-
Chuncheon, Gangwon-do, Korea, Republikken, 200-704
- Chuncheon Sacred Heart Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Patients with chronic hepatitis
Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
|
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Patients with liver cirrhosis
Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The Association of HVPG and PUD in Patients With Liver Cirrhosis
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The Association Between PUD and HVPG in Patients With Chronic Hepatitis
Tidsramme: Retrospective case-control study (from 2009 to 2012, up to 3 years)
|
Retrospective case-control study (from 2009 to 2012, up to 3 years)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Chang Seok Bang, M.D, Department of Internal Medicine, Hallym University College of Medicine
- Studiestol: Gwang Ho Baik, M.D, Department of Internal Medicine, Hallym University College of Internal Medicine
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BCS-1
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