Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01944878
Enrollment
455
Registered
2013-09-18
Start date
2013-05-31
Completion date
2013-08-31
Last updated
2014-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Liver Disease, Cirrhosis

Keywords

Peptic ulcer, Liver cirrhosis, Portal hypertension

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.

Interventions

None listed

Sponsors

Chuncheon Sacred Heart Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Association of HVPG and PUD in Patients With Liver CirrhosisRetrospective 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

MeasureTime frame
The Association Between PUD and HVPG in Patients With Chronic HepatitisRetrospective case-control study (from 2009 to 2012, up to 3 years)

Countries

South Korea

Participant flow

Recruitment details

We analyzed the medical records of 455 hepatic vein pressure gradient (HVPG) and esophagogastroduodenoscopy (EGD) patients who had LC or chronic hepatitis in a single tertiary hospital.

Pre-assignment details

800 HVPG measurement cases (Initial). Missing data (3), failure of HVPG measurements (8), cases without EGD (196); including 35 cases of patients on B-blocker, EGD over 3 months from HVPG measurement (79), incomplete EGD due to remnant food materials (19), cases having a history of gastrectomy (5), acute hepatopathy (5), and HCC (30) were excluded.

Participants by arm

ArmCount
Patients With Chronic Hepatitis
Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
127
Patients With Liver Cirrhosis
Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
328
Total455

Baseline characteristics

CharacteristicPatients With Chronic HepatitisPatients With Liver CirrhosisTotal
Age, Continuous45 years52 years50 years
alcoholc56 participants233 participants289 participants
HVPG (mmHg)3.5 mmHg15 mmHg12 mmHg
Medication (NSAIDs, aspirin, clopidogrel, ticlopidine, steroid)7 participants16 participants23 participants
PUD13 participants59 participants72 participants
Sex: Female, Male
Female
46 Participants70 Participants116 Participants
Sex: Female, Male
Male
81 Participants258 Participants339 Participants
smoking39 participants164 participants203 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1270 / 328
serious
Total, serious adverse events
0 / 1270 / 328

Outcome results

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.

Time frame: Retrospective case-control study (from 2009 to 2012, up to 3 years)

ArmMeasureValue (MEDIAN)
PUD in Liver CirrhosisThe Association of HVPG and PUD in Patients With Liver Cirrhosis14.5 mmHg
No PUD in Liver CirrhosisThe Association of HVPG and PUD in Patients With Liver Cirrhosis15.3 mmHg
Secondary

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)

ArmMeasureValue (MEDIAN)
PUD in Liver CirrhosisThe Association Between PUD and HVPG in Patients With Chronic Hepatitis3.7 mmHg
No PUD in Liver CirrhosisThe Association Between PUD and HVPG in Patients With Chronic Hepatitis3.4 mmHg

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026