Trial Outcomes & Findings for The Association With Peptic Ulcer Disease and Hepatic Vein Pressure Gradient (NCT NCT01944878)
NCT ID: NCT01944878
Last Updated: 2014-07-24
Results Overview
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.
COMPLETED
455 participants
Retrospective case-control study (from 2009 to 2012, up to 3 years)
2014-07-24
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
328
|
|
Overall Study
COMPLETED
|
127
|
328
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Association With Peptic Ulcer Disease and Hepatic Vein Pressure Gradient
Baseline characteristics by cohort
| Measure |
Patients With Chronic Hepatitis
n=127 Participants
Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
|
Patients With Liver Cirrhosis
n=328 Participants
Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
n=5 Participants
|
52 years
n=7 Participants
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
258 Participants
n=7 Participants
|
339 Participants
n=5 Participants
|
|
HVPG (mmHg)
|
3.5 mmHg
n=5 Participants
|
15 mmHg
n=7 Participants
|
12 mmHg
n=5 Participants
|
|
PUD
|
13 participants
n=5 Participants
|
59 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Medication (NSAIDs, aspirin, clopidogrel, ticlopidine, steroid)
|
7 participants
n=5 Participants
|
16 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
smoking
|
39 participants
n=5 Participants
|
164 participants
n=7 Participants
|
203 participants
n=5 Participants
|
|
alcoholc
|
56 participants
n=5 Participants
|
233 participants
n=7 Participants
|
289 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
PUD in Liver Cirrhosis
n=59 Participants
Patients with PUD in liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
|
No PUD in Liver Cirrhosis
n=269 Participants
Patients without PUD in liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
|
|---|---|---|
|
The Association of HVPG and PUD in Patients With Liver Cirrhosis
|
14.5 mmHg
Interval 11.5 to 19.5
|
15.3 mmHg
Interval 10.2 to 20.3
|
SECONDARY outcome
Timeframe: Retrospective case-control study (from 2009 to 2012, up to 3 years)Outcome measures
| Measure |
PUD in Liver Cirrhosis
n=13 Participants
Patients with PUD in liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
|
No PUD in Liver Cirrhosis
n=114 Participants
Patients without PUD in liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
|
|---|---|---|
|
The Association Between PUD and HVPG in Patients With Chronic Hepatitis
|
3.7 mmHg
Interval 2.15 to 5.3
|
3.4 mmHg
Interval 2.0 to 5.78
|
Adverse Events
Patients With Chronic Hepatitis
Patients With Liver Cirrhosis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Chang Seok Bang
Hallym University College of Medicine, Chuncheon Sacred Heart Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place