NCT01944878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
455

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 6, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
10 months until next milestone

Results Posted

Study results publicly available

July 24, 2014

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

3 months

First QC Date

September 6, 2013

Results QC Date

January 23, 2014

Last Update Submit

July 22, 2014

Conditions

CirrhosisChronic Liver Disease

Keywords

Peptic ulcerLiver cirrhosisPortal hypertension

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • The Association Between PUD and HVPG in Patients With Chronic Hepatitis

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

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Investigators will analyze the medical records of hepatic vein pressure gradient (HVPG) and esophagogastroduodenoscopy (EGD) cases who had LC or chronic hepatitis in single tertiary hospital of Korea.

You may qualify if:

  • The patients who underwent hepatic vein pressure gradient (HVPG) measurement and esophagogastroduodenoscopy (EGD) and also had LC or chronic hepatitis

You may not qualify if:

  • The patients who have missing or incomplete HVPG or EGD data
  • The patients who underwent gastrectomy
  • The patients who have systemic malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chuncheon Sacred Heart hospital

Chuncheon, Gangwon-do, 200-704, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 7560857BACKGROUND

  • 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.

    PMID: 12169979BACKGROUND

  • 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.

    PMID: 15948813BACKGROUND

  • 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.

    PMID: 24902119DERIVED

MeSH Terms

Conditions

FibrosisPeptic UlcerLiver CirrhosisHypertension, Portal

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesLiver Diseases

Results Point of Contact

Title
Dr. Chang Seok Bang
Organization
Hallym University College of Medicine, Chuncheon Sacred Heart Hospital
cloudslove@naver.com
+82-33-240-5000

Study Officials

  • Chang Seok Bang, M.D

    Department of Internal Medicine, Hallym University College of Medicine

    PRINCIPAL INVESTIGATOR

  • Gwang Ho Baik, M.D

    Department of Internal Medicine, Hallym University College of Internal Medicine

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 6, 2013

First Posted

September 18, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

July 24, 2014

Results First Posted

July 24, 2014

Record last verified: 2014-07

Locations

KR(1)