Clinical trial NCT03195634: WFA+M2BP in Evaluation of Portal Hypertension and Clinical Outcome in Patients With Liver Cirrhosis
Official title: WFA+M2BP in Evaluation of Portal Hypertension and Clinical Outcome in Patients With Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Portal Hypertension
Cirrhosis
Keywords: Cirrhosis
Portal Hypertension
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
First posted: 2017-06-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From June 2017 to March 2018, patients with cirrhosis admitted to either of the two participating hospitals were consecutively enrolled.

Hospitals: Shanghai Changzheng hospital and Shandong Provincial Hospital

Brief summary: Portal hypertension is a common complication of chronic liver diseases and is responsible for most clinical consequences of cirrhosis. measurement of the hepatic venous pressure gradient(HVPG) is the gold standard for evaluating the presence and severity of portal hypertension, this technique is considered invasive and is not routinely performed in all centers. Wisteria floribunda agglutinin-positive human Mac-2 binding protein (WFA+-M2BP) is a secreted N-glycoprotein, which has been reported as a novel marker in assessing liver fibrosis.However, the correlation of WFA+-M2BP with HVPG is unclear.The aim of this study was to explore the relationship between WFA+-M2BP and HVPG.

Detailed description: Portal hypertension is a common complication of chronic liver diseases and is responsible for most clinical consequences of cirrhosis. Accurate assessment of portal hypertension is essential for strategy of treatment and judgement of prognosis. Although measurement of the hepatic venous pressure gradient(HVPG) is the gold standard for evaluating the presence and severity of portal hypertension, this technique is considered invasive and is not routinely performed in all centers. Therefore, it is urgent to explore a noninvasive assessment of portal hypertension.

Wisteria floribunda agglutinin-positive human Mac-2 binding protein (WFA+-M2BP) is a secreted N-glycoprotein, which has been reported as a novel marker in assessing liver fibrosis. Recently, a retrospective study investigated the role of WFA+-M2BP in assessing the degree of liver cirrhosis and predicting mortality. However, the correlation of WFA+-M2BP with HVPG is unclear. And the role of WFA+-M2BP in predicting the clinical outcome of liver fibrosis patients is needed to be further evaluated.

The aim of this study was to explore the relationship between WFA+-M2BP and HVPG, as well as its predictive ability of complication rate, including large varices, bleed status, and ascites, and liver disease-related mortality.

Eligibility criteria: Inclusion Criteria:

1. Patients agreed to sign the informed consents
2. Patients aged 18-80 years,males or females
3. Patients with liver cirrhosis was diagnosed by previous liver biopsy or by compatible clinical, biochemical, and ultrasonographic/CT/MRI findings.
4. Patients were not treated with nonselective β-blockers(propranolol or carvedilol ) within previous 3 months

Exclusion Criteria:

1. Uncontrolled hypertension, diabetes or other serious cardiac problems（NYHA class IV）and pulmonary disease
2. Severe renal function injury(serum creatinine≥1.2 fold of upper limits of normal)
3. Conformed or highly suspicious diagnosis of liver malignant tumors or concomitant disease with reduced life expectancy
4. Acute hepatic failure or acute on chronic liver failure(ACLF)
5. Human immunodeficiency virus(HIV) infection
6. Previous portosystemic shunt
7. After liver transplantation
8. Pregnancy and breastfeeding
9. With contraindications of intervention surgery(hypersensitivity to iodinated contrast media, puncture site infection, severe coagulation defects, uncontrolled hyperthyroidism and multiple myeloma)
10. Participated in other drug clinical trails within 3 months
11. The researchers thought it was not suitable for this clinical trail

Primary outcomes:
measure: Changes of portal pressure (PP)
timeFrame: 3 months
measure: serum WFA+-M2BP levels
timeFrame: 3 months
Secondary outcomes:
measure: number of death or liver transplantation
timeFrame: up to 1 year
measure: complications of cirrhosis
timeFrame: up to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, Shanghai
name: Wei-Fen Xie, MD
role: PRINCIPAL_INVESTIGATOR
References: