MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy
MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy
The purpose of this study is to determine the effect on the (carbon 13
 labelled(13C)-Methacetin Breath Test (MBT) of i.v. propranolol, a non-selective beta blocker
 (NSBB) following initial administration and after chronic use of each of these agents. The
 correlation of the MBT with Hepatic Venous Pressure Gradient (HVPG) measurement before and
 after treatment will be assessed. Additionally, the MBT measurements following 60 days of
 therapy will be compared to the first MBT measurement and to the second MBT measurement, post
 HVPG. Each patient's subsequent MBT measurement will be compared to his previous MBT results
 in order to determine his/her response to therapy.
Variceal bleeding is a life threatening complication of cirrhosis, which still carries a high
 mortality. Non selective beta-adrenergic blockers are effective at preventing first time
 variceal bleeding and re-bleeding. The efficacy of these drugs depends on the magnitude of
 reduction in portal pressure after administration, which varies widely between patients.
 Studies have shown that a reduction in portal pressure (as measured by HVPG) to 20% from
 baseline or to values ≤ 12 millimeters of mercury (mmHg) is associated with a low residual
 risk of bleeding . Patients with such a reduction are considered to be "responders" to beta
 blocker (BB) therapy. Unfortunately, a significant percentage of patients do not respond to
 therapy and need to be prescribed to an alternative therapy. The clinical application of this
 observation is limited since it requires a repeated HVPG measurement,which is not feasible in
 most cases. A non-invasive breath test that can assess portal pressure in correlation to HVPG
 and allow efficient management of patients at risk, could be very useful.
Inclusion Criteria:

 -> 18 years old (M/F)

 -Diagnosis of cirrhosis: i. By liver biopsy ii. Or strong suspicion of cirrhosis by
 accepted criteria for the clinical diagnosis of cirrhosis (e.g. peripheral edema or
 varices, palpable hard left lobe of the liver, small right lobe span or palpable
 splenomegaly), and/or radiological evidence of cirrhosis (by abdominal US, CT, or MRI,
 showing a nodular liver and/or portosystemic collaterals with portal vein patency and/or
 ascites and/or splenomegaly, and/or colloid shift on a colloid-isotope liver-spleen scan),
 and/or laboratory variables (platelets <100,000/mm3, albumin< 3.5g/dL, or international
 normalized ratio (INR)>1.3) iii. Presence of esophageal varices (without previous variceal
 bleeding episode) or HVPG≥10mmHg 12mmHg from previous testing.

 -Has been scheduled for hemodynamic study testing, including response to acute therapy.-

 Exclusion Criteria:

 -  Patients already receiving beta blockers

 -  Hepatocellular carcinoma

 -  Portal vein thrombosis

 -  Contraindications to non-selective beta blocker Propanolol

 -  Cholestatic liver disease

 -  Severe heart, pulmonary or renal disease.

 -  Patient has previous surgical bypass surgery for morbid obesity

 -  Patient has extensive small bowel resection

 -  Any major surgery in the past 3 months.

 -  Patient is a recipient of any organ transplant

 -  Patient allergic to acetaminophen.

 -  Patients who are taking hepatotoxic drugs

 -  Patient, based on the opinion of the investigator, should not be enrolled into this
 study.

 -  Patients unable or unwilling to sign informed consent

 -  Patients that are participating in other clinical trials evaluating experimental
 treatments or procedures or have participated in a clinical trial in the past 3
 months.