Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of Endoscopic Variceal Ligation (EVL) and Propranolol in Secondary Prophylaxis of Variceal Bleeding in Patients With Non Cirrhotic Portal Hypertension (NCPH): A Prospective Randomized Controlled Trial
Brief Summary: Background: Variceal bleeding is a major cause of morbidity and mortality in patients with Non Cirrhotic Portal Hypertension (NCPH). Beta blockers (BB) and endoscopic variceal ligation (EVL) have been used to prevent rebleeding in these patients, largely based on data from cirrhotic patients. Endotherapy in the form of EST has been well studied in preventing rebleed in patients with NCPH. Initial studies showed that EST significantly reduced the rebleeding rate in patients of NCPH. Data from these studies suggests a rebleed rate of approximately 25% at 2yr and 35% at 5 years.

Beta blockers have been found to be quite effective in both primary as well as secondary prophylaxis of variceal bleeding in cirrhotic and are accepted mode of treatment. In contrast to liver cirrhosis, published data on the effect of beta blocker therapy on NCPH are scanty. Animal data and human data suggests that beta blockers reduce portal pressure in patients with NCPH. In two placebo controlled trials of propranolol on secondary prophylaxis of variceal bleeding in non cirrhotic patients. both studies demonstrated the efficacy of propranolol in decreasing rebleed rate. However, no comparisons hae been made with EVL till date.

Hypothesis: The investigators hypothesis that In patients with NCPH, treatment with beta blockers will lead to reduction in portal pressure and decrease in portosystemic shunting leading to reduction in variceal rebleeding Aim of the study: Aim: To compare the efficacy and safety of Propranolol and EVL in the prevention of variceal rebleeding in patients with NCPH.


Options:
A: Inclusion Criteria:

* All patients with UGI bleeding (blood in the esophagus, stomach, or duodenum) who enter the emergency room or develop bleeding while in the hospital or are transferred from nearby hospitals and are suspected of having cirrhosis and BEV will be eligible for consideration (all comers).
* Those who are shown to have the findings of cirrhosis and esophageal varices that:

  * Are seen to be actively bleeding;
  * Have an adherent clot;
  * Have no other associated lesion that could reasonably account for bleeding of that magnitude (such as large gastric or duodenal varices, GU, DU, etc)
* Require 2 or more units of blood transfusion, will be included in the study.

Exclusion Criteria:

* None
B: Inclusion Criteria:

* Liver biopsy compatible with cirrhosis.
* Absence of gastroesophageal varices.
* An increased hepatic venous pressure gradient (HVPG) (6mmHg).
* Age over 18 and below 76 years.
* Informed, written consent.
* Absence of exclusion criteria.

Exclusion Criteria:

* Presence of ascites that requires specific treatment (diuretics, paracentesis, peritoneo-venous shunt, etc).
* Proven hepatocellular carcinoma by radiological or histological criteria.
* Splenic or portal vein thrombosis by Doppler-ultrasound.
* Presence of any concurrent disease that is expected to decrease life expectancy to less than one year.
* Patients taking diuretics, beta-blockers, clonidine, prazosin, nitrates, molsidomine and any drug which may have an effect on splanchnic hemodynamics/portal pressure.
* Patients participating in other pharmacological randomized clinical trials.
* Patients with primary biliary cirrhosis and primary sclerosing cholangitis will also be excluded since these entities have a slower progression of the disease, are usually enrolled in other clinical trials and are transplanted at an earlier stage.
* Contraindications to beta-blockers: asthma, COPD with positive broncoconstrictive test, heart failure, A-V block, aortic valve stenosis, organic psychosis, insulin-dependent diabetes, hypersensitivity to beta-blockers.
* Women who are pregnant, nursing or of childbearing potential and who are not using oral or mechanical contraception.
C: Inclusion Criteria:

* All patients with UGI bleeding who are shown to have the findings of cirrhosis and esophagogastric varices or portal hypertensive gastropathy and require 2 or more units of blood transfusion will be included.

Exclusion Criteria:

* None
D: Inclusion Criteria:

* Patients with Non Cirrhotic Portal Hypertension (NCPH) presenting to our Liver Diseases Follow-up Clinic with history of hemetemesis and/or malena within the past 6 weeks and proven to have esophageal varices as the bleeding source on upper GI endoscopy

Exclusion Criteria:

* A history of surgery for portal hypertension
* Patients already on a EST, EVL, or glue injection program before presenting to our hospital
* Patients already on beta blockers for primary prophylaxis of variceal bleed
* Severe cardiopulmonary or renal disease
* Bradycardia (basal heart rate, \<50 beats per minute \[bpm\]) or complete heart block
* A history of severe side effects or contraindications to β- blockers, like bronchial asthma, diabetes mellitus, heart failure, peripheral vascular disease, prostatic hypertrophy, or arterial hypotension (systolic blood pressure \<90 mm Hg)
* Refusal to give informed written consent to participate in the trial
* Patients bleeding from gastric varices or Portal Hypertensive Gastropathy (PHG).
* Patients who had a failure of primary hemostasis during acute bleed were also excluded.

Answer: D