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Esophageal and Gastric Varices clinical trials

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NCT ID: NCT02504723 Recruiting - Clinical trials for Esophageal and Gastric Varices

Carvedilol as an Adjunct to Endoscopic Cyanoacrylate Injection for Secondary Prophylaxis of Gastric Variceal Bleeding

Start date: January 2011
Phase: Phase 4
Study type: Interventional

Gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal bleeding but is associated with a high rebleeding rate. Carvedilol is a potent non-selective β-blocker. The role of carvedilol in the prevention of recurrent gastric variceal bleeding is not studied. This study aimed at evaluating the efficacy of carvedilol as an adjunct to gastric variceal obturation in the secondary prophylaxis of gastric variceal bleeding.

NCT ID: NCT02475122 Completed - Cirrhosis Clinical Trials

Prognostic Value of Measuring DsAz by MRI in Cirrhotic Patients on Prophylactic Treatment With β Blocker (AzyMR)

AzyMR
Start date: October 2014
Phase: N/A
Study type: Interventional

Portal hypertension (PHT) that leads to esophageal varices is clinically present, at the time of diagnosis, in 60% of cirrhotic patients (Groszmann NEJM 2005). Variceal bleeding is a life-threatening complication. The yearly incidence of the first variceal bleeding in cirrhotic patients is estimated to 4%. This risk increases to 15% when medium or large varices are initially present, (D'amico Baillieres Clin Gastroenterol 1997); Therefore, for patient with medium or large varices a primary prophylaxis treatment with nonselective beta-blockers must be instituted decreasing risk of bleeding approximately by half (d'amico Hepatology 2005). The method to evaluate the efficacy of beta blockers treatment is the hepatic venous pressure gradient (HVPG). HVPG < 12 mmHg or a decrease of HVPG of 20% after beta blocker treatment reduce dramatically the risk of bleeding (Feu F. Lancet 1995). But a good response (HVPG < 12 mmHg or reduction > 20%) to beta blockers was observed only in almost 30 % of patients. In non responder patients, the variceal bleeding incidence is estimated to 24 % at 2 years. In this situation, alternative treatments to beta-blockers have been suggested: endoscopic ligation, which was shown to be as effective as beta blockers in primary prevention, and more recently carvedilol (Reiberger, Gut 2012). So, HVPG monitoring may provide critical information for patients. However, because of its technical requirement and its invasivity, HVPG measurement is not feasible in clinical practice . So, there is a general consensus to continue indefinitely beta blockers treatment without control of hemodynamic efficiency (merkel J. Hepatology 2009). Previous studies have suggested the interest of azygos blood flow measurements for evaluating hemodynamic changes in the esophageal collateral vessels of patients with portal hypertension (Bosch J. Hepatology 1985 ). More recently Magnetic Resonance Imaging (MRI) has been reported to be an efficient technique to assess azygos blood flow (Gouya Radiology 2011) in cirrhotic patients. Its feasibility is obviously higher than HVPG measurement. However, in the same way that HVPG, a large-scale implementation in clinical practice of azygos blood flow measurement by MRI requires to specify minimal absolute threshold, or relative post-therapeutic decrease, related with no variceal bleeding.

NCT ID: NCT02468206 Completed - Gastric Varices Clinical Trials

Secondary Prophylaxis of Gastric Variceal Bleed

Start date: June 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal rebleeding and improvement in survival.

NCT ID: NCT02468180 Recruiting - Gastric Varices Clinical Trials

Primary Prophylaxis of Gastric Variceal Bleed

Start date: June 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal bleeding.

NCT ID: NCT02468167 Recruiting - Gastric Varices Clinical Trials

Acute Gastric Variceal Bleeding: Endoscopic Treatment Versus BRTO

Start date: June 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the management of acute gastric bleeding.

NCT ID: NCT02465645 Completed - Clinical trials for Cirrhosis With Esophageal Varices

To Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices.

Start date: June 1, 2015
Phase: N/A
Study type: Interventional

After successful screening of patients based on inclusion criteria, we will measure the baseline Hepatic Venous Pressure Gradient. At day 1 patients will undergo complete blood investigation including complete haemogram, kidney function test, liver function test, prothrombin time, AFP (Alfa Feto Protein) level, chest x ray, ultrasonography, fibroscan. Routine complete physical examination will be done.

NCT ID: NCT02385422 Recruiting - Liver Cirrhosis Clinical Trials

The Effect of Carvedilol Vs Propranolol in Cirrhotic Patients With Variceal Bleeding

Start date: March 2015
Phase: Phase 4
Study type: Interventional

To compare the efficacy and safety of Carvedilol and Propranolol in patients with cirrhosis-related esophagogastric varices after multiple endoscopic treatments for secondary prophylaxis.

NCT ID: NCT02364297 Recruiting - Portal Hypertension Clinical Trials

TIPS in Fundal Variceal Bleeding (the TFB Study)

TFB
Start date: September 2015
Phase: N/A
Study type: Interventional

In the last years, important advances have been done in the treatment and prevention of fundal variceal bleeding in patients with cirrhosis. Experts agree that the combination of pharmacological and endoscopic therapy (with tissue adhesives) should be the first line therapy in the acute bleeding episode from isolated gastric varices (IGV1) or type 2 gastroesophageal varices (GOV2) varices; whereas transjugular intrahepatic portosystemic shunt (TIPS) is considered a rescue therapy. TIPS has been shown to effectively prevent variceal rebleeding but with a potential increase in the incidence of hepatic encephalopathy and/or liver failure. In this sense, a recent randomized controlled trial (RCT) in esophageal variceal bleeding showed that an early TIPS, performed during the first 72h after patient admission resulted in a significant decrease in failure to control bleeding and early and late rebleeding. Moreover, survival was also significantly increased as well as other portal-hypertension related complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, etc). The present study is directed at comparing the outcome of patients with acute bleeding from fundal varices (IGV1 or GOV2) treated by standard therapy (vasoactive drugs + endoscopic injection of tissue adhesives) with or without early TIPS (performed during the first 1-5 days after admission). Main end-point will be survival free of variceal rebleeding at 1 year from inclusion.

NCT ID: NCT02361593 Completed - Esophageal Varices Clinical Trials

Transparent Cap-assisted Endoscopic Sclerotherapy

Start date: April 2015
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate efficacy and safety of transparent cap-assisted endoscopic sclerotherapyI(lauromacrogol injection) in management of esophageal varices.

NCT ID: NCT02330731 Completed - Gastric Varices Clinical Trials

N-butyl-2-cyanoacrylate, Iso-amyl-2-cyanoacrylate and Hypertonic Glucose With 72% Chromated Glycerin in Gastric Varices

Start date: January 2012
Phase: N/A
Study type: Interventional

AIM: To compare between n-butyl-2-cyanoacrylate, iso-amyl-2-cyanoacrylate and mixture of 72% chromated glycerin with hypertonic glucose solution in management of gastric varices. METHODS: Ninety patients with gastric varices presented to Endoscopy Unit of Ain Shams University Hospital were included. They were randomly allocated into three groups; each group included 30 patients treated with intravariceal sclerosant injections in biweekly sessions till complete obturation of gastric varices; Group I (n-butyl-2-cyanoacrylate; Histoacryl®), Group II (iso-amyl-2-cyanoacrylate; Amcrylate®) and Group III (mixture of 72% chromated glycerin; Scleremo® with glucose solution 25%). All the procedures were done electively without active bleeding. Recruited patients were followed up for 3 months.