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Gastric Varices Bleeding clinical trials

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NCT ID: NCT06370169 Recruiting - Clinical trials for Gastric Varices Bleeding

EUS Guided Coil Embolization for Primary Prophylaxis of Gastric Varices

EUS
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices. All procedures will be performed with patient under deep sedation or general anaesthesia under the supervision of an anaesthesiologist.

NCT ID: NCT06122792 Not yet recruiting - Portal Hypertension Clinical Trials

Preemptive TIPS for Gastric Variceal Bleeding in Patients With Cirrhosis

Start date: January 2024
Phase: N/A
Study type: Interventional

The prevalence of gastric varices is approximately 20%. It is important to note that gastric varices tend to bleed more severely, have a higher morbidity and mortality rate, and have a 35% to 90% risk of rebleeding after the cessation of acute hemorrhage. Because of the relatively low prevalence of gastric varices, the existing clinical studies have many deficiencies, and there is much controversy in the academic community, the optimal treatment and prevention strategies for gastric varices have not yet been fully defined. In the last few years, important advances have been made in the treatment and prevention of gastric variceal bleeding in patients with cirrhosis. Experts agree that the combination of pharmacological and endoscopic injection of tissue adhesives should be the first line of 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 fundal variceal bleeding showed that an early TIPS, performed during the first 5 days after patient admission resulted in a significant decrease in failure to control bleeding and early and late rebleeding. However, the study was conducted for 4 years and only included 25 patients. Due to insufficient sample size, it was unable to reflect whether priority TIPS can bring survival benefits to patients with gastric variceal bleeding. Therefore, there is an urgent need for multi-center clinical studies with large samples to provide high-quality evidence in the field of prioritizing TIPS for the treatment of acute gastric variceal bleeding. The present study aims to compare the preemptive TIPS (performed during the first 72 hours after endoscopy) with standard second prophylaxis (endoscopic injection of tissue adhesives plus carvedilol) for patients with acute bleeding from gastric varices (IGV1 or GOV2). The primary outcome will be a 6-week mortality from inclusion.

NCT ID: NCT06106971 Recruiting - Clinical trials for Gastric Varices Bleeding

Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding

Start date: June 28, 2018
Phase: Phase 3
Study type: Interventional

The goal of this randomized controlled trial is to compare the rebleeding rate in cirhotic patients with gastric variceal bleeding receiving balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection. The main questions it aims to answer are: - Recurrent gastric variceal bleeding - Further decompensation of liver cirrhosis Participants will receive balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection. Researchers will compare balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection to see if the rebleeding rate associated with balloon-occluded retrograde transvenous obliteration is lower than that associated with endoscopic tissue glue injection.

NCT ID: NCT05859009 Withdrawn - Clinical trials for Endoscopic Ultrasound

Primary Prevention of Gastric Varices Bleed

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Primary prophylaxis of gastric varices is an important area of research, as gastric varices are a common complication of cirrhosis of the liver. Cirrhosis is a condition in which the liver becomes scarred and loses its ability to function properly, and it is a leading cause of morbidity and mortality worldwide. Gastric varices occur in up to 30% of patients with cirrhosis, and they can rupture, leading to life-threatening bleeding. The clinical, epidemiological, and public health context of primary prophylaxis of gastric varices is therefore the need to prevent the development of this complication in patients at risk for cirrhosis and to reduce the associated morbidity and mortality. The clinical trials on primary prophylaxis of gastric varices are therefore focused on evaluating the safety and efficacy of various interventions, such as beta-blockers and endoscopic techniques, in reducing the risk of gastric varices in patients with cirrhosis. The goal of this trial is to find the most effective and safe strategies for primary prophylaxis of gastric varices, in order to improve the outcomes for patients with cirrhosis.

NCT ID: NCT05545475 Recruiting - Clinical trials for Anticoagulants and Bleeding Disorders

Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices

Start date: January 1, 2022
Phase:
Study type: Observational

This study aimed to clarify the safety of anticoagulant therapy after glue injection for cirrhotic variceal bleeding patients with portal vein thrombosis.

NCT ID: NCT05521685 Completed - Clinical trials for Gastric Varices Bleeding

Impact of EUS Guided Treatment of Gastric Varices

Start date: April 19, 2022
Phase:
Study type: Observational

The purpose of the study is to determine the clinical impact of cyanoacrylate tissue adhesive treatment for Gastric Varices performed by Indiana University EUS physicians.

NCT ID: NCT04198259 Not yet recruiting - Liver Cirrhoses Clinical Trials

Interventional Devascularization Plus HVPG‐Guided Carvedilol Therapy vs TIPS

Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Gastric varices (GV) are present in around 20% of patients with cirrhosis. Bleeding from GV accounts for 10-20% of all variceal bleeding. For the prevention of gastric variceal bleeding, TIPS or BRTO as firstline treatments were suggested. No randomized trials have compared BRTO with other therapies. BRTO and its variations might increase portal pressure and might worsen complications, such as ascites or bleeding from EV. In this regard, if NSBB is combined with BRTO and its variations (we called interventional devascularization) for those HVPG responders, the drawbacks of interventional devascularization might be overcome. Therefore, the investigators conducted this RCT to compare the effectiveness and safety of TIPS with those of interventional devascularization in the prevention of rebleeding from gastric varices.

NCT ID: NCT03853720 Not yet recruiting - Gastric Varix Clinical Trials

Combined and Simultaneous Approach for the Treatment of High-risk Gastric Varices Using B-RTO and EVO

BeRTO
Start date: April 2019
Phase: N/A
Study type: Interventional

The aim of this pilot study is to evaluate the efficacy and safety of combined and simultaneous endoscopic variceal obliteration together with balloon occluded-retrograde transvenous obliteration (B-RTO) for the treatment of high-risk gastric varices

NCT ID: NCT03438916 Completed - Liver Cirrhosis Clinical Trials

MRI to Assess the Effect of Non-selective Beta-blocker in Patients With Cirrhosis

Start date: April 1, 2017
Phase:
Study type: Observational

Background: Standardization and new therapeutic treatments of variceal bleeding has significantly reduced the mortality the last 25 years, but there is still a high 6-week mortality around 15-20% and 1-year mortality of about 40%. Cirrhotic patients without prophylactic treatment suffer a risk of 60% of re-bleeding within the first year after the first bleeding episode. Variceal ligation and NSBB are the standard therapy as secondary prophylaxis, while only non-selective beta-blocker (NSBB) is offered as first-line therapy in primary prophylaxis. If portal pressure is reduced to a value below 12 mmHg or by 20% (10% if assessed by intravenous administrations), the risk of bleeding is substantially reduced, but not all patients respond to the treatment with propranolol (40-50%). Hence, patients who are non-responders to NSBB should be offered alternative treatment with e.g. carvedilol, which is a combined alpha-beta-receptor blocker or endoscopic band ligation. Currently, the response to NSBB is assessed invasively during a liver vein catheterization (LVC). Unfortunately, only a few centres in the world can perform this procedure and there are no reliable non-invasive alternatives to assess the respond to NSBB, which is of extreme importance, since non-responders have three fold increased risk of a new variceal bleeding episode. Aim: In general the aim of the project is to develop faster and non-invasive methods to evaluate portal hypertension and individual pharmacological response of NSBB in patients with cirrhosis. Furthermore, we expect to detect changes in liver and spleen stiffness as measured by MR-Elastography (MRE) after NSBB and that these depend on the drug-related effects on portal pressure. Study design and patients: 39 patients with cirrhosis and esophageal varices that require NSBB (propranolol) treatment. Patients are assessed with LVC, MR-scans, echocardiography and biochemical tests. LVC is the gold standard method to test if patients respond to propranolol treatment. At visit 1. the response to NSBB is defined as a reduction of HVPG ≥10%, or to a HVPG< 12mmHg after intravenous NSBB administrations during LVC. MRI-scan with intraveneus NSBB administration is performed at visit 2. Minimum 5 days of NSBB wash out between visit 1 and 2.