View clinical trials related to Gastric Varix.
Filter by:The aim of this study is to explore whether using endoscopic ultrasound (EUS) to assess gastric varices (GV) and giving additional treatment according to the diameter and blood flow of residual after endoscopic cyanoacrylate injection for GV can reduce the rate of GV rebleeding, mortality, the risk of adverse events, and cost-effectiveness. This study is a multicenter prospective, open-label, randomized controlled study, including 5 study centers: Renmin Hospital of Wuhan University, Beijing Friendship Hospital, Capital Medical University, The Southwest Hospital of Army Medical University, Affiliated Hospital of Zunyi Medical University and Shanxi Coal Center Hospital. The total sample size is 150 patients, with 75 patients in the EUS evaluation group and 75 patients in the control group, respectively. The patients who meet the inclusion and exclusion criteria are randomly assigned to EUS evaluation group and control group by using block randomization. The EUS evaluation group uses EUS to observe the diameter and blood flow of residual variceal veins after endoscopic cyanoacrylate injection for GV to evaluate the embolization effect. Endoscopic cyanoacrylate injection is performed again if the diameter of variceal vein is larger than 5 mm and with blood flow signal. After the injection, the blood flow signal is confirmed disappear by EUS. The control group return to the ward after endoscopic cyanoacrylate injection, without EUS evaluation. During the study, the patients are followed up for at least 12 months, and they are requested to return to the hospital for follow-up at 1 month, 3 months, 6 months and 12 months after the treatment, respectively. The data of baseline, treatment, postoperative and follow-up of the two groups are need to collect. The primary outcome of this study is rebleeding rate. Secondary outcomes are eradication rate of GV, mortality rate, retreatment, and cost-effectiveness.
Gastrointestinal bleeding is a common complication of liver cirrhosis which caused by esophageal and gastric varices. The risk of bleeding from gastric varices is relatively low. However, the bleeding is usually significant and severe. Current guidelines recommend endoscopic glue injection as the first line of treatment for gastric variceal bleeding. Although this technique has been shown to be effective, it is associated with many severe adverse events including systemic embolization, fever, chest pain, and even death. The rate of hemostasis has been reported to be as high as 91-100% but the rebleeding rate from gastric varices still present. Endoscopic ultrasound (EUS) guided therapy has recently been introduced as a more effective and safer option than endoscopic therapy for gastric varices. EUS-guided therapy includes EUS guided Cyanoacrylate injection alone or in combination with EUS-guided coiling. It offers the advantage of directly visualizing the varices and delivering targeted therapy. A standard endoscopic examination only allows the evaluation of superficial varices. The use of Endoscopic ultrasound facilitates evaluation of peri-gastric and perforating vessels, which are directly involved in variceal development. EUS also facilitates accurate placement of the coil and preserves the naturally formed splenorenal shunt. Balloon-occluded retrograde transvenous obliteration(BRTO) has been reported to achieve satisfactory bleeding control rates for isolated gastric varices with High hemostasis rates and low rebleeding rate. Despite all these promising results, there are scarce studies describing and comparing the efficacy of EUS-guided therapy and BRTO in patients with gastric varices. Further prospective comparative studies are needed.
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