View clinical trials related to Gastric Varix.
Filter by:The goal of this exploratory validation study is to compare levels of expertise (or non-expertise) between GI fellows and experts with the varix trainer. The main question it aim to answer is: Can the varix trainer distinguish levels of expertise (or non-expertise) between novices and experts for specific skills (torque, small wheel and retroflexion techniques)? Does the training with the varix trainer improves these specific skills of GI fellows? Participants will do the pre-training test, practicing eight-sessions (each session is approximately 15minutes) and then do the post-training test.
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.
This study is a retrospective, multi-center and observational clinical study. Renmin Hospital of Wuhan University, Beijing Friendship Hospital, Capital Medical University, The fifth medical center of PLA General Hospital, Zhongshan Hospital, Fudan University, Shanghai, Nanjing Drum Tower Hospital affiliated Nanjing University Medical School and Xiangyang Central Hospital will participate in the study. Investigators would like to provide evidence-based medical evidence by evaluating and comparing the efficacy and safety of endoscopic ultrasound (EUS)-guided coil embolization combined with endoscopic cyanoacrylate injection and balloon-occluded retrograde transvenous obliteration (BRTO) in the treatment of gastric varices (GV) with spontaneous portosystemic shunt (SPSS). Between January 2014 and December 2020, patients with GV secondary to portal hypertension admitted to a tertiary medical center, are enrolled consecutively according to the following criteria: (1) ageā„18 years; (2)endoscopic examination confirms the presence of GV; (3) CTA of the portal system and EUS revealed the presence of SPSS, the diameter was between 5 mm to 15 mm; (4) treatment with EUS-guided coil combined with endoscopic cyanoacrylate injection or BRTO. Exclusion criteria are as follows: (1)malignant tumors; (2) hepatic encephalopathy, hepatorenal syndrome or multiple organ failure; (3) previously received esophagus or stomach surgery; (4) pregnant. Investigators will collect patients' data of baseline character, treatment, postoperative and follow-up. All patients will be followed up until the progress of the disease or the end of the study. And rebleeding, ectopic embolism, survival, and sequential treatment will be recorded during the follow-up period. The primary endpoint are five-day rebleeding rate and six-week mortality rate. The secondary endpoint are: technical success rate, incidence of ectopic embolism, eradication of GV, one-year rebleeding rate, one-year mortality rate, and cost-effectiveness ratio. All data and information use SPSS statistical software to complete all statistical analysis.
Gastric varices occur in patients with portal hypertension, mostly secondary to liver cirrhosis. Although they bleed less frequently than oesophageal varices, gastric variceal bleeding tends to be more severe with reported higher mortality. Endoscopic variceal obliteration (EVO) by direct endoscopic injection (DEI) using tissue adhesives like glue, CYA or histoacryl demonstrated higher hemostasis and lower bleeding rates compared to band ligation or sclerotherapy. Nevertheless, CYA treatment is known to be associated with significant adverse events like para-variceal injection, hemorrhage from post injection ulcer, needle sticking in the varix, intra-peritoneal injection leading to peritonitis and adherence of the glue to the endoscope, fever, embolization into the renal vein, IVC, pulmonary or systemic vessels. Endoscopic ultrasound (EUS) offers unique access to abdominal arterial and venous vasculature. This has had the most clinical impact on the treatment of gastroesophageal varices, where EUS may play a role both in the management and can deliver therapy in the form of glue injection, endovascular coil placement or a combination of the two. EUS enables an assessment using Doppler to confirm vessel obliteration after treatment. However, targeting the perforating feeder vessel rather than the varix lumen itself may theoretically minimize the amount of CYA needed to achieve obliteration of GVs and thereby reduce the risk of embolization.
We design a randomized trial to clarify the necessity of antibiotic prophylaxis for the patients chronic liver disease with gastric varices treated by elective GVO.
The EUS-guided combined therapy of coilingand 2-octyl-cyanoacrylate in patients with gastric varices reduced rebleeding and need for reintervention in comparison to EUS-guided coiling alone.The purpose of this study is to determine the efficacy of the primary prophylaxis of GOV II and IGV I with the EUS combined therapy versus beta blocker therapy in patients GOV II and IGV that have never bleed.
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
This is a diagnostic accuracy study. Eligible individuals will be enrolled and asked to undergo ds-MCE and EGD examinations. EGD is the reference standard against which ds-MCE is compared, and it will be performed within 48 hours after ds-MCE examination. The primary outcome is the sensitivity and specificity of ds-MCE in identifying the presence of esophagogastric (EGV) in patients with cirrhosis, using detection by EGD as the reference. The diagnostic accuracy of ds-MCE in detection of high-risk EV, high-risk EGV, EV, large EV, red signs of EV, GV, cardiofundal GV and PHG compared with the EGD will also be assessed. The incidence of PHE in small bowel under ds-MCE, the examination time of ds-MCE and EGD procedures, patient satisfaction assessment and safety evaluation will also be evaluated.
Balloon-occluded retrograde transvenous obliteration (BRTO) has been effective method to manage gastric varices. However, more than one third of patients after BRTO treatment experienced worsening of esophageal varices. The present study was designed to evaluate the effect of post-BRTO propranolol adminstration on the change of esophageal varices.