Preemptive TIPS for Gastric Variceal Bleeding in Patients With Cirrhosis
- Conditions
- Portal HypertensionGastric Varices BleedingPortosystemic Shunt
- Interventions
- Procedure: preemptive TIPSProcedure: standard second prophylaxis
- Registration Number
- NCT06122792
- Lead Sponsor
- West China Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 144
- Cirrhosis (diagnosed by imaging, laboratory tests, clinical symptoms, or liver biopsy);
- Admission due to acute bleeding from gastric varices (IGV1 or GOV2).
- Prior treatment with TIPS or surgical shunt;
- Presence of contraindications to endoscopic treatment, carvedilol, or TIPS;
- Presence of hepatocellular carcinoma exceeding Milan criteria;
- Presence of other systemic malignant tumors with expected survival time not exceeding 6 months;
- Presence of uncontrollable infection or sepsis;
- Presence of cardiac, pulmonary, or renal failure;
- Pregnant or lactating women;
- Refusal to sign the informed consent form.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Preemptive TIPS preemptive TIPS Standard treatment to achieve initial hemostasis: vasoactive drugs (somatostatin or terlipressin) + endoscopic hemostasis according to the center protocol. Performance of TIPS in the first 72 hours following initial endoscopic hemostasis. Standard Therapy standard second prophylaxis Standard treatment to achieve initial hemostasis: vasoactive drugs (somatostatin or terlipressin) + endoscopic hemostasis according to the center protocol. Standard combined endoscopic and pharmacological therapy as secondary prophylaxis (carvedilol + repeated endoscopic injection of tissue adhesives until the eradication of the gastric varices).
- Primary Outcome Measures
Name Time Method 6-week mortality 6 weeks The rate of mortality during the first 6 weeks after inclusion in the study.
- Secondary Outcome Measures
Name Time Method 1-year mortality 1 year The rate of mortality during the first 1 year after inclusion in the study.
adverse events 1 year Events of various complications such as infections, new tumours, organ failure, peptic ulcers, etc., occurring after randomisation up to the follow-up period.
5-day treatment failure 5 days Incidence of cases requiring adjustment of treatment strategy within 5 days of initial standardised treatment: vomiting of blood or drainage of ≥100 ml of fresh blood from a gastric tube after 2 hours of treatment, hypovolemic shock, drop in haemoglobin of 30 g/L or more within 24 hours without transfusion.
decompensation events 1 year Rates with rebleeding, new overt ascites (moderate-heavy) or increased degree of ascites, overt hepatic encephalopathy (West-Heaven grades 2-4), or jaundice (total bilirubin \>51 mmol/L) from 5 days after initial standardised treatment up to 1 year.