Clinical trial NCT06122792: Preemptive TIPS for Gastric Variceal Bleeding in Patients With Cirrhosis
Official title: Preemptive Transjugular Intrahepatic Portosystemic Shunt for Gastric Variceal Bleeding in Patients With Cirrhosis: A Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Portal Hypertension
Gastric Varices Bleeding
Portosystemic Shunt
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Beijing YouAn Hospital
name: Renmin Hospital of Wuhan University
name: Second Affiliated Hospital of Nanchang University
name: Guangzhou First People's Hospital
First posted: 2023-11-08
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Cirrhosis (diagnosed by imaging, laboratory tests, clinical symptoms, or liver biopsy);
* Admission due to acute bleeding from gastric varices (IGV1 or GOV2).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 6-week mortality
timeFrame: 6 weeks
Secondary outcomes:
measure: 5-day treatment failure
timeFrame: 5 days
measure: 1-year mortality
timeFrame: 1 year
measure: decompensation events
timeFrame: 1 year
measure: adverse events
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: Xuefeng Luo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Escorsell A, Garcia-Pagan JC, Alvarado-Tapia E, Aracil C, Masnou H, Villanueva C, Bosch J. Pre-emptive TIPS for the treatment of bleeding from gastric fundal varices: Results of a randomised controlled trial. JHEP Rep. 2023 Mar 1;5(6):100717. doi: 10.1016/j.jhepr.2023.100717. eCollection 2023 Jun.