Preemptive TIPS for Variceal Bleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital
About this trial
Portal vein thrombosis (PVT) can lead to a further increase in portal venous pressure and increase the risk of rebleeding. Whether patients with acute esophagogastric variceal bleeding with occlusive PVT benefit from preemptive TIPS is still controversial. The present study is directed at comparing the outcome of patients with acute variceal bleeding with occlusive PVT treated by standard therapy (vasoactive drugs + endoscopic variceal ligation) with or without preemptive TIPS (performed during the first 1-3 days after endoscopic procedure). The primary outcome is survival free of variceal rebleeding at 6 weeks from inclusion.
Eligibility criteria
Qualifiers
Cirrhosis (diagnosed by imaging, laboratory tests, clinical symptoms, or liver biopsy);
Admission due to acute bleeding from esophagogastric varices;
Thrombus in the main trunk of the portal vein occupying ≥50% of the lumen.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- preemptive TIPS
- standard second prophylaxis
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
West China Hospital
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
Beijing YouAn Hospital
Collaborator
Beijing Friendship Hospital
Collaborator
Beijing 302 Hospital
Collaborator
Source ClinicalTrials.gov