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Preemptive TIPS for Variceal Bleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis

ConditionsPortal HypertensionPortal Vein ThrombosisEsophageal Varix BleedingPortosystemic Shunt
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • preemptive TIPS

    Procedure/Surgery

    The TIPS procedure should be performed within 72 hours after the initial endoscopic examination or treatment. An 8 mm Viatorr stent will be used for TIPS establishment. The aim will be to reduce the portal pressure gradient below 12 mm Hg. Embolization, either with coils or glue, can be performed, if it is felt necessary, especially in patients where portography shows the filling of large portosystemic collaterals feeding the varices. After TIPS, anticoagulation will not be used as a rule but is allowed if the attending physician thinks that it is warranted.

  • standard second prophylaxis

    Procedure/Surgery

    Patients will receive vasoactive drugs up to 5 days; then a non-selective beta-blocker (carvedilol) will be started with an initial dose of 6.25 mg, the dose of propranolol will be increased to 12.5 mg. The second elective session of endoscopic band ligation will be performed within the first 28 days after the initial endoscopic treatment. The following sessions will be performed at 28 +/- 3 days intervals until variceal eradication. Once eradication is achieved, endoscopic monitoring will be performed every 6 months. If varices reappear, new band ligation will be performed.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Standard TherapyActive comparator 1 intervention
Group B: Preemptive TIPSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

6-week mortality

The rate of mortality during the first 6 weeks after inclusion in the study.

Time frame
6 weeks

Secondary outcomes

1

5-day treatment failure

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.

Time frame
5 days
2

1-year mortality

The rate of mortality during the first 1 year after inclusion in the study.

Time frame
1 year
3

decompensation events

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.

Time frame
1 year
4

adverse events

Events of various complications such as infections, new tumours, organ failure, peptic ulcers, etc., occurring after randomisation up to the follow-up period.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

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