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Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma

ConditionsAdvanced Hepatocellular CarcinomaVariceal Bleeding
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;

presence of PVTT with III-IV grade by Cheng's criteria;

having PVTT induced portal hypertension;

TIPS was performed within 72 hours after the endoscopic hemostasis;

Disqualifiers

recurrent HCC;

PVTT at I-II grade by Cheng's criteria;

age < 18 years or > 75 years;

advanced HCC with more than five metastases;

Trial design

Design model

Single group

Treatments tested in this trial

  • Early TIPS

    Procedure/Surgery

    TIPS was performed within 72 hours after the endoscopic hemostasis.

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: Early transjugular intrahepatic portosystemic shunt (TIPS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rates of technical success

Patients did not occur gastrointestinal hemorrhage and the stent unobstructed 3 months after TIPS.

Time frame
3 months

Secondary outcomes

1

Rates of gastrointestinal hemorrhage

Patients occur gastrointestinal hemorrhage within 6 months after TIPS.

Time frame
6 months
2

Progression-Free-Survival (PFS)

Progression was defined as progressive disease by independent radiologic review.

Time frame
12 months
3

Overall survival (OS)

OS is the length of time from the date of inclusion until death from any cause.

Time frame
12 months
4

Objective response rate (ORR)

ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.

Time frame
12 months

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Chinese PLA General Hospital

Collaborator

Source ClinicalTrials.gov
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