Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Portal hypertension by main trunk portal vein tumor thrombus (PVTT) is a severe disease. Patients usually die of gastrointestinal hemorrhage rather than tumor progression. It is vital to prevent the portal hypertension. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective method to alleviate the portal pressure. Then the risk of gastrointestinal hemorrhage is decreased which provides an opportunity for system therapy. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective for cirrhosis induced portal hypertension. However, the PVTT induced portal hypertension still needs clinical evidence. In this study, the investigators explore the early TIPS for advanced hepatocellular carcinoma with main trunk portal vein tumor thrombus induced acute variceal bleeding. The investigators aim to added clinical evidence for this subtype of advanced HCC.

Conditions

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Advanced Hepatocellular Carcinoma Variceal Bleeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Early transjugular intrahepatic portosystemic shunt (TIPS) within 72 hours after acute variceal bleeding.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

TIPS was performed within 72 hours after variceal bleeding.

Study Groups

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Early transjugular intrahepatic portosystemic shunt (TIPS)

TIPS was performed within 72 hours after the endoscopic hemostasis.

Group Type EXPERIMENTAL

Early TIPS

Intervention Type PROCEDURE

TIPS was performed within 72 hours after the endoscopic hemostasis.

Interventions

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Early TIPS

TIPS was performed within 72 hours after the endoscopic hemostasis.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
2. presence of PVTT with III-IV grade by Cheng's criteria;
3. having PVTT induced portal hypertension;
4. TIPS was performed within 72 hours after the endoscopic hemostasis;
5. metastases with limited five sites and no more two organs involved;
6. number of Intrahepatic tumors were no more than five;
7. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
8. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
9. no history of other malignancies;
10. agreed to participated in this clinical trial;
11. Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.

Exclusion Criteria

1. recurrent HCC;
2. PVTT at I-II grade by Cheng's criteria;
3. age \< 18 years or \> 75 years;
4. advanced HCC with more than five metastases;
5. Number of Intrahepatic tumors were more than five;
6. no response to Lenvatinib;
7. life expectancy less than 3 months.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No