Therapeutic Effect of Ethanol-gelfoam Mixture for the Treatment of Arterioportal Shunts (APS) in Patients With HCC

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-12-31

Brief Summary

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Transcatheter arterial chemoembolization (TACE) is a key palliative treatment for patients with inoperable hepatocellular carcinoma (HCC). Arterioportal shunts (APS) can aggravate portal hypertension and the shunts let lipiodol flow to normal liver tissue and result in poor Lipiodol deposition in the tumor, causing liver ischemia.

Occlusion of APS is a vital and initial step for the following embolization of tumor. Ethanol-gelfoam mixture(EGM) and gelfoam only both can occlude APS in patients with hepatocellular carcinoma (HCC).

The aim of this study was to evaluate the efficacy and safety of EGM in treatment of APS in the procedure of TACE, and to analyze the prognostic factors for survival in this kind of patients.

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Detailed Description

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TACE+EGM

Occlude APS with EGM and perform TACE sequentially

Group Type EXPERIMENTAL

TACE

Intervention Type PROCEDURE

Transarterial chemoembolisation (TACE)

EGM

Intervention Type DRUG

Occlude arterioportal shunts(APS) with ethanol/gelfoam mixture(EGM)

TACE+PVA

Occlude APS with PVA and perform TACE sequentially

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type PROCEDURE

Transarterial chemoembolisation (TACE)

PVA

Intervention Type DRUG

Occlude arterioportal shunts(APS) with PVA

Interventions

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TACE

Transarterial chemoembolisation (TACE)

Intervention Type PROCEDURE

EGM

Occlude arterioportal shunts(APS) with ethanol/gelfoam mixture(EGM)

Intervention Type DRUG

PVA

Occlude arterioportal shunts(APS) with PVA

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age \> 18
* Child-Pugh A or B cirrhosis
* ECOG performance status Grade 2 or below
* No serious concurrent medical illness
* No prior treatment (including surgery) for HCC
* Histologically or cytologically proven HCC (an alphafetoprotein level \> 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection can be considered eligible at investigator's discretion)
* Unresectable and locally advanced disease without extra-hepatic disease
* Massive expansive or nodular tumor morphology with measurable lesion on CT
* Size of largest tumor \<= 15cm in largest dimension
* Number of main tumor \<= 5, excluding associated small satellite lesions
* Arterioportal shunts (APS) is found in the angiography of HCC blood supply

Exclusion Criteria

* History of prior malignancy except skin cancer
* History of significant concurrent medical illness such as ischemic heart disease or heart failure
* History of acute tumor rupture
* Serum creatinine level \> 180 umol/L
* Presence of biliary obstruction not amenable to percutaneous drainage
* Child-Pugh C cirrhosis
* History of hepatic encephalopathy, or
* Intractable ascites not controllable by medical therapy, or
* History of variceal bleeding within last 3 months, or
* Serum total bilirubin level \> 50 umol/L, or
* Serum albumin level \< 28g/L, or
* INR \> 1.3
* Presence of extrahepatic metastasis
* Predominantly infiltrative lesion
* Diffuse tumor morphology with extensive lesions involving both lobes.
* Hepatic artery thrombosis, or
* Partial or complete thrombosis of the main portal vein, or
* Tumor invasion of portal branch of contralateral lobe, or
* Hepatic vein tumor thrombus

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No