NCT02338297

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

A Randomized Controlled Trial of Ethanol-gelfoam Mixture(EGM) Versus Gelfoam for the Treatment of Arterioportal Shunts (APS) in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolization (TACE)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
PROCEDURE	TACE	Transarterial chemoembolisation (TACE)
DRUG	EGM	Occlude arterioportal shunts(APS) with ethanol/gelfoam mixture(EGM)
DRUG	PVA	Occlude arterioportal shunts(APS) with PVA

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-02-01
• Completion: 2017-12-01
• First posted: 2015-01-14
• Last updated: 2016-04-01

Locations

2 sites across 1 country: China