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Guidance assessment consultation document for HTG10870 Melphalan chemosaturation with percutaneous hepatic artery perfusion and hepatic vein isolation for primary or metastatic cancer in the liver

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2 Information about the procedure

2.1

Melphalan chemosaturation with percutaneous hepatic artery perfusion and hepatic vein isolation is done under general anaesthesia. A high dose of melphalan chemotherapy is delivered directly into the hepatic artery, which supplies the liver. Blood leaving the liver is diverted out of the body and filtered to reduce the level of melphalan before being returned to the circulation. The aim is to allow high doses of melphalan chemotherapy to be used, which would otherwise not be tolerated because of severe systemic side effects.

2.2

The procedure uses veno-venous bypass perfusion and the extracorporeal circulation is operated by a clinical perfusion scientist. An infusion catheter is inserted, typically into the femoral artery, and guided into the hepatic artery. A multi‑lumen, double-balloon catheter is inserted into the inferior vena cava and across the hepatic veins. The balloons are inflated so that all blood leaving the liver through the hepatic veins enters the catheter rather than the systemic circulation. High doses of melphalan are infused directly into the liver through the hepatic artery infusion catheter over about 30 minutes. Blood leaving the liver passes through an extracorporeal filtration system to remove most of the melphalan and is returned to the circulation through a catheter in the internal jugular vein, in the neck. Full anticoagulation with heparin is needed throughout the procedure.

2.3

The procedure causes significant changes in the person's haemodynamic status. This is managed by the anaesthetic team with support from a clinical perfusion scientist.