Isolated hypoxic hepatic perfusion (IHHP) using balloon catheter techniques: From laboratory to the clinic towards a percutaneous procedure

Background/Aims: The success of ana our extensive experience with TNF alpha -based isolated limb perfusions in patients with unresectable extremity sof t tissue sarcomas made us explore the possibilities for a similar approach for the treatment of hepatic metastases. After experience with the classic surgical isolated hepatic perfusion in pi gs and in patients, we concluded that the classic surgical approach was ass ociated with serious drawbacks i.e., magnitude of the procedure with morbid ity, lack of repeatability of the procedure, complexity and costs. These pr oblems were addressed in a program aimed at developing a repeatable method of isolated perfusion of the liver with minimally invasive techniques. Methodology: We validated the methodology of isolated hypoxic hepatic perfu sion using balloon catheter techniques in pigs. Results: The excellent pharmacokinetic profile of the procedure, resulting in very high regional drug concentrations and negligible systemic drug conc entrations, allowed us to move on to the clinic and start to study and furt her develop this method in a phase I-II study using the drug melphalan, in patients with irresectable hepatic metastases. Conclusions: We aim to develop step by step a fully percutaneous approach f or isolated hypoxic hepatic perfusion.