2 The procedure
2.1.1 This procedure can be carried out in patients with primary or secondary (metastatic) liver cancer.
2.1.2 Treatment strategies for patients with liver cancer depend on tumour type, location, number and size. Most patients with liver cancer cannot benefit from surgical treatment and are treated with palliative intent. For some patients, liver resection surgery, either on its own or in combination with other treatments, may be beneficial.
2.2.1 The procedure is carried out with the patient under general anaesthesia. The liver is removed through an abdominal incision and is perfused with a preservative solution. A bloodless resection of the diseased hepatic parenchyma is then performed, allowing complex reconstruction of the hepatic and portal vein structures, and the liver is reimplanted into the patient. The procedure can be performed with or without venovenous bypass.
Sections 2.3 and 2.4 describe efficacy and safety outcomes which were available in the published literature and which the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.
2.3.1 In a case series of 24 patients (22 with cancer) treated by ex-vivo hepatic resection and reimplantation, it was possible to resect and reimplant the liver in 91% (20/22) of the patients with cancer. In the case series of 24 patients (22 with cancer), 59% (13/22) survived the procedure and were discharged. Of the 13 patients who survived the procedure, 77% (10/13) died of tumour recurrence at between 12-month and 36-month follow-up. In a case series of 8 patients with liver metastases from colorectal cancer, 4 patients were treated by ex-vivo resection, of whom 2 were alive at 5-month follow-up (1 patient with tumour recurrence in the bone). The third patient died after 30 months and the fourth died 15 days after the operation. In a case series of 16 patients treated by liver resection with hepatic vein reconstruction, 2 patients were treated by ex-vivo resection. One of the 2 patients, with hepatocellular carcinoma, was alive and disease free at 52-month follow-up. The other patient, with colorectal metastases, was free of hepatic involvement at death following small bowel perforation after 4 months of follow-up. A case report of a single patient with hepatocellular carcinoma reported that the patient was alive with no recurrence 1 year after ex-vivo hepatic resection.
2.3.2 In the case series of 24 patients (22 with cancer), the mean operative time was 13.54 hours, and the mean anhepatic phase was 6.67 hours.
2.3.3 The Specialist Advisers stated that the key efficacy outcome of this procedure is survival.
2.4.1 Of the 22 patients with cancer in the case series of 24 patients treated by ex-vivo liver resection, 41% (9/22) died postoperatively during the same admission episode as the operation (exact timing of death not stated). In the same study, 32% of patients (7/22) required donor liver transplantation either immediately (2 patients) or at a subsequent procedure (5 patients; exact timing of transplantation not stated).
2.4.2 In the case series of 8 patients, of the 4 patients undergoing ex-vivo resection, 1 patient died after 15 days from respiratory failure, renal failure and haemopneumothorax; and 1 patient developed inferior vena caval obstruction requiring stenting and pleural effusion requiring drainage.
2.4.3 The Specialist Advisers stated that adverse events (reported in the literature or anecdotally) include mortality, liver failure and bleeding/requirement for blood transfusion. The Specialist Advisers also commented that the procedure may increase the demand for donor livers.