Ex-vivo hepatic resection and reimplantation for liver cancer (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional procedure consultation document

Ex-vivo hepatic resection and reimplantation for liver cancer

The liver may be affected by cancer, either spreading from other parts of the body or developing from within the organ. In some patients, the tumour may develop in parts of the liver that are dangerous or impossible to treat with surgery, for example, when the tumour is very close to major veins that connect to the liver. This procedure involves removing the liver from the body, cutting away the diseased tissue, and reimplanting the remaining tumour-free liver into the patient.

 

The National Institute for Health and Clinical Excellence (NICE) is examining ex-vivo hepatic resection and reimplantation for liver cancer and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about ex-vivo hepatic resection and reimplantation for liver cancer.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

  • comments on the provisional recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

  • The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
  • The Advisory Committee will then prepare draft guidance which will be the basis for NICE's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 27 January 2009

Target date for publication of guidance: April 2009

 

1 Provisional recommendations
1.1 Current evidence on ex-vivo hepatic resection and reimplantation for liver cancer raises concerns about the safety and efficacy of the procedure. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research. It should only be used for patients who would otherwise not survive, and for whom other treatment options have failed or are inappropriate.
1.2

Clinicians wishing to undertake ex-vivo hepatic resection and reimplantation for liver cancer should take the following actions.

  • Inform the clinical governance leads in their Trusts.
  • Ensure that patients understand the uncertainty about the procedure's safety and efficacy; specifically the risks of death or serious morbidity, and the possible need for liver transplantation.   Clear written information should be provided. In addition, the use of NICE's information for patients ('Understanding NICE guidance') is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]
  • Audit and review clinical outcomes of all patients having ex-vivo hepatic resection and reimplantation (see section 3.1).
2 The procedure
2.1 Indications and current treatments
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, however, liver resection surgery, either on its own or in combination with other treatment modalities, may be beneficial.
2.2 Outline of the procedure
2.2.1 The procedure is carried out with the patient under general anaesthesia. The liver is removed from the patient 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 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 from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP205overview.

 

2.3 Efficacy
2.3.1 In a case series of 24 patients (22 with cancer) treated by ex-vivo hepatic resection and reimplantation, 59% (13/22) survived the procedure and were discharged alive. In a case series of 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 had tumour recurrence in the bone); a third patient died after 30 months. 
2.3.2 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 when they died following small bowel perforation at 4-month 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.
2.3.3 In the case series of 24 patients (22 with cancer), it was possible to resect and reimplant the liver in 91% (20/22) of the patients with cancer. The mean operative time was 13.54 hours, and the mean anhepatic phase was 6.67 hours (timing not reported separately for patients with cancer).
2.3.4 The Specialist Advisers stated that the key efficacy outcome by which to evaluate this procedure should be survival.
2.4 Safety
2.4.1 Of the 22 patients with cancer reported 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). Among the 13 patients who survived the procedure and were discharged alive in this study, 77% (10/13) died of tumour recurrence between 12-month and 36-month follow-up 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 a pleural effusion requiring drainage.
2.4.3 The Specialist Advisers considered adverse events relating to the procedure known from the literature or anecdotally to include mortality, liver failure, bleeding/requirement for blood transfusion. The Specialist Advisers also commented that the procedure may increase the demand for donor livers.
3 Further information
3.1 This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing audit support (which is for use at local discretion), which will be available when the guidance is published.

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

December, 2008

This page was last updated: 30 March 2010