Living-donor liver transplantation (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Living-donor liver transplantation

Many diseases can damage the liver. If damage is severe, a liver transplantation may be necessary. Living-donor liver transplantation is the replacement of a diseased liver with part of a healthy liver from a donor (usually a relative or spouse).

The National Institute for Health and Clinical Excellence is examining living-donor liver transplantation and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about living-donor liver transplantation.

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 preliminary recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence.

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

The process that the Institute 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  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

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

Closing date for comments: 22 August 2006
Target date for publication of guidance: December 2006


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


1 Provisional recommendations
1.1

Current evidence on the efficacy of living-donor liver transplantation and its safety profile for suitable recipients appears adequate to support the use of this procedure.

1.2

The procedure should only be used in selected patients whose condition has become an imminent threat to their lives.

1.3

However, current evidence suggests that living-donor liver transplantation carries a significant risk of morbidity and a small risk of death for donors. Therefore clinicians wishing to undertake this procedure should take the following actions.

  • Inform the clinical governance leads in their Trusts.
  • Ensure that donors receive thorough physical and psychological screening, and counselling about the morbidity and risks associated with this procedure. They should also be provided with clear written information. In addition, use of the Institute’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/IPG XXXpublicinfo).
  • Audit and review clinical outcomes of all people donating livers for transplantation (see section 3.1).
1.4 Living-donor liver transplantation should only be performed in specialist centres in the context of a multidisciplinary team.
1.5

Clinicians should enter all donors and recipients into the UK & Ireland Liver Transplant Audit (www.rcseng.ac.uk/surgical_research_units/ceu/projects/proj_liver.html).

1.6

The UK Transplant Advisory Group is developing national standards for living-donor liver transplantation .

 

2 The procedure
2.1 Indications
2.1.1

Liver transplantation is a treatment option for patients with end-stage liver failure and may also be indicated in patients with some types of primary liver cancer. End-stage liver failure may be acute or chronic. In children, the most common cause of end-stage liver failure is congenital biliary atresia.

2.1.2

Living donation is an alternative to cadaveric organ donation and is an option for patients for whom cadaveric transplantation is unavailable or whose clinical condition is deteriorating to the point of transplant ineligibility while waiting for a cadaveric donor. Living donation may also be an option for critically ill children. The living donor is usually a blood relative, but could also be a spouse or partner.

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2.2 Outline of the procedure
2.2.1

Living donation is an alternative to cadaveric organ donation and is an option for patients for whom cadaveric transplantation is unavailable or whose clinical condition is deteriorating to the point of transplant ineligibility while waiting for a cadaveric donor. Living donation may also be an option for critically ill children. The living donor is usually a blood relative, but could also be a spouse or partner.

2.2.2

The graft size required is determined by the ratio of body size between the donor and recipient. Right-lobe transplants are chosen for many adult recipients, whereas left-lobe transplants are used more commonly for children and adult recipients with a small body size.

2.2.3

The right lobe is generally considered to provide a better graft because it provides a larger volume of liver parenchyma, and the blood and biliary vessels are larger and easier to anastomose. However, right hepatectomy is a more complex procedure than left hepatectomy and may be associated with an increased risk to the donor.

 

2.3 Efficacy
2.3.1

In a review of primary studies assessing outcomes following adult-to-child liver transplantation, median 5-year survival was generally higher in the living-donor group (92%) than in the cadaveric-graft group (81%) (based on eight studies looking at 1091 living grafts and 4550 whole-organ cadaveric grafts). Graft survival was also higher with living-donor grafts: the median 5-year survival rate was 81% in the living-donor group, compared with 73% in the cadaveric-graft group.

2.3.2

The evidence for efficacy in adult-to-adult transplantation was based on a systematic review and a large case–control study. No significant differences in recipient survival at 12 months were found in three comparative studies included in the review (80–100% in the living-donor group and 75–90% in the cadaveric-graft group). In 65 non-comparative studies included in the review, recipient survival rates ranged from 43% to 100% at follow-up of 1–36 months.

2.3.3

Graft survival was also reported in three comparative studies. At follow-up of at least 12 months, graft survival was 75–89% in the living-donor groups, compared with 73–89% in the cadaveric-graft groups.

2.3.4

In a systematic review of donor outcomes it was reported that nearly all donors returned to normal activity by 6 months (based on 18 studies). By 6 months, donors’ livers had regenerated to a median of 89% of their original size (based on 16 studies). The authors of the systematic review noted that relatively few studies have assessed quality of life and psychological outcomes in donors. For more details, refer to the sources of evidence (see appendix).

2.3.5

The majority of Specialist Advisers noted that living-donor liver transplantation is an established procedure in end-stage liver disease, particularly in children. However, there are still some uncertainties about long-term survival and graft function in comparison with cadaveric-liver grafts.

 

2.4 Safety
2.4.1

Biliary complications (leaks and strictures) were the most commonly reported complications for both child and adult recipients. In a review of literature assessing outcomes following adult-to-child liver transplantation, the incidence of biliary complications ranged from 5% to 14% (based on four studies). Other complications reported included portal vein and hepatic artery thrombosis.

2.4.2

In a systematic review of outcomes in adult recipients, the median reported biliary complication rate was 22% (based on 75 studies). Other common complications included infection, and hepatic and vascular complications, with median reported rates of 19%, 21% and 7%, respectively.

2.4.3

In a systematic review of outcomes in donors, mortality was estimated to be about 0.2% (12/6000). At least seven of these deaths involved adult-to-adult donation, and the risk of mortality appeared to be higher for right-lobe donation (0.23–0.5%) than for left-lobe donation (0.05–0.21%).

2.4.4

Donor morbidity ranged from 0% to 100%, with a median of 16% (based on 131 studies). Complications included biliary leaks and strictures, pulmonary embolism, small bowel obstruction, pleural effusion and bleeding. Similar results were reported in two large case series, with overall morbidity rates of 13% (52/386) and 16% (238/1508). In both studies, the frequency of postoperative complications was significantly higher in right-lobe donors compared with left-lobe donors. One study also reported that more serious complications occurred in those who had donated right-lobe grafts. For more details, refer to the sources of evidence (see appendix).

2.4.5

The Specialist Advisers considered the main complications for the recipient following living-donor liver transplantation to be biliary and vascular complications. With respect to donors, the Specialist Advisers expressed concerns about donor risk. It was noted that donor mortality varied depending on the size of the liver donated, with right hepatectomy possibly associated with increased risk.

 

3 Further information
3.1 This guidance requires that clinicians undertaking the procedure make special arrangements for audit. The Institute has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
August 2006

Appendix: Sources of evidence

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

  • 'Interventional procedure overview of living-donor liver transplantation', April 2006.

Available from: www.nice.org.uk/ip253overview

This page was last updated: 04 February 2011

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.

Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.