Cirrhosis in over 16s: assessment and management

Search and selection strategy

We searched for new evidence related to the whole guideline based on 2 searches: the first search for the diagnosis and monitoring sections of the guideline included observational and experimental studies and systematic reviews; the second search for the management section of the guideline included randomised controlled trials and systematic reviews.

We found 38 studies in a search for diagnosis and monitoring studies published between 24 August 2015 and 30 November 2019.

We found 27 studies in a search for management studies published between 24 August 2015 and 30 November 2019.

We also included 17 relevant studies and 3 guidelines from a total of 46 references identified by topic experts; 16 of the relevant studies were identified by searches.

One recent Cochrane systematic review (Komolafe et al.) recommended by a topic expert published in January 2020 was outside of the search period, but as it provides important evidence in a key area for the guideline it was included in the evidence summary below.

From all sources, we considered 67 studies to be relevant to the guideline.

See appendix A for details of all evidence considered, and references.

Views of topic experts

We considered the views of topic experts who were recruited to the NICE Centre for Guidelines Expert Advisers Panel to represent their specialty. For this surveillance review, topic experts completed a questionnaire about developments in evidence, policy and services related to the guideline.

We received 6 questionnaire responses from experts which included 2 consultant readers in hepatology, a general practitioner with special interest in liver disease, a specialist nurse and 2 professors (clinical) of hepatology.

Five topic experts thought the guideline should be updated and 1 expert identified that it should not be updated.

Reasons to consider updating included the following points:

Other sources of information

We considered all other correspondence received since the guideline was published.

In March 2019, the MHRA issued restrictions and precautions for the use of fluoroquinolone antibiotics because of rare reports of disabling and potentially long-lasting or irreversible side effects (see the MHRA's drug safety update for details). The current 2019/20 surveillance review was conducted early to enable a check of the use of fluoroquinolones in the guideline.

Views of stakeholders

Stakeholders are consulted on all surveillance reviews except if the whole guideline will be updated and replaced. Because this surveillance proposal was to update part of the guideline, we consulted with stakeholders.

Seven stakeholders commented and 6 agreed to a partial update of the guideline. Responses were received from 2 commercial companies, 1 hospital trust, 3 professional bodies and 1 charity; the 3 professional bodies provided joint responses.

Stakeholders highlighted 3 main areas, beyond the area for proposed update, where they felt an update was necessary. First, joint comments from 2 stakeholders queried whether liver ultrasound (with or without serum alpha-fetoprotein) is an appropriate tool for surveillance of hepatocellular carcinoma (HCC) in all patient groups. The current review only concerned the appropriate surveillance interval, and method of surveillance was beyond the scope. The stakeholders identified that tools for detecting HCC is an area where new research may emerge in the future. We will consider this area at the next surveillance review.

Joint comments from 3 stakeholders identified a new study on the primary prevention of ascites in people with compensated cirrhosis. However, this topic was not covered by the original guideline as its objective was to cover areas of uncertainty or variability in practice and to aid non-specialists, and thus was not in the scope of the surveillance review.

A stakeholder queried whether the guideline should specify that covered transjugular intrahepatic portosystemic shunt (that is, PTFE-covered stents) should be used for people with cirrhosis who have refractory ascites, in preference to bare metal stents. There was, however, no direct evidence to support such a change, although we will revisit this issue at future review timepoints.

Two stakeholders identified that the ELF test, which is mentioned in the diagnosis section of the guideline is not available in all localities. This issue was also raised by 1 topic expert. The recommendations concerning ELF tests are adapted from NICE's guideline on non-alcoholic fatty liver disease (NAFLD): assessment and management. The recommendation to consider the ELF test, with a threshold of 10.51 to test for advanced fibrosis, is based on evidence that it was the most diagnostically accurate and also the most cost-effective test compared with all other testing and non-testing strategies. We have noted this implementation issue for the forthcoming review of the NAFLD guideline.

At the time of consultation we asked stakeholders for views on the use of non-invasive tests, in place of endoscopy, as a method to identify oesophageal varices. There was general consensus that non-invasive approaches have significant limitations, that further long-term study is necessary and that the guideline position that endoscopy should be used remains sound.

No changes to the surveillance proposal were made in response to stakeholders' comments.

See appendix B for full details of stakeholders' comments and our responses.

See ensuring that published guidelines are current and accurate in developing NICE guidelines: the manual for more details on our consultation processes.