S. Heinrich, Andreia Margarida Carvalho de Matos, Jordi Colmenero, Ahmed M. Elsharkawy, Soňa Fraňková, Jan Halbritter, Anna Mrzljak, Roman‐Ulrich Müller, Rafaela Pereira, Pavel Strnad, Carmen A. J. Teemer, Jef Verbeek, Karolina M. Wronka, Frederik Nevens, Richard Taubert, Joost P.H. Drenth, the European Reference Network on Hepatological Liver Diseases (ERN RARE‐LIVER)
Polycystic liver disease (PLD) is a rare genetic disorder characterised by progressive liver enlargement due to multiple cysts. The main symptoms are liver volume-related. Although randomised controlled trials have shown that somatostatin analogues (SSAs) reduce liver volume as well as symptoms, specific guidance on when and how to use SSAs in clinical practice is still lacking. A panel of 15 hepatologists and nephrologists developed practical guidance on SSA use, based on a systematic literature search, expert surveys, and clinical experience. This consensus was reached during a two-day workshop by the European Reference Network on Hepatological Diseases, using 11 predefined key questions and an iterative Delphi process. PLD patients with liver volume-related symptoms, diffuse disease, and significant hepatomegaly are eligible for SSA therapy, regardless of kidney function. Disease burden should be assessed with validated PROMs as well as liver volumetry before and during treatment. Symptom relief without liver growth is a valid treatment response. Therapy may continue until the natural course of disease slows down (e.g., with the onset of menopause). Trials report benefits of SSA therapy for up to 3-4 years. Early discontinuation may cause a rebound of liver volume. As SSA therapy remains off-label, limited access and reimbursement hamper widespread use in Europe. We present state-of-the-art guidance on the practical use of the only available medical therapy for severe PLD including eligibility, start and stop criteria and identifying research gaps. This consensus-based guidance provides much-needed practical recommendations for the use of somatostatin analogues in managing severe polycystic liver disease. By defining eligibility, treatment goals, and monitoring strategies, it supports more standardised, patient-centered care across Europe.