Italian Society of Urology

Treating the tumour, saving the kidney: the challenge of personalised surgery

The i-RECORD registry brings together 50 hospitals from the United States to Europe, and from China to Japan, with 6,500 patients already enrolled, and its headquarters in Florence

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4' min read

Translated by AI
Versione italiana

4' min read

Translated by AI
Versione italiana

Renal cell carcinoma is a silent enemy. In its early stages, it causes no pain and shows no obvious signs; today, in most cases, the diagnosis is incidental, resulting from ultrasound or CT scans carried out for other clinical reasons. This widespread use of diagnostic imaging has changed the landscape of the disease: we are no longer dealing with large, symptomatic tumours, but with small, asymptomatic nodules detected at an early stage. In Italia, where there are over 13,000 new diagnoses annually and a prevalence of around 155,000 people, early diagnosis is a crucial turning point: when the tumour is confined to the organ – as is the case in more than half of all cases – surgery becomes a curative and definitive treatment.

The rise of conservative surgery

Whilst for decades the standard approach has been radical nephrectomy – that is, the removal of the entire organ (a procedure that remains irreplaceable for extensive or complex tumours) – the last thirty years have seen the rise of conservative, or nephron-sparing, surgery: selectively removing the tumour whilst preserving the nephrons, the functional units of the kidney. Preserving the healthy parenchyma is supported by specific pathophysiological evidence: the removal of the organ reduces the overall functional reserve, exacerbating the long-term risk of hypertension and cardiovascular complications, with a severe impact on quality of life. Furthermore, retaining the original kidney ensures an essential biological reserve should kidney stones, urological conditions or tumour recurrences develop in the contralateral organ in the future – scenarios in which having only one kidney would make any surgical treatment more complex and increase the risk of requiring dialysis.

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What do the guidelines set out?

The guidelines recommend partial nephrectomy as the first-line treatment for confined tumours measuring less than 7 centimetres. Today, leading-edge surgical practice successfully applies this approach even to tumours larger than 7 centimetres in selected cases, although such complex procedures remain the preserve of very high-volume centres. The kidney is, in fact, the most highly vascularised organ in the body, traversed by large blood vessels: selective resection requires extreme precision, and its feasibility depends on the size and position of the tumour, its proximity to the urinary tract, as well as the patient’s condition and the surgeon’s experience.

The advent of minimally invasive laparoscopic surgery and, above all, robotic surgery – with its three-dimensional, magnified view – now makes it possible to operate through small incisions, reducing post-operative pain and hospital stays. Technology even supports the surgeon with three-dimensional and holographic models to plan the operation before entering the operating theatre. Nevertheless, the proliferation of options – which, for elderly and frail patients, includes active surveillance or thermal ablation techniques (which destroy the tumour using heat or cold without removing it) – raises complex questions, which have so far been explored in a fragmented and retrospective body of scientific literature.

The objectives of the i-RECORD project

To fill this gap, i-RECORD (international REgistry of COnservative or Radical treatment of localised kiDney tumours) was established. Promoted and funded by the Italian Society of Urology (SIU) – the institution that promotes national excellence, including through the ‘Bollino Arancione’ initiative – this prospective, independent and international registry monitors patients with scheduled follow-up appointments for up to five years. Using an innovative multi-arm, multi-stage (MAMS) statistical model, i-RECORD does not merely record short-, medium- and long-term outcomes, but analyses the clinical decision-making process in relation to comorbidities, hospital resources and the country’s socio-health context.

The project represents the culmination of an Italian initiative launched fifteen years ago with the RECORD 1 (2009–2012, 800 patients across 19 urology centres) and RECORD 2 (2013–2016, over 4,000 cases across 26 centres), whose studies, published in leading international journals, have shaped the scientific literature on positive surgical margins and complications. Today, i-RECORD brings together 50 of the world’s most highly qualified hospitals, selected according to strict criteria of expertise and located across four continents: from the United States to Europe, from Russia to China, from Japan to Singapore, with around 6,500 patients already enrolled, working towards a target of over 10,000 patients.

The transition to personalised medicine

The global coordination centre is based at the Careggi University Hospital in Florence. Under my leadership, the complex scientific and organisational management of the international network within the research department of the Italian Society of Urology is entrusted to Professor Andrea Mari, who heads the Clinical Trials and Translational Research section, and to Dr Sabrina De Cillis, head of the Real-World Data section.

The ultimate goal is the definitive transition towards medicine tailored to the individual patient. As Professor Giuseppe Carrieri, President of the SIU, pointed out, the challenge of modern surgery is not to remove the tumour at any cost, but to treat the person as a whole: every kidney we manage to save represents a fundamental investment in the patient’s future health. Through the i-RECORD registry, Italia is not merely a bystander to this epidemiological and technological shift, but is playing a steadfast role in its international governance.

*Head of the Research Department at the SIU (Italian Society of Urology) and Director of the SOD for Minimally Invasive Oncological Urology and Andrology at the Careggi University Hospital in Florence

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