Nephron Sparing Treatment (NEST) for Small Renal Masses: A Feasibility Cohort-embedded Randomised Controlled Trial Comparing Percutaneous Cryoablation and Robot-assisted Partial Nephrectomy.

Autor: Neves JB; Division of Surgery and Interventional Sciences, University College London, London, UK; Specialist Centre for Kidney Cancer, Royal Free Hospital, London, UK., Warren H; Division of Surgery and Interventional Sciences, University College London, London, UK; Specialist Centre for Kidney Cancer, Royal Free Hospital, London, UK., Santiapillai J; Division of Surgery and Interventional Sciences, University College London, London, UK; Specialist Centre for Kidney Cancer, Royal Free Hospital, London, UK., Rode N; Specialist Centre for Kidney Cancer, Royal Free Hospital, London, UK., Cullen D; Specialist Centre for Kidney Cancer, Royal Free Hospital, London, UK., Pavlou M; Department of Statistical Science, University College London, London, UK., Walkden M; Specialist Centre for Kidney Cancer, Royal Free Hospital, London, UK; Department of Interventional Radiology, University College London Hospital, London, UK., Patki P; Specialist Centre for Kidney Cancer, Royal Free Hospital, London, UK., Barod R; Division of Surgery and Interventional Sciences, University College London, London, UK; Specialist Centre for Kidney Cancer, Royal Free Hospital, London, UK., Mumtaz F; Division of Surgery and Interventional Sciences, University College London, London, UK; Specialist Centre for Kidney Cancer, Royal Free Hospital, London, UK., Aitchison M; Specialist Centre for Kidney Cancer, Royal Free Hospital, London, UK., Bandula S; Department of Interventional Radiology, University College London Hospital, London, UK., Pizzo E; Department of Allied Health Research, University College London, London, UK., Ranieri V; Clinical Psychology, Tavistock and Portman Foundation Trust, London, UK., Williams N; Division of Surgery and Interventional Sciences, University College London, London, UK., Wildgoose W; Patient Representative, London, UK., Gurusamy K; Division of Surgery and Interventional Sciences, University College London, London, UK., Emberton M; Division of Surgery and Interventional Sciences, University College London, London, UK; Department of Urology, University College London Hospital, London, UK., Bex A; Division of Surgery and Interventional Sciences, University College London, London, UK; Specialist Centre for Kidney Cancer, Royal Free Hospital, London, UK., Tran MGB; Division of Surgery and Interventional Sciences, University College London, London, UK; Specialist Centre for Kidney Cancer, Royal Free Hospital, London, UK. Electronic address: m.tran@ucl.ac.uk.
Jazyk: angličtina
Zdroj: European urology [Eur Urol] 2024 Apr; Vol. 85 (4), pp. 333-336. Date of Electronic Publication: 2023 Sep 09.
DOI: 10.1016/j.eururo.2023.07.012
Abstrakt: There is a paucity of high-level evidence on small renal mass (SRM) management, as previous classical randomised controlled trials (RCTs) failed to meet accrual targets. Our objective was to assess the feasibility of recruitment to a cohort-embedded RCT comparing cryoablation (CRA) to robotic partial nephrectomy (RPN). A total of 200 participants were recruited to the cohort, of whom 50 were enrolled in the RCT. In the CRA intervention arm, 84% consented (95% confidence interval [CI] 64-95%) and 76% (95% CI 55-91%) received CRA; 100% (95% CI 86-100%) of the control arm underwent RPN. The retention rate was 90% (95% CI 79-96%) at 6 mo. In the RPN group 2/25 (8%) were converted intra-operative to radical nephrectomy. Postoperative complications (Clavien-Dindo grade 1-2) occurred in 12% of the CRA group and 29% of the RPN group. The median length of hospital stay was shorter for CRA (1 vs 2 d; p = 0.019). At 6 mo, the mean change in renal function was -5.0 ml/min/1.73 m 2 after CRA and -5.8 ml/min/1.73 m 2 after RPN. This study demonstrates the feasibility of a cohort-embedded RCT comparing CRA and RPN. These data can be used to inform multicentre trials on SRM management. PATIENT SUMMARY: We assessed whether patients with a small kidney tumour would consent to a trial comparing two different treatments: cryoablation (passing small needles through the skin to freeze the kidney tumour) and surgery to remove part of the kidney. We found that most patients agreed and a full trial would therefore be feasible.
(Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE