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Clinical Trial
. 2023 May;41(5):1337-1344.
doi: 10.1007/s00345-023-04366-3. Epub 2023 Apr 21.

The role of warm ischemia time on functional outcomes after robotic partial nephrectomy: a radionuclide renal scan study from the clock randomized trial

Alessan Dro Antonelli  1   2 , Luca Cindolo  3 , Marco Sandri  4 , Alessandro Veccia  5   6 , Filippo Annino  7 , Francesco Bertagna  8 , Fabrizio Di Maida  9 , Antonio Celia  10 , Carlo D'Orta  3 , Bernardino De Concilio  10 , Maria Furlan  5 , Valentina Giommoni  7 , Manuela Ingrosso  3 , Andrea Mari  9 , Roberto Nucciotti  11 , Catia Olianti  12 , Angelo Porreca  13 , Giulia Primiceri  3 , Luigi Schips  3 , Francesco Sessa  9 , Pierluigi Bove  14 , Claudio Simeone  5 , Andrea Minervini  9 ; AGILE Group (Italian Group for Advanced Laparo-Endoscopic Surgery)
Affiliations
Clinical Trial

The role of warm ischemia time on functional outcomes after robotic partial nephrectomy: a radionuclide renal scan study from the clock randomized trial

Alessan Dro Antonelli et al. World J Urol. 2023 May.

Abstract

Purpose: To evaluate the relationship between warm ischemia time (WIT) duration and renal function after robot-assisted partial nephrectomy (RAPN).

Methods: The CLOCK trial is a phase 3 randomized controlled trial comparing on- vs off-clamp RAPN. All patients underwent pre- and postoperative renal scintigraphy. Six-month absolute variation of eGFR (AV-GFR), rate of relative variation in eGFR over 25% (RV-GFR > 25), absolute variation of split renal function (SRF) at scintigraphy (AV-SRF). The relationships WIT/outcomes were assessed by correlation graphs and then modeled by uni- and multivariable regression.

Results: 324 patients were included (206 on-clamp, 118 off-clamp RAPN). Correlation graphs showed a threshold on WIT equal to 10 min. The differences in outcome measures between cases with WIT < vs ≥ 10 min were: AV-GFR - 3.7 vs - 7.5 ml/min (p < 0.001); AV-SRF - 1% vs - 3.6% (p < 0.001); RV-GFR > 25 9.3% vs 17.8% (p = 0.008). Multivariable models found that AV-GFR was related to WIT ≥ 10 min (regression coefficient [RC] - 0.52, p = 0.019), age (RC - 0.35, p = 0.001) and baseline eGFR (RC - 0.30, p < 0.001); RV-GFR > 25 to WIT ≥ 10 min (odds ratio [OR] 1.11, p = 0.007) and acute kidney injury defined as > 50% increase in serum creatinine (OR 19.7, p = 0.009); AV-SRF to WIT ≥ 10 min (RC - 0.30, p = 0.018), baseline SRF (RC - 0.76, p < 0.001) and RENAL score (RC - 0.60. p = 0.028). The main limitation was that the CLOCK trial was designed on a different endpoint and therefore the present analysis could be underpowered.

Conclusions: Up to 10 min WIT had no consequences on functional outcomes. Above the 10-min threshold, a statistically significant, but clinically negligible impact was found.

Keywords: Off-clamp; On-clamp; Partial nephrectomy; Renal tumor; Robotic; Warm ischemia time.

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Conflict of interest statement

None.

Figures

Fig. 1
Fig. 1
Visual assessment drawing scatter plots with a nonparametric regression line of a the absolute variation of eGFR (AV-GFR) at 6 months; b the rate of relative variation in eGFR over 25% (RV-GFR > 25) at 6 months; c the absolute variation in the SRF of the operated kidney at scintigraphy (AV-SRF) at 6 months
See this image and copyright information in PMC

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