Evidence map›Paper›PMID 37085644›Full record

Trial reportWorld journal of urology2023

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, Luca Cindolo, Marco Sandri, Alessandro Veccia, Filippo Annino, Francesco Bertagna, Fabrizio Di Maida, Antonio Celia, Carlo D'Orta, Bernardino De Concilio and 14 more

Abstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in World journal of urology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Alessan Dro AntonelliUrology Unit, ASST Spedali Civili Hospital, University of Brescia, Brescia, Italy. alessandro.antonelli@univr.it.
Luca CindoloUrology Unit, D'Annunzio Hospital, University of Chieti, Chieti, Italy.
Marco SandriBig and Open Data Innovation Laboratory (BODaI-Lab), University of Brescia, Brescia, Italy.
Alessandro VecciaUrology Unit, ASST Spedali Civili Hospital, University of Brescia, Brescia, Italy.ORCID http://orcid.org/0000-0001-5947-3206
Filippo AnninoUrology Unit San Donato Hospital, Arezzo, Italy.
Francesco BertagnaNuclear Medicine Unit ASST Spedali Civili Hospital, University of Brescia, Brescia, Italy.
Fabrizio Di MaidaUrology Unit, Careggi Hospital, University of Florence, Florence, Italy.
Antonio CeliaUrology Unit, San Bassiano Hospital, Bassano Del Grappa, Italy.
Carlo D'OrtaUrology Unit, D'Annunzio Hospital, University of Chieti, Chieti, Italy.
Bernardino De ConcilioUrology Unit, San Bassiano Hospital, Bassano Del Grappa, Italy.
Maria FurlanUrology Unit, ASST Spedali Civili Hospital, University of Brescia, Brescia, Italy.
Valentina GiommoniUrology Unit San Donato Hospital, Arezzo, Italy.
Manuela IngrossoUrology Unit, D'Annunzio Hospital, University of Chieti, Chieti, Italy.
Andrea MariUrology Unit, Careggi Hospital, University of Florence, Florence, Italy.
Roberto NucciottiUrology Unit, Misericordia Hospital, Grosseto, Italy.
Catia OliantiNuclear Medicine Unit Careggi Hospital, University of Florence, Florence, Italy.
Angelo PorrecaUrology Unit, Policlinico of Abano, Abano Terme, Italy.
Giulia PrimiceriUrology Unit, D'Annunzio Hospital, University of Chieti, Chieti, Italy.
Luigi SchipsUrology Unit, D'Annunzio Hospital, University of Chieti, Chieti, Italy.
Francesco SessaUrology Unit, Careggi Hospital, University of Florence, Florence, Italy.
Pierluigi BoveUrology Unit, S. Carlo di Nancy Hospital, Rome, Italy.
Claudio SimeoneUrology Unit, ASST Spedali Civili Hospital, University of Brescia, Brescia, Italy.
Andrea MinerviniUrology Unit, Careggi Hospital, University of Florence, Florence, Italy.
AGILE Group (Italian Group for Advanced Laparo-Endoscopic Surgery)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

methodsThe 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.

results324 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.

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

Indexed as

Kidney NeoplasmsRoboticsRobotic Surgical ProceduresGlomerular Filtration RateHumansNephrectomyRadioisotopesRadionuclide ImagingRetrospective StudiesTreatment OutcomeWarm IschemiaRadioisotopesOff-clampOn-clampPartial nephrectomyRenal tumorRoboticWarm ischemia time

Identifiers

PMID37085644
PMCPMC10188582

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.