Deviation from the Protocol of a Randomized Clinical Trial Comparing On-Clamp versus Off-Clamp Laparoscopic Partial Nephrectomy (CLOCK II Laparoscopic Study): A Real-Life Analysis

Bove, Pierluigi; Bertolo, Riccardo; Sandri, Marco; Cipriani, Chiara; Leonardo, Costantino; Parma, P.; Falsaperla, Mario; Veneziano, Domenico; Celia, Antonio; Mari, Andrea; Antonelli, Alessandro

doi:10.1097/ju.0000000000001417

Cited by 12 publications

(8 citation statements)

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“…However, surgeons in that trial could change their strategy (from off-clamp to on-clamp), as hilum had been isolated beforehand. 4 Tuderti et al appropriately pointed out how intraoperative ultrasonography is key in these cases, and we totally agree with that. An additional tool that is likely to be implemented in the near future is 3-D imaging and intraoperative surgical navigation.…”

Section: Editorial Commentsupporting

confidence: 82%

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Editorial Comment to Expanding the limits of nephron‐sparing surgery: Surgical technique and mid‐term outcomes of purely off‐clamp robotic partial nephrectomy for totally endophytic renal tumors

2022

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Section: Editorial Commentsupporting

confidence: 82%

“…In the recently reported CLOCK Randomized Clinical Trial, tumor size and complete endophytic growth pattern predicted shift‐on‐clamp while preventing shift‐off‐clamp. However, surgeons in that trial could change their strategy (from off‐clamp to on‐clamp), as hilum had been isolated beforehand 4 . Tuderti et al .…”

mentioning

confidence: 99%

Editorial Comment to Expanding the limits of nephron‐sparing surgery: Surgical technique and mid‐term outcomes of purely off‐clamp robotic partial nephrectomy for totally endophytic renal tumors

2022

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“…In some of these patients the surgeon decided preoperatively to clamp despite randomization to the off‐clamp arm due to concern about tumour complexity ( n = 14), but in the great majority ( n = 55, 35% of the off‐clamp cohort) conversion occurred due to perception of ‘excessive bleeding’. A previous report from this trial demonstrated that safe outcomes were obtained despite these conversions, and perhaps sensible and timely conversion may have contributed to this [ 42 ].…”

Section: Randomized Trials: On‐clamp Vs Off‐clamp Pnmentioning

confidence: 96%

“…CLOCK was designed with only the most dedicated and experienced robotic surgeon participating at each centre to optimize surgical quality [ 41 , 42 ]. Despite this, cross‐over was substantial, including 69 cases (43%) in the off‐clamp group who eventually ended up on‐clamp.…”

Section: Randomized Trials: On‐clamp Vs Off‐clamp Pnmentioning

confidence: 99%

Every decade counts: a narrative review of functional recovery after partial nephrectomy

Campbell

Campbell²,

Muñoz-López

et al. 2022

BJU International

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To provide a narrative review of the major advances regarding ischaemia and functional recovery after partial nephrectomy (PN), along with the ongoing controversies. MethodsKey articles reflecting major advances regarding ischaemia and functional recovery after PN were identified. Special emphasis was placed on contributions that changed perspectives about surgical management. Priority was also placed on randomized trials of off-clamp vs on-clamp cohorts. ResultsA decade ago, 'Every minute counts' was published, showing strong correlations between duration of ischaemia and development of acute kidney injury (AKI) and chronic kidney disease after clamped PN. This reinforced perspectives that ischaemia was the main modifiable factor that could be addressed to improve functional outcomes and helped spur efforts towards reduced or zero ischaemia PN. These approaches were associated with strong functional recovery and some peri-operative risk, although they were generally safe in experienced hands. Further research demonstrated that, when parenchymal volume changes were incorporated into the analyses, ischaemia lost statistical significance, and percent parenchymal volume saved proved to be the main determinant. Cold ischaemia was confirmed to be highly protective, and limited warm ischaemia also proved to be safe. The reconstructive phase of PN, with avoidance of parenchymal devascularization, appears to be most important for functional outcomes. Randomized trials of on-clamp vs off-clamp PN have shown minimal impact of ischaemia on functional recovery. ConclusionsThe past decade has witnessed great progress regarding functional recovery after PN, with many lessons learned. However, there are still unanswered questions, including: What is the threshold of warm ischaemia at which irreversible ischaemic injury begins to develop? Are some cohorts at increased risk for AKI or irreversible ischaemic injury? and Which patients should be prioritized for zero-ischaemia PN?

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“…In 14 of these patients the surgeon decided preoperatively to clamp due to tumour complexity, but in the great majority (55 patients, 35% of the off-clamp cohort) conversion occurred due to intraoperative bleeding [1]. A previous report from this trial demonstrated that safe outcomes were obtained despite these conversions, and perhaps timely conversion may have contributed to this [6].…”

Section: Off-clamp Partial Nephrectomy: Level 1 Data Regarding Real-world Utility (Or Futility)mentioning

confidence: 99%

Off‐clamp partial nephrectomy: Level 1 data regarding real‐world utility (or futility)

Campbell

Yasuda

2022

BJU International

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Deviation from the Protocol of a Randomized Clinical Trial Comparing On-Clamp versus Off-Clamp Laparoscopic Partial Nephrectomy (CLOCK II Laparoscopic Study): A Real-Life Analysis

Cited by 12 publications

References 0 publications

Editorial Comment to Expanding the limits of nephron‐sparing surgery: Surgical technique and mid‐term outcomes of purely off‐clamp robotic partial nephrectomy for totally endophytic renal tumors

Editorial Comment to Expanding the limits of nephron‐sparing surgery: Surgical technique and mid‐term outcomes of purely off‐clamp robotic partial nephrectomy for totally endophytic renal tumors

Every decade counts: a narrative review of functional recovery after partial nephrectomy

Off‐clamp partial nephrectomy: Level 1 data regarding real‐world utility (or futility)

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