The Cold Ischemia Robot-assisted Partial Nephrectomy

NCT07326280 — Not applicable, Recruiting, 310 participants, Sun Yat-sen University
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The Impact of Cold Ischemia on Recovery From Ischemia After Robot-assisted Partial Nephrectomy: A Randomized Controlled Clinical Study

RegistryNCT07326280
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment310 (Estimated)
SponsorSun Yat-sen University (Other)
ConditionsRenal Cell Carcinoma, Renal Function Abnormal
InterventionsCold ischemia robot-assisted partial nephrectomy, Warm ischemia robot-assisted partial nephrectomy (Procedure)
Datesstart 2024-01-01, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2026-01-08, last updated 2026-01-08
Locations1 site in China

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-Summary

To establish evidence that cold ischemia, achieved through the use of ice slush, can improve the recovery from ischemia on the operated kidney in patients undergoing robot-assisted partial nephrectomy.

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+Detailed description

Randomly dividing the study cohorts into two groups. One group undergoing cold ischemia partial nephrectomy and the other undergoing warm ischemia partial nephrectomy. Comparing the short-term renal function recovery between the two groups.

+Arms and interventions

ArmTypeInterventionsDescription
Cold ischemiaExperimentalProcedure: Cold ischemia robot-assisted partial nephrectomyDuring the surgical procedure, employing ice to achieve local hypothermia in the kidneys.
Warm ischemiaActive comparatorProcedure: Warm ischemia robot-assisted partial nephrectomyNot applying local hypothermia to the kidneys during the surgical procedure
  • Cold ischemia robot-assisted partial nephrectomy (Procedure): During the surgical procedure, employing ice to achieve local hypothermia in the kidneys.
  • Warm ischemia robot-assisted partial nephrectomy (Procedure): Not applying local hypothermia to the kidneys during the surgical procedure

+Outcome measures

Primary outcomes

  • Recovery from ischemia [1-12 months after surgery]: (%GFR saved)/(%parenchymal mass preserved)

Secondary outcomes

  • surgical duration [Intraoperative]: The duration of the surgery
  • surgical complications [1-12 months after surgery]: Intraoperative and postoperative complication incidence rate
  • The extent of decline in the long-term GFR (month13-24) on the operated kidney compared to the new baseline GFR(months 1-12). [up to 2 years after surgery]: Postoperative short-term GFR(months 1-12) minus long-term GFR(month13-24)

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

\- 18 to 80 years old; 2. Intending to perform robot-assisted partial nephrectomy

Exclusion Criteria:

* Anesthesiologist assessment: Patient unsuitable for general anesthesia;
* Having severe cardiovascular and cerebrovascular diseases;
* horseshoe kidney;
* pregnant women

+Locations (1)

FacilityCityCountryStatus
651 Dongfeng Road East, Yuexiu District, Guangzhou, P.R. China Sun Yat-sen University Cancer Center；Guangzhou, GuangdongChinaRecruiting

+Investigators