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NCT Number: NCT07326280

The Cold Ischemia Robot-assisted Partial Nephrectomy

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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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Renal Function Abnormal Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Recovery from ischemia

    Time frame: 1-12 months after surgery

    (%GFR saved)/(%parenchymal mass preserved)

Secondary outcomes

  1. surgical duration

    Time frame: Intraoperative

    The duration of the surgery

  2. surgical complications

    Time frame: 1-12 months after surgery

    Intraoperative and postoperative complication incidence rate

  3. The extent of decline in the long-term GFR (month13-24) on the operated kidney compared to the new baseline GFR(months 1-12).

    Time frame: up to 2 years after surgery

    Postoperative short-term GFR(months 1-12) minus long-term GFR(month13-24)

Study contacts

Contact information is provided by the study sponsor or research team.

Fangjian Zhou, professor

CONTACT

[email protected]

020-87343865

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

The Impact of Cold Ischemia on Recovery From Ischemia After Robot-assisted Partial Nephrectomy: A Randomized Controlled Clinical Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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