The Cold Ischemia Robot-assisted Partial Nephrectomy

January 7, 2026 updated by: ZHOU FANGJIAN, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

310

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • 651 Dongfeng Road East, Yuexiu District, Guangzhou, P.R. China Sun Yat-sen University Cancer Center；

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cold ischemia
During the surgical procedure, employing ice to achieve local hypothermia in the kidneys.
Procedure: Cold ischemia robot-assisted partial nephrectomy
During the surgical procedure, employing ice to achieve local hypothermia in the kidneys.
Active Comparator: Warm ischemia
Not applying local hypothermia to the kidneys during the surgical procedure
Procedure: Warm ischemia robot-assisted partial nephrectomy
Not applying local hypothermia to the kidneys during the surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery from ischemia
Time Frame: 1-12 months after surgery
(%GFR saved)/(%parenchymal mass preserved)
1-12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical duration
Time Frame: Intraoperative
The duration of the surgery
Intraoperative
surgical complications
Time Frame: 1-12 months after surgery
Intraoperative and postoperative complication incidence rate
1-12 months after surgery
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)
up to 2 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Fangjian Zhou, professor, Sun Yat-sen University Cancer Center (SYSUCC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL-B2022-518-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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