The Cold Ischemia Robot-assisted Partial Nephrectomy

NCT07326280 | Recruiting DMC

• 1 other identifier: SL-B2022-518-03
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Carcinoma; Renal Function Abnormal

Outcome Measures

Primary Outcomes (1)

• Recovery from ischemia

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

  1-12 months after surgery

Secondary Outcomes (3)

• surgical duration

  Intraoperative

• surgical complications

  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).

  up to 2 years after surgery

Study Arms (2)

Cold ischemia

EXPERIMENTAL

During the surgical procedure, employing ice to achieve local hypothermia in the kidneys.

Procedure: Cold ischemia robot-assisted partial nephrectomy

Warm ischemia

ACTIVE COMPARATOR

Not applying local hypothermia to the kidneys during the surgical procedure

Procedure: Warm ischemia robot-assisted partial nephrectomy

Interventions

Cold ischemia robot-assisted partial nephrectomy PROCEDURE

During the surgical procedure, employing ice to achieve local hypothermia in the kidneys.

Cold ischemia

Warm ischemia robot-assisted partial nephrectomy PROCEDURE

Not applying local hypothermia to the kidneys during the surgical procedure

Warm ischemia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Fangjian Zhou, professor

  Sun Yat-sen University Cancer Center (SYSUCC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fangjian Zhou, professor

CONTACT

020-87343865; zhoufj@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Randomly dividing the study cohorts into two groups. One group undergoing cold ischemia robot-assisted partial nephrectomy，while the other group undergoing warm ischemia robot-assisted partial nephrectomy

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 8, 2026
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)