Status:

RECRUITING

Prospective Study on the Safety and Efficacy of Robot-Assisted Laparoscopic Partial Nephrectomy With Renal Artery Off-Clamp in the Treatment of cT1 Renal Tumors

Lead Sponsor:

The First Affiliated Hospital with Nanjing Medical University

Conditions:

RCC, Renal Cell Cancer

Partial Nephrectomy

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

Renal tumors are common urological cancers, with over 430,000 new cases and more than 170,000 deaths globally in 2020. In China, renal cancer ranks third among urological malignancies, with an increas...

Eligibility Criteria

Inclusion

  • Imaging examination confirms a T1 renal tumor (including T1a and T1b), and the investigator deems partial nephrectomy to be beneficial.
  • Age ranges from 18 to 90 years.
  • No history of severe kidney disease or autoimmune disorders.
  • Cardiopulmonary function indicates the ability to tolerate major abdominal surgery.
  • ECOG performance status score is 0 or 1.
  • Willingness to undergo zero-ischemia partial nephrectomy and able to provide written informed consent, understanding and agreeing to comply with the study requirements and evaluation schedule.

Exclusion

  • Imaging assessment shows a tumor stage of ≥T2.
  • Imaging indicates that the tumor is located in the renal pelvis or is a Wilms' tumor, etc.
  • The investigator considers the patient unsuitable for partial nephrectomy.
  • Major surgery or significant trauma occurred within 28 days prior to enrollment.
  • Live vaccine received within 28 days prior to enrollment.
  • Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral treatment occurred within 14 days prior to enrollment.
  • Any traditional Chinese medicine or herbal supplements for cancer treatment taken within 14 days prior to enrollment.
  • Participation in any other clinical trials.

Key Trial Info

Start Date :

December 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2027

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06908902

Start Date

December 1 2024

End Date

December 31 2027

Last Update

April 3 2025

Active Locations (1)

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1

The first affiliated hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210000