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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

RecruitingNAAges 18 Years - 80 YearsAllThe First Affiliated Hospital with Nanjing Medica…
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In plain words

What the trial is, and whether it could suit you

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 increasing incidence. Risk factors include smoking, obesity, hypertension, and family history. Surgery, including partial nephrectomy and radical nephrectomy, is the primary treatment. According to AJCC staging, tumors ≤7 cm confined to the kidney are classified as T1 stage. Studies show no significant difference in cancer-specific survival between partial nephrectomy and radical nephrectomy for T1 tumors, and partial nephrectomy preserves renal function, reducing the risk of metabolic and cardiovascular diseases. Therefore, European guidelines recommend partial nephrectomy for cT1a-b tumors. Partial nephrectomy can be performed via open surgery, laparoscopy, or robotic assistance, each with pros

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • partial nephrectomy with main or branch renal artery clamping
  • partial nephrectomy with zero renal artery clamping
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Where

1 site
The first affiliated hospital of Nanjing Medical University
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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