RecruitingNot ApplicableNCT06908902

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


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

60 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

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 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 and cons. Robotic or laparoscopic approaches have less blood loss and shorter hospital stays compared to open surgery. A 7-year follow-up shows no significant difference in oncological outcomes. The surgical goal is to remove the tumor with negative margins while preserving normal renal tissue. Factors such as preoperative renal function, ischemia time, extent of normal tissue resection, blood loss, and suturing technique affect postoperative renal function. Renal artery clamping is often required during partial nephrectomy to improve visibility, but it leads to ischemia-reperfusion injury, so minimizing damage is crucial. Controlling warm ischemia time is an effective strategy, with guidelines recommending ischemia time under 30 minutes. Studies show that continuous or knotless suturing techniques reduce ischemia time and blood loss. Additionally, minimizing the ischemic area helps protect renal function. Our center explored branch renal artery clamping, which, although increasing ischemia time, better protects kidney function. A study showed a smaller decline in glomerular filtration rate (GFR) with branch clamping compared to conventional clamping. Gill et al. reported a "zero-ischemia" technique using controlled hypotension and selective clamping of higher-level renal artery branches, showing no significant change in serum creatinine or GFR. However, both renal artery clamping techniques cause ischemia-reperfusion injury, affecting renal function. A study of robotic-assisted partial nephrectomy found that 20.2% of patients had worsened chronic kidney disease (CKD) staging, with statistically significant differences in preoperative and postoperative GFR and CKD staging. For patients with solitary or functionally solitary kidneys, or those with comorbidities like hypertension or diabetes, renal artery clamping may worsen acute renal dysfunction and increase the risk of long-term kidney failure. Avoiding renal artery clamping may reduce ischemia-reperfusion injury, but its safety and efficacy remain unclear. A retrospective study of 537 solitary kidney patients undergoing open surgery with different vascular management strategies (no clamping, warm ischemia, and cold ischemia) showed that the risk of renal failure was lower in patients without ischemia. While this study focused on open surgery, it raises the question of whether zero-ischemia partial nephrectomy is feasible in minimally invasive surgery. A study on 141 renal angiomyolipoma patients using a zero-ischemia technique showed no significant change in GFR. However, this method may not be suitable for malignant tumors. the investigators aims to evaluate whether robotic-assisted laparoscopic partial nephrectomy using a zero-ischemia technique for cT1 renal tumors can better protect renal function, reduce postoperative complications, and not affect oncological outcomes.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and outcomes of a robotic-assisted kidney surgery technique called "zero-ischemia partial nephrectomy," which removes only the tumor while keeping blood flowing to the kidney (no clamp), to determine if it reduces kidney damage compared to the standard approach. **You may be eligible if...** - You are between 18 and 90 years old - Imaging has confirmed a T1 kidney tumor (up to 7 cm) and your surgeon recommends partial removal - You are in good overall health and your heart and lungs can tolerate major surgery - You do not have severe kidney disease or autoimmune disorders **You may NOT be eligible if...** - Your tumor is larger (stage T2 or higher) based on imaging - Your tumor is in the kidney's collecting system or is a different type of kidney tumor - Your surgeon determines you are not a suitable candidate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREpartial nephrectomy with main or branch renal artery clamping

Robotic-assisted laparoscopic or laparoscopic partial nephrectomy with main or branch renal artery clamping

PROCEDUREpartial nephrectomy with zero renal artery clamping

Robotic-assisted laparoscopic partial nephrectomy with zero renal artery clamping


Locations(1)

The first affiliated hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06908902


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