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Tests a kidney tumor surgery done without blocking blood flow to the kidney

Compares two robot-assisted kidney surgeries for cT1 renal tumors in adults.

Key facts

Who runs it
The First Affiliated Hospital with Nanjing Medical University
Where
Nanjing, ChinaSee the site
Trial code
Registry title
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
Status
Recruiting
People taking part
60 people, planned
Started
1 Dec 2024
Expected to end
31 Dec 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • partial nephrectomy with main or branch renal artery clamping
  • partial nephrectomy with zero renal artery clamping
Record updated
3 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a small kidney tumor (T1) that can be treated by partial removal of the kidney. It compares surgery done with and without clamping the kidney's blood vessel.

Age
18 to 90 years in the inclusion criteria; the registry header lists 18 to 80 years.
Sex
All sexes can join.
Disease stage
A T1 kidney tumor (T1a or T1b) seen on imaging, where the investigator thinks partial nephrectomy would be beneficial.
Earlier treatment
No major surgery or significant trauma in the 28 days before joining. No live vaccine in the last 28 days. No traditional Chinese medicine or herbal supplements for cancer in the last 14 days.

Main reasons for not taking part

  • Tumor stage T2 or higher on imaging
  • Tumor in the renal pelvis or a Wilms' tumor
  • History of severe kidney disease or autoimmune disorders
  • Severe infection needing antibacterial, antifungal or antiviral treatment in the last 14 days
  • Taking part in another clinical trial

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Participation in any other clinical trials

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in China

  • The First Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaContact: Qiang Lu, PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • renal artery block-off setTreatment being tested

    Treatment: partial nephrectomy with zero renal artery clamping

  • renal artery block setExisting treatment, for comparison

    Treatment: partial nephrectomy with main or branch renal artery clamping

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests a kidney tumor surgery done without blocking blood flow to the kidneyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06908902, who can take part
Record updated
3 April 2025