Robot-assisted surgery for early-stage kidney tumors
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
This study is testing whether robot-assisted surgery without clamping the renal artery can safely and effectively treat early-stage kidney tumors while helping patients recover faster and keep their kidney function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06908902 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of robot-assisted laparoscopic partial nephrectomy with renal artery off-clamp for treating cT1 renal tumors. It aims to compare outcomes between traditional artery clamping and zero-clamping techniques during surgery. The study includes patients aged 18 to 90 who have confirmed T1 renal tumors and are deemed suitable for partial nephrectomy. The goal is to preserve kidney function while minimizing surgical risks and recovery time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with confirmed cT1 renal tumors who can tolerate major abdominal surgery.
Not a fit: Patients with tumors staged ≥T2 or those with severe kidney disease or autoimmune disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and better preservation of kidney function for patients with early-stage renal tumors.
How similar studies have performed: Previous studies have shown promising results with robotic and laparoscopic approaches for partial nephrectomy, indicating potential success for this method.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nanjing, Jiangsu
- The first affiliated hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Xiao Yang, PhD
- Email: yangxiao2915@163.com
- Phone: +8613951813528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.