Robot-assisted surgery for kidney tumors without sutures
Zero Ischemia Robot-Assisted Microwave Ablation Assisted Suture-less Enucleation of Renal Cell Carcinoma With T1 Stage: A Randomized Clinical Trial
This study is testing a new robot-assisted surgery method for kidney tumors that doesn’t use stitches to see if it helps patients keep more of their kidney function compared to standard surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 15 Years to 80 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06715878 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a novel approach to treating T1 stage renal cell carcinoma (RCC) using zero ischemia robot-assisted microwave ablation combined with suture-less tumor enucleation. The study aims to enhance renal function preservation compared to traditional laparoscopic methods by utilizing real-time contrast-enhanced ultrasonography to monitor tumor ablation during surgery. By minimizing bleeding and simplifying the surgical process, this technique seeks to improve outcomes for patients undergoing nephron-sparing surgery. The trial will involve patients with newly diagnosed unilateral T1 RCC who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with sporadic, unilateral, newly diagnosed T1 renal cell carcinoma who are scheduled for robot-assisted laparoscopic nephron-sparing surgery.
Not a fit: Patients over 80 years old or those with other renal diseases that could affect kidney function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better preservation of kidney function in patients undergoing surgery for renal tumors.
How similar studies have performed: Previous studies have shown success with similar zero ischemia techniques in laparoscopic surgery, but this specific robotic approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma 2. patients scheduled for robot-assisted laparoscopic nephron sparing surgery 3. patients with normal contralateral renal function (differential renal function of \>40% as determined by radionuclide scintigraphy) 4. patients agreeable to participate in this long-term follow-up study Exclusion Criteria: 1. patients' age \>80 years 2. patients with other renal diseases (including kidney stone, glomerular nephritis, etc.)which might affect the renal function of the operative kidney 3. patients not able to tolerate the robot-assisted laparoscopic procedure 4. patients with previous renal surgery or history of any inflammatory conditions of the operative kidney 5. patients with the renal tumor involving urinary collecting system or distance from the tumor edge to the collecting system ≤ 4 mm
Where this trial is running
Shanghai
- Ethics Committee of Shanghai Renji Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Jiwei Huang, PhD.
- Email: huangjiwei@renji.com
- Phone: 02168383204
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.