Off-clamp, sutureless robot-assisted partial nephrectomy for small kidney tumors
Official title: Application of the "Off-Clamp And Sutureless" Technique in Robot-Assisted Partial Nephrectomy: A Single-Center, Prospective Cohort Study
Run by The First Affiliated Hospital with Nanjing Medical University · NCT07141225 · Data updated 2026-11-12
This will try a robot-assisted partial nephrectomy that avoids artery clamping and sutures to better preserve kidney function in adults with renal tumors up to 7 cm.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 190 (estimated) |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | June 1, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | September 5, 2025 |
| Trial ID | NCT07141225 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with a single renal tumor ≤7 cm on imaging, no collecting system invasion, and planned robot-assisted partial nephrectomy are ideal candidates.
✕Probably not a fit
Patients with distant metastases, multiple lesions not amenable to simultaneous resection, prior systemic therapy, or those who require conversion to radical nephrectomy or open surgery are unlikely to benefit from the off-clamp sutureless approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional protocol uses a robot-assisted partial nephrectomy technique that omits renal artery clamping and replaces traditional renorrhaphy with haemostatic, sutureless measures. Eligible adults with single renal tumors ≤7 cm and no collecting system invasion receive the off-clamp sutureless approach and are followed for perioperative outcomes and renal function changes. Key outcomes include intraoperative blood loss, operative time, conversions to open or radical surgery, postoperative complications, and changes in estimated glomerular filtration rate (eGFR). Patients with distant metastasis, multiple unresectable lesions, prior systemic therapy, or intraoperative conversion are excluded from analysis.
Why it matters
Potential benefit: If successful, the technique could reduce warm ischemia–related injury and better preserve postoperative kidney function compared with conventional clamped, sutured partial nephrectomy.
How similar studies have gone: Some retrospective series and small institutional reports suggest off-clamp and sutureless techniques are feasible and may preserve renal function, but high-quality randomized evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 18 and 80 years old, regardless of gender; 2. Radiological findings demonstrating a tumor size of ≤7 cm; 3. Imaging studies showing no evidence of collecting system invasion; 4. Scheduled to undergo robot-assisted partial nephrectomy (RAPN). Exclusion Criteria: 1. Preoperative imaging demonstrating evidence of distant metastasis or lymph node involvement; 2. Unilateral or bilateral multiple lesions not amenable to simultaneous resection; 3. History of prior systemic therapy, including molecular targeted therapy, immunotherapy, or chemotherapy; 4. Intraoperative conversion to radical nephrectomy; 5. Intraoperative conversion to open surgery.
Where it's running
-
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, China Recruiting
Study contacts
- Principal investigator: Pengfei Shao, Professor — The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital), Nanjing, Jiangsu 210036
- Study coordinator: Pengfei Shao, Professor
- Email: spf032@hotmail.com
- Phone: +8613851925825
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.