Off-clamp, sutureless robot-assisted partial nephrectomy vs conventional robot-assisted partial nephrectomy
Official title: Effect of Non-Clamping and Sutureless Technique on Postoperative Renal Function in Robot-Assisted Partial Nephrectomy: A Single-Center Prospective Randomized Controlled Trial
Run by The First Affiliated Hospital with Nanjing Medical University · NCT07888608 · Data updated 2026-11-12
This trial tests whether removing a small kidney tumor without clamping the blood supply and without stitching the kidney bed preserves kidney function better than the standard robot-assisted surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 304 (estimated) |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | October 1, 2026 |
| Main results expected | October 1, 2028 |
| Study ends | October 1, 2029 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07888608 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 with a single renal tumor ≤5 cm, tumor distance from the collecting system ≥4 mm, RENAL score ≤9, and adequate baseline kidney function.
✕Probably not a fit
Patients with more complex tumors, impaired baseline kidney function, or anatomy unsuitable for off-clamp, sutureless technique may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares two surgical approaches for small, localized kidney tumors: off-clamp, sutureless robot-assisted partial nephrectomy and the conventional robot-assisted partial nephrectomy with artery clamping and sutured reconstruction. The main focus is to see if avoiding clamping and suturing can reduce kidney injury and preserve renal function after surgery. Eligible participants are adults aged 18–75 with tumors up to 5 cm, suitable anatomy, and normal or near-normal preoperative kidney function. Patients will be assigned to one of the two surgical techniques and followed for renal outcomes and safety. The study builds on retrospective data suggesting potential renal function benefits with the off-clamp, sutureless approach.
Why it matters
Potential benefit: If successful, patients may experience better preservation of kidney function after surgery with the off-clamp, sutureless technique.
How similar studies have gone: Prior retrospective studies suggest the off-clamp, sutureless approach can be noninferior in safety and may preserve renal function, but randomized evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Imaging indicates a renal tumor measuring ≤5 cm. * The tumor is located ≥4 mm from the collecting system. * Total R.E.N.A.L. nephrometry score ≤9. * Age 18-75 years. * American Society of Anesthesiologists (ASA) physical status classification ≤III. * Preoperative estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m². Exclusion Criteria: * Missing preoperative imaging or laboratory test results. * Preoperative imaging indicating a completely endophytic tumor or tumor involvement of the collecting system. * Evidence of distant metastasis or lymph node metastasis on preoperative imaging. * Receipt of preoperative antitumor treatment, such as targeted therapy or immunotherapy. * Preoperative hydronephrosis, renal calculi, or other conditions affecting renal function; or use of medications or treatments that may affect renal function. * Solitary kidney, previous renal surgery, chronic kidney disease, multiple renal tumors, or bilateral renal tumors. * Severe systemic disease or other conditions that may interfere with the study. * Refusal to participate in the study or refusal to sign the informed consent form. * Poor compliance or inability to complete follow-up assessments required to obtain the study endpoints.
Where it's running
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The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, China Recruiting
Study contacts
- Principal investigator: Pengfei Shao — 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.