Off-clamp, sutureless robot-assisted partial nephrectomy for small kidney tumors

Application of the "Off-Clamp And Sutureless" Technique in Robot-Assisted Partial Nephrectomy: A Single-Center, Prospective Cohort Study

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

• Phase: NA
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07141225 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Nanjing, Jiangsu

• 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

Conditions: Renal and Urinary Disorders, Renal Cancer, Renal Particial, robot-assisted partial nephrectomy, off-clamp, sutureless, postoperative renal function preservation