NCT07141225 Application of the "Off-Clamp And Sutureless" Technique in Robot-Assisted Partial Nephrectomy
| NCT ID | NCT07141225 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shao Pengfei |
| Condition | Renal and Urinary Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-06-01 |
Trial Parameters
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Brief Summary
The detection rate of renal masses smaller than 7 cm has significantly increased in recent years. To preserve postoperative renal function to the greatest extent possible, guidelines from the European Association of Urology (EAU), the National Comprehensive Cancer Network (NCCN), and others have endorsed partial nephrectomy (PN) as the preferred treatment strategy for small renal masses. In conventional PN, it is necessary to clamp the renal artery or its branch arteries and employ a double-layer suturing technique to close the resection bed. This controls bleeding, maintains a clear surgical field, and prevents postoperative urinary leakage. The maximum safe duration of warm ischemia to avoid irreversible renal parenchymal damage remains controversial, though most studies indicate a window of 20-30 minutes. Consequently, the "off-clamp sutureless" concept has gained prominence. Its core principle is to avoid renal artery clamping and replace suturing with novel haemostatic techniques, thereby maximizing the preservation of healthy renal parenchyma. With the diversification of haemostatic material options and the widespread adoption of robotic-assisted systems, the off-clamp sutureless strategy has become technically feasible for small renal masses with low complexity . Multiple retrospective studies demonstrate that the off-clamp sutureless technique is non-inferior, offering safety and surgical outcomes comparable to conventional robot-assisted partial nephrectomy (RAPN). However, it is important to note that current research predominantly focuses on tumors ≤4 cm, is largely retrospective, and suffers from limited sample sizes. More robust, evidence-based medical evidence is required to support its application for larger tumors or those with complex anatomy.
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.