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 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 190 participants in total. It began in 2025-06-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Pengfei Shao, Professor
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital), Nanjing, Jiangsu 210036
Frequently Asked Questions
Who can join the NCT07141225 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Renal and Urinary Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07141225 currently recruiting?
Yes, NCT07141225 is actively recruiting participants. Contact the research team at spf032@hotmail.com for enrollment information.
Where is the NCT07141225 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07141225 clinical trial?
NCT07141225 is sponsored by Shao Pengfei. The principal investigator is Pengfei Shao, Professor at The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital), Nanjing, Jiangsu 210036. The trial plans to enroll 190 participants.