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NCT07141225Recruiting

Application of the "Off-Clamp And Sutureless" Technique in Robot-Assisted Partial Nephrectomy

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

Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
190 (estimated)
First submitted
19 Aug 2025
Start date
1 Jun 2025
Primary completion date
1 Jun 2027
Lead sponsor
Shao Pengfei
NCT number
NCT07141225

What you commit to

  • Study type: Interventional
  • Planned participants: 190
  • From 1 Jun 2025 to the primary completion date, 1 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Unilateral or bilateral multiple lesions not amenable to simultaneous resection;
  • History of prior systemic therapy, including molecular targeted therapy, immunotherapy, or chemotherapy;
  • Intraoperative conversion to open surgery.

Other

  • Preoperative imaging demonstrating evidence of distant metastasis or lymph node involvement;
  • Intraoperative conversion to radical nephrectomy;

Who the study is looking for

  • Age between 18 and 80 years old, regardless of gender;
  • Radiological findings demonstrating a tumor size of ≤7 cm;
  • Imaging studies showing no evidence of collecting system invasion;
  • Scheduled to undergo robot-assisted partial nephrectomy (RAPN).

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
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NanjingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.