Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07141225

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

Led by Shao Pengfei · Updated on 2025-09-05

190

Participants Needed

1

Research Sites

160 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years old, regardless of gender
  • Radiological findings showing a tumor size of 7 cm or less
  • Imaging studies showing no evidence of collecting system invasion
  • Scheduled to undergo robot-assisted partial nephrectomy (RAPN)
Not Eligible

You will not qualify if you...

  • Imaging showing evidence of distant metastasis or lymph node involvement
  • Unilateral or bilateral multiple lesions not suitable for simultaneous removal
  • History of prior systemic therapy including molecular targeted therapy, immunotherapy, or chemotherapy
  • Conversion to radical nephrectomy during surgery
  • Conversion to open surgery during operation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Nanjing, Jiangsu, China, 210036

Actively Recruiting

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Research Team

P

Pengfei Shao, Professor

CONTACT

H

Haoqi Miao, Postgraduate

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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