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

NCT07141225 | Recruiting

• 1 other identifier: 2025-SR-568
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal and Urinary Disorders; Renal Cancer; Renal Particial

Keywords

robot-assisted partial nephrectomy; off-clamp; sutureless; postoperative renal function preservation

Outcome Measures

Primary Outcomes (1)

• Bilateral Kidney GFR

  Measured by 99mTc-DTPA

  3 months after surgery

Secondary Outcomes (2)

• Perioperative Complication Rate

  1 week after surgery

• Intraoperative Blood Loss

  during surgery

Study Arms (1)

Off-Clamp Sutureless Group

EXPERIMENTAL

Procedure: Off-Clamp Sutureless Technique

Interventions

Off-Clamp Sutureless Technique PROCEDURE

During the procedure, the renal artery and its branches are not clamped. The tumor is completely resected with a gross margin of 0.5-1 cm from its edge. Monopolar or bipolar electrocautery is used for hemostasis during resection. Following tumor removal, the renal resection bed is subjected to meticulous hemostasis, followed by the application of hemostatic agents without suture closure.

Off-Clamp Sutureless Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Shao Pengfei: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210036, China

RECRUITING

MeSH Terms

Conditions

Urologic Diseases; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Kidney Diseases

Study Officials

• Pengfei Shao, Professor

  The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital), Nanjing, Jiangsu 210036

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengfei Shao, Professor

CONTACT

+8613851925825; spf032@hotmail.com

Haoqi Miao, Postgraduate

CONTACT

mhq@stu.njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)