Tests a kidney surgery technique without clamping blood flow for kidney tumors
Tests a robot-assisted kidney tumor removal without clamping blood vessels, in adults with kidney masses.
Key facts
- Who runs it
- Shao Pengfei
- Where
- Nanjing, ChinaSee the site
- Trial code
- Registry title
- Application of the "Off-Clamp And Sutureless" Technique in Robot-Assisted Partial Nephrectomy
- Status
- Recruiting
- People taking part
- 190 people, planned
- Started
- 1 Jun 2025
- Expected to end
- 30 Jun 2028
- Type of study
- Interventional
- Treatments tested
- Off-Clamp Sutureless Technique
- Record updated
- 5 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a kidney tumor of 7 cm (2.8 in) or smaller who are scheduled for robot-assisted partial nephrectomy (surgery that removes only the tumor part of the kidney).
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Kidney tumor of 7 cm (2.8 in) or smaller on imaging, with no sign that it has grown into the collecting system of the kidney.
- Earlier treatment
- People who have had earlier systemic therapy (targeted therapy, immunotherapy or chemotherapy) cannot join.
Main reasons for not taking part
- Imaging shows distant spread (metastasis) or lymph node involvement
- Several tumors in one or both kidneys that cannot be removed in one operation
- Earlier targeted therapy, immunotherapy or chemotherapy
- Surgery changed to removal of the whole kidney during the operation
- Surgery changed to open surgery during the operation
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
- Preoperative imaging demonstrating evidence of distant metastasis or lymph node involvement
- Intraoperative conversion to radical nephrectomy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)Nanjing, ChinaContact: Pengfei Shao, ProfessorTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- Off-Clamp Sutureless GroupTreatment being tested
Treatment: Off-Clamp Sutureless Technique
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Application of the "Off-Clamp And Sutureless" Technique in Robot-Assisted Partial Nephrectomy: A Single-Center, Prospective Cohort Study
- Plain-language title
- Tests a kidney surgery technique without clamping blood flow for kidney tumorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07141225, who can take part
- Record updated
- 5 September 2025