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Renal and Urinary DisordersNCT07141225

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

A study testing Off-Clamp Sutureless Technique in people with Renal and Urinary Disorders and Renal Cancer, run by Shao Pengfei at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Off-Clamp Sutureless Technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
1 siteChina
Study dates
1 Jun 2025to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pengfei Shao, Professor contact

+8613851925825

spf032@hotmail.com

Haoqi Miao, Postgraduate contact

mhq@stu.njmu.edu.cn

China1 site, 1 recruiting
  • The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)

    Nanjing, Jiangsu, 210036

    Pengfei Shao, Professor, 13851925825, spf032@hotmail.com

    Haoqi Miao, Postgraduate, +86 13276636957, mhq@stu.njmu.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed description

The detection rate of renal masses smaller than 7 cm has increased significantly in recent years. To maximize the preservation of postoperative renal function, guidelines from the European Association of Urology (EAU), the National Comprehensive Cancer Network (NCCN), and others have established partial nephrectomy (PN) as the preferred treatment option for small renal masses.

In conventional PN, the renal artery or its segmental branches must be clamped, and the renal defect is typically closed using a multilayer suturing technique to control bleeding, maintain a clear surgical field, and prevent postoperative urinary leakage. The maximum safe duration of warm ischemia time (WIT) remains controversial, though most studies suggest a limit of 20-30 minutes to avoid irreversible renal parenchymal damage. In murine models, renal damage increases steeply after ischemia exceeds 30 minutes. Furthermore, the renorrhaphy suture technique has a steep learning curve, and the suturing process itself can cause additional injury to the renal vasculature, potentially compromising global renal function . Notably, up to 30% of patients with normal preoperative renal function may experience a decline in their estimated glomerular filtration rate (eGFR) to <60 mL/min/1.73 m² post-surgery, and nearly 10% may suffer a >50% reduction in renal function . Consequently, the concept of a "zero-ischemia sutureless" approach has gained traction. Its core principle is to avoid renal artery clamping and replace suturing with novel haemostatic methods, thereby maximizing the preservation of healthy renal parenchyma. With the expanding array of haemostatic agents and the widespread adoption of robotic-assisted systems, the zero-ischemia sutureless strategy has become technically feasible for small renal masses with low complexity.

Findings from multiple retrospective studies indicate that the zero-ischemia sutureless technique is non-inferior, demonstrating comparable safety and surgical outcomes to standard robot-assisted partial nephrectomy (RAPN). A study by Antonio Franco et al. reported a median decline in overall renal function of only 10 mL/min after zero-ischemia sutureless surgery, supporting its role as a safe procedure that effectively preserves postoperative renal function and reduces complications. In a review, J. C. Moreno Cortés highlighted that replacing traditional artery clamping and suturing with mono- or bipolar electrocautery and new haemostatic agents offers a simpler and faster method for reconstruction. This approach simplifies the surgical steps without increasing the risk of complications. However, it is important to note that current research is predominantly focused on tumours ≤4 cm, is largely retrospective, and often involves small sample sizes. More robust evidence from prospective studies is needed to support the application of this technique for larger or anatomically complex tumours.

Being tested
Off-Clamp Sutureless Technique
Keywords
robot-assisted partial nephrectomy, off-clamp, sutureless, postoperative renal function preservation
Medical subject headings
Urologic Diseases, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Off-Clamp Sutureless TechniqueProcedure or surgery

    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.

Study groups in NCT07141225
Study groupRoleWhat they receive
Off-Clamp Sutureless GroupExperimentalNot described
Receives: Procedure: Off-Clamp Sutureless Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bilateral Kidney GFR

    Measured by 99mTc-DTPA

    Measured: 3 months after surgery

Secondary outcomes (2)
  1. Perioperative Complication Rate

    Measured: 1 week after surgery

  2. Intraoperative Blood Loss

    Measured: during surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2025
  2. Study start1 Jun 2025
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
190 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07141225
Sponsor's protocol ID
2025-SR-568
Status last verified
Aug 2025
First submitted
19 Aug 2025
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Without obtaining prior consent from the participant.

Questions about this trial

What is this clinical trial studying?

A study testing Off-Clamp Sutureless Technique in people with Renal and Urinary Disorders and Renal Cancer, run by Shao Pengfei at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pengfei Shao, Professor (+8613851925825, spf032@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bilateral Kidney GFR (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.

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