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.
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
- Conditions the study is for
- Renal and Urinary Disorders, Renal Cancer, Renal Particial
- 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.
Haoqi Miao, Postgraduate contact
China1 site, 1 recruiting
- 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
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.
- Conditions
- Renal and Urinary Disorders, Renal Cancer, Renal Particial
- 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 group | Role | What they receive |
|---|---|---|
| Off-Clamp Sutureless Group | Experimental | Not described Receives: Procedure: Off-Clamp Sutureless Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral Kidney GFR
Measured by 99mTc-DTPA
Measured: 3 months after surgery
Secondary outcomes (2)
Perioperative Complication Rate
Measured: 1 week after surgery
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.
- First posted26 Aug 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal and Urinary DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shao Pengfei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shao Pengfei, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Pengfei Shao, Professor, Principal investigator, The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital), Nanjing, Jiangsu 210036
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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the "Off-Clamp And Sutureless" Technique in Robot-Assisted Partial Nephrectomy: A Single-Center, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07141225
- Acronym / sponsor ID
- 2025-SR-568
- Conditions
- Renal and Urinary Disorders, Renal Cancer, Renal Particial
- Keywords
- robot-assisted partial nephrectomy, off-clamp, sutureless, postoperative renal function preservation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Shao PengfeiUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Off-Clamp Sutureless Group | Experimental | Procedure: Off-Clamp Sutureless Technique |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Off-Clamp Sutureless TechniqueDuring 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. | Procedure or surgery | Off-Clamp Sutureless Group |
Primary outcome
Bilateral Kidney GFR
Time frame: 3 months after surgery
Measured by 99mTc-DTPA
2 secondary outcomes
Perioperative Complication Rate
Time frame: 1 week after surgery
Intraoperative Blood Loss
Time frame: during surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No. Without obtaining prior consent from the participant.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haoqi Miao, Postgraduate contact
Pengfei Shao, Professor principal investigator
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital), Nanjing, Jiangsu 210036
1 site in 1 country: see every site and its status.
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.