Renal NeoplasmsNCT07888608
Effect of Non-Clamping and Sutureless Technique on Postoperative Renal Function in Robot-Assisted Partial Nephrectomy
A study testing Off-Clamp, Sutureless Robot-Assisted Partial Nephrectomy and Conventional Robot-Assisted Partial Nephrectomy With Artery Clamping and Sutured Reconstruction in people with Renal Neoplasms and Localized Kidney Tumors, run by Shao Pengfei at 1 site in China.
Trial summary
Partial nephrectomy is an operation that removes a kidney tumor while leaving the rest of the kidney in place. It is used to treat selected patients with small tumors confined to the kidney. Robot-assisted surgery allows the surgeon to control surgical instruments precisely during this procedure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Neoplasms, Localized Kidney Tumors
- What is being tested?
- Off-Clamp, Sutureless Robot-Assisted Partial Nephrectomy and Conventional Robot-Assisted Partial Nephrectomy With Artery Clamping and Sutured Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 1 Oct 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Imaging indicates a renal tumor measuring ≤5 cm.
- The tumor is located ≥4 mm from the collecting system.
- Total R.E.N.A.L. nephrometry score ≤9.
- Age 18-75 years.
- American Society of Anesthesiologists (ASA) physical status classification ≤III.
- Preoperative estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m².
Who cannot join
- Missing preoperative imaging or laboratory test results.
- Preoperative imaging indicating a completely endophytic tumor or tumor involvement of the collecting system.
- Evidence of distant metastasis or lymph node metastasis on preoperative imaging.
- Receipt of preoperative antitumor treatment, such as targeted therapy or immunotherapy.
- Preoperative hydronephrosis, renal calculi, or other conditions affecting renal function; or use of medications or treatments that may affect renal function.
- Solitary kidney, previous renal surgery, chronic kidney disease, multiple renal tumors, or bilateral renal tumors.
Show all 9Show fewer
- Severe systemic disease or other conditions that may interfere with the study.
- Refusal to participate in the study or refusal to sign the informed consent form.
- Poor compliance or inability to complete follow-up assessments required to obtain the study endpoints.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, 210036
Pengfei Shao, Professor, +8613851925825, spf032@hotmail.com
Kezheng Shao, Postgraduate, +8615250848630, 2273340668@qq.com
About this study
Official title: Effect of Non-Clamping and Sutureless Technique on Postoperative Renal Function in Robot-Assisted Partial Nephrectomy: A Single-Center Prospective Randomized Controlled Trial
Partial nephrectomy is an operation that removes a kidney tumor while leaving the rest of the kidney in place. It is used to treat selected patients with small tumors confined to the kidney. Robot-assisted surgery allows the surgeon to control surgical instruments precisely during this procedure.
During standard surgery, the surgeon temporarily clamps the artery supplying the kidney to reduce bleeding while removing the tumor. The surgeon then closes the wound with stitches to help prevent bleeding and urine leakage. However, temporarily stopping blood flow and stitching the surrounding kidney tissue may affect how well the kidney works after surgery.
Read more
An alternative approach, called "off-clamp, sutureless" surgery, removes the tumor without clamping the kidney artery and uses materials that help stop bleeding instead of stitches to close the wound. This approach may reduce injury to healthy kidney tissue. Early studies, including research at the investigators' hospital, suggest that it may help preserve kidney function. However, stronger evidence is needed to determine how its benefits and risks compare with standard surgery.
This study will randomly assign participants to receive either off-clamp, sutureless robot-assisted partial nephrectomy or standard robot-assisted partial nephrectomy with artery clamping and stitches. The study will compare kidney function and surgical safety between the two groups. It will also examine whether the results differ according to how complex the kidney tumor is.
The findings may help identify which patients are most likely to benefit from the off-clamp, sutureless approach and guide the development of a standardized surgical procedure.
Read the detailed description
In conventional robot-assisted partial nephrectomy (RAPN), the renal artery or its branches are occluded using vascular clamps, and the renal defect is closed using a two-layer suturing technique to control bleeding, maintain a clear operative field, and prevent postoperative urine leakage. Conventional RAPN typically requires dissection and clamping of the main renal artery, and the resulting warm ischemia time is closely associated with postoperative changes in renal function. In addition, two-layer suturing of the tumor resection bed and renal parenchyma may induce localized ischemia and damage small intraparenchymal vessels, potentially resulting in the loss of functioning nephrons.
These concerns have prompted increasing interest in an off-clamp, sutureless approach. This technique avoids renal artery clamping and replaces suturing with alternative hemostatic methods to maximize preservation of normal renal parenchyma. With the expanding range of hemostatic materials and the widespread adoption of robotic surgical systems, off-clamp, sutureless RAPN has become technically feasible for small renal tumors of low complexity. Several retrospective studies have suggested that this approach may be noninferior to conventional RAPN, with comparable safety and surgical outcomes.
The investigators' preliminary research also suggests that off-clamp, sutureless RAPN provides better preservation of renal function at 3 months after surgery than conventional on-clamp RAPN with sutured reconstruction. Following propensity score matching (PSM) to reduce selection bias and balance baseline characteristics, the matched off-clamp and on-clamp groups (n = 60 each) demonstrated a statistically significant difference in the decline in estimated glomerular filtration rate (eGFR), favoring the off-clamp group (1.21 versus 5.02 mL/min/1.73 m²; P = 0.021).
However, existing studies have predominantly focused on tumors measuring ≤4 cm in diameter, and most have been retrospective studies with relatively small sample sizes. Further evidence is needed to establish the feasibility of the off-clamp, sutureless approach for larger or anatomically more complex tumors.
This prospective randomized controlled trial aims to validate the preliminary findings. Stratified block randomization will be used to minimize bias, and the effects of the technique will be evaluated across subgroups defined by the R.E.N.A.L. nephrometry score. The study seeks to clarify the surgical indications for off-clamp, sutureless RAPN and support the development of a standardized surgical technique.
- Conditions
- Renal Neoplasms, Localized Kidney Tumors
- Being tested
- Off-Clamp, Sutureless Robot-Assisted Partial Nephrectomy, Conventional Robot-Assisted Partial Nephrectomy With Artery Clamping and Sutured Reconstruction
- Keywords
- Robot-Assisted Partial Nephrectomy, Nephron-Sparing Surgery, Off-Clamp Partial Nephrectomy, Sutureless Partial Nephrectomy, Renal Function Preservation
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off-Clamp, Sutureless Robot-Assisted Partial NephrectomyProcedure or surgery
Robot-assisted removal of the kidney tumor while preserving the remaining kidney, without clamping the renal artery or using sutures to close the renal defect. Hemostasis will be achieved using hemostatic materials.
Conventional Robot-Assisted Partial Nephrectomy With Artery Clamping and Sutured ReconstructionProcedure or surgery
Robot-assisted removal of the kidney tumor while preserving the remaining kidney, with temporary clamping of the renal artery or its branches. After tumor removal, the resection bed and renal parenchyma will be reconstructed using two-layer suturing.
| Study group | Role | What they receive |
|---|---|---|
| Off-Clamp, Sutureless Robot-Assisted Partial Nephrectomy | Experimental | Robot-assisted removal of the kidney tumor while preserving the remaining kidney, without clamping the renal artery or using sutures to close the renal defect. Hemostasis will be achieved using hemostatic materials. Receives: Procedure: Off-Clamp, Sutureless Robot-Assisted Partial Nephrectomy |
| Conventional Robot-Assisted Partial Nephrectomy | Active comparator | Robot-assisted removal of the kidney tumor while preserving the remaining kidney, with temporary clamping of the renal artery or its branches. After tumor removal, the resection bed and renal parenchyma will be reconstructed using two-layer suturing. Receives: Procedure: Conventional Robot-Assisted Partial Nephrectomy With Artery Clamping and Sutured Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline to 3 Months After Surgery
eGFR will be calculated from serum creatinine measured before surgery and at the 3-month postoperative follow-up using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. The decline in eGFR will be calculated as preoperative eGFR minus postoperative eGFR and expressed in mL/min/1.73 m². A smaller decline indicates better preservation of kidney function.
Measured: Baseline and 3 months after surgery
Secondary outcomes (4)
Estimated Intraoperative Blood Loss
Estimated blood loss will be calculated as the volume collected in the suction canister minus the volume of irrigation fluid, plus the blood loss absorbed by gauze, determined by weighing the gauze. The median estimated blood loss will be compared between the off-clamp, sutureless RAPN group and the conventional RAPN group.
Measured: Perioperative
Surgical Completion Rate
Surgical completion will be assessed by recording the number of participants requiring conversion from:
- Off-clamp, sutureless RAPN to conventional on-clamp, sutured RAPN;
- Partial nephrectomy to radical nephrectomy; or
- Minimally invasive surgery to open surgery.
The surgical completion rate and conversion rates will be compared between the two groups.
Measured: Perioperative
Negative Surgical Margin Rate
The negative surgical margin rate will be determined based on the routine postoperative pathological examination of the resected specimen and compared between the two groups.
Measured: 1 week after surgery
Postoperative Complication Rate
Postoperative complications graded as Clavien-Dindo grade II or higher will be recorded. The proportion of participants experiencing such complications will be compared between the two groups.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Oct 2026
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 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, 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
- NCT07888608
- Sponsor's protocol ID
- 2026-SR-0117
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-Clamping and Sutureless Technique on Postoperative Renal Function in Robot-Assisted Partial Nephrectomy: A Single-Center Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07888608
- Acronym / sponsor ID
- 2026-SR-0117
- Conditions
- Renal Neoplasms, Localized Kidney Tumors
- Keywords
- Robot-Assisted Partial Nephrectomy, Nephron-Sparing Surgery, Off-Clamp Partial Nephrectomy, Sutureless Partial Nephrectomy, Renal Function Preservation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Shao PengfeiUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 22 Oct 2026 (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.
Partial nephrectomy is an operation that removes a kidney tumor while leaving the rest of the kidney in place. It is used to treat selected patients with small tumors confined to the kidney. Robot-assisted surgery allows the surgeon to control surgical instruments precisely during this procedure.
During standard surgery, the surgeon temporarily clamps the artery supplying the kidney to reduce bleeding while removing the tumor. The surgeon then closes the wound with stitches to help prevent bleeding and urine leakage. However, temporarily stopping blood flow and stitching the surrounding kidney tissue may affect how well the kidney works after surgery.
An alternative approach, called "off-clamp, sutureless" surgery, removes the tumor without clamping the kidney artery and uses materials that help stop bleeding instead of stitches to close the wound. This approach may reduce injury to healthy kidney tissue. Early studies, including research at the investigators' hospital, suggest that it may help preserve kidney function. However, stronger evidence is needed to determine how its benefits and risks compare with standard surgery.
This study will randomly assign participants to receive either off-clamp, sutureless robot-assisted partial nephrectomy or standard robot-assisted partial nephrectomy with artery clamping and stitches. The study will compare kidney function and surgical safety between the two groups. It will also examine whether the results differ according to how complex the kidney tumor is.
The findings may help identify which patients are most likely to benefit from the off-clamp, sutureless approach and guide the development of a standardized surgical procedure.
Detailed description
In conventional robot-assisted partial nephrectomy (RAPN), the renal artery or its branches are occluded using vascular clamps, and the renal defect is closed using a two-layer suturing technique to control bleeding, maintain a clear operative field, and prevent postoperative urine leakage. Conventional RAPN typically requires dissection and clamping of the main renal artery, and the resulting warm ischemia time is closely associated with postoperative changes in renal function. In addition, two-layer suturing of the tumor resection bed and renal parenchyma may induce localized ischemia and damage small intraparenchymal vessels, potentially resulting in the loss of functioning nephrons.
These concerns have prompted increasing interest in an off-clamp, sutureless approach. This technique avoids renal artery clamping and replaces suturing with alternative hemostatic methods to maximize preservation of normal renal parenchyma. With the expanding range of hemostatic materials and the widespread adoption of robotic surgical systems, off-clamp, sutureless RAPN has become technically feasible for small renal tumors of low complexity. Several retrospective studies have suggested that this approach may be noninferior to conventional RAPN, with comparable safety and surgical outcomes.
The investigators' preliminary research also suggests that off-clamp, sutureless RAPN provides better preservation of renal function at 3 months after surgery than conventional on-clamp RAPN with sutured reconstruction. Following propensity score matching (PSM) to reduce selection bias and balance baseline characteristics, the matched off-clamp and on-clamp groups (n = 60 each) demonstrated a statistically significant difference in the decline in estimated glomerular filtration rate (eGFR), favoring the off-clamp group (1.21 versus 5.02 mL/min/1.73 m²; P = 0.021).
However, existing studies have predominantly focused on tumors measuring ≤4 cm in diameter, and most have been retrospective studies with relatively small sample sizes. Further evidence is needed to establish the feasibility of the off-clamp, sutureless approach for larger or anatomically more complex tumors.
This prospective randomized controlled trial aims to validate the preliminary findings. Stratified block randomization will be used to minimize bias, and the effects of the technique will be evaluated across subgroups defined by the R.E.N.A.L. nephrometry score. The study seeks to clarify the surgical indications for off-clamp, sutureless RAPN and support the development of a standardized surgical technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Off-Clamp, Sutureless Robot-Assisted Partial Nephrectomy | Experimental | Procedure: Off-Clamp, Sutureless Robot-Assisted Partial NephrectomyRobot-assisted removal of the kidney tumor while preserving the remaining kidney, without clamping the renal artery or using sutures to close the renal defect. Hemostasis will be achieved using hemostatic materials. |
| Conventional Robot-Assisted Partial Nephrectomy | Active comparator | Procedure: Conventional Robot-Assisted Partial Nephrectomy With Artery Clamping and Sutured ReconstructionRobot-assisted removal of the kidney tumor while preserving the remaining kidney, with temporary clamping of the renal artery or its branches. After tumor removal, the resection bed and renal parenchyma will be reconstructed using two-layer suturing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Imaging indicates a renal tumor measuring ≤5 cm.
- The tumor is located ≥4 mm from the collecting system.
- Total R.E.N.A.L. nephrometry score ≤9.
- Age 18-75 years.
- American Society of Anesthesiologists (ASA) physical status classification ≤III.
Key exclusion criteria (9 listed)
- Missing preoperative imaging or laboratory test results.
- Preoperative imaging indicating a completely endophytic tumor or tumor involvement of the collecting system.
- Evidence of distant metastasis or lymph node metastasis on preoperative imaging.
- Receipt of preoperative antitumor treatment, such as targeted therapy or immunotherapy.
- Preoperative hydronephrosis, renal calculi, or other conditions affecting renal function; or use of medications or treatments that may affect renal function.
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 Robot-Assisted Partial NephrectomyRobot-assisted removal of the kidney tumor while preserving the remaining kidney, without clamping the renal artery or using sutures to close the renal defect. Hemostasis will be achieved using hemostatic materials. | Procedure or surgery | Off-Clamp, Sutureless Robot-Assisted Partial Nephrectomy |
| Conventional Robot-Assisted Partial Nephrectomy With Artery Clamping and Sutured ReconstructionRobot-assisted removal of the kidney tumor while preserving the remaining kidney, with temporary clamping of the renal artery or its branches. After tumor removal, the resection bed and renal parenchyma will be reconstructed using two-layer suturing. | Procedure or surgery | Conventional Robot-Assisted Partial Nephrectomy |
Primary outcome
Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline to 3 Months After Surgery
Time frame: Baseline and 3 months after surgery
eGFR will be calculated from serum creatinine measured before surgery and at the 3-month postoperative follow-up using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. The decline in eGFR will be calculated as preoperative eGFR minus postoperative eGFR and expressed in mL/min/1.73 m². A smaller decline indicates better preservation of kidney function.
4 secondary outcomes
Estimated Intraoperative Blood Loss
Time frame: Perioperative
Surgical Completion Rate
Time frame: Perioperative
Negative Surgical Margin Rate
Time frame: 1 week after surgery
Postoperative Complication Rate
Time frame: up to 1 year
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 22 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Pengfei Shao 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 Robot-Assisted Partial Nephrectomy and Conventional Robot-Assisted Partial Nephrectomy With Artery Clamping and Sutured Reconstruction in people with Renal Neoplasms and Localized Kidney Tumors, 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 6 inclusion and 9 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 22 Oct 2026. 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?
Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline to 3 Months After Surgery (time frame: Baseline and 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 22 Oct 2026.