An interventional study of Off-Clamp, Sutureless Robot-Assisted Partial Nephrectomy and Conventional Robot-Assisted Partial Nephrectomy With Artery Clamping and Sutured Reconstruction in Renal Neoplasms and Localized Kidney Tumors, sponsored by Shao Pengfei. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Shao Pengfei · Not applicable, Interventional, and Treatment
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.
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.
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This study's planned enrollment of 304 is above the median of 43 across 664 interventional studies indexed under Kidney Neoplasms.
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Exclusion Criteria:
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.
Procedure: Off-Clamp, Sutureless Robot-Assisted Partial Nephrectomy
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.
Procedure: Conventional Robot-Assisted Partial Nephrectomy With Artery Clamping and Sutured Reconstruction
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.
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.
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.
Time frame: Baseline and 3 months after surgery
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.
Time frame: Perioperative
Surgical Completion Rate
Surgical completion will be assessed by recording the number of participants requiring conversion from: 1. Off-clamp, sutureless RAPN to conventional on-clamp, sutured RAPN; 2. Partial nephrectomy to radical nephrectomy; or 3. Minimally invasive surgery to open surgery. The surgical completion rate and conversion rates will be compared between the two groups.
Time frame: 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.
Time frame: 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.
Time frame: up to 1 year
Plan to share: No
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Shao Pengfei