ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses
ConditionRenal Cell Carcinoma (RCC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Florida
About this trial
During partial nephrectomy surgery, efforts at minimizing ischemia while maximizing renal parenchymal volume are desirable to preserve renal function1,2. Not only clamping of the hilum but the renorrhaphy portion of the procedure also can have a significant negative impact on renal function3-5. It is possible to perform this procedure without clamping the hilum and also without formal renorrhaphy. However robust prospective formal evaluation of safety, risks, and potential benefits and whether or not the technique can be employed in a generalized fashion has not been studied.
Demonstration of safety and generalizability may open a whole new avenue of approaching nephron sparing and renal function sparing kidney surgery and decrease potential risks for long term kidney disease in patients with renal masses. This study will investigate the safety, efficacy, and generalizability of the use of clampless, sutureless partial nephrectomy in the treatment of renal cell carcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥ 18 years of age.
Patients undergoing partial nephrectomy for renal masses ≤ 7 cm
Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen [as determined by the treating physician or approved by the Principal Investigator] may be included).
A clinical diagnosis consistent with renal cell carcinoma, cT1-3 N0 M0 without renal vein thrombus.
Disqualifiers
Bleeding disorder (any congenital bleeding diathesis)
Liver dysfunction with end stage liver disease as determined by the treating investigator
Presence of renal vein thrombus
End stage renal disease (eGFR < 15 using Cockcroft-gault formula or receiving renal replacement therapy (i.e. dialysis))
Trial design
Design model
Single group
Treatments tested in this trial
sutureless, clampless partial nephrectomy
Procedure/SurgeryAll subjects will undergo a clampless, sutureless robotic partial nephrectomy.
Treatment groups
59 Participants
are divided into 1 treatment groupGroup A: Clampless, sutureless robotic partial nephrectomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Positive margin rate
Determine the positive margin rate, as measured on the pathology report 2-3 weeks post-surgery.
Time frame
2-3 weeks post-surgery2
Transfusion rate
Determine the transfusion rate, as measured approximately 4 weeks post-surgery via review of patient medical records.
Time frame
4 weeks post-surgerySecondary outcomes
1
Renal dysfunction (1 day post-surgery)
Determine subject renal dysfunction, measured using estimated glomerular filtration rate using Cockcroft-gault formula, at 1-day post-surgery.
Time frame
1 day post-surgery2
Renal dysfunction (2-3 weeks post-surgery)
Determine subject renal dysfunction, measured using estimated glomerular filtration rate using Cockcroft-gault formula, at 2-3 weeks post-surgery.
Time frame
2-3 weeks post-surgery3
Renal dysfunction (6 months post-surgery)
Determine subject renal dysfunction, measured using estimated glomerular filtration rate using Cockcroft-gault formula, at 6 months post-surgery.
Time frame
6 months post-surgery4
Estimated blood loss
Determine the estimated blood loss, as determined on the operative report.
Time frame
at time of partial nephrectomySponsors and contacts
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Source ClinicalTrials.gov