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
Qualifiers
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
Treatments tested in this trial
- sutureless, clampless partial nephrectomy
Treatment groups
59 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov