Trial Information

Prospective Randomized Comparison of Clamped Versus Unclamped Partial Nephrectomy

PRIMARY OBJECTIVES: I. To compare the changes in renal function (post-operative compared to
pre-operative) in patients undergoing unclamped partial nephrectomy with or without
controlled hypotension (Arm A) vs. those undergoing partial nephrectomy with hilar clamping
(Arm B), as measured by change in estimated glomerular filtration rate (eGFR). SECONDARY
OBJECTIVES: I. To compare the changes in renal function (post-operative compared to
pre-operative) in patients undergoing unclamped partial nephrectomy with or without
controlled hypotension (Arm A) vs. those undergoing partial nephrectomy with hilar clamping
(Arm B), as measured by change in MAG3 (% of function attributed to affected kidney) and
change in serum creatinine. II. To evaluate the safety of the unclamped procedure by
estimating the differences in complication rates in patients undergoing unclamped partial
nephrectomy with or without controlled hypotension (Arm A) vs. patients undergoing partial
nephrectomy with hilar clamping (Arm B) in terms of intra-operative complications and
post-operative complications. III. To evaluate the surgical effectiveness of the unclamped
procedure by estimating the differences between patients undergoing unclamped partial
nephrectomy with or without controlled hypotension (Arm A) vs. patients undergoing partial
nephrectomy with hilar clamping (Arm B) in terms of surgical margin status, estimated blood
loss, and transfusion rate (intraoperative and post-operative). TERTIARY OBJECTIVES: I.
To record and compare the intrarenal blood flow and resistive index measurements in order to
determine if a relationship exists between intraoperative findings and postoperative renal
function. II. To quantify the amount of acute kidney injury (AKI) and compare the
differences between patients undergoing unclamped partial nephrectomy with or without
controlled hypotension (Arm A) vs. patients undergoing partial nephrectomy with hilar
clamping (Arm B) as measured by urinary and serum biomarkers. III. To compare the effects
of the unclamped procedure (Arm A) to the clamped procedure (Arm B) in patients with
baseline eGFR < 60, and in patients with age >= 75 (exploratory subset analyses).
OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients undergo
unclamped partial nephrectomy. Some patients may undergo unclamped partial nephrectomy with
controlled hypotension. ARM B: Patients undergo clamped partial nephrectomy. After
completion of study treatment, patients are followed up at 1 week and then at 1, 3, 6, and
12 months.