Recurrent Renal Cell Cancer
Conditions
Brief summary
This randomized pilot trial studies clamped or unclamped surgery in treating patients with kidney cancer. Unclamped surgery for kidney cancer may have fewer side effects
Detailed description
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.
Interventions
PROCEDURErobot-assisted laparoscopic surgery
Unclamped partial nephrectomy
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Solitary renal mass or solitary complex renal cyst Bosniak \>/= Grade 3 * Clinical stage T1a, T1b * Body Mass Index (BMI) \< 40 * Surgical candidate (preoperative cardiac and anesthesia clearance obtained) * Able to give informed consent * 24 hour urine collection complete and report obtained * MAG-3/DTPA scan completed and report obtained
Exclusion criteria
* Pregnancy * More than 1 renal mass or complex renal cyst Bosniak \>/= Grade 3 on ipsilateral kidney * Previous renal surgery on the ipsilateral kidney * Clinical Stage T2 or greater * BMI \> 40 * Contraindication to systemic hypotension: * Left Main Coronary Arterial Disease * Severe cardiac decompensation (ejection fraction \[EF\] \< 40%) * Prior history of cerebrovascular accident * Unable to consent * Unwilling or unable to potentially receive blood transfusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in renal function as measured by eGFR | Up to 1 year | Measured by eGFR, MAG-3 Nuclear Renal Scan, and serum creatinine. The two arms will be compared using regression methods that will account for repeated measures and the pre-randomization stratification. |
Secondary
| Measure | Time frame |
|---|---|
| Estimated blood loss during surgery | Up to 1 year |
| Rate of blood transfusion during and after surgery | Up to 1 year |
| Number of patients with positive surgical margins | Up to 1 year |
| Number of patients with complications during surgery and at 90 days post surgery | Up to 1 year |
| Intra-renal blood flow measurements | Up to 1 year |
| Resistive index measurements | Up to 1 year |
| Number of patients with adverse events | Up to 1 year |
Countries
United States
Outcome results
None listed