Clamped or Unclamped Surgery in Treating Patients With Kidney Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Randomized Comparison of Clamped Versus Unclamped Partial Nephrectomy

Conditions
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Recurrent Renal Cell Cancer

Intervention / Treatment
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* Procedure: robot-assisted laparoscopic surgery
* Procedure: robot-assisted laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (unclamped partial nephrectomy)<br>Patients undergo unclamped partial nephrectomy. Some patients may undergo unclamped partial nephrectomy with controlled hypotension. | Procedure: robot-assisted laparoscopic surgery<br>* Unclamped partial nephrectomy<br>|
| Active Comparator: Arm B (clamped partial nephrectomy)<br>Patients undergo clamped partial nephrectomy. | Procedure: robot-assisted laparoscopic surgery<br>* Undergo clamped partial nephrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in renal function as measured by eGFR | 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. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| Number of patients with adverse events |  | Up to 1 year | 
| Intra-renal blood flow measurements |  | Up to 1 year | 
| Resistive index measurements |  | Up to 1 year |