Prospective Randomized Comparison of Clamped Versus Unclamped Partial Nephrectomy
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| City: |
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Los Angeles |
| State: |
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California |
| Zip Code: |
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90033 |
| Conditions: |
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Recurrent Renal Cell Cancer |
| Purpose: |
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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
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| Study Summary: |
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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.
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| 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
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| NCT ID: |
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NCT01547676 |
| Primary Contact: |
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Principal Investigator
Mihir Desai
USC/Norris Comprehensive Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Los Angeles, California 90033
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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