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Prospective Randomized Comparison of Clamped Versus Unclamped Partial Nephrectomy


N/A
18 Years
N/A
Not Enrolling
Both
Recurrent Renal Cell Cancer

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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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Change from baseline in renal function as measured by eGFR

Outcome Description:

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.

Outcome Time Frame:

Up to 1 year

Safety Issue:

No

Principal Investigator

Mihir Desai

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

4K-10-2

NCT ID:

NCT01547676

Start Date:

December 2011

Completion Date:

December 2015

Related Keywords:

  • Recurrent Renal Cell Cancer
  • Carcinoma, Renal Cell

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800