Clinical trial NCT01547676: Clamped or Unclamped Surgery in Treating Patients With Kidney Cancer
Official title: Prospective Randomized Comparison of Clamped Versus Unclamped Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Recurrent Renal Cell Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in renal function as measured by eGFR
timeFrame: Up to 1 year
Secondary outcomes:
measure: Estimated blood loss during surgery
timeFrame: Up to 1 year
measure: Rate of blood transfusion during and after surgery
timeFrame: Up to 1 year
measure: Number of patients with positive surgical margins
timeFrame: Up to 1 year
measure: Number of patients with complications during surgery and at 90 days post surgery
timeFrame: Up to 1 year
measure: Number of patients with adverse events
timeFrame: Up to 1 year
measure: Intra-renal blood flow measurements
timeFrame: Up to 1 year
measure: Resistive index measurements
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Mihir Desai
role: PRINCIPAL_INVESTIGATOR
References: