Clamped or Unclamped Surgery in Treating Patients With Kidney Cancer

University of Southern California

Status

Terminated

Conditions

Recurrent Renal Cell Cancer

Treatments

Procedure: robot-assisted laparoscopic surgery

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01547676

NCI-2012-00057 (Registry Identifier)

4K-10-2

Details and patient eligibility

About

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

Full 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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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