Clamped or Unclamped Surgery in Treating Patients With Kidney Cancer

Prospective Randomized Comparison of Clamped Versus Unclamped Partial Nephrectomy

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

Study Overview

• Status: Terminated
• Conditions: Recurrent Renal Cell Cancer
• Intervention / Treatment: Procedure: robot-assisted laparoscopic surgery; Procedure: robot-assisted laparoscopic surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC/Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm A (unclamped partial nephrectomy); Patients undergo unclamped partial nephrectomy. Some patients may undergo unclamped partial nephrectomy with controlled hypotension.	Procedure: robot-assisted laparoscopic surgery; Unclamped partial nephrectomy; Procedure: robot-assisted laparoscopic surgery; Undergo clamped partial nephrectomy
ACTIVE_COMPARATOR: Arm B (clamped partial nephrectomy); Patients undergo clamped partial nephrectomy.	Procedure: robot-assisted laparoscopic surgery; Unclamped partial nephrectomy; Procedure: robot-assisted laparoscopic surgery; Undergo clamped partial nephrectomy

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: February 10, 2012
• First Submitted That Met QC Criteria: March 5, 2012
• First Posted (ESTIMATE): March 8, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: 4K-10-2; NCI-2012-00057 (REGISTRY: CTRP (Clinical Trial Reporting Program))