Clamped or Unclamped Surgery in Treating Patients With Kidney Cancer

This study has been terminated.
(P.I. decided to terminate study due to multiple unresolved issues)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01547676
First received: February 10, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Recurrent Renal Cell Cancer
Procedure: robot-assisted laparoscopic surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Prospective Randomized Comparison of Clamped Versus Unclamped Partial Nephrectomy

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Change from baseline in renal function as measured by eGFR [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Estimated blood loss during surgery [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
  • Rate of blood transfusion during and after surgery [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
  • Number of patients with positive surgical margins [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
  • Number of patients with complications during surgery and at 90 days post surgery [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
  • Number of patients with adverse events [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
  • Intra-renal blood flow measurements [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Resistive index measurements [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: December 2011
Estimated Study Completion Date: September 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: Arm B (clamped partial nephrectomy)
Patients undergo clamped partial nephrectomy.
Procedure: robot-assisted laparoscopic surgery
Undergo clamped partial nephrectomy

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547676

Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Mihir Desai University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01547676     History of Changes
Other Study ID Numbers: 4K-10-2, NCI-2012-00057
Study First Received: February 10, 2012
Last Updated: January 27, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014