Clamped or Unclamped Surgery in Treating Patients With Kidney Cancer

Recurrent Renal Cell Cancer Clinical Trial

Official title:

Prospective Randomized Comparison of Clamped Versus Unclamped Partial Nephrectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01547676
• Other study ID #: 4K-10-2
• Secondary ID: NCI-2012-00057
• Status: Terminated
• Phase: N/A
• First received: February 10, 2012
• Last updated: March 25, 2015
• Start date: December 2011
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Recurrent Renal Cell Cancer

Intervention

Procedure:
• robot-assisted laparoscopic surgery
Unclamped partial nephrectomy
• robot-assisted laparoscopic surgery
Undergo clamped partial nephrectomy

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Estimated blood loss during surgery		Up to 1 year	Yes
Secondary	Rate of blood transfusion during and after surgery		Up to 1 year	Yes
Secondary	Number of patients with positive surgical margins		Up to 1 year	Yes
Secondary	Number of patients with complications during surgery and at 90 days post surgery		Up to 1 year	Yes
Secondary	Number of patients with adverse events		Up to 1 year	Yes
Secondary	Intra-renal blood flow measurements		Up to 1 year	No
Secondary	Resistive index measurements		Up to 1 year	No