Clamped or Unclamped Surgery in Treating Patients With Kidney Cancer

NCT ID: NCT01547676

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-09-30

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.

Conditions

Recurrent Renal Cell Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm A (unclamped partial nephrectomy)

Patients undergo unclamped partial nephrectomy. Some patients may undergo unclamped partial nephrectomy with controlled hypotension.

Group Type: EXPERIMENTAL

robot-assisted laparoscopic surgery

Intervention Type: PROCEDURE

Unclamped partial nephrectomy

Arm B (clamped partial nephrectomy)

Patients undergo clamped partial nephrectomy.

Group Type: ACTIVE_COMPARATOR

robot-assisted laparoscopic surgery

Intervention Type: PROCEDURE

Undergo clamped partial nephrectomy

Interventions

robot-assisted laparoscopic surgery

Unclamped partial nephrectomy

Intervention Type: PROCEDURE

robot-assisted laparoscopic surgery

Undergo clamped partial nephrectomy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mihir Desai

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

NCI-2012-00057

Identifier Type: REGISTRY

Identifier Source: secondary_id

4K-10-2

Identifier Type: -

Identifier Source: org_study_id