Clamped or Unclamped Surgery in Treating Patients With Kidney Cancer
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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 |
- 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.
- 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 ]
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (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 |
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| United States, California | |
| USC/Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033 | |
| Principal Investigator: | Mihir Desai | USC/Norris Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | USC/Norris Comprehensive Cancer Center |
| 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: | February 11, 2013 |
| 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 May 23, 2013