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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00057 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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P.I. decided to terminate study due to multiple unresolved issues
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (unclamped partial nephrectomy) | Experimental | Patients undergo unclamped partial nephrectomy. Some patients may undergo unclamped partial nephrectomy with controlled hypotension. |
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| Arm B (clamped partial nephrectomy) | Active Comparator | Patients undergo clamped partial nephrectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| robot-assisted laparoscopic surgery | Procedure | Unclamped partial nephrectomy |
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| 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
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:
Unable to consent
Unwilling or unable to potentially receive blood transfusion
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| Name | Affiliation | Role |
|---|---|---|
| Mihir Desai | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| robot-assisted laparoscopic surgery | Procedure | Undergo clamped partial nephrectomy |
|
| 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 |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |