Renal Cancer, Renal Ischemia
Conditions
Keywords
off-clamp, partial nephrectomy, renal cancer treatment, renal ischemia
Brief summary
The purpose of this research study is to compare the effects on kidney function after performing the removal of a kidney tumor with or without clamping the blood vessels during surgery.
Interventions
PROCEDUREOff-clamp partial nephrectomy
Sponsors
Midwest Stone Institute.
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 and older. * Patients willing and able to sign consent. * Patients with an organ confined renal mass planning to undergo a robotic assisted partial nephrectomy (RAPN). * Patient with Karnofsky Performance Status (KPS) equal to or greater than 40.
Exclusion criteria
* Patients under 18. * Patients with Karnofsky Performance Status (KPS) less than 40. * Patients with non-organ confined renal masses (invading renal vein, inferior vena cava, peri-renal tissue, ipsilateral adrenal gland, or metastasis). * Patients with bilateral synchronous renal masses. * Patients who can not discontinue Plavix, Coumadin or other anti-platelet or anti-coagulant medications. * Patients with renal lesions determined to be too complex to perform a RAPN without clamp by the surgeon. (The renal mass may be deemed too difficult based on pre-operatively radiological findings. The surgeon's decision to exclude a mass from a robotic assisted partial nephrectomy would be based on a higher risk of positive margin or complication if a RAPN was performed.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in eGFR | baseline and 3 months post nephrectomy | Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy. |
| Percent Change From Baseline in Split Renal Function | baseline to 3 months post nephrectomy | Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Observations With Metastasis | 3 years | Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy. |
| Operative Time Measured in Minutes. | At the time of nephrectomy | Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy. |
| Warm Ischemia Time Measured in Minutes. | At the time of nephrectomy. | Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy. |
| Percent of Observations With Positive Surgical Margins. | at the time of nephrectomy | Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins. |
| Number of Hospital Days Post Nephrectomy. | Day of nephrectomy to day of hospital discharge. | Perioperative outcomes will be assessed based number of hospital days post nephrectomy. |
| Percent of Observations With Postoperative Complications. | Within 3 months post nephrectomy. | Perioperative outcomes will be assessed based on percent of observations with postoperative complications. |
| Percent of Observations With Intra-operative Complications. | At the time of nephrectomy | Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy. |
| Estimated Blood Loss | At the time of nephrectomy | Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Off-clamp Partial Nephrectomy Partial nephrectomy will be performed without clamping of the renal blood vessels.
Off-clamp partial nephrectomy | 40 |
| Traditional Partial Nephrectomy Partial nephrectomy will be performed with clamping of the renal blood vessels. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Off-clamp Partial Nephrectomy | Total | Traditional Partial Nephrectomy |
|---|---|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 9.8 | 58.0 years STANDARD_DEVIATION 10.5 | 59.4 years STANDARD_DEVIATION 11.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 37 Participants | 74 Participants | 37 Participants |
| Region of Enrollment United States | 40 participants | 80 participants | 40 participants |
| Sex: Female, Male Female | 18 Participants | 29 Participants | 11 Participants |
| Sex: Female, Male Male | 22 Participants | 51 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 4 / 40 |
| serious Total, serious adverse events | 2 / 40 | 4 / 40 |
Outcome results
Primary
Percent Change From Baseline in eGFR
Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.
Time frame: baseline and 3 months post nephrectomy
Population: Missing 3 postoperative eGFR from the Traditional Partial Nephrectomy group and 6 from the Off-Clamp Partial Nephrectomy group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Off-clamp Partial Nephrectomy | Percent Change From Baseline in eGFR | -10.7 percent change in eGFR |
| Traditional Partial Nephrectomy | Percent Change From Baseline in eGFR | -9.4 percent change in eGFR |
Primary
Percent Change From Baseline in Split Renal Function
Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy.
Time frame: baseline to 3 months post nephrectomy
Population: Missing 1 postoperative renal scan from the Traditional Partial Nephrectomy group and 7 from the Off-Clamp Partial Nephrectomy group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Off-clamp Partial Nephrectomy | Percent Change From Baseline in Split Renal Function | -11.2 percent change in split renal function |
| Traditional Partial Nephrectomy | Percent Change From Baseline in Split Renal Function | -11.8 percent change in split renal function |
Secondary
Estimated Blood Loss
Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.
Time frame: At the time of nephrectomy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off-clamp Partial Nephrectomy | Estimated Blood Loss | 184.1 Milliliters | Standard Deviation 193.3 |
| Traditional Partial Nephrectomy | Estimated Blood Loss | 178.5 Milliliters | Standard Deviation 207.5 |
Secondary
Number of Hospital Days Post Nephrectomy.
Perioperative outcomes will be assessed based number of hospital days post nephrectomy.
Time frame: Day of nephrectomy to day of hospital discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off-clamp Partial Nephrectomy | Number of Hospital Days Post Nephrectomy. | 1.8 Days | Standard Deviation 0.9 |
| Traditional Partial Nephrectomy | Number of Hospital Days Post Nephrectomy. | 1.7 Days | Standard Deviation 1.2 |
Secondary
Operative Time Measured in Minutes.
Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy.
Time frame: At the time of nephrectomy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off-clamp Partial Nephrectomy | Operative Time Measured in Minutes. | 178.0 Minutes | Standard Deviation 44.4 |
| Traditional Partial Nephrectomy | Operative Time Measured in Minutes. | 156.0 Minutes | Standard Deviation 40.6 |
Secondary
Percent of Observations With Intra-operative Complications.
Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy.
Time frame: At the time of nephrectomy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Off-clamp Partial Nephrectomy | Percent of Observations With Intra-operative Complications. | 2.5 % of cases with intraop complications |
| Traditional Partial Nephrectomy | Percent of Observations With Intra-operative Complications. | 0.0 % of cases with intraop complications |
Secondary
Percent of Observations With Metastasis
Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy.
Time frame: 3 years
Population: Only malignant cases were included in the analysis of metastasis on follow-up imaging.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Off-clamp Partial Nephrectomy | Percent of Observations With Metastasis | 0.0 percent of cases with metastasis on f/u |
| Traditional Partial Nephrectomy | Percent of Observations With Metastasis | 2.9 percent of cases with metastasis on f/u |
Secondary
Percent of Observations With Positive Surgical Margins.
Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins.
Time frame: at the time of nephrectomy
Population: Only malignant cases were included in the analysis of positive margins.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Off-clamp Partial Nephrectomy | Percent of Observations With Positive Surgical Margins. | 6.3 percent of cases with positive margins |
| Traditional Partial Nephrectomy | Percent of Observations With Positive Surgical Margins. | 5.9 percent of cases with positive margins |
Secondary
Percent of Observations With Postoperative Complications.
Perioperative outcomes will be assessed based on percent of observations with postoperative complications.
Time frame: Within 3 months post nephrectomy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Off-clamp Partial Nephrectomy | Percent of Observations With Postoperative Complications. | 20.0 % of cases with postop complications |
| Traditional Partial Nephrectomy | Percent of Observations With Postoperative Complications. | 17.5 % of cases with postop complications |
Secondary
Warm Ischemia Time Measured in Minutes.
Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy.
Time frame: At the time of nephrectomy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off-clamp Partial Nephrectomy | Warm Ischemia Time Measured in Minutes. | 0.0 Minutes | Standard Deviation 0 |
| Traditional Partial Nephrectomy | Warm Ischemia Time Measured in Minutes. | 19.1 Minutes | Standard Deviation 7.5 |