N/A
N=80
Off Clamp Randomization
Renal Cancer · Renal Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT01732120 ↗Enrolled (actual)
80
Serious AEs
7.5%
Results posted
Jun 2022
Primary outcome: Primary: Percent Change From Baseline in eGFR — -10.7; -9.4 percent change in eGFR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Off-clamp partial nephrectomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in eGFR |
-10.7; -9.4 | — |
| PRIMARY Percent Change From Baseline in Split Renal Function |
-11.2; -11.8 | — |
| SECONDARY Percent of Observations With Positive Surgical Margins. |
6.3; 5.9 | — |
| SECONDARY Estimated Blood Loss |
184.1; 178.5 | — |
| SECONDARY Percent of Observations With Metastasis |
0.0; 2.9 | — |
| SECONDARY Operative Time Measured in Minutes. |
178.0; 156.0 | — |
| SECONDARY Warm Ischemia Time Measured in Minutes. |
0.0; 19.1 | — |
| SECONDARY Percent of Observations With Intra-operative Complications. |
2.5; 0.0 | — |
| SECONDARY Number of Hospital Days Post Nephrectomy. |
1.8; 1.7 | — |
| SECONDARY Percent of Observations With Postoperative Complications. |
20.0; 17.5 | — |
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.
Eligibility Criteria
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.)
Data sourced from ClinicalTrials.gov (NCT01732120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.