Clinical trial · Interventional
Off Clamp Randomization
Evaluation of the Off-Clamp Robot-Assisted Partial Nephrectomy Technique in the Management of Renal Tumors
NCT01732120CI-TRIAL-00066561completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cancer | Kidney Neoplasm | PROBABILISTIC | 0.70 |
| Renal Ischemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Off-clamp partial nephrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Off-clamp partial nephrectomy
- description
- Partial nephrectomy will be performed without clamping of the renal blood vessels.
- interventionNames
- Procedure: Off-clamp partial nephrectomy
- type
- NO_INTERVENTION
- label
- Traditional partial nephrectomy
- description
- Partial nephrectomy will be performed with clamping of the renal blood vessels.
Primary outcomes (2)
- measure
- Percent Change From Baseline in eGFR
- timeFrame
- baseline and 3 months post nephrectomy
- description
- Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.)
References
Publications (0)
Data not yet available
No reference posted for this study.