Clinical trial NCT01732120: Off Clamp Randomization
Official title: Evaluation of the Off-Clamp Robot-Assisted Partial Nephrectomy Technique in the Management of Renal Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Cancer
Renal Ischemia
Keywords: off-clamp
partial nephrectomy
renal cancer treatment
renal ischemia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Midwest Stone Institute.
First posted: 2012-11-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.)

Primary outcomes:
measure: Percent Change From Baseline in eGFR
timeFrame: baseline and 3 months post nephrectomy
measure: Percent Change From Baseline in Split Renal Function
timeFrame: baseline to 3 months post nephrectomy
Secondary outcomes:
measure: Percent of Observations With Positive Surgical Margins.
timeFrame: at the time of nephrectomy
measure: Estimated Blood Loss
timeFrame: At the time of nephrectomy
measure: Percent of Observations With Metastasis
timeFrame: 3 years
measure: Operative Time Measured in Minutes.
timeFrame: At the time of nephrectomy
measure: Warm Ischemia Time Measured in Minutes.
timeFrame: At the time of nephrectomy.
measure: Percent of Observations With Intra-operative Complications.
timeFrame: At the time of nephrectomy
measure: Number of Hospital Days Post Nephrectomy.
timeFrame: Day of nephrectomy to day of hospital discharge.
measure: Percent of Observations With Postoperative Complications.
timeFrame: Within 3 months post nephrectomy.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Robert S Figenshau, MD
role: PRINCIPAL_INVESTIGATOR
References: