Clinical trial NCT02131376: Investigating a Novel Modifiable Factor Affecting Renal Function After Partial Nephrectomy: Cortical Renorrhaphy
Official title: Investigating a Novel Modifiable Factor Affecting Renal Function After Partial Nephrectomy: Cortical Renorrhaphy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Renal Cell Carcinoma
Keywords: carcinoma, renal cell
partial nephrectomy
kidney function test
robotics
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 26
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: Preserving kidney function during removal of a kidney tumor is becoming increasingly important as rates of chronic kidney disease increase. A novel modifiable factor (suture closure of the defect caused by tumor removal) was discovered on retrospective studies to account for nearly two-thirds of the 15% volume loss commonly seen in operated kidneys. We hypothesize that a randomized controlled surgical trial will show that omitting the suture closure both preserves renal function and will not lead to unreasonable postoperative complications.

Detailed description: Purpose: To evaluate a never before studied modifiable factor affecting renal function after partial nephrectomy: the suture closure of the renal cortex after tumor removal (renorrhaphy).

Background:

There is increasing interest in preserving renal function when removing renal tumors. This is partly due to studies that link chronic kidney disease with cardiovascular events and overall survival. There is an approximate loss of 10% overall renal function after partial nephrectomy along with a loss of 15% of the volume in the operated kidney. Studies point to 3 factors leading to this loss in renal function after partial nephrectomy: 1) Poor preoperative renal function, 2) Ischemia time (clamping the renal blood vessels to decrease bleeding during surgery, and 3) Loss in renal volume from the surgery.

The only factor that is considered modifiable is ischemia time, especially when over 20-25-minutes in duration. Modern techniques now aid in keeping the ischemia time below the 25-minute cutoff. Leading experts from institutions such as the Cleveland Clinic, The University of Southern California, and The Mayo Clinic have concluded that the most important factor in preserving renal function, renal volume loss, is not modifiable.

Specific Aims: Our question is: if we are removing non-functional tissue (tumor) then why is there a loss in renal volume (15%) and function (10%)? We hypothesize that by omitting one particular step during surgery, sewing closed the defect caused by tumor removal, we will be able to improve renal volume loss and function (RENORRHAPHY CLIP http://youtu.be/NXOtUHdigj4). Indiana University is in a unique position to study this hypothesis as two of our surgeons have routinely omitted closing the defect left after tumor removal (NO RENORRHAPHY CLIP http://youtu.be/ZisMjrm85s8).

In a recently accepted abstract, we discovered that omitting the cortical closure (n=28) resulted in a 0.8% loss in glomerular filtration rate while using the closure resulted in a 7.3% loss (p=0.03). Following this discovery a 3D modeling project was performed to isolate the volume loss in operated kidneys using pre- and postoperative CT scans (not yet published). In this study, we discovered a 15% volume loss with cortical closure (n=38) compared to only a 5% loss without closure (n=20, p \< 0.001).

Bias and confounders cannot completely be removed from our retrospective data making it hard to believe that others will consider our hypothesis without a randomized controlled trial (RCT). We propose a RCT for robotic partial nephrectomy (20 stitch closure vs. 20 no stitch closure) with the primary outcome being volume change in the affected kidney.

Eligibility criteria: 3.0 INCLUSION/EXCLUSION CRITERIA

3.1 Inclusion criteria:

* ≥ 18 years of age.
* Must provide written informed consent
* Presence of cT1 renal mass by diagnostic CT assessment.
* Scheduled for partial nephrectomy of renal mass.
* Expected survival of at least 3 months.
* ECOG ≤ 1.
* Negative serum/urine pregnancy test within 24 hours for females of child bearing age prior to surgery
* Recovered from toxicity of any prior therapy to grade 1 or better
* If biopsy of mass has been done, pathology must be consistent with RCC.

3.2 Exclusion criteria:

* Solitary kidney
* Multiple or bilateral renal masses when more than one mass is operated on at the same time or within 4-months of each other.
* Hepatic or renal toxicity (GFR \<30) greater than or equal to Grade 2 (using CTCAE version 4 standard definitions)
* Bleeding diathesis or inability to hold anticoagulation for surgery
* Participation in another investigational trial concurrently or within 30 days
* Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.

Primary outcomes:
measure: %Loss renal volume
timeFrame: 4months
Secondary outcomes:
measure: Operative and postoperative complications
timeFrame: through 4months
measure: Resistive index
timeFrame: In the operating room prior to resection (baseline) and immediately after resection of tumor
measure: Surgeon survey
timeFrame: immediately after surgery is complete
measure: Predicted volume loss
timeFrame: 4months
measure: %Loss in GFR
timeFrame: 4months
measure: Adverse events as defined by the Clavien-Dindo classification system.
timeFrame: Through 4months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
Study officials:
affiliation: Indiana University Health
name: Chandru P Sundaram, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University Health
name: Clinton D Bahler, MD
role: PRINCIPAL_INVESTIGATOR
References: