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Investigating a Novel Modifiable Factor Affecting Renal Function After Partial Nephrectomy: Cortical Renorrhaphy

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ClinicalTrials.gov Identifier: NCT02131376
Recruitment Status : Recruiting
First Posted : May 6, 2014
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Chandru Sundaram, Indiana University

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Procedure: Non-renorrhaphy Procedure: Renorrhaphy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigating a Novel Modifiable Factor Affecting Renal Function After Partial Nephrectomy: Cortical Renorrhaphy
Actual Study Start Date : May 9, 2014
Estimated Primary Completion Date : November 28, 2019
Estimated Study Completion Date : November 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Active Comparator: Cortical renorrhaphy
Cortical renorrhaphy is performed after partial nephrectomy using a running barbed suture on MH (36mm) needle. Polymer locking clips are used to maintain tension. A base layer running stitch is performed prior to the cortical renorrhaphy.
Procedure: Renorrhaphy
After tumor resection the patient will have both a deep and cortical layer reconstruction
Other Name: renal reconstruction

Experimental: Non-renorrhaphy
The suture closure of the renal cortex after tumor removal is omitted. A base layer running stitch only is performed for hemostasis and urine leak prevention.
Procedure: Non-renorrhaphy
The suture closure of the renal cortex after tumor removal is omitted. A base layer running stitch only is performed for hemostasis and urine leak prevention.
Other Name: renal reconstruction




Primary Outcome Measures :
  1. %Loss renal volume [ Time Frame: 4months ]
    % loss in renal volume (cm3) of the operated kidney (post-operative CT at 4 mo vs. - pre-operative CT) using Phillips IntelliSpace portal semi-automated segmentation algorithm.


Secondary Outcome Measures :
  1. Operative and postoperative complications [ Time Frame: through 4months ]
    Operative and postoperative complications (urine leak, bleeds) through the 4month follow-up

  2. Resistive index [ Time Frame: In the operating room prior to resection (baseline) and immediately after resection of tumor ]
    This is a "change" outcome measure. Pre and post-partial nephrectomy on the day of surgery Doppler/US arterial resistive index changes are recorded.

  3. Surgeon survey [ Time Frame: immediately after surgery is complete ]
    Postoperative surgeon survey evaluating comfort with surgery—Likert scale questionnaire

  4. Predicted volume loss [ Time Frame: 4months ]
    Assess the volume loss predicted by a preoperative scoring system. The preoperative volume loss prediction will be compared to the 4month volume loss calculation based on CT scans.

  5. %Loss in GFR [ Time Frame: 4months ]
    % eGFR loss from pre to postoperative (4mo) followup

  6. Adverse events as defined by the Clavien-Dindo classification system. [ Time Frame: Through 4months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131376


Locations
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United States, Indiana
IU Health University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Courtney Dhondt    317-274-1791    cgerler@iu.edu   
Contact: Clint Bahler, MD    317-274-1798    cdbahler@iupui.edu   
Principal Investigator: Chandru Sundaram, MD         
Sub-Investigator: Clint Bahler, MD         
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Chandru P Sundaram, MD Indiana University Health
Principal Investigator: Clinton D Bahler, MD Indiana University Health

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Responsible Party: Chandru Sundaram, Professor of Urology, Indiana University
ClinicalTrials.gov Identifier: NCT02131376     History of Changes
Other Study ID Numbers: IUCRO-0459
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Keywords provided by Chandru Sundaram, Indiana University:
carcinoma, renal cell
partial nephrectomy
kidney function test
robotics
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases