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

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

Condition: Renal Cell Carcinoma

Intervention:

  • Procedure: Non-renorrhaphy
  • Procedure: Renorrhaphy

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02131376

Sponsor: Indiana University

Primary Outcome Measures:

  • Measure: %Loss renal volume
  • Time Frame: 4months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Operative and postoperative complications
  • Time Frame: through 4months
  • Safety Issue:
  • Measure: Resistive index
  • Time Frame: In the operating room prior to resection (baseline) and immediately after resection of tumor
  • Safety Issue:
  • Measure: Surgeon survey
  • Time Frame: immediately after surgery is complete
  • Safety Issue:
  • Measure: Predicted volume loss
  • Time Frame: 4months
  • Safety Issue:
  • Measure: %Loss in GFR
  • Time Frame: 4months
  • Safety Issue:
  • Measure: Adverse events as defined by the Clavien-Dindo classification system.
  • Time Frame: Through 4months
  • Safety Issue:

Estimated Enrollment: 40

Study Start Date: May 9, 2014

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Exclusion Criteria:

  1. 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.

Location:

  • IU Health University Hospital
  • Indianapolis Indiana 46202 United States

View trial on ClinicalTrials.gov

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