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

NCT02131376 | Terminated DMC

• 1 other identifier: IUCRO-0459
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Keywords

carcinoma, renal cell; partial nephrectomy; kidney function test; robotics

Outcome Measures

Primary Outcomes (1)

• %Loss renal volume

  % 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.

  4months

Secondary Outcomes (6)

• Operative and postoperative complications

  through 4months

• Resistive index

  In the operating room prior to resection (baseline) and immediately after resection of tumor

• Surgeon survey

  immediately after surgery is complete

• Predicted volume loss

  4months

• %Loss in GFR

  4months

Study Arms (2)

Cortical renorrhaphy

ACTIVE COMPARATOR

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

Non-renorrhaphy

EXPERIMENTAL

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

Interventions

Non-renorrhaphy PROCEDURE

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.

Also known as: renal reconstruction

Non-renorrhaphy

Renorrhaphy PROCEDURE

After tumor resection the patient will have both a deep and cortical layer reconstruction

Also known as: renal reconstruction

Cortical renorrhaphy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• ≥ 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.
• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Chandru P Sundaram, MD

  Indiana University Health

  PRINCIPAL INVESTIGATOR

• Clinton D Bahler, MD

  Indiana University Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 6, 2014
• Study Start: May 9, 2014
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: November 23, 2020

Record last verified: 2020-11

Locations

US (1)