Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy

Randomized, Prospective Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy

The aim of this study is to evaluate whether Hemostatic Agents (HA) make a significant clinical difference in patient outcomes when used for Robotic-Assisted Laparoscopic Partial Nephrectomy (RALPN). The result of this trial will determine whether HAs are necessary for use during RALPN or if they can be omitted from the surgical tools available during this procedure. This study has a direct clinical implication on a patient's outcomes following RALPN, specifically whether patients will have better, worse, or unchanged outcomes with RALPN if HAs are used.

Study Overview

• Status: Withdrawn
• Conditions: Renal Malignant Tumor; Robotic-Assisted Laparoscopic Partial Nephrectomy; Hemostatic Agents
• Intervention / Treatment: Device: Hemostat

Detailed Description

Partial nephrectomy is a surgical procedure wherein a diseased segment of a kidney is surgically removed, leaving behind the remaining healthy kidney parenchyma. This surgical procedure is typically performed to remove mass lesions suspicious for malignancy. A major goal of partial nephrectomy is to spare as much renal function as possible by preserving the healthy portion of the kidney while removing only the pathologic portion of the kidney.

Hemostatic agents (HA) are devices commonly used during robotic-assisted laparoscopic partial nephrectomy (RALPN) due to the risk of bleeding posed by incising a highly vascular organ. The use of various HAs as part of the surgical technique for RALPN is well-described. Potential benefits such as lower blood loss, lower rate of urine leak, and lower blood product transfusion rates have been suggested in small case series. However, larger prospective studies have failed to demonstrate these benefits of HAs. They report similar patient outcomes regardless of HA use. However, these studies are subject to selection bias given the lack of randomization, and they had a small relative number of partial nephrectomies performed without HAs.

To the knowledge of the investigators, no randomized trials have addressed the use of HAs in RALPN. Randomized, controlled trials for partial hepatectomy and knee arthroplasty have shown no benefit when using hemostatic agents to control bleeding.

At the home institution for this study, surgeons routinely use HAs in the resection bed during RALPN. Available, FDA approved, commercial agents include Floseal and Nu-Knit®. Each unit of HA costs $150 - $419 per unit, and often multiple units are used during a given procedure. The hospital is paid a set amount based on the patient's insurance for performing the procedure regardless of use of HA. The use of HAs therefore increases costs incurred by the hospital when performing these procedures. It is imperative to determine if this expenditure is justified.

The primary aim of this study is to compare surgical outcomes in patients undergoing RALPN with and without the use of hemostatic agents. Given the small nature of and conflicting information from the aforementioned cohort studies, it is imperative to remove selection bias and perform a randomized comparison of HA use. This study will provide a much more definitive head-to-head comparison of the overall utility of HAs. Additionally, it may provide more information about differential patient selection for more appropriate and judicious use of HAs. No study has evaluated differential patient selection for HA use, and therefore any finding in this realm would be novel.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female patients aged 18 years and older.
• Patients must have a solid or cystic renal mass suspicious for malignancy by imaging with ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI).
• Patients must be initially scheduled RALPN as opposed to radical nephrectomy or other techniques for partial nephrectomy such as open surgery or pure laparoscopy without robot assistance.
• Patients with bilateral kidneys or a solitary kidney, so long as these are native kidneys as opposed to a transplanted kidney.
• Patients can have the common single renal artery and single renal vein, or they can have common variants such as two renal arteries and/or two renal veins.

Exclusion Criteria:

• Patients on hemodialysis.
• Patients who have had a renal transplantation.
• Patients on therapeutic anticoagulation prior to surgery (example anticoagulants include: aspirin 325 mg daily, clopidogrel, warfarin, fondaparinux, dabigatran, and rivaroxaban). However, patients who take aspirin 81 mg daily as their daily regimen will be included.
• Patients with bleeding disorders (example: hemophilia) and other documented coagulopathy (example: chronic liver disease) with international normalized ratio (INR) > 1.0 at baseline.
• Patients who have had a prior surgical procedure, aside from percutaneous renal biopsy, on the kidney in the current operation.
• Patients with over 100 mL of estimated blood loss (calculated by anesthesia team using the suction canisters) prior to clamping of the renal hilum will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1; Patients undergoing RALPN with the use of HAs by a surgeon.	Device: Hemostat; Hemostatic agents, if used at all during surgery, will be applied laparoscopically into the tumor bed to stop bleeding. The type of hemostat will be decided by the surgeon according to the anatomy of the tumor bed.; Other Names: Surgicel Nu-Knit; FLOSEAL Hemostatic Matrix
NO_INTERVENTION: Group 2; Patients undergoing RALPN without the use of HAs by a surgeon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in hemoglobin	This will be measured as the difference between the hemoglobin obtained postoperatively (measured at approximately 4 am in the morning after surgery) and the hemoglobin obtained preoperatively in the holding area on the day of surgery.	Morning after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of major bleeding complications	Major complications are blood loss requiring transfusion of packed red blood cells, reoperation, and endovascular ablation	30 days following surgery
Safety monitoring parameters	Incidence of any of the following: urine leak, stroke, cardiac arrest, myocardial infarction, and death.	30 days following surgery
Operating room parameters	The number of sutures used during renorrhaphy and capsular closure.	Total duration of surgery
Operating room parameters	Duration of renorrhaphy.	Total duration of surgery
Operating room parameters	Number of patients in Group 2 (no HA) who required HA at the surgeon's discretion.	Total duration of surgery
Total length of in-patient hospital stay	Total length of all inpatient hospital stay over 30 days measured in days.	30 days following surgery
Total charges	Total charges for all inpatient care over 30 days using billing information recorded in the Northwestern Electronic Data Warehouse.	30 days following surgery

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Robert Nadler, MD, Professor of Urology, Feinberg School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2018
• Primary Completion (ANTICIPATED): May 1, 2019
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: April 18, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (ACTUAL): May 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Kidney
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Coagulants; Hemostatics
• Other Study ID Numbers: STU00206993

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes