Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy

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

The purpose of this study is to evaluate the necessity of using hemostatic agents as a tool when performing robotic partial nephrectomy in the treatment of kidney cancer. This project asks whether patients who undergo robotic partial nephrectomy without the surgeon using hemostatic agents during the procedure will have the same, fewer, or more complications than when patients undergo this same surgery with the surgeon using hemostatic agents during the procedure.

Study Overview

• Status: Recruiting
• Conditions: Kidney Cancer
• Intervention / Treatment: Device: Hemostatic Agent; Other: No Hemostatic Agent

• Study Type: Interventional
• Enrollment (Estimated): 178
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arieh Shalhav, MD; Phone Number: 773-834-9889

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • The University of Chicago
      • Contact: Arieh Shalhav, MD; Phone Number: 773-834-9889
      • Principal Investigator: Arieh Shalhav, MD
      • Principal Investigator: Scott Eggener, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and female patients aged 18 years and older.
2. 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).
3. 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.
4. Patients with bilateral kidneys or a solitary kidney, so long as these are native kidneys as opposed to a transplanted kidney.
5. 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:

1. Patients on hemodialysis.
2. Patients who have had a renal transplantation.
3. 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.
4. Patients with bleeding disorders (example: hemophilia) and other documented coagulopathy (example: chronic liver disease) with INR greater than 1.0 at baseline.
5. Patients who have had a prior surgical procedure, aside from percutaneous renal biopsy, on the kidney in the current operation.
6. 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: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (Hemostatic Agents Plus +)	Device: Hemostatic Agent; Patients undergoing robotic-assisted laparoscopic partial nephrectomy with the use of hemostatic agents by a surgeon
Active Comparator: Group 2 (Hemostatic Agents Negative -); No Hemostatic Agent	Other: No Hemostatic Agent; Patients undergoing robotic-assisted laparoscopic partial nephrectomy without the use of hemostatic agents by a surgeon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
An absolute change in hemoglobin	The change in hemoglobin will be measured as the difference between the hemoglobin obtained postoperatively and the hemoglobin obtained preoperatively.	up to 6 months

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	up to 6 months
Safety monitoring parameters: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Safety monitoring parameters including stroke, death, cardiac arrest, myocardial infarction and urine leak	up to 6 months
Operating room parameters	Operating room parameters including number of sutures used during renorrhaphy and capsular closure, duration of renorrhaphy and patients in group 2 with no hemostatic agents who required HA at the surgeons discretion	up to 6 months
Patients with a hospital stay over 30 days	Total length of all inpatient hospital stay over 30 days measured in days	up to 6 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Arieh Shalhav, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms; Coagulants; Hemostatics
• Other Study ID Numbers: IRB15-0519

Drug and device information, study documents

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