Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy

NCT04120805 | Active Not Recruiting FDA Device

• 1 other identifier: IRB15-0519
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total number of major bleeding complications

  up to 6 months

• Safety monitoring parameters: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  up to 6 months

• Operating room parameters

  up to 6 months

• Patients with a hospital stay over 30 days

  up to 6 months

Study Arms (2)

Group 1 (Hemostatic Agents Plus +)

EXPERIMENTAL

Device: Hemostatic Agent

Group 2 (Hemostatic Agents Negative -)

ACTIVE COMPARATOR

No Hemostatic Agent

Other: No Hemostatic Agent

Interventions

Hemostatic Agent DEVICE

Patients undergoing robotic-assisted laparoscopic partial nephrectomy with the use of hemostatic agents by a surgeon

Group 1 (Hemostatic Agents Plus +)

No Hemostatic Agent OTHER

Patients undergoing robotic-assisted laparoscopic partial nephrectomy without the use of hemostatic agents by a surgeon

Group 2 (Hemostatic Agents Negative -)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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 INR greater than 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Arieh Shalhav, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: October 9, 2019
• Study Start: January 1, 2016
• Primary Completion: April 8, 2025
• Study Completion: March 1, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

US (1)