Kidney CancerNCT04120805
Randomized Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy
A study testing Hemostatic Agent and No Hemostatic Agent in people with Kidney Cancer, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Hemostatic Agent and No Hemostatic Agent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 18 Nov 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Kidney Cancer
- Being tested
- Hemostatic Agent, No Hemostatic Agent
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemostatic AgentDevice
Patients undergoing robotic-assisted laparoscopic partial nephrectomy with the use of hemostatic agents by a surgeon
No Hemostatic AgentOther
Patients undergoing robotic-assisted laparoscopic partial nephrectomy without the use of hemostatic agents by a surgeon
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Hemostatic Agents Plus +) | Experimental | Not described Receives: Device: Hemostatic Agent |
| Group 2 (Hemostatic Agents Negative -) | Active comparator | No Hemostatic Agent Receives: Other: No Hemostatic Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin
The change in hemoglobin will be measured as the difference between the hemoglobin obtained postoperatively (day 1) and the hemoglobin obtained preoperatively (on the day of surgery before the operation).
Measured: 1 day
Secondary outcomes (6)
Total Number of Patients With Major Bleeding Complications
Major bleeding complications is a composite outcome including blood products transfusion, reoperation, or the need for endovascular evaluation or embolization.
Measured: up to 30 days
Safety Monitoring Parameters: Number of Participants With Surgery-related Adverse Event (Stroke, Death, Cardiac Arrest, Myocardial Infarction, or Urine Leak)
Safety monitoring parameters included stroke, death, cardiac arrest, myocardial infarction and urine leak.
Measured: up to 30 days
Duration of Renorrhaphy
Measured: Up to 24 hours
Number of Sutures Used During Renorrhaphy and Capsular Closure.
Measured: Up to 24 hours
HA Required
The number of patients in group 2 (HA-) who required hemostatic agents at the surgeon's discretion.
Measured: Up to 24 hours
Patients With a Hospital Stay Over 30 Days
Total length of all inpatient hospital stay over 30 days measured in days
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Jan 2016
- Primary completion8 Apr 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arieh Shalhav, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120805
- Sponsor's protocol ID
- IRB15-0519
- Status last verified
- Sep 2026
- First submitted
- 14 Jan 2019
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Lazarovich A, Tremblay S, Nottingham C, Lescay H, Nusbaum DJ, Cooper C, Labbate C, Bristol S, Karrison T, Shalhav AL, Eggener S. Randomized, Prospective Evaluation of Hemostatic Agents in Robotic-Assisted Laparoscopic Partial Nephrectomy. J Urol. 2026 May;215(5):526-534. doi: 10.1097/JU.0000000000004889. Epub 2025 Dec 8.
PubMed 41360001