Back to resultsRandom Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy
Primary Purpose
Kidney Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hemostatic Agent
No Hemostatic Agent
Sponsored by
About this trial
This is an interventional supportive care trial for Kidney Cancer
Eligibility Criteria
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 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.
Sites / Locations
- The University of ChicagoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1 (Hemostatic Agents Plus +)
Group 2 (Hemostatic Agents Negative -)
Arm Description
No Hemostatic Agent
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Total number of major bleeding complications
Major complications are blood loss requiring transfusion of packed red blood cells, reoperation and endovascular ablation
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
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
Patients with a hospital stay over 30 days
Total length of all inpatient hospital stay over 30 days measured in days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04120805
Brief Title
Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy
Official Title
Randomized, Prospective Evaluation of Hemostatic Agents in Robotic-Assisted Laparoscopic Partial Nephrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
178 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (Hemostatic Agents Plus +)
Arm Type
Experimental
Arm Title
Group 2 (Hemostatic Agents Negative -)
Arm Type
Active Comparator
Arm Description
No Hemostatic Agent
Intervention Type
Device
Intervention Name(s)
Hemostatic Agent
Intervention Description
Patients undergoing robotic-assisted laparoscopic partial nephrectomy with the use of hemostatic agents by a surgeon
Intervention Type
Other
Intervention Name(s)
No Hemostatic Agent
Intervention Description
Patients undergoing robotic-assisted laparoscopic partial nephrectomy without the use of hemostatic agents by a surgeon
Primary Outcome Measure Information:
Title
An absolute change in hemoglobin
Description
The change in hemoglobin will be measured as the difference between the hemoglobin obtained postoperatively and the hemoglobin obtained preoperatively.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Total number of major bleeding complications
Description
Major complications are blood loss requiring transfusion of packed red blood cells, reoperation and endovascular ablation
Time Frame
up to 6 months
Title
Safety monitoring parameters: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Safety monitoring parameters including stroke, death, cardiac arrest, myocardial infarction and urine leak
Time Frame
up to 6 months
Title
Operating room parameters
Description
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
Time Frame
up to 6 months
Title
Patients with a hospital stay over 30 days
Description
Total length of all inpatient hospital stay over 30 days measured in days
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arieh Shalhav, MD
Phone
773-834-9889
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arieh Shalhav, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arieh Shalhav, MD
Phone
773-834-9889
First Name & Middle Initial & Last Name & Degree
Arieh Shalhav, MD
First Name & Middle Initial & Last Name & Degree
Scott Eggener, MD
12. IPD Sharing Statement
Learn more about this trial
Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy
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