Robotic-Assisted Laparoscopic Partial NephrectomyNCT03528057
Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy
A study testing Hemostat in people with Robotic-Assisted Laparoscopic Partial Nephrectomy and Hemostatic Agents, run by Northwestern University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Robotic-Assisted Laparoscopic Partial Nephrectomy, Hemostatic Agents, Renal Malignant Tumor
- What is being tested?
- Hemostat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2018to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 89 years
- 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 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: 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.
Read the 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.
- Conditions
- Robotic-Assisted Laparoscopic Partial Nephrectomy, Hemostatic Agents, Renal Malignant Tumor
- Being tested
- Hemostat
- Keywords
- Kidney
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemostatDevice
Also called Surgicel Nu-Knit, FLOSEAL Hemostatic Matrix
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Patients undergoing RALPN with the use of HAs by a surgeon. Receives: Device: Hemostat |
| Group 2 | No intervention | Patients undergoing RALPN without the use of HAs by a surgeon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Morning after surgery
Secondary outcomes (7)
Total number of major bleeding complications
Major complications are blood loss requiring transfusion of packed red blood cells, reoperation, and endovascular ablation
Measured: 30 days following surgery
Safety monitoring parameters
Incidence of any of the following: urine leak, stroke, cardiac arrest, myocardial infarction, and death.
Measured: 30 days following surgery
Operating room parameters
The number of sutures used during renorrhaphy and capsular closure.
Measured: Total duration of surgery
Operating room parameters
Duration of renorrhaphy.
Measured: Total duration of surgery
Operating room parameters
Number of patients in Group 2 (no HA) who required HA at the surgeon's discretion.
Measured: Total duration of surgery
Total length of in-patient hospital stay
Total length of all inpatient hospital stay over 30 days measured in days.
Measured: 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.
Measured: 30 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start18 Apr 2018
- Primary completionMay 2019 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: Difficulty recruiting participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic-Assisted Laparoscopic Partial NephrectomyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert B. Nadler, Northwestern University
- Investigators
- Robert Nadler, MD, Principal investigator, Professor of Urology, Feinberg School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528057
- Sponsor's protocol ID
- STU00206993
- Status last verified
- Jul 2019
- First submitted
- 18 Apr 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT03528057
- Acronym / sponsor ID
- STU00206993
- Conditions
- Robotic-Assisted Laparoscopic Partial Nephrectomy, Hemostatic Agents, Renal Malignant Tumor
- Keywords
- Kidney
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: HemostatPatients undergoing RALPN with the use of HAs by a surgeon. |
| Group 2 | No intervention | –Patients undergoing RALPN without the use of HAs by a surgeon |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemostatAlso: Surgicel Nu-Knit, FLOSEAL Hemostatic MatrixHemostatic 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. | Device | Group 1 |
Primary outcome
Absolute change in hemoglobin
Time frame: Morning after surgery
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.
7 secondary outcomes
Total number of major bleeding complications
Time frame: 30 days following surgery
Safety monitoring parameters
Time frame: 30 days following surgery
Operating room parameters
Time frame: Total duration of surgery
Operating room parameters
Time frame: Total duration of surgery
Operating room parameters
Time frame: Total duration of surgery
Total length of in-patient hospital stay
Time frame: 30 days following surgery
Total charges
Time frame: 30 days following surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Not yet recruiting
A Study of 3D Visualization Techniques to Improve the Quality and Safety of Robot-assisted Nephron Sparing Surgery for Complex Renal Tumors.
Kidney Neoplasms / Surgery, Robotic Surgical Procedures
Recruiting
Robot-assisted Laparoscopic Partial Nephrectomy Via the Extraperitoneal Approach in the Prone Position Versus the Lateral Position
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Nadler, MD principal investigator
Professor of Urology, Feinberg School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemostat in people with Robotic-Assisted Laparoscopic Partial Nephrectomy and Hemostatic Agents, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in hemoglobin (time frame: Morning after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.