Small Renal MassesPhase 3RALPLPNNXNCT02933398
A Trial Comparing - Robotic Assisted Versus Laparoscopic Partial Nephrectomy For Small Renal Masses
A Phase 3 study testing Robotic Assisted Nephrectomy and Laparoscopic Assisted Nephrectomy in people with Small Renal Masses, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
A prospective, randomized, controlled trial including patients who are diagnosed with a small renal mass (<4 cm) amenable to resection using either RALPN or LPN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Renal Masses
- What is being tested?
- Robotic Assisted Nephrectomy and Laparoscopic Assisted Nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2021to Dec 2022
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at least 18 years of age and capable of giving informed consent
- Patients scheduled for treatment of a renal tumor suitable to undergo LPN /RALPN
- Patients with SRMs (tumor(s) ≤ 4 cm)
Who cannot join
- Large tumors > 4.0cm
- Unable to have a general anesthetic
- Unable to comply with post-operative follow-up protocol
- Uncorrectable bleeding diathesis
- Tumors unsuitable for LPN/RALPN technique
- Evidence of metastatic disease
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- Prior surgery on the affected kidney
- Ectopic or malrotated kidney
- Mental health condition that precludes informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Healthcare Hamilton - McMaster Institute of Urology
Hamilton, Ontario, L8N4A6
About this study
Official title: A Prospective Randomized Controlled Trial Comparing Two Minimally Invasive Surgical Modalities - Robotic Assisted Vs. Pure Laparoscopic Partial Nephrectomy For Small Renal Masses.
A prospective, randomized, controlled trial including patients who are diagnosed with a small renal mass (<4 cm) amenable to resection using either RALPN or LPN.
Read the detailed description
Small renal masses (SRM) <4cm are increasingly being discovered incidentally on imaging. The standard of care for management of SRMs is partial nephrectomy whenever feasible. In the last 10 years, a minimally invasive laproscopic approach has largely supplanted open surgery for the treatment of SRMs. Robot-assisted laparoscopic partial nephrectomy (RALPN) has emerged as an alternative to laparoscopic partial nephrectomy (LPN) and has been able to bridge the technical difficulties of LPN. The big question about the role and cost of RALPN in comparison to LPN especially in Canadian healthcare for SRMs still remains unanswered.
The objective of this proposed study is to conduct a randomized controlled trial to determine whether RALPN is better than LPN for the management of patients with SRMs. The primary outcomes will be warm ischemia time and secondary outcomes will be estimated glomerular filtration rate (eGFR), estimated blood loss, complication rate, length of hospital stay, positive surgical margin rate and cost comparison of these two techniques.
- Conditions
- Small Renal Masses
- Being tested
- Robotic Assisted Nephrectomy, Laparoscopic Assisted Nephrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assisted NephrectomyProcedure or surgery
Robotic (Davinci)
Laparoscopic Assisted NephrectomyProcedure or surgery
Regular Laparoscopic Technique.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Assisted Partial Nephrectomy | Active comparator | Current standard for partial nephrectomies. Receives: Procedure: Robotic Assisted Nephrectomy |
| Robotic Assisted Partial Nephrectomy | Active comparator | Possible new standard for partial nephrectomies. Receives: Procedure: Laparoscopic Assisted Nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Warm ischemia time
It will be measured intraoperatively from the time of application of Satinsky clamp on the renal hilum to the release of clamp (in minutes).
Measured: Duration of the Surgical Procedure (Nephrectomy)
Secondary outcomes (8)
eGFR
It will be measured preoperatively, postoperatively and at each of the follow-up visit.
Measured: Up to 24 months post operatively.
Estimated blood loss
Will be measured intraoperatively from the amount of blood (ml) in the suction container.
Measured: Duration of the Surgical Procedure (Nephrectomy)
Complication rates as per Clavien-Dindo classification
It will be recorded for the intra-operative, post-operative and follow-up period.
Measured: Up to 24 months post-operatively.
Conversion rate to radical nephrectomy or OPN due to technical difficulty.
From the start of the partial nephrectomy in minutes to the time it was decided to convert to a radical nephrectomy.
Measured: Duration of the Surgical Procedure
Postoperative pain
Measured: Minutes to hours after nephrectomy up to 3 months post-operatively.
Length of hospital stay
Calculated from day of admission to day of discharge from hospital.
Measured: 3-7 Days
Positive surgical margin rate
Will be based on the final pathology results which are usually ready in 1-2 weeks post surgery. Distance to surgical margin will be looked at (mm to cm).
Measured: 14 days
Costs of treatment
Clinical data and resource use for both treatments will be collected and unit cost estimates will be based on the St. Joseph Healthcare case-costing system. The cost will be conducted from the perspective of Ontario Ministry of Health and Long-term Care. The cost of hospital stay will be calculated along with any hospital stay/procedure associated with a post-op complication.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startDec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Renal MassesStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Kapoor, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933398
- Sponsor's protocol ID
- RALPLPNNX
- Acronym
- RALPLPNNX
- Status last verified
- Mar 2021
- First submitted
- 10 Oct 2014
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing Two Minimally Invasive Surgical Modalities - Robotic Assisted Vs. Pure Laparoscopic Partial Nephrectomy For Small Renal Masses.
- ClinicalTrials.gov ID
- NCT02933398
- Acronym / sponsor ID
- RALPLPNNX / RALPLPNNX
- Conditions
- Small Renal Masses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 14 Oct 2016 (estimated)
- 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.
A prospective, randomized, controlled trial including patients who are diagnosed with a small renal mass (<4 cm) amenable to resection using either RALPN or LPN.
Detailed description
Small renal masses (SRM) <4cm are increasingly being discovered incidentally on imaging. The standard of care for management of SRMs is partial nephrectomy whenever feasible. In the last 10 years, a minimally invasive laproscopic approach has largely supplanted open surgery for the treatment of SRMs. Robot-assisted laparoscopic partial nephrectomy (RALPN) has emerged as an alternative to laparoscopic partial nephrectomy (LPN) and has been able to bridge the technical difficulties of LPN. The big question about the role and cost of RALPN in comparison to LPN especially in Canadian healthcare for SRMs still remains unanswered.
The objective of this proposed study is to conduct a randomized controlled trial to determine whether RALPN is better than LPN for the management of patients with SRMs. The primary outcomes will be warm ischemia time and secondary outcomes will be estimated glomerular filtration rate (eGFR), estimated blood loss, complication rate, length of hospital stay, positive surgical margin rate and cost comparison of these two techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Assisted Partial Nephrectomy | Active comparator | Procedure: Robotic Assisted NephrectomyCurrent standard for partial nephrectomies. |
| Robotic Assisted Partial Nephrectomy | Active comparator | Procedure: Laparoscopic Assisted NephrectomyPossible new standard for partial nephrectomies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients at least 18 years of age and capable of giving informed consent
- Patients scheduled for treatment of a renal tumor suitable to undergo LPN /RALPN
- Patients with SRMs (tumor(s) ≤ 4 cm)
Key exclusion criteria (9 listed)
- Large tumors > 4.0cm
- Unable to have a general anesthetic
- Unable to comply with post-operative follow-up protocol
- Uncorrectable bleeding diathesis
- Tumors unsuitable for LPN/RALPN technique
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 |
|---|---|---|
| Robotic Assisted NephrectomyRobotic (Davinci) | Procedure or surgery | Laparoscopic Assisted Partial Nephrectomy |
| Laparoscopic Assisted NephrectomyRegular Laparoscopic Technique. | Procedure or surgery | Robotic Assisted Partial Nephrectomy |
Primary outcome
Warm ischemia time
Time frame: Duration of the Surgical Procedure (Nephrectomy)
It will be measured intraoperatively from the time of application of Satinsky clamp on the renal hilum to the release of clamp (in minutes).
8 secondary outcomes
eGFR
Time frame: Up to 24 months post operatively.
Estimated blood loss
Time frame: Duration of the Surgical Procedure (Nephrectomy)
Complication rates as per Clavien-Dindo classification
Time frame: Up to 24 months post-operatively.
Conversion rate to radical nephrectomy or OPN due to technical difficulty.
Time frame: Duration of the Surgical Procedure
Postoperative pain
Time frame: Minutes to hours after nephrectomy up to 3 months post-operatively.
Length of hospital stay
Time frame: 3-7 Days
Positive surgical margin rate
Time frame: 14 days
Costs of treatment
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Robotic Assisted Nephrectomy and Laparoscopic Assisted Nephrectomy in people with Small Renal Masses, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Mar 2021. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anil Kapoor, MD, FRCSC (905-522-1155 ext. 33218, akapoor@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Warm ischemia time (time frame: Duration of the Surgical Procedure (Nephrectomy)). 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 19 Mar 2021.