Partial NephrectomyPhase 2NCT01720693
Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy
A Phase 2 study testing Hypoperfusion of renal artery in people with Partial Nephrectomy and Renal Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Many patients who are candidates for nephron-sparing surgery, partial nephrectomy is now the standard treatment with a surgical, small, clinical T1 tumor (<7 cm). In many recent studies, partial nephrectomy provides equivalent oncologic, and superior functional, outcomes compared with the standard radical nephrectomy… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Partial Nephrectomy, Renal Cell Carcinoma
- What is being tested?
- Hypoperfusion of renal artery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Dec 2014
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be at least 18 years old scheduled for open partial nephrectomy
Who cannot join
- No prior diagnosis of renal artery disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Examine a Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy
Many patients who are candidates for nephron-sparing surgery, partial nephrectomy is now the standard treatment with a surgical, small, clinical T1 tumor (<7 cm). In many recent studies, partial nephrectomy provides equivalent oncologic, and superior functional, outcomes compared with the standard radical nephrectomy over the short and long term (2, 3). Partial nephrectomy techniques, whether open, laparoscopic or robotic, typically involve hilar clamping, which creates the desired bloodless operative field, allowing for more precise tumor excision and renal reconstruction. This hilar clamping eventually may lead to ischemic kidney injury which can compromise the functional outcomes of the remaining kidney.We are working now to develop a novel technique of Hypo-Perfusion by achieving partial renal arterial clamping, with the goal of completely eliminating surgical ischemia to the renal remnant.
- Conditions
- Partial Nephrectomy, Renal Cell Carcinoma
- Being tested
- Hypoperfusion of renal artery
- Keywords
- partial nephrectomy, hypoperfusion, renal function
- 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.
Hypoperfusion of renal arteryProcedure or surgery
The renal artery is occluded to 30% of it's baseline, prior to kidney tumour removal
| Study group | Role | What they receive |
|---|---|---|
| hypoperfusion | Experimental | Hypoperfusion of the renal artery Receives: Procedure: Hypoperfusion of renal artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To perfect the Renal Hypoperfusion during partial nephrectomy is feasible safe and result in better renal function than complete occlusion of renal blood flow
renal function will be measured using creatinine, eGFR, 24 hr creat clearance, and NGAL biomarker of acute kidney injury
Measured: up to 2 weeks prior to surgery and up to 24 hrs post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2014
- Study completionDec 2014
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial NephrectomyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Jewett, M.D., Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720693
- Sponsor's protocol ID
- Hypoperfusion
- Status last verified
- Feb 2015
- First submitted
- 29 Oct 2012
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Examine a Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT01720693
- Acronym / sponsor ID
- Hypoperfusion
- Conditions
- Partial Nephrectomy, Renal Cell Carcinoma
- Keywords
- partial nephrectomy, hypoperfusion, renal function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Nov 2012 (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.
Many patients who are candidates for nephron-sparing surgery, partial nephrectomy is now the standard treatment with a surgical, small, clinical T1 tumor (<7 cm). In many recent studies, partial nephrectomy provides equivalent oncologic, and superior functional, outcomes compared with the standard radical nephrectomy over the short and long term (2, 3). Partial nephrectomy techniques, whether open, laparoscopic or robotic, typically involve hilar clamping, which creates the desired bloodless operative field, allowing for more precise tumor excision and renal reconstruction. This hilar clamping eventually may lead to ischemic kidney injury which can compromise the functional outcomes of the remaining kidney.We are working now to develop a novel technique of Hypo-Perfusion by achieving partial renal arterial clamping, with the goal of completely eliminating surgical ischemia to the renal remnant.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypoperfusion | Experimental | Procedure: Hypoperfusion of renal arteryHypoperfusion of the renal artery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient must be at least 18 years old scheduled for open partial nephrectomy
Key exclusion criteria (1 listed)
- No prior diagnosis of renal artery disease
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 |
|---|---|---|
| Hypoperfusion of renal arteryThe renal artery is occluded to 30% of it's baseline, prior to kidney tumour removal | Procedure or surgery | hypoperfusion |
Primary outcome
To perfect the Renal Hypoperfusion during partial nephrectomy is feasible safe and result in better renal function than complete occlusion of renal blood flow
Time frame: up to 2 weeks prior to surgery and up to 24 hrs post surgery
renal function will be measured using creatinine, eGFR, 24 hr creat clearance, and NGAL biomarker of acute kidney injury
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
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Perioperative Ursodeoxycholic Acid for Renal Protection in Adults Undergoing Partial Nephrectomy for Renal Tumors
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QLESP Block for Pain Control in Robotic Partial Nephrectomy
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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.
Michael Jewett, M.D. principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypoperfusion of renal artery in people with Partial Nephrectomy and Renal Cell Carcinoma, run by University Health Network, Toronto 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 11 Feb 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
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?
To perfect the Renal Hypoperfusion during partial nephrectomy is feasible safe and result in better renal function than complete occlusion of renal blood flow (time frame: up to 2 weeks prior to surgery and up to 24 hrs post 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 11 Feb 2015.