Small Renal MassPhase 2/3ZILPAREMZNCT02634385
Zero Ischemia Laparoscopic Partial Nephrectomy
A Phase 2/3 study testing Renal Artery Embolization and Partial Nephrectomy (Surgical Resection) in people with Small Renal Mass, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Laparoscopic partial nephrectomy (LPN) is often reserved for patients with a small peripheral tumour, in the hands of an experienced surgeon since it demands a high degree of endoscopic skill. Renal vessel clamp for vascular control is a required step during standard LPN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Renal Mass
- What is being tested?
- Renal Artery Embolization and Partial Nephrectomy (Surgical Resection)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Jun 2016
- Phase
- Phase 2/3
- 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
- T1a renal cell carcinomas diagnosed by ultrasonography (US), computed tomography (CT) or fine needle aspiration
- tumor size <4cm in diameter
- predominant exophytic growth
- intraparenchymal depth no greater than 1.5cm, with a minimum distance of 5mm from the urinary collecting system
Who cannot join
- predominant endophytic nature (depth </= 1.5 cm)
- nearness (<0.5cm) of the tumor to the urinary collecting system
- multiple ipsilateral lesions
- pregnancy
- allergy to intravenous contrast dye
- absolute contraindications to surgical intervention
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: Zero Ischemia Laparoscopic Partial Nephrectomy in Combination With Superselective Renal Artery Embolization for Small Renal Masses: A Feasibility Trial
Laparoscopic partial nephrectomy (LPN) is often reserved for patients with a small peripheral tumour, in the hands of an experienced surgeon since it demands a high degree of endoscopic skill. Renal vessel clamp for vascular control is a required step during standard LPN. However, this creates a time limiting step for the surgeon and induces renal injury via warm ischemia and reperfusion injury. This novel approach can substantially reduce renal injury during LPN via superselective embolization of level II renal arteries pre-operatively. This technique facilitates the performance of a clamp-less, zero-ischemia LPN, significantly simplifying the procedure by remove time thresholds within which to perform tumor excision. The preliminary results are promising; however, there is a need for further corroboration of their results, in addition to a randomized controlled trial comparing this modified, zero ischemia technique with standard LPN.
Read the detailed description
The potential utility of a zero ischemia, laparoscopic, partial nephrectomy portends significant implications for both the surgeon and patient. Firstly, the technical difficulty of a partial nephrectomy will be reduced to a more achievable level owing mainly to the removal of a time limit on surgical resection. With the blood flow halted to downstream tissue containing the renal neoplasm from preoperative embolization, resection can be made to the tumor without clamping of the main renal arteries. This minimizes the ischemic time to non-neoplastic renal tissue, allowing for a renal protective effect. Without the need for clamping, the overall surgical operative time is drastically reduced. With excision made at the ischemic tissue, intra-operative bleeding and ease can be achieved. More surgeons can ultimately attempt at LPN by removing the single most limiting surgical factor, warm ischemic time.
- Conditions
- Small Renal Mass
- Being tested
- Renal Artery Embolization, Partial Nephrectomy (Surgical Resection)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Artery EmbolizationProcedure or surgery
Patients will be receiving embolization prior to planned partial nephrectomy.
Partial Nephrectomy (Surgical Resection)Procedure or surgery
Patients will be undergoing planned partial nephrectomy post embolization.
| Study group | Role | What they receive |
|---|---|---|
| Small Renal Mass | No intervention | Patient's with a small renal mass will be undergoing embolization prior to laparoscopic partial nephrectomy. Receives: Procedure: Renal Artery Embolization; Procedure: Partial Nephrectomy (Surgical Resection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extirpative time
From initial renal tissue breach until completion of bolster placement. Calculated in minutes.
Measured: Duration of Surgical Procedure
Warm ischemia time
From renal vessel clamping to unclamping during nephrectomy (only if clamping has occurred). Calculated in minutes.
Measured: Duration of Surgical Procedure
Mean estimated blood loss (measured in ml)
From the start of procedure (Nephrectomy), until the end of the procedure.
Measured: Duration of Surgical Procedure
Secondary outcomes (6)
Mean hospital stay
Date admitted for procedure until date of discharge. Measure in calendar days.
Measured: 2-10 Days
Blood transfusions
Prior to Embolization procedure and pre and post-nephrectomy.
Measured: From date of pre-op up to 6 months post-op
Conversion to other type of surgery (i.e. Radical Nephrectomy)
Minutes from the start of procedure (Nephrectomy).
Measured: Duration of Surgical Procedure
Identification of other complications (i.e. readmission, arteriovenous malformations)
Complications will be monitored after patient is discharged up until two years post-operatively.
Measured: Up to 24 months post-operatively.
Overall survival rates
Follow-up will be monitored.
Measured: Up to 24 months post-operatively.
Pathological Results (% of negative margins and benign versus malignant tumours).
Pathology results are usually not released until 7-14 days post nephrectomy.
Measured: 7 to 14 days post nephrectomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2016 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: No funding to start project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Renal MassStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- NCT02634385
- Sponsor's protocol ID
- ZILPAREMBZ14
- Acronym
- ZILPAREMZ
- Status last verified
- Jul 2016
- First submitted
- 10 Oct 2014
- Last updated
- 27 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zero Ischemia Laparoscopic Partial Nephrectomy in Combination With Superselective Renal Artery Embolization for Small Renal Masses: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT02634385
- Acronym / sponsor ID
- ZILPAREMZ / ZILPAREMBZ14
- Conditions
- Small Renal Mass
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding to start project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 18 Dec 2015 (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.
Laparoscopic partial nephrectomy (LPN) is often reserved for patients with a small peripheral tumour, in the hands of an experienced surgeon since it demands a high degree of endoscopic skill. Renal vessel clamp for vascular control is a required step during standard LPN. However, this creates a time limiting step for the surgeon and induces renal injury via warm ischemia and reperfusion injury. This novel approach can substantially reduce renal injury during LPN via superselective embolization of level II renal arteries pre-operatively. This technique facilitates the performance of a clamp-less, zero-ischemia LPN, significantly simplifying the procedure by remove time thresholds within which to perform tumor excision. The preliminary results are promising; however, there is a need for further corroboration of their results, in addition to a randomized controlled trial comparing this modified, zero ischemia technique with standard LPN.
Detailed description
The potential utility of a zero ischemia, laparoscopic, partial nephrectomy portends significant implications for both the surgeon and patient. Firstly, the technical difficulty of a partial nephrectomy will be reduced to a more achievable level owing mainly to the removal of a time limit on surgical resection. With the blood flow halted to downstream tissue containing the renal neoplasm from preoperative embolization, resection can be made to the tumor without clamping of the main renal arteries. This minimizes the ischemic time to non-neoplastic renal tissue, allowing for a renal protective effect. Without the need for clamping, the overall surgical operative time is drastically reduced. With excision made at the ischemic tissue, intra-operative bleeding and ease can be achieved. More surgeons can ultimately attempt at LPN by removing the single most limiting surgical factor, warm ischemic time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Small Renal Mass | No intervention | Procedure: Renal Artery Embolization, Procedure: Partial Nephrectomy (Surgical Resection)Patient's with a small renal mass will be undergoing embolization prior to laparoscopic partial nephrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- T1a renal cell carcinomas diagnosed by ultrasonography (US), computed tomography (CT) or fine needle aspiration
- tumor size <4cm in diameter
- predominant exophytic growth
- intraparenchymal depth no greater than 1.5cm, with a minimum distance of 5mm from the urinary collecting system
Key exclusion criteria (6 listed)
- predominant endophytic nature (depth </= 1.5 cm)
- nearness (<0.5cm) of the tumor to the urinary collecting system
- multiple ipsilateral lesions
- pregnancy
- allergy to intravenous contrast dye
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 |
|---|---|---|
| Renal Artery EmbolizationPatients will be receiving embolization prior to planned partial nephrectomy. | Procedure or surgery | Small Renal Mass |
| Partial Nephrectomy (Surgical Resection)Patients will be undergoing planned partial nephrectomy post embolization. | Procedure or surgery | Small Renal Mass |
Primary outcome
Extirpative time
Time frame: Duration of Surgical Procedure
From initial renal tissue breach until completion of bolster placement. Calculated in minutes.
Warm ischemia time
Time frame: Duration of Surgical Procedure
From renal vessel clamping to unclamping during nephrectomy (only if clamping has occurred). Calculated in minutes.
Mean estimated blood loss (measured in ml)
Time frame: Duration of Surgical Procedure
From the start of procedure (Nephrectomy), until the end of the procedure.
6 secondary outcomes
Mean hospital stay
Time frame: 2-10 Days
Blood transfusions
Time frame: From date of pre-op up to 6 months post-op
Conversion to other type of surgery (i.e. Radical Nephrectomy)
Time frame: Duration of Surgical Procedure
Identification of other complications (i.e. readmission, arteriovenous malformations)
Time frame: Up to 24 months post-operatively.
Overall survival rates
Time frame: Up to 24 months post-operatively.
Pathological Results (% of negative margins and benign versus malignant tumours).
Time frame: 7 to 14 days post nephrectomy.
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 27 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Renal Artery Embolization and Partial Nephrectomy (Surgical Resection) in people with Small Renal Mass, 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 4 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 27 Jul 2016. 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 combined 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.
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?
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?
Extirpative time (time frame: Duration of Surgical Procedure). The study lists 3 primary outcomes in all. 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 27 Jul 2016.