Renal CancerNCT01732120
Off Clamp Randomization
A study testing Off-clamp partial nephrectomy in people with Renal Cancer and Renal Ischemia, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to compare the effects on kidney function after performing the removal of a kidney tumor with or without clamping the blood vessels during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer, Renal Ischemia
- What is being tested?
- Off-clamp partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 and older.
- Patients willing and able to sign consent.
- Patients with an organ confined renal mass planning to undergo a robotic assisted partial nephrectomy (RAPN).
- Patient with Karnofsky Performance Status (KPS) equal to or greater than 40.
Who cannot join
- Patients under 18.
- Patients with Karnofsky Performance Status (KPS) less than 40.
- Patients with non-organ confined renal masses (invading renal vein, inferior vena cava, peri-renal tissue, ipsilateral adrenal gland, or metastasis).
- Patients with bilateral synchronous renal masses.
- Patients who can not discontinue Plavix, Coumadin or other anti-platelet or anti-coagulant medications.
- Patients with renal lesions determined to be too complex to perform a RAPN without clamp by the surgeon. (The renal mass may be deemed too difficult based on pre-operatively radiological findings. The surgeon's decision to exclude a mass from a robotic assisted partial nephrectomy would be based on a higher risk of positive margin or complication if a RAPN was performed.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Evaluation of the Off-Clamp Robot-Assisted Partial Nephrectomy Technique in the Management of Renal Tumors
The purpose of this research study is to compare the effects on kidney function after performing the removal of a kidney tumor with or without clamping the blood vessels during surgery.
- Conditions
- Renal Cancer, Renal Ischemia
- Being tested
- Off-clamp partial nephrectomy
- Keywords
- off-clamp, partial nephrectomy, renal cancer treatment, renal ischemia
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off-clamp partial nephrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Off-clamp partial nephrectomy | Experimental | Partial nephrectomy will be performed without clamping of the renal blood vessels. Receives: Procedure: Off-clamp partial nephrectomy |
| Traditional partial nephrectomy | No intervention | Partial nephrectomy will be performed with clamping of the renal blood vessels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in eGFR
Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.
Measured: baseline and 3 months post nephrectomy
Percent Change From Baseline in Split Renal Function
Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy.
Measured: baseline to 3 months post nephrectomy
Secondary outcomes (8)
Percent of Observations With Positive Surgical Margins.
Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins.
Measured: at the time of nephrectomy
Estimated Blood Loss
Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.
Measured: At the time of nephrectomy
Percent of Observations With Metastasis
Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy.
Measured: 3 years
Operative Time Measured in Minutes.
Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy.
Measured: At the time of nephrectomy
Warm Ischemia Time Measured in Minutes.
Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy.
Measured: At the time of nephrectomy.
Percent of Observations With Intra-operative Complications.
Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy.
Measured: At the time of nephrectomy
Number of Hospital Days Post Nephrectomy.
Perioperative outcomes will be assessed based number of hospital days post nephrectomy.
Measured: Day of nephrectomy to day of hospital discharge.
Percent of Observations With Postoperative Complications.
Perioperative outcomes will be assessed based on percent of observations with postoperative complications.
Measured: Within 3 months post nephrectomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startNov 2012
- Primary completion31 May 2017
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Midwest Stone Institute.
- Responsible party
- Sponsor
- Investigators
- Robert S Figenshau, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732120
- Sponsor's protocol ID
- myIRB ID 201208091
- Status last verified
- Jul 2022
- First submitted
- 16 Nov 2012
- Last updated
- 19 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Off-Clamp Robot-Assisted Partial Nephrectomy Technique in the Management of Renal Tumors
- ClinicalTrials.gov ID
- NCT01732120
- Acronym / sponsor ID
- myIRB ID 201208091
- Conditions
- Renal Cancer, Renal Ischemia
- Keywords
- off-clamp, partial nephrectomy, renal cancer treatment, renal ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Midwest Stone Institute.
- Study start
- Nov 2012
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 Nov 2012 (estimated)
- Results
- Posted 9 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare the effects on kidney function after performing the removal of a kidney tumor with or without clamping the blood vessels during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Off-clamp partial nephrectomy | Experimental | Procedure: Off-clamp partial nephrectomyPartial nephrectomy will be performed without clamping of the renal blood vessels. |
| Traditional partial nephrectomy | No intervention | –Partial nephrectomy will be performed with clamping of the renal blood vessels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 and older.
- Patients willing and able to sign consent.
- Patients with an organ confined renal mass planning to undergo a robotic assisted partial nephrectomy (RAPN).
- Patient with Karnofsky Performance Status (KPS) equal to or greater than 40.
Key exclusion criteria (6 listed)
- Patients under 18.
- Patients with Karnofsky Performance Status (KPS) less than 40.
- Patients with non-organ confined renal masses (invading renal vein, inferior vena cava, peri-renal tissue, ipsilateral adrenal gland, or metastasis).
- Patients with bilateral synchronous renal masses.
- Patients who can not discontinue Plavix, Coumadin or other anti-platelet or anti-coagulant medications.
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 |
|---|---|---|
| Off-clamp partial nephrectomy | Procedure or surgery | Off-clamp partial nephrectomy |
Primary outcome
Percent Change From Baseline in eGFR
Time frame: baseline and 3 months post nephrectomy
Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.
Percent Change From Baseline in Split Renal Function
Time frame: baseline to 3 months post nephrectomy
Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy.
8 secondary outcomes
Percent of Observations With Positive Surgical Margins.
Time frame: at the time of nephrectomy
Estimated Blood Loss
Time frame: At the time of nephrectomy
Percent of Observations With Metastasis
Time frame: 3 years
Operative Time Measured in Minutes.
Time frame: At the time of nephrectomy
Warm Ischemia Time Measured in Minutes.
Time frame: At the time of nephrectomy.
Percent of Observations With Intra-operative Complications.
Time frame: At the time of nephrectomy
Number of Hospital Days Post Nephrectomy.
Time frame: Day of nephrectomy to day of hospital discharge.
Percent of Observations With Postoperative Complications.
Time frame: Within 3 months post nephrectomy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 S Figenshau, MD principal investigator
Washington University 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 Off-clamp partial nephrectomy in people with Renal Cancer and Renal Ischemia, run by Washington University School of Medicine 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 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: finished, as of the sponsor's last update on 19 May 2023. 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?
Yes. Results are posted in the registry (first posted 9 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change From Baseline in eGFR (time frame: baseline and 3 months post nephrectomy). The study lists 2 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 19 May 2023.