Recurrent Renal Cell CancerNCT01547676
Clamped or Unclamped Surgery in Treating Patients With Kidney Cancer
A study testing robot-assisted laparoscopic surgery in people with Recurrent Renal Cell Cancer, run by University of Southern California at 1 site in United States.
Trial summary
This randomized pilot trial studies clamped or unclamped surgery in treating patients with kidney cancer. Unclamped surgery for kidney cancer may have fewer side effects Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Renal Cell Cancer
- What is being tested?
- robot-assisted laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Sep 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solitary renal mass or solitary complex renal cyst Bosniak >/= Grade 3
- Clinical stage T1a, T1b
- Body Mass Index (BMI) < 40
- Surgical candidate (preoperative cardiac and anesthesia clearance obtained)
- Able to give informed consent
- 24 hour urine collection complete and report obtained
- MAG-3/DTPA scan completed and report obtained
Who cannot join
- Pregnancy
- More than 1 renal mass or complex renal cyst Bosniak >/= Grade 3 on ipsilateral kidney
- Previous renal surgery on the ipsilateral kidney
- Clinical Stage T2 or greater
- BMI > 40
- Contraindication to systemic hypotension:
Show all 11Show fewer
- Left Main Coronary Arterial Disease
- Severe cardiac decompensation (ejection fraction [EF] < 40%)
- Prior history of cerebrovascular accident
- Unable to consent
- Unwilling or unable to potentially receive blood transfusion
Trial locations and contacts
1 site in 1 country.
United States1 site
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Prospective Randomized Comparison of Clamped Versus Unclamped Partial Nephrectomy
This randomized pilot trial studies clamped or unclamped surgery in treating patients with kidney cancer. Unclamped surgery for kidney cancer may have fewer side effects
Read the detailed description
PRIMARY OBJECTIVES: I. To compare the changes in renal function (post-operative compared to pre-operative) in patients undergoing unclamped partial nephrectomy with or without controlled hypotension (Arm A) vs. those undergoing partial nephrectomy with hilar clamping (Arm B), as measured by change in estimated glomerular filtration rate (eGFR). SECONDARY OBJECTIVES: I. To compare the changes in renal function (post-operative compared to pre-operative) in patients undergoing unclamped partial nephrectomy with or without controlled hypotension (Arm A) vs. those undergoing partial nephrectomy with hilar clamping (Arm B), as measured by change in MAG3 (% of function attributed to affected kidney) and change in serum creatinine. II. To evaluate the safety of the unclamped procedure by estimating the differences in complication rates in patients undergoing unclamped partial nephrectomy with or without controlled hypotension (Arm A) vs. patients undergoing partial nephrectomy with hilar clamping (Arm B) in terms of intra-operative complications and post-operative complications. III. To evaluate the surgical effectiveness of the unclamped procedure by estimating the differences between patients undergoing unclamped partial nephrectomy with or without controlled hypotension (Arm A) vs. patients undergoing partial nephrectomy with hilar clamping (Arm B) in terms of surgical margin status, estimated blood loss, and transfusion rate (intraoperative and post-operative). TERTIARY OBJECTIVES: I. To record and compare the intrarenal blood flow and resistive index measurements in order to determine if a relationship exists between intraoperative findings and postoperative renal function. II. To quantify the amount of acute kidney injury (AKI) and compare the differences between patients undergoing unclamped partial nephrectomy with or without controlled hypotension (Arm A) vs. patients undergoing partial nephrectomy with hilar clamping (Arm B) as measured by urinary and serum biomarkers. III. To compare the effects of the unclamped procedure (Arm A) to the clamped procedure (Arm B) in patients with baseline eGFR < 60, and in patients with age >= 75 (exploratory subset analyses). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients undergo unclamped partial nephrectomy. Some patients may undergo unclamped partial nephrectomy with controlled hypotension. ARM B: Patients undergo clamped partial nephrectomy. After completion of study treatment, patients are followed up at 1 week and then at 1, 3, 6, and 12 months.
- Conditions
- Recurrent Renal Cell Cancer
- Being tested
- robot-assisted laparoscopic surgery
- 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.
robot-assisted laparoscopic surgeryProcedure or surgery
Unclamped partial nephrectomy
robot-assisted laparoscopic surgeryProcedure or surgery
Undergo clamped partial nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Arm A (unclamped partial nephrectomy) | Experimental | Patients undergo unclamped partial nephrectomy. Some patients may undergo unclamped partial nephrectomy with controlled hypotension. Receives: Procedure: robot-assisted laparoscopic surgery |
| Arm B (clamped partial nephrectomy) | Active comparator | Patients undergo clamped partial nephrectomy. Receives: Procedure: robot-assisted laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in renal function as measured by eGFR
Measured by eGFR, MAG-3 Nuclear Renal Scan, and serum creatinine. The two arms will be compared using regression methods that will account for repeated measures and the pre-randomization stratification.
Measured: Up to 1 year
Secondary outcomes (7)
Estimated blood loss during surgery
Measured: Up to 1 year
Rate of blood transfusion during and after surgery
Measured: Up to 1 year
Number of patients with positive surgical margins
Measured: Up to 1 year
Number of patients with complications during surgery and at 90 days post surgery
Measured: Up to 1 year
Number of patients with adverse events
Measured: Up to 1 year
Intra-renal blood flow measurements
Measured: Up to 1 year
Resistive index measurements
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 posted8 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionSep 2013
- Study completionSep 2014
Why it stopped: P.I. decided to terminate study due to multiple unresolved issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mihir Desai, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547676
- Sponsor's protocol ID
- 4K-10-2
- Other IDs
- NCI-2012-00057
- Status last verified
- Mar 2015
- First submitted
- 10 Feb 2012
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Clamped Versus Unclamped Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT01547676
- Acronym / sponsor ID
- 4K-10-2
- Conditions
- Recurrent Renal Cell Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: P.I. decided to terminate study due to multiple unresolved issues
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 8 Mar 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.
This randomized pilot trial studies clamped or unclamped surgery in treating patients with kidney cancer. Unclamped surgery for kidney cancer may have fewer side effects
Detailed description
PRIMARY OBJECTIVES: I. To compare the changes in renal function (post-operative compared to pre-operative) in patients undergoing unclamped partial nephrectomy with or without controlled hypotension (Arm A) vs. those undergoing partial nephrectomy with hilar clamping (Arm B), as measured by change in estimated glomerular filtration rate (eGFR). SECONDARY OBJECTIVES: I. To compare the changes in renal function (post-operative compared to pre-operative) in patients undergoing unclamped partial nephrectomy with or without controlled hypotension (Arm A) vs. those undergoing partial nephrectomy with hilar clamping (Arm B), as measured by change in MAG3 (% of function attributed to affected kidney) and change in serum creatinine. II. To evaluate the safety of the unclamped procedure by estimating the differences in complication rates in patients undergoing unclamped partial nephrectomy with or without controlled hypotension (Arm A) vs. patients undergoing partial nephrectomy with hilar clamping (Arm B) in terms of intra-operative complications and post-operative complications. III. To evaluate the surgical effectiveness of the unclamped procedure by estimating the differences between patients undergoing unclamped partial nephrectomy with or without controlled hypotension (Arm A) vs. patients undergoing partial nephrectomy with hilar clamping (Arm B) in terms of surgical margin status, estimated blood loss, and transfusion rate (intraoperative and post-operative). TERTIARY OBJECTIVES: I. To record and compare the intrarenal blood flow and resistive index measurements in order to determine if a relationship exists between intraoperative findings and postoperative renal function. II. To quantify the amount of acute kidney injury (AKI) and compare the differences between patients undergoing unclamped partial nephrectomy with or without controlled hypotension (Arm A) vs. patients undergoing partial nephrectomy with hilar clamping (Arm B) as measured by urinary and serum biomarkers. III. To compare the effects of the unclamped procedure (Arm A) to the clamped procedure (Arm B) in patients with baseline eGFR < 60, and in patients with age >= 75 (exploratory subset analyses). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients undergo unclamped partial nephrectomy. Some patients may undergo unclamped partial nephrectomy with controlled hypotension. ARM B: Patients undergo clamped partial nephrectomy. After completion of study treatment, patients are followed up at 1 week and then at 1, 3, 6, and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (unclamped partial nephrectomy) | Experimental | Procedure: robot-assisted laparoscopic surgeryPatients undergo unclamped partial nephrectomy. Some patients may undergo unclamped partial nephrectomy with controlled hypotension. |
| Arm B (clamped partial nephrectomy) | Active comparator | Procedure: robot-assisted laparoscopic surgeryPatients undergo clamped partial nephrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Solitary renal mass or solitary complex renal cyst Bosniak >/= Grade 3
- Clinical stage T1a, T1b
- Body Mass Index (BMI) < 40
- Surgical candidate (preoperative cardiac and anesthesia clearance obtained)
- Able to give informed consent
Key exclusion criteria (11 listed)
- Pregnancy
- More than 1 renal mass or complex renal cyst Bosniak >/= Grade 3 on ipsilateral kidney
- Previous renal surgery on the ipsilateral kidney
- Clinical Stage T2 or greater
- BMI > 40
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 |
|---|---|---|
| robot-assisted laparoscopic surgeryUnclamped partial nephrectomy | Procedure or surgery | Arm A (unclamped partial nephrectomy) |
| robot-assisted laparoscopic surgeryUndergo clamped partial nephrectomy | Procedure or surgery | Arm B (clamped partial nephrectomy) |
Primary outcome
Change from baseline in renal function as measured by eGFR
Time frame: Up to 1 year
Measured by eGFR, MAG-3 Nuclear Renal Scan, and serum creatinine. The two arms will be compared using regression methods that will account for repeated measures and the pre-randomization stratification.
7 secondary outcomes
Estimated blood loss during surgery
Time frame: Up to 1 year
Rate of blood transfusion during and after surgery
Time frame: Up to 1 year
Number of patients with positive surgical margins
Time frame: Up to 1 year
Number of patients with complications during surgery and at 90 days post surgery
Time frame: Up to 1 year
Number of patients with adverse events
Time frame: Up to 1 year
Intra-renal blood flow measurements
Time frame: Up to 1 year
Resistive index measurements
Time frame: Up to 1 year
Results and safety
The study was stopped early (reason given: P.I. decided to terminate study due to multiple unresolved issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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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.
Mihir Desai principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robot-assisted laparoscopic surgery in people with Recurrent Renal Cell Cancer, run by University of Southern California 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 7 inclusion and 11 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 27 Mar 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 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 stopped early (reason given: P.I. decided to terminate study due to multiple unresolved issues). 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?
Change from baseline in renal function as measured by eGFR (time frame: Up to 1 year). 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 Mar 2015.