Kidney NeoplasmsNCT01809119
Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy
A study testing Partial nephrectomy in people with Kidney Neoplasms, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Partial nephrectomy is considered the standard treatment for renal tumors smaller than 7 cm. With the evolution of image diagnostic tools and dissemination of its use, smaller tumors are being commonly diagnosed and treated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Neoplasms
- What is being tested?
- Partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2012to Jan 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with renal tumor cT1N0M0; (<7 cm)
- Normal renal function (serum creatinine <1.2 and glomerular filtration rate> 60mL/min/1.73m2)
- Tumor only
Who cannot join
- Functional or anatomical solitary kidney
- Horseshoe kidney, ectopic or malformed
- Clinical contraindication to surgery
- Contraindication to laparoscopic surgery
- Association with other renal pathologies
- Evidence of lymph node or systemic disease in preoperative staging
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Cancer Institute of the State of São Paulo
São Paulo, 01246-000
Sanarelly P Adonias, Study Coordinator, +55 11 3893-2528, enfpesq2.urousp@gmail.com
Marcos F Dall'Oglio, M.D Associate Professor
About this study
Partial nephrectomy is considered the standard treatment for renal tumors smaller than 7 cm. With the evolution of image diagnostic tools and dissemination of its use, smaller tumors are being commonly diagnosed and treated. The partial open nephrectomy is still considered the gold standard technique for nephron sparing surgery, especially when the surgeon is not experienced with the minimally invasive surgery. In the last 15 years, uncountable minimally invasive techniques were developed, including the laparoscopic partial nephrectomy. The objective of this study is compare the partial laparoscopic nephrectomy to open partial nephrectomy in terms of perioperative, oncologic and functional outcomes. A balanced randomized prospective trial will be conducted. One group of patients will be submitted to to open partial nephrectomy while the other group of patients will be submitted to laparoscopic partial nephrectomy. A randomized prospective trial comparing the two techniques is necessary to determine the differences in outcomes between them and if the laparoscopic partial nephrectomy can be performed without harms to the patients.
- Conditions
- Kidney Neoplasms
- Being tested
- Partial nephrectomy
- Keywords
- Kidney Neoplasms, Minimally invasive surgery, Renal cell carcinoma
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial nephrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Partial Nephrectomy | Experimental | Patients with kidney neoplasms submitted to laparoscopic partial nephrectomy Receives: Procedure: Partial nephrectomy |
| Open Partial Nephrectomy | Active comparator | Patients with kidney neoplasms submitted to open partial nephrectomy Receives: Procedure: Partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Complications
Measured: 6 months
Secondary outcomes (2)
Renal Function
Measured: 2 years
Oncological outcomes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmsStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Marcos Francisco Dall'Oglio, University of Sao Paulo
- Investigators
- Marcos F Dall'Oglio, M.D., Associate Professor, Study director, Cancer Institute of the State of São Paulo - University of Sao PauloGiuliano B Guglielmetti, Doctor, Principal investigator, Cancer Institute of the State of São Paulo - University of Sao PauloAlexandre C Sant'Anna, Doctor, Study chair, Cancer Institute of the State of São Paulo - University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809119
- Sponsor's protocol ID
- UROUSP - 005
- Status last verified
- May 2018
- First submitted
- 8 Mar 2013
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT01809119
- Acronym / sponsor ID
- UROUSP - 005
- Conditions
- Kidney Neoplasms
- Keywords
- Kidney Neoplasms, Minimally invasive surgery, Renal cell carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Dec 2012
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 12 Mar 2013 (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.
Partial nephrectomy is considered the standard treatment for renal tumors smaller than 7 cm. With the evolution of image diagnostic tools and dissemination of its use, smaller tumors are being commonly diagnosed and treated. The partial open nephrectomy is still considered the gold standard technique for nephron sparing surgery, especially when the surgeon is not experienced with the minimally invasive surgery. In the last 15 years, uncountable minimally invasive techniques were developed, including the laparoscopic partial nephrectomy. The objective of this study is compare the partial laparoscopic nephrectomy to open partial nephrectomy in terms of perioperative, oncologic and functional outcomes. A balanced randomized prospective trial will be conducted. One group of patients will be submitted to to open partial nephrectomy while the other group of patients will be submitted to laparoscopic partial nephrectomy. A randomized prospective trial comparing the two techniques is necessary to determine the differences in outcomes between them and if the laparoscopic partial nephrectomy can be performed without harms to the patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Partial Nephrectomy | Experimental | Procedure: Partial nephrectomyPatients with kidney neoplasms submitted to laparoscopic partial nephrectomy |
| Open Partial Nephrectomy | Active comparator | Procedure: Partial nephrectomyPatients with kidney neoplasms submitted to open partial nephrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with renal tumor cT1N0M0; (<7 cm)
- Normal renal function (serum creatinine <1.2 and glomerular filtration rate> 60mL/min/1.73m2)
- Tumor only
Key exclusion criteria (6 listed)
- Functional or anatomical solitary kidney
- Horseshoe kidney, ectopic or malformed
- Clinical contraindication to surgery
- Contraindication to laparoscopic surgery
- Association with other renal pathologies
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 |
|---|---|---|
| Partial nephrectomy | Procedure or surgery | Laparoscopic Partial Nephrectomy, Open Partial Nephrectomy |
Primary outcome
Surgical Complications
Time frame: 6 months
2 secondary outcomes
Renal Function
Time frame: 2 years
Oncological outcomes
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
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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.
Marcos F Dall'Oglio, M.D., Associate Professor study director
Cancer Institute of the State of São Paulo - University of Sao Paulo
Giuliano B Guglielmetti, Doctor principal investigator
Cancer Institute of the State of São Paulo - University of Sao Paulo
Alexandre C Sant'Anna, Doctor study chair
Cancer Institute of the State of São Paulo - University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial nephrectomy in people with Kidney Neoplasms, run by University of Sao Paulo at 1 site in Brazil.
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 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: status not confirmed, as of the sponsor's last update on 14 May 2018. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanarelly P Adonias, Study Coordinator (+ 55 11 3893-2528, enfpesq2.urousp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Complications (time frame: 6 months). 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 14 May 2018.