Carcinoma, Renal CellNCT03900364
a Prospective Trial Comparing Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy
A study testing partial nephrectomy in people with Carcinoma, Renal Cell and Renal Malignant Tumor, run by Salzburger Landeskliniken at 1 site in Austria.
Trial summary
In this trial the investigators want to examine and compare oncological and surgical outcomes of two surgical techniques in a prospective, randomised, single-blind trial. Therefore the investigators are going to include 30 patients with a renal mass who need surgical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Renal Malignant Tumor, Renal Cyst
- 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
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 3 Sep 2018to 15 Oct 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- minimum age of 18 years
- solid renal mass suspicious for renal cell carcinoma or at least Bosniak III cyst
- signed informed consent
Who cannot join
- performed kidney surgery at the same side
- Pregnancy
- RENAL Nephrometry score III
Trial locations and contacts
1 site in 1 country.
Austria1 site
Uniklinikum Salzburg, Department for Urology and Andrology
Salzburg, 5020
About this study
Official title: Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy: A Prospective, Randomised, Single-blind Trial Comparing Two Surgical Techniques
In this trial the investigators want to examine and compare oncological and surgical outcomes of two surgical techniques in a prospective, randomised, single-blind trial. Therefore the investigators are going to include 30 patients with a renal mass who need surgical treatment. When they fulfill the inclusion criteria they get randomised either for robot-assisted partial nephrectomy or laparoscopic partial nephrectomy. Primary endpoint is the oncological outcome (residual tumor classification, TNM classification), secondary endpoints are operation time, time of ischemia, blood loss, pain after surgery, kidney function, complications and hospital stay.
Read the detailed description
All patients taking part in the study are first given a R.E.N.A.L. nephrometry score. Based on that score they are allocate to either of :
cohort I (low complexity of the tumour) or cohort II (intermediate complexity of the tumour).
Thereafter, the patient will be randomly placed into either to laparoscopic partial nephrectomy or robotic-assisted partial nephrectomy. Both these surgical techniques are well established and standardized procedures to remove a renal mass.
Preoperatively, the preparation is nearly the same for both techniques. The patient is positioned in flank position with the affected side up.
Thereafter:
Pneumoperitoneum is achieved with a Veress needle and trocars which are placed under direct vision. The only difference between the two techniques is the number of trocars, performing the laparoscopic partial nephrectomy three or four ports are used, performing the robotic-assisted partial nephrectomy five ports are used.
Intraabdominal, the kidney is exposed by incising along the Toldt line to moblize the colon. After exposing the ureter and the gonadal vein dissection is continued proximally toward the renal hilum. Following this, Gerota's fascia is incised to expose the tumour and the surrounding renal capsule. Now the renal artery has to be clamped to avoid bleeding followed by excision of the tumour. The surgery takes about three hours, the complication rate is more the same for both techniques.
Primary endpoint is the resection margin to see if there are any difference between the two surgical techniques.
Information about the resection margin and pathological staging will be given through our pathological department. The histological examination normally takes about five to seven days.
Further parameters are taken by following schema:
Information about age, sex, body mass index, other diseases and medication is documented on the day of inpatient admission.
Blood samples for haemoglobin and kidney function are taken at the day of inpatient admission, four hours after surgery, first day after surgery and the day of discharge from hospital.
The duration of surgery is documented throughout the operative protocol. R.E.N.A.L Nephrometry score is evaluated preoperative, to be able to compare the complexity of surgery.
Renal ischemia is documented throughout the operative protocol. Blood loss is documented during surgery. Pain is documented with the aid of the visual analogue scale (VAS Scale). This will be evaluated four hours after surgery, day one after surgery, day two after surgery and on the day of discharge from hospital.
Complications are documented with the aid of the clavien-dindo classification. Three follow-ups will be performed. The first follow-up will be held two weeks after surgery to discuss the histological result and examine haemoglobin, kidney function and pain. The second follow-up will be held six months after surgery, the third follow-up 12 months after surgery. At this time a re-examination again haemoglobin and kidney function will be performed as well as a computed tomography.
- Conditions
- Carcinoma, Renal Cell, Renal Malignant Tumor, Renal Cyst, Renal Tumor
- Being tested
- partial nephrectomy
- Keywords
- partial nephrectomy, robot-assisted partial nephrectomy, laparoscopic partial nephrectomy
- 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.
partial nephrectomyProcedure or surgery
Partial nephrectomy is the standard technique for organ-sparing resection of renal tumors. The EAU Guidelines recommend partial nephrectomy to all patients with T1 tumours and can be performed either with an open, pure laparoscopic or robot-assisted approach, based on surgeon's expertise and skills.
| Study group | Role | What they receive |
|---|---|---|
| robot-assisted partial nephrectomy | Other | partial nephrectomy performed with the da Vinci Surgical System Receives: Procedure: partial nephrectomy |
| laparoscopic partial nephrectomy | Other | partial nephrectomy performed with conventional laparoscopic surgery Receives: Procedure: partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with R0 status
The tumor status following further treatment is described by the residual tumor classification. R0 means no residual tumor, R1 means microscopic residual tumor. The investigators are going to examine if there are any significant differences concerning tumor status between these two surgical techniques
Measured: one year
Secondary outcomes (7)
Operation time
time of surgery (in minutes)
Measured: one year
Ischemia time
Time of warm ischemia during laparoscopic or robot-assisted partial nephrectomy
Measured: one year
Blood loss
The amount of blood loss during performing partial nephrectomy
Measured: one year
Postoperative pain
Postoperative pain is going to be documented with the aid of the visual analogue scale. The visual analogue scale is a validated, subjective measure for pain. With the aid of a scale from zero to ten which represents a continuum between 'no pain' (0) and 'worst pain' (10) the subjective pain of each participant will be evaluated. This will be done four hours after surgery, day one after surgery, day two after surgery and on the day of discharge from hospital.
Measured: one year
Kidney function
Before and after surgery blood samples are taken to evaluate the kidney function with the aid of Serum creatinine and the glomerular Filtration rate
Measured: one year
Complications
Postoperative complications evaluated by 'clavien-dindo' classification
Measured: one year
Hospital stay
The length of hospital stay
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start3 Sep 2018
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salzburger Landeskliniken
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas Oberhammer, Salzburger Landeskliniken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900364
- Sponsor's protocol ID
- AT2019
- Status last verified
- Sep 2021
- First submitted
- 12 Feb 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy: A Prospective, Randomised, Single-blind Trial Comparing Two Surgical Techniques
- ClinicalTrials.gov ID
- NCT03900364
- Acronym / sponsor ID
- AT2019
- Conditions
- Carcinoma, Renal Cell, Renal Malignant Tumor, Renal Cyst, Renal Tumor
- Keywords
- partial nephrectomy, robot-assisted partial nephrectomy, laparoscopic partial nephrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Salzburger LandesklinikenUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 3 Apr 2019 (actual)
- 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.
In this trial the investigators want to examine and compare oncological and surgical outcomes of two surgical techniques in a prospective, randomised, single-blind trial. Therefore the investigators are going to include 30 patients with a renal mass who need surgical treatment. When they fulfill the inclusion criteria they get randomised either for robot-assisted partial nephrectomy or laparoscopic partial nephrectomy. Primary endpoint is the oncological outcome (residual tumor classification, TNM classification), secondary endpoints are operation time, time of ischemia, blood loss, pain after surgery, kidney function, complications and hospital stay.
Detailed description
All patients taking part in the study are first given a R.E.N.A.L. nephrometry score. Based on that score they are allocate to either of :
cohort I (low complexity of the tumour) or cohort II (intermediate complexity of the tumour).
Thereafter, the patient will be randomly placed into either to laparoscopic partial nephrectomy or robotic-assisted partial nephrectomy. Both these surgical techniques are well established and standardized procedures to remove a renal mass.
Preoperatively, the preparation is nearly the same for both techniques. The patient is positioned in flank position with the affected side up.
Thereafter:
Pneumoperitoneum is achieved with a Veress needle and trocars which are placed under direct vision. The only difference between the two techniques is the number of trocars, performing the laparoscopic partial nephrectomy three or four ports are used, performing the robotic-assisted partial nephrectomy five ports are used.
Intraabdominal, the kidney is exposed by incising along the Toldt line to moblize the colon. After exposing the ureter and the gonadal vein dissection is continued proximally toward the renal hilum. Following this, Gerota's fascia is incised to expose the tumour and the surrounding renal capsule. Now the renal artery has to be clamped to avoid bleeding followed by excision of the tumour. The surgery takes about three hours, the complication rate is more the same for both techniques.
Primary endpoint is the resection margin to see if there are any difference between the two surgical techniques.
Information about the resection margin and pathological staging will be given through our pathological department. The histological examination normally takes about five to seven days.
Further parameters are taken by following schema:
Information about age, sex, body mass index, other diseases and medication is documented on the day of inpatient admission.
Blood samples for haemoglobin and kidney function are taken at the day of inpatient admission, four hours after surgery, first day after surgery and the day of discharge from hospital.
The duration of surgery is documented throughout the operative protocol. R.E.N.A.L Nephrometry score is evaluated preoperative, to be able to compare the complexity of surgery.
Renal ischemia is documented throughout the operative protocol. Blood loss is documented during surgery. Pain is documented with the aid of the visual analogue scale (VAS Scale). This will be evaluated four hours after surgery, day one after surgery, day two after surgery and on the day of discharge from hospital.
Complications are documented with the aid of the clavien-dindo classification. Three follow-ups will be performed. The first follow-up will be held two weeks after surgery to discuss the histological result and examine haemoglobin, kidney function and pain. The second follow-up will be held six months after surgery, the third follow-up 12 months after surgery. At this time a re-examination again haemoglobin and kidney function will be performed as well as a computed tomography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robot-assisted partial nephrectomy | Other | Procedure: partial nephrectomypartial nephrectomy performed with the da Vinci Surgical System |
| laparoscopic partial nephrectomy | Other | Procedure: partial nephrectomypartial nephrectomy performed with conventional laparoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- minimum age of 18 years
- solid renal mass suspicious for renal cell carcinoma or at least Bosniak III cyst
- signed informed consent
Key exclusion criteria (3 listed)
- performed kidney surgery at the same side
- Pregnancy
- RENAL Nephrometry score III
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 nephrectomyPartial nephrectomy is the standard technique for organ-sparing resection of renal tumors. The EAU Guidelines recommend partial nephrectomy to all patients with T1 tumours and can be performed either with an open, pure laparoscopic or robot-assisted approach, based on surgeon's expertise and skills. | Procedure or surgery | laparoscopic partial nephrectomy, robot-assisted partial nephrectomy |
Primary outcome
Number of participants with R0 status
Time frame: one year
The tumor status following further treatment is described by the residual tumor classification. R0 means no residual tumor, R1 means microscopic residual tumor. The investigators are going to examine if there are any significant differences concerning tumor status between these two surgical techniques
7 secondary outcomes
Operation time
Time frame: one year
Ischemia time
Time frame: one year
Blood loss
Time frame: one year
Postoperative pain
Time frame: one year
Kidney function
Time frame: one year
Complications
Time frame: one year
Hospital stay
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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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 study testing partial nephrectomy in people with Carcinoma, Renal Cell and Renal Malignant Tumor, run by Salzburger Landeskliniken at 1 site in Austria.
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 3 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 28 Sep 2021. 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 Austria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with R0 status (time frame: one 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 28 Sep 2021; AzTrials last refreshed its copy on 27 Oct 2026.