Renal Cell CarcinomaNCT02849119
Transperitoneal vs Retroperitoneal Laparoscopic or Robotic Partial Nephrectomy
A study testing Laparoscopic or robotic partial nephrectomy in people with Renal Cell Carcinoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Both laparoscopic partial nephrectomy (LPN) and robotic partial nephrectomy (RPN) can be performed through transperitoneal (TP) or retroperitoneal (RP) approach. RP approach is less utilized than TP approach because of technical difficulties when using rigid laparoscopic instruments in the small space of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Laparoscopic or robotic partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Jan 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients are going to undergo LPN or RPN with renal mass =<4cm
Who cannot join
- Bilateral renal masses Solitary kidney Previous underwent nephrectomy refuse to be enrolled the study pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Seoul, 06351
Seongil Seo, MD, 82-10-9933-3556, siseo@skku.edu
Inhyuck Gong, doctor, 82-10-3110-2791, kornumber1@naver.com
About this study
Official title: Comparison of Peri-operative Outcomes of Laparoscopic or Robotic Partial Nephrectomy for Small Renal Mass: Transperitoneal vs Retroperitoneal Approach
Both laparoscopic partial nephrectomy (LPN) and robotic partial nephrectomy (RPN) can be performed through transperitoneal (TP) or retroperitoneal (RP) approach. RP approach is less utilized than TP approach because of technical difficulties when using rigid laparoscopic instruments in the small space of retroperitoneum cavity. However, with advanced surgical skills and thoughtful patient selection, RP approach may be associated with shorter operative time (OT), less estimated blood loss (EBL), shorter length of hospital stay (LOS) compared with TP approach.
Therefore, the investigators performed randomized control trial to compare the outcomes of the two approaches (TP-LPN or RPN vs RP-LPN or RPN).
Read the detailed description
Partial nephrectomy is the standard treatment for small renal masses. The evolution of minimally invasive partial nephrectomy led to widespread utilization of laparoscopic (LPN) and robotic partial nephrectomy (RPN). Both LPN and RPN can be performed through transperitoneal (TP) or retroperitoneal (RP) approach. RP approach is less utilized than TP approach because of technical difficulties when using rigid laparoscopic instruments in the small space of retroperitoneum cavity. However, with advanced surgical skills and thoughtful patient selection, RP approach may be associated with shorter OT, less EBL, shorter LOS compared with TP approach.
Therefore, the investigators performed randomized control trial to compare the outcomes of the two approaches (TP-LPN or RPN vs RP-LPN or RPN).
The purpose of this study To compare the treatment outcomes of the transperitoneal and retroperitoneal approach during LPN or RPN in treatment of small renal masses.
Inclusion criteria During the study period, a small renal mass (less than 4cm, T1a stage) patients are going to underwent LPN or RPN.
Exclusion criteria
- Patients who underwent radical nephrectomy
- Patients with bilateral renal masses
- Patients with a solitary kidney
- Patients reject a written informed consent
- Pregnancy
The number of target subjects More than 106 patients who meet the inclusion criteria
- Conditions
- Renal Cell Carcinoma
- Being tested
- Laparoscopic or robotic partial nephrectomy
- Keywords
- Robot; Laparoscopic, Partial nephrectomy, Transperitoneal, Retroperitoneal, Laparoscopic Surgery, Surgical Procedures, Robotic, 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.
Laparoscopic or robotic partial nephrectomyProcedure or surgery
Laparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach
| Study group | Role | What they receive |
|---|---|---|
| Transperitoneal approach | Experimental | Laparoscopic or Robotic Partial Nephrectomy through transperitoneal approach Receives: Procedure: Laparoscopic or robotic partial nephrectomy |
| Retroperitoneal approach | Experimental | Laparoscopic or Robotic Partial Nephrectomy through retroperitoneal approach Receives: Procedure: Laparoscopic or robotic partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Operative time of partial nephrectomy
Measured: Intraoperative
Secondary outcomes (4)
Warm ischemic time (minutes)
Vessel clamping time during partial nephrectomy
Measured: Intraoperative
Number of participants with treatment-related adverse events as assessed by Clavien-Dindo classification
Measured: from date of surgery, to 1 year postoperatively
Change of differential glomerular filtration rate (dGFR) measured by renal scan
Measured: Preoperative dGFR and postoperative 1 year
Overall disease-free survival time (month)
Disease free means no local recurrence, no metastasis.
Measured: from date of surgery, to 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seongil Seo, MD, Study chair, Urology department of Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849119
- Sponsor's protocol ID
- 2015-03-068-002
- Status last verified
- Sep 2015
- First submitted
- 28 Jun 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Peri-operative Outcomes of Laparoscopic or Robotic Partial Nephrectomy for Small Renal Mass: Transperitoneal vs Retroperitoneal Approach
- ClinicalTrials.gov ID
- NCT02849119
- Acronym / sponsor ID
- 2015-03-068-002
- Conditions
- Renal Cell Carcinoma
- Keywords
- Robot; Laparoscopic, Partial nephrectomy, Transperitoneal, Retroperitoneal, Laparoscopic Surgery, Surgical Procedures, Robotic, Nephrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 29 Jul 2016 (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.
Both laparoscopic partial nephrectomy (LPN) and robotic partial nephrectomy (RPN) can be performed through transperitoneal (TP) or retroperitoneal (RP) approach. RP approach is less utilized than TP approach because of technical difficulties when using rigid laparoscopic instruments in the small space of retroperitoneum cavity. However, with advanced surgical skills and thoughtful patient selection, RP approach may be associated with shorter operative time (OT), less estimated blood loss (EBL), shorter length of hospital stay (LOS) compared with TP approach.
Therefore, the investigators performed randomized control trial to compare the outcomes of the two approaches (TP-LPN or RPN vs RP-LPN or RPN).
Detailed description
Partial nephrectomy is the standard treatment for small renal masses. The evolution of minimally invasive partial nephrectomy led to widespread utilization of laparoscopic (LPN) and robotic partial nephrectomy (RPN). Both LPN and RPN can be performed through transperitoneal (TP) or retroperitoneal (RP) approach. RP approach is less utilized than TP approach because of technical difficulties when using rigid laparoscopic instruments in the small space of retroperitoneum cavity. However, with advanced surgical skills and thoughtful patient selection, RP approach may be associated with shorter OT, less EBL, shorter LOS compared with TP approach.
Therefore, the investigators performed randomized control trial to compare the outcomes of the two approaches (TP-LPN or RPN vs RP-LPN or RPN).
The purpose of this study To compare the treatment outcomes of the transperitoneal and retroperitoneal approach during LPN or RPN in treatment of small renal masses.
Inclusion criteria During the study period, a small renal mass (less than 4cm, T1a stage) patients are going to underwent LPN or RPN.
Exclusion criteria
- Patients who underwent radical nephrectomy
- Patients with bilateral renal masses
- Patients with a solitary kidney
- Patients reject a written informed consent
- Pregnancy
The number of target subjects More than 106 patients who meet the inclusion criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transperitoneal approach | Experimental | Procedure: Laparoscopic or robotic partial nephrectomyLaparoscopic or Robotic Partial Nephrectomy through transperitoneal approach |
| Retroperitoneal approach | Experimental | Procedure: Laparoscopic or robotic partial nephrectomyLaparoscopic or Robotic Partial Nephrectomy through retroperitoneal approach |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients are going to undergo LPN or RPN with renal mass =<4cm
Key exclusion criteria (1 listed)
- Bilateral renal masses Solitary kidney Previous underwent nephrectomy refuse to be enrolled the study pregnancy
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 |
|---|---|---|
| Laparoscopic or robotic partial nephrectomyLaparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach | Procedure or surgery | Retroperitoneal approach, Transperitoneal approach |
Primary outcome
Operative time
Time frame: Intraoperative
Operative time of partial nephrectomy
4 secondary outcomes
Warm ischemic time (minutes)
Time frame: Intraoperative
Number of participants with treatment-related adverse events as assessed by Clavien-Dindo classification
Time frame: from date of surgery, to 1 year postoperatively
Change of differential glomerular filtration rate (dGFR) measured by renal scan
Time frame: Preoperative dGFR and postoperative 1 year
Overall disease-free survival time (month)
Time frame: from date of surgery, to 1 year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Seongil Seo, MD study chair
Urology department of Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic or robotic partial nephrectomy in people with Renal Cell Carcinoma, run by Samsung Medical Center at 1 site in South Korea.
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 1 inclusion and 1 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 29 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 South Korea. 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 Seongil Seo, MD (82-10-9933-3556, siseo@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Intraoperative). 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 29 Jul 2016.