Renal TumorPIONEER-OPTNCT05377632
Comparing Two Different Approaches in Robotic-Assisted Renal Surgery
A study testing Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN) in people with Renal Tumor, run by Lukas J Hefermehl at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine if the novel TR approach is superior to the standard RP approach. The anticipated study outcome is a time saving of at least 30% from first skin incision to detection of the renal artery compared to the conventional RP approach, and also a better workspace perception by the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Tumor
- What is being tested?
- Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 May 2022to 15 Jan 2025
- 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
- Age 18 years or older
- Patient with a renal tumor or non-functionally kidney that is a candidate for robotic assisted surgery (RAS) nephrectomy or partial nephrectomy (PN)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
Who cannot join
- Renal vein tumor thrombus
- Pregnancy or suspected pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Modified Novel Trans-Retro Approach vs Conventional Retroperitoneal Approach in Robotic-Assisted Renal Surgery: An Open Label Randomized Controlled Trial
The purpose of this study is to determine if the novel TR approach is superior to the standard RP approach. The anticipated study outcome is a time saving of at least 30% from first skin incision to detection of the renal artery compared to the conventional RP approach, and also a better workspace perception by the operating surgeon.
Read the detailed description
The trans abdominal approach (TA) for total and partial nephrectomy (PN) has been widely adopted due to the easy trocar placement and the good working space. The retroperitoneal approach (RP) has gained popularity because the renal artery is often found fast and the operation remains in an anatomically separated space, making it preferable, especially for patients who underwent abdominal surgery in the past. However, both approaches face difficulties. Trocar placement for RP can be challenging, and the working space often is limited, while TA is impaired in cases of dorsal tumors and dissection of the renal artery can be challenging due to the anatomic localization dorsally to the renal vein. Up until now, no direct systematically and prospective comparison of these two approaches was performed.
The overall objective of this trial is to assess if the novel TR approach is superior to the conventional RP approach in performing robotic assisted (partial) nephrectomy. To date, no systematic, prospective, randomised study has been conducted on this topic and described in the literature.
- Conditions
- Renal Tumor
- Being tested
- Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)
- Keywords
- robotic surgery, renal tumor
- 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.
Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)Procedure or surgery
laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN) include bilateral tumors or tumors in a solitary kidney. Relative indications include familial renal cancer syndromes such as Von Hippel-Lindau, hereditary leiomyomatosis, or hereditary papillary renal cell carcinoma. Patients with chronic kidney disease are generally offered nephron sparing surgery for hope of future renal function preservation. This reasoning also applies to those patients with preexisting diseases that may threaten a solitary kidney such as uncontrolled diabetes and hypertension.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid-Group | Active comparator | Laparoscopic and Robotic-assisted combined (partial) nephrectomy via the hybrid (trans-peritoneal and retroperitoneal) access route Receives: Procedure: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN) |
| Retroperitoneal-Group | Active comparator | Robotic-assisted laparoscopic (partial) nephrectomy via the retroperitoneal access route Receives: Procedure: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of the renal artery
Time from first skin incision to detection of the renal artery [Time in minutes]
Measured: During procedure/surgery
Secondary outcomes (18)
Operative time
The time from [Skin Incision] to [Skin Closure] in minutes as documented in OR-Management Information System
Measured: During procedure/surgery
Robot docking time
The time from [Skin Incision] to [robot docking] in minutes as documented in OR-Spreadsheet.
Measured: During procedure/surgery
Instrument insertion time
The time from [Skin Incision] to [insertion of the last instrument] in minutes as documented in OR-Spreadsheet
Measured: During procedure/surgery
Off-console time
The time from [Skin Incision] to [start of first instrument movement by console surgeon] in minutes as documented in OR-Spreadsheet
Measured: During procedure/surgery
Ischemia time
The time from [Placement of clamp on artery] to [Release of clamp] in minutes indicated by the console surgeon documented by the anesthesiologist
Measured: During procedure/surgery
Surgical conversion to open surgery
Conversion from robotic to open surgery
Measured: During procedure/surgery
Surgical conversion to radical nephrectomy
Conversion partial to radical nephrectomy
Measured: During procedure/surgery
Intraoperative blood loss
Volume of blood loss during the surgical procedure in mL
Measured: During procedure/surgery
Console surgeons perception of Trocar placement and working space
Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)
Measured: During procedure/surgery
Side assistants perception of Trocar placement and working space
Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)
Measured: During procedure/surgery
Pain assessment
Assessment of pain level via the Visual Analogue Scale (VAS, 1-10, higher scores mean more pain)
Measured: During the hospital stay (up to day 7)
Pain Management
Documentation of pain management (according to the WHO Analgesic Ladder, 1-4, higher scores mean more intense pain treatment)
Measured: During the hospital stay (up to day 7)
Kidney function via the estimated glomerular filtration rate (eGRF)
Data will be gathered from routine examination, not a mandatory assessment (Lab value read-outs from in the clinical Information System) [ml/min/1,73 m2]
Measured: During the hospital stay (up to day 7)
Post operative complications
Any Clavien-Dindo I-V post-operative complication (standard classification for complication in surgery
Measured: Day 30
Length of stay Length of stay
Time from surgery to discharge in days [d]
Measured: During the hospital stay (up to day 7)
Procedure related readmissions
Readmission that can be linked to the (partial) nephrectomy, binary [Yes/No]
Measured: Day 30
Procedure related reoperations
Re-operation that can be linked to the partial nephrectomy, binary [Yes/No]
Measured: Day 30
Comprehensive Complication Index
Any complication that occurred within 30 days post surgery, Scale [from 0 (no complication) to 100 (death)]
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start15 May 2022
- Primary completion15 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TumorStudies 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lukas J Hefermehl
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Baden
- Responsible party
- Sponsor-investigator, Lukas J Hefermehl, Kantonsspital Baden
- Investigators
- Lukas J Hefermehl, MD, Principal investigator, Kantonsspital Baden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377632
- Sponsor's protocol ID
- PIONEER-OPTICS
- Acronym
- PIONEER-OPT
- Status last verified
- Nov 2025
- First submitted
- 3 May 2022
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that will be recorded in this study will be available on reasonable request from the PI
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Modified Novel Trans-Retro Approach vs Conventional Retroperitoneal Approach in Robotic-Assisted Renal Surgery: An Open Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05377632
- Acronym / sponsor ID
- PIONEER-OPT / PIONEER-OPTICS
- Conditions
- Renal Tumor
- Keywords
- robotic surgery, renal tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lukas J HefermehlUniversity, hospital or other
- Collaborators
- Kantonsspital Baden
- Study start
- 15 May 2022 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 17 May 2022 (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.
The purpose of this study is to determine if the novel TR approach is superior to the standard RP approach. The anticipated study outcome is a time saving of at least 30% from first skin incision to detection of the renal artery compared to the conventional RP approach, and also a better workspace perception by the operating surgeon.
Detailed description
The trans abdominal approach (TA) for total and partial nephrectomy (PN) has been widely adopted due to the easy trocar placement and the good working space. The retroperitoneal approach (RP) has gained popularity because the renal artery is often found fast and the operation remains in an anatomically separated space, making it preferable, especially for patients who underwent abdominal surgery in the past. However, both approaches face difficulties. Trocar placement for RP can be challenging, and the working space often is limited, while TA is impaired in cases of dorsal tumors and dissection of the renal artery can be challenging due to the anatomic localization dorsally to the renal vein. Up until now, no direct systematically and prospective comparison of these two approaches was performed.
The overall objective of this trial is to assess if the novel TR approach is superior to the conventional RP approach in performing robotic assisted (partial) nephrectomy. To date, no systematic, prospective, randomised study has been conducted on this topic and described in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid-Group | Active comparator | Procedure: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)Laparoscopic and Robotic-assisted combined (partial) nephrectomy via the hybrid (trans-peritoneal and retroperitoneal) access route |
| Retroperitoneal-Group | Active comparator | Procedure: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)Robotic-assisted laparoscopic (partial) nephrectomy via the retroperitoneal access route |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Patient with a renal tumor or non-functionally kidney that is a candidate for robotic assisted surgery (RAS) nephrectomy or partial nephrectomy (PN)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
Key exclusion criteria (2 listed)
- Renal vein tumor thrombus
- Pregnancy or suspected 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 |
|---|---|---|
| Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN) include bilateral tumors or tumors in a solitary kidney. Relative indications include familial renal cancer syndromes such as Von Hippel-Lindau, hereditary leiomyomatosis, or hereditary papillary renal cell carcinoma. Patients with chronic kidney disease are generally offered nephron sparing surgery for hope of future renal function preservation. This reasoning also applies to those patients with preexisting diseases that may threaten a solitary kidney such as uncontrolled diabetes and hypertension. | Procedure or surgery | Hybrid-Group, Retroperitoneal-Group |
Primary outcome
detection of the renal artery
Time frame: During procedure/surgery
Time from first skin incision to detection of the renal artery [Time in minutes]
18 secondary outcomes
Operative time
Time frame: During procedure/surgery
Robot docking time
Time frame: During procedure/surgery
Instrument insertion time
Time frame: During procedure/surgery
Off-console time
Time frame: During procedure/surgery
Ischemia time
Time frame: During procedure/surgery
Surgical conversion to open surgery
Time frame: During procedure/surgery
Surgical conversion to radical nephrectomy
Time frame: During procedure/surgery
Intraoperative blood loss
Time frame: During procedure/surgery
Console surgeons perception of Trocar placement and working space
Time frame: During procedure/surgery
Side assistants perception of Trocar placement and working space
Time frame: During procedure/surgery
Pain assessment
Time frame: During the hospital stay (up to day 7)
Pain Management
Time frame: During the hospital stay (up to day 7)
Kidney function via the estimated glomerular filtration rate (eGRF)
Time frame: During the hospital stay (up to day 7)
Post operative complications
Time frame: Day 30
Length of stay Length of stay
Time frame: During the hospital stay (up to day 7)
Procedure related readmissions
Time frame: Day 30
Procedure related reoperations
Time frame: Day 30
Comprehensive Complication Index
Time frame: Day 30
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 Nov 2025.
- Individual participant dataSharing planned: No. The data that will be recorded in this study will be available on reasonable request from the PI
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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.
Lukas J Hefermehl, MD principal investigator
Kantonsspital Baden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN) in people with Renal Tumor, run by Lukas J Hefermehl at 1 site in Switzerland.
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 2 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 Nov 2025. 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 Switzerland. 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?
detection of the renal artery (time frame: During procedure/surgery). 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 Nov 2025.