Clinical trial · Interventional
Open vs Robotic Assisted Partial Nephrectomy
NCT03849820CI-TRIAL-00091080OpeRaterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to low enrollment the study was terminated
Summary
Brief summary (as posted)
To demonstrate that Robotic-Assisted partial nephrectomy is superior to Open partial nephrectomy in reducing the number of 30 day post-operative complications (Clavien-Dindo Type I-V) for patients with intermediate to high complexity kidney tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cancer | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Open partial nephrectomy | Other | — | UNRESOLVED |
| Robotic-assisted partial nephrectomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Robotic-assisted partial nephrectomy
- description
- da Vinci surgical robotic assisted partial nephrectomy
- interventionNames
- Device: Robotic-assisted partial nephrectomy
- type
- ACTIVE_COMPARATOR
- label
- Open partial nephrectomy
- description
- Open partial nephrectomy surgery
- interventionNames
- Other: Open partial nephrectomy
Primary outcomes (1)
- measure
- 30 day complications
- timeFrame
- Day of surgery to 30th post operative day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Patient with a renal tumor that is a candidate for OPEN surgery and robotic assisted surgery (RAS) partial nephrectomy (PN) * R.E.N.A.L. score ≥ 7 * eGFR ≥ 50 ml/min/1.73 m² * Anticoagulation is accepted according to the surgeon's practice Exclusion Criteria: * Solitary kidney or functionally solitary kidney * Prior surgery at the affected kidney excluding endoscopic kidney stone surgery * Bilateral tumors * Multiple renal tumors requiring excision * Renal vein tumor thrombus * Likely insufficient volume of remaining parenchyma after partial nephrectomy to maintain viable kidney remnant * Metastatic disease with life expectancy of less than 1 year * Pregnancy or suspected pregnancy * Planned concomitant procedure * Subject who is unable or unwilling to comply with the protocol requirements * Subject considered to be from a vulnerable population according to IS0 14155:2011
References
Publications (1)
- RESULTGrimm MO, Bedke J, Nyarangi-Dix J, Khoder W, Foller S, Sommerfeld HJ, Giessing M, Heck M, Meissner W, Slee A, Leucht K, von Rundstedt F, Theil G, Buse S, Siemer S, Albers P, Gratzke C, Hohenfellner M, Stenzl A. Open versus robotic-assisted partial nephrectomy in patients with intermediate/high-complexity kidney tumours: final results of the randomised, controlled, open-label, multicentre trial OpeRa. Ann Oncol. 2025 Aug;36(8):988-998. doi: 10.1016/j.annonc.2025.04.005. Epub 2025 Apr 16. PMID 40250528