Clinical trial · Interventional
Endoscopic Robot-Assisted Simple Enucleation Versus Standard Robot-Assisted Partial Nephrectomy in the Treatment of T1 Renal Cell Carcinoma
Endoscopic Robot-Assisted Simple Enucleation Versus Standard Robot-Assisted Partial Nephrectomy in the Treatment of T1 Renal Cell Carcinoma: A Non-inferiority Randomized Controlled Trial
NCT03624673CI-TRIAL-00051077unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a non-inferiority, randomized controlled trial to compare the peri-operative, renal functional and oncologic outcomes of endoscopic robot-assisted simple enucleation(ERASE) and standard robot-assisted partial nephrectomy(RAPN) in the treatment of T1 renal cell carcinoma.
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 Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopic robot-assisted simple enucleation | Procedure | — | UNRESOLVED |
| standard robot-assisted partial nephrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- endoscopic robot-assisted simple enucleation
- description
- Simple enucleation consists of excising the tumor by blunt dissection following the natural cleavage plane between the peritumoral capsule and the renal parenchyma without removing a visible rim of healthy renal tissue.
- interventionNames
- Procedure: endoscopic robot-assisted simple enucleation
- type
- ACTIVE_COMPARATOR
- label
- standard robot-assisted partial nephrectomy
- description
- Standard partial nephrectomy is defined as the excision of the tumor and of an additional margin of healthy peritumor renal parenchyma.
- interventionNames
- Procedure: standard robot-assisted partial nephrectomy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma 2. ECOG score \<=1 3. RENAL score \<=9 4. patients with normal contralateral renal function 5. patients giving consent to the participation in the current clinical trial Exclusion Criteria: 1. intolerance of robotic surgery 2. metastastic renal cell carcinoma 3. RENAL score \>=10 4. entry into collection system or hematuria 5. patients with a history of other renal diseases, such as urinary lithiasis 6. patients with a history of renal surgery
References
Publications (1)
- DERIVEDLu Q, Zhao X, Zhang S, Wang G, Ji C, Liu G, Fu Y, Xu L, Zhang S, Li X, Gan W, Zhang G, Guo H. Robot-assisted Simple Enucleation Versus Standard Robot-assisted Partial Nephrectomy for Low- or Intermediate-complexity, Clinical T1 Renal Tumors: A Randomized Controlled Noninferiority Trial. Eur Urol Oncol. 2024 Apr;7(2):275-281. doi: 10.1016/j.euo.2023.07.019. Epub 2023 Aug 18. PMID 37598032