Clinical trial · Interventional
Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses
NCT04096534CI-TRIAL-00058711NORPNcompletedN/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 study evaluates novel surgical approach in treating small renal masses. Half of participants will undergo hypotonic zero-ischaemia partial nephrectomy (standard of care), while the other half will undergo normotonic zero-ischaemia partial nephrectomy (experimental method).
Conditions
Conditions (2)
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 Malignant Tumor | Renal Cell Carcinoma | PROBABILISTIC | 0.70 |
| Renal Tumor | Kidney Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypotonic partial nephrectomy | Procedure | — | UNRESOLVED |
| Normotonic partial nephrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Normotonic partial nephrectomy
- description
- Performing a partial nephrectomy under normal body blood pressure
- interventionNames
- Procedure: Normotonic partial nephrectomy
- type
- ACTIVE_COMPARATOR
- label
- Hypotonic partial nephrectomy
- description
- Performing a partial nephrectomy under hypotonic body blood pressure
- interventionNames
- Procedure: Hypotonic partial nephrectomy
Primary outcomes (2)
- measure
- Renal function
- timeFrame
- within the first 3 month after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Suspected by computed tomography or another instrumental method renal mass * Clinical stage T1-2N0-2M0-1 (distant metastases must be resectable) * Indications for partial nephrectomy * Eastern Cooperative Oncology Group status 0-2 * At least 18 years of age * Written informed consent Exclusion Criteria: * Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol * Pregnancy or breast feeding * Medical contraindications for surgical treatment * Synchronous or metachronous malignancy * Non-resectable distant metastases * The patient's refusal to perform research procedures. * Refusal of the patient to continue participation in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.