Clinical trial · Interventional
Investigating a Novel Modifiable Factor Affecting Renal Function After Partial Nephrectomy: Cortical Renorrhaphy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual, interim analysis showed no statistical significance
Summary
Brief summary (as posted)
Preserving kidney function during removal of a kidney tumor is becoming increasingly important as rates of chronic kidney disease increase. A novel modifiable factor (suture closure of the defect caused by tumor removal) was discovered on retrospective studies to account for nearly two-thirds of the 15% volume loss commonly seen in operated kidneys. We hypothesize that a randomized controlled surgical trial will show that omitting the suture closure both preserves renal function and will not lead to unreasonable postoperative complications.
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 |
|---|---|---|---|
| Non-renorrhaphy | Procedure | — | UNRESOLVED |
| Renorrhaphy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cortical renorrhaphy
- description
- Cortical renorrhaphy is performed after partial nephrectomy using a running barbed suture on MH (36mm) needle. Polymer locking clips are used to maintain tension. A base layer running stitch is performed prior to the cortical renorrhaphy.
- interventionNames
- Procedure: Renorrhaphy
- type
- EXPERIMENTAL
- label
- Non-renorrhaphy
- description
- The suture closure of the renal cortex after tumor removal is omitted. A base layer running stitch only is performed for hemostasis and urine leak prevention.
- interventionNames
- Procedure: Non-renorrhaphy
Primary outcomes (1)
- measure
- %Loss renal volume
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
3.0 INCLUSION/EXCLUSION CRITERIA 3.1 Inclusion criteria: * ≥ 18 years of age. * Must provide written informed consent * Presence of cT1 renal mass by diagnostic CT assessment. * Scheduled for partial nephrectomy of renal mass. * Expected survival of at least 3 months. * ECOG ≤ 1. * Negative serum/urine pregnancy test within 24 hours for females of child bearing age prior to surgery * Recovered from toxicity of any prior therapy to grade 1 or better * If biopsy of mass has been done, pathology must be consistent with RCC. 3.2 Exclusion criteria: * Solitary kidney * Multiple or bilateral renal masses when more than one mass is operated on at the same time or within 4-months of each other. * Hepatic or renal toxicity (GFR \<30) greater than or equal to Grade 2 (using CTCAE version 4 standard definitions) * Bleeding diathesis or inability to hold anticoagulation for surgery * Participation in another investigational trial concurrently or within 30 days * Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
References
Publications (0)
Data not yet available