Clinical trial · Interventional
Circulating Tumor Cell Reducing No-touch Nephrectomy
No-touch Radical Nephrectomy Technique Reduces Circulating Tumor Cell Release in Renal Cell Carcinoma Patients - a Randomized Controlled Trial
- 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 will study circulating tumor cell (CTC) release during laparoscopic radical nephrectomy (LRN) for RCC. The main objective is to determine if CTC release can be reduced during RN by using a no-touch technique, with an early renal pedicle ligation. The investigators also aim to describe the CTC profile in terms of CTC count (CTCn), epithelial/mesenchymal status, and CTC cellular features in renal cell carcinoma (RCC) patients, stratified by "primary tumor, regional nodes, metastasis" (TNM) staging, histological subtype, and other clinical and radiological features. Patients undergoing RN will enter a two-arm prospective single-center randomized controlled trial (RCT), comparing a no-touch RN technique, with direct pedicle ligation (Group A) vs. the more conventional approach of kidney traction and manipulation to reach the renal pedicle before its ligation (Group B). A microfluidic size-based CTC isolation device will be used to capture and count CTCs from peripheral blood samples of these patients. CTCs will be identified by staining with antibodies to cytokeratin 8/18, vimentin, 4',6-diamidino-2-phenylindole (DAPI), and cluster of differentiation antigen 45 (CD45). CTC release will be correlated with the disease-free survival (DFS), and overall survival (OS). The investigators will determine if CTC reducing no-touch radical nephrectomy technique improves these hard outcomes.
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 |
|---|---|---|---|
| Circulating Tumor Cell | — | UNRESOLVED | — |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional laparoscopic radical nephrectomy | Procedure | — | UNRESOLVED |
| Laparoscopic total nephrectomy control arm | Procedure | — | UNRESOLVED |
| No-touch laparoscopic radical nephrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- No-touch laparoscopic radical nephrectomy
- description
- Group A patients will undergo a no-touch laparoscopic radical nephrectomy, with the dissection being done through the Gerota's fascia plane until exposure of the corresponding great vessel (vena cava on the right side, and aorta on the left side) is obtained. The renal pedicle will be directly isolated, and ligated using Weck® clips with no kidney manipulation.
- interventionNames
- Procedure: No-touch laparoscopic radical nephrectomy
- type
- ACTIVE_COMPARATOR
- label
- Conventional laparoscopic radical nephrectomy
- description
- Group B patients will undergo a conventional laparoscopic radical nephrectomy approach, starting with opening of the Gerota's fascia, identification of the ureter, traction on the peri-renal fat below the ureter while dissecting cephalad until the renal pedicle is reached. The renal pedicle will then be isolated while maintaining traction on the kidney, and peri-renal fat, and ligated using Weck® clips.
- interventionNames
- Procedure: Conventional laparoscopic radical nephrectomy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Renal mass on renal imaging compatible with kidney cancer * Indication for laparoscopic radical nephrectomy Exclusion Criteria: * History of other cancer (carcinoma) * Previous systemic therapy for renal cell carcinoma * human immunodeficiency virus (HIV) positive * Hepatitis C virus (HCV) positive * hepatitis B virus (HBV) positive
References
Publications (0)
Data not yet available