Clinical trial · Interventional
CLamp vs Off Clamp Kidney During Partial Nephrectomy
Prospective Randomized Trial Comparing Clamp Versus Clampless Robot Assisted Partial Nephrectomy
NCT02287987CI-TRIAL-00020430CLOCKunknownN/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)
Prospective, randomized trial comparing surgical, functional and oncological outcomes between clamp and clamp-less robot assisted partial nephrectomy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glomerular Filtration Rate | — | UNRESOLVED | — |
| Kidney Neoplasm | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Nephrectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clampless Robotic partial nephrectomy | Procedure | — | UNRESOLVED |
| Clamp Robotic partial nephrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Clamp
- description
- Laparoscopic robot-assisted partial nephrectomy with clamping the renal pedicle during the resection of the tumor
- interventionNames
- Procedure: Clamp Robotic partial nephrectomy
- type
- EXPERIMENTAL
- label
- Off clamp
- description
- Laparoscopic robot-assisted partial nephrectomy without clamping the renal pedicle during the resection of the tumor
- interventionNames
- Procedure: Clampless Robotic partial nephrectomy
Primary outcomes (1)
- measure
- Glomerular Filtration Rate (GFR) variation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * normal coagulation trim * pre operative Glomerular Filtration Rate (GFR) \> 60 ml/min * healty contralateral kidney * low (4-6) or intermediate (7-10) RENAL score * availability of Da Vinci Robotic System Exclusion Criteria: * altered coagulation trim * pre operative Glomerular Filtration Rate (GFR) \< 60 ml/min * anatomic or functional solitary kidney * RENAL score \>10
References
Publications (10)
- BACKGROUNDThompson RH, Lane BR, Lohse CM, Leibovich BC, Fergany A, Frank I, Gill IS, Blute ML, Campbell SC. Every minute counts when the renal hilum is clamped during partial nephrectomy. Eur Urol. 2010 Sep;58(3):340-5. doi: 10.1016/j.eururo.2010.05.047. Epub 2010 Jun 9. PMID 20825756
- BACKGROUNDFicarra V, Minervini A, Antonelli A, Bhayani S, Guazzoni G, Longo N, Martorana G, Morgia G, Mottrie A, Porter J, Simeone C, Vittori G, Zattoni F, Carini M. A multicentre matched-pair analysis comparing robot-assisted versus open partial nephrectomy. BJU Int. 2014 Jun;113(6):936-41. doi: 10.1111/bju.12570. Epub 2014 May 22. PMID 24219227
- BACKGROUNDMinervini A, Siena G, Antonelli A, Bianchi G, Bocciardi AM, Cosciani Cunico S, Ficarra V, Fiori C, Fusco F, Mari A, Martorana G, Medica M, Mirone V, Morgia G, Porpiglia F, Rocco F, Rovereto B, Schiavina R, Simeone C, Terrone C, Volpe A, Carini M, Serni S; Members of the RECORd Project-LUNA Foundation. Open versus laparoscopic partial nephrectomy for clinical T1a renal masses: a matched-pair comparison of 280 patients with TRIFECTA outcomes (RECORd Project). World J Urol. 2014 Feb;32(1):257-63. doi: 10.1007/s00345-013-1155-7. Epub 2013 Sep 7. PMID 24013181
- BACKGROUNDBorm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007 Dec;60(12):1234-8. doi: 10.1016/j.jclinepi.2007.02.006. Epub 2007 Jun 6. PMID 17998077
- BACKGROUNDKaczmarek BF, Tanagho YS, Hillyer SP, Mullins JK, Diaz M, Trinh QD, Bhayani SB, Allaf ME, Stifelman MD, Kaouk JH, Rogers CG. Off-clamp robot-assisted partial nephrectomy preserves renal function: a multi-institutional propensity score analysis. Eur Urol. 2013 Dec;64(6):988-93. doi: 10.1016/j.eururo.2012.10.009. Epub 2012 Oct 16. PMID 23122834
- BACKGROUNDKutikov A, Uzzo RG. The R.E.N.A.L. nephrometry score: a comprehensive standardized system for quantitating renal tumor size, location and depth. J Urol. 2009 Sep;182(3):844-53. doi: 10.1016/j.juro.2009.05.035. Epub 2009 Jul 17.