Clinical trial NCT02287987: CLamp vs Off Clamp Kidney During Partial Nephrectomy
Official title: Prospective Randomized Trial Comparing Clamp Versus Clampless Robot Assisted Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nephrectomy
Kidney Neoplasm
Glomerular Filtration Rate
Keywords: Renal function
Off-clamp
Partial nephrectomy
Robotic
Hylar clamping
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomized trial comparing surgical, functional and oncological outcomes between clamp and clamp-less robot assisted partial nephrectomy.


Eligibility criteria: 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

Primary outcomes:
measure: Glomerular Filtration Rate (GFR) variation
timeFrame: 3-6 months
Secondary outcomes:
measure: Feasibility of clampless robotic partial nephrectomy
timeFrame: Duration of the surgical procedure
measure: Morbidity of clampless robotic partial nephrectomy
timeFrame: 90 days
measure: Oncological safety of clampless robotic partial nephrectomy
timeFrame: 15 days
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Clinical Department of Urology, university Hospital Spedali Civili di Brescia
Study officials:
affiliation: Spedali Civili di Brescia
name: Alessandro Antonelli, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thompson 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.
citation: Ficarra 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.
citation: Minervini 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.
citation: Borm 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.
citation: Kaczmarek 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.
citation: Kutikov 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.
citation: Minervini A, Carini M, Uzzo RG, Campi R, Smaldone MC, Kutikov A. Standardized reporting of resection technique during nephron-sparing surgery: the surface-intermediate-base margin score. Eur Urol. 2014 Nov;66(5):803-5. doi: 10.1016/j.eururo.2014.06.002. Epub 2014 Jun 18.
citation: Antonelli A, Cindolo L, Sandri M, Bertolo R, Annino F, Carini M, Celia A, D'Orta C, De Concilio B, Furlan M, Giommoni V, Ingrosso M, Mari A, Muto G, Nucciotti R, Porreca A, Primiceri G, Schips L, Sessa F, Simeone C, Veccia A, Minervini A; AGILE Group (Italian Group for Advanced Laparo-Endoscopic Surgery). Safety of on- vs off-clamp robotic partial nephrectomy: per-protocol analysis from the data of the CLOCK randomized trial. World J Urol. 2020 May;38(5):1101-1108. doi: 10.1007/s00345-019-02879-4. Epub 2019 Jul 24.