CLamp vs Off Clamp Kidney During Partial Nephrectomy

Nephrectomy Clinical Trial

— CLOCK  

Official title:

Prospective Randomized Trial Comparing Clamp Versus Clampless Robot Assisted Partial Nephrectomy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02287987
• Other study ID #: CLOCKBS 1.1
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 10, 2014
• Last updated: January 3, 2016
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: January 2016
• Source: Azienda Ospedaliera Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerular Filtration Rate
• Kidney Neoplasm
• Kidney Neoplasms
• Nephrectomy

Intervention

Procedure:
• Clamp Robotic partial nephrectomy
Renal artery clamping during partial nephrectomy
• Clampless Robotic partial nephrectomy
Robotic partial nephrectomy without renal artery clamping

Locations

Country	Name	City	State
Italy	Clinical Department of Urology, university Hospital Spedali Civili di Brescia	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Spedali Civili di Brescia

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. Epub 2007 Jun 6. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glomerular Filtration Rate (GFR) variation	difference between pre and post operative Glomerular Filtration Rate (GFR)	3-6 months	No
Secondary	Feasibility of clampless robotic partial nephrectomy	number of cases shifted from clampless to clamping procedure; time of suture of the renal parenchyma; overall operative time.	Duration of the surgical procedure	No
Secondary	Morbidity of clampless robotic partial nephrectomy	Estimated blood loss; pre/post operative variation of hemoglobin value; overall complications rate; bleeding complications rate	90 days	Yes
Secondary	Oncological safety of clampless robotic partial nephrectomy	positive surgical margins rate	15 days	Yes

External Links

•   EAU guidelines 2014