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CLamp vs Off Clamp Kidney During Partial Nephrectomy (CLOCK)

Primary Purpose

Nephrectomy, Kidney Neoplasm, Glomerular Filtration Rate

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Clamp Robotic partial nephrectomy
Clampless Robotic partial nephrectomy
Sponsored by
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrectomy focused on measuring Renal function, Off-clamp, Partial nephrectomy, Robotic, Hylar clamping

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Department of Urology, university Hospital Spedali Civili di Brescia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clamp

Off clamp

Arm Description

Laparoscopic robot-assisted partial nephrectomy with clamping the renal pedicle during the resection of the tumor

Laparoscopic robot-assisted partial nephrectomy without clamping the renal pedicle during the resection of the tumor

Outcomes

Primary Outcome Measures

Glomerular Filtration Rate (GFR) variation
difference between pre and post operative Glomerular Filtration Rate (GFR)

Secondary Outcome Measures

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.
Morbidity of clampless robotic partial nephrectomy
Estimated blood loss; pre/post operative variation of hemoglobin value; overall complications rate; bleeding complications rate
Oncological safety of clampless robotic partial nephrectomy
positive surgical margins rate

Full Information

First Posted
October 10, 2014
Last Updated
January 3, 2016
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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1. Study Identification

Unique Protocol Identification Number
NCT02287987
Brief Title
CLamp vs Off Clamp Kidney During Partial Nephrectomy
Acronym
CLOCK
Official Title
Prospective Randomized Trial Comparing Clamp Versus Clampless Robot Assisted Partial Nephrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrectomy, Kidney Neoplasm, Glomerular Filtration Rate
Keywords
Renal function, Off-clamp, Partial nephrectomy, Robotic, Hylar clamping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clamp
Arm Type
Active Comparator
Arm Description
Laparoscopic robot-assisted partial nephrectomy with clamping the renal pedicle during the resection of the tumor
Arm Title
Off clamp
Arm Type
Experimental
Arm Description
Laparoscopic robot-assisted partial nephrectomy without clamping the renal pedicle during the resection of the tumor
Intervention Type
Procedure
Intervention Name(s)
Clamp Robotic partial nephrectomy
Intervention Description
Renal artery clamping during partial nephrectomy
Intervention Type
Procedure
Intervention Name(s)
Clampless Robotic partial nephrectomy
Intervention Description
Robotic partial nephrectomy without renal artery clamping
Primary Outcome Measure Information:
Title
Glomerular Filtration Rate (GFR) variation
Description
difference between pre and post operative Glomerular Filtration Rate (GFR)
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
Feasibility of clampless robotic partial nephrectomy
Description
number of cases shifted from clampless to clamping procedure; time of suture of the renal parenchyma; overall operative time.
Time Frame
Duration of the surgical procedure
Title
Morbidity of clampless robotic partial nephrectomy
Description
Estimated blood loss; pre/post operative variation of hemoglobin value; overall complications rate; bleeding complications rate
Time Frame
90 days
Title
Oncological safety of clampless robotic partial nephrectomy
Description
positive surgical margins rate
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Antonelli, Doctor
Organizational Affiliation
Spedali Civili di Brescia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Department of Urology, university Hospital Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20825756
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.
Results Reference
background
PubMed Identifier
24219227
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.
Results Reference
background
PubMed Identifier
24013181
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.
Results Reference
background
PubMed Identifier
17998077
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.
Results Reference
background
PubMed Identifier
23122834
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.
Results Reference
background
PubMed Identifier
19616235
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.
Results Reference
background
PubMed Identifier
24954792
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.
Results Reference
background
PubMed Identifier
31342246
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.
Results Reference
derived
Links:
URL
http://www.uroweb.org/guidelines
Description
EAU guidelines 2014

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CLamp vs Off Clamp Kidney During Partial Nephrectomy

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