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Status unknownNCT02287987CLOCKUpdated Jan 5, 2016

CLamp vs Off Clamp Kidney During Partial Nephrectomy

An interventional study of Clamp Robotic partial nephrectomy and Clampless Robotic partial nephrectomy in Nephrectomy, Kidney Neoplasm and Glomerular Filtration Rate, sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-01-05.

Sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Nephrectomy
  • Kidney Neoplasm
  • Glomerular Filtration Rate

Browse trials for

Keywords

  • Renal function
  • Off-clamp
  • Partial nephrectomy
  • Robotic
  • Hylar clamping
03

In context

Kidney Neoplasms

973 studies on the registry are indexed under Kidney Neoplasms; 214 are open to participants now.

This study's planned enrollment of 200 is above the median of 43 across 664 interventional studies indexed under Kidney Neoplasms.

Browse Kidney Neoplasms studies →

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia is the lead sponsor of 84 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • altered coagulation trim
  • pre operative Glomerular Filtration Rate (GFR) \< 60 ml/min
  • anatomic or functional solitary kidney
  • RENAL score >10
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Clamp

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

    Procedure: Clamp Robotic partial nephrectomy

  • Experimental
    Off clamp

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

    Procedure: Clampless Robotic partial nephrectomy

Interventions

  • ProcedureClamp Robotic partial nephrectomy

    Renal artery clamping during partial nephrectomy

  • ProcedureClampless Robotic partial nephrectomy

    Robotic partial nephrectomy without renal artery clamping

06

What researchers measure

Primary outcomes

  1. Glomerular Filtration Rate (GFR) variation

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

    Time frame: 3-6 months

Secondary outcomes

  1. 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.

    Time frame: Duration of the surgical procedure

  2. Morbidity of clampless robotic partial nephrectomy

    Estimated blood loss; pre/post operative variation of hemoglobin value; overall complications rate; bleeding complications rate

    Time frame: 90 days

  3. Oncological safety of clampless robotic partial nephrectomy

    positive surgical margins rate

    Time frame: 15 days

07

Study locations

1 site
  • Clinical Department of Urology, university Hospital Spedali Civili di Brescia
    Brescia, 25123, Italy
08

References and documents

Publications

  • 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. PubMed 20825756 ↗
  • 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. PubMed 24219227 ↗
  • 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. PubMed 24013181 ↗
  • 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. PubMed 17998077 ↗
  • 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. PubMed 23122834 ↗
  • 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. PubMed 19616235 ↗
  • 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. PubMed 24954792 ↗
  • Bertolo R, Antonelli A, Minervini A, Campi R. Off-clamp Versus On-clamp Partial Nephrectomy: Re-envision of a Dilemma. Eur Urol Oncol. 2024 Apr;7(2):173-176. doi: 10.1016/j.euo.2023.12.009. Epub 2024 Jan 19. PubMed 38245480 ↗
  • Bertolo R, Bove P, Sandri M, Celia A, Cindolo L, Cipriani C, Falsaperla M, Leonardo C, Mari A, Parma P, Veccia A, Veneziano D, Minervini A, Antonelli A; AGILE Group (Italian Group for Advanced Laparoendoscopic Surgery). Randomized Clinical Trial Comparing On-clamp Versus Off-clamp Laparoscopic Partial Nephrectomy for Small Renal Masses (CLOCK II Laparoscopic Study): A Intention-to-treat Analysis of Perioperative Outcomes. Eur Urol Open Sci. 2022 Oct 28;46:75-81. doi: 10.1016/j.euros.2022.10.007. eCollection 2022 Dec. PubMed 36506251 ↗
  • 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. PubMed 31342246 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02287987
Lead sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Responsible party
Alessandro Antonelli (Dr, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia) — Principal investigator
First posted
Nov 11, 2014
Start date
Oct 2014
Primary completion
Oct 2016 (estimated)
Completion
Oct 2016 (estimated)
Last update
Jan 5, 2016

Study contacts

Alessandro Antonelli, Doctor
principal investigator · Spedali Civili di Brescia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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