NCT02287987

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

October 10, 2014

Last Update Submit

January 3, 2016

Conditions

NephrectomyKidney NeoplasmGlomerular Filtration Rate

Keywords

Renal functionOff-clampPartial nephrectomyRoboticHylar clamping

Outcome Measures

Primary Outcomes (1)

  • Glomerular Filtration Rate (GFR) variation

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

    3-6 months

Secondary Outcomes (3)

  • Feasibility of clampless robotic partial nephrectomy

    Duration of the surgical procedure

  • Morbidity of clampless robotic partial nephrectomy

    90 days

  • Oncological safety of clampless robotic partial nephrectomy

    15 days

Study Arms (2)

Clamp

ACTIVE COMPARATOR

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

Procedure: Clamp Robotic partial nephrectomy

Off clamp

EXPERIMENTAL

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

Procedure: Clampless Robotic partial nephrectomy

Interventions

Clamp Robotic partial nephrectomyPROCEDURE

Renal artery clamping during partial nephrectomy

Clamp
Clampless Robotic partial nephrectomyPROCEDURE

Robotic partial nephrectomy without renal artery clamping

Off clamp

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Department of Urology, university Hospital Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Related Publications (9)

  • 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.

    PMID: 20825756BACKGROUND

  • 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.

    PMID: 24219227BACKGROUND

  • 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.

    PMID: 24013181BACKGROUND

  • 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.

    PMID: 17998077BACKGROUND

  • 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.

    PMID: 23122834BACKGROUND

  • 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.

    PMID: 19616235BACKGROUND

  • 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.

    PMID: 24954792BACKGROUND

  • 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.

    PMID: 36506251DERIVED

  • 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.

    PMID: 31342246DERIVED

Related Links

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Alessandro Antonelli, Doctor

    Spedali Civili di Brescia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 10, 2014

First Posted

November 11, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

IT(1)