NephrectomyCLOCKNCT02287987

CLamp vs Off Clamp Kidney During Partial Nephrectomy

A study testing Clamp Robotic partial nephrectomy and Clampless Robotic partial nephrectomy in people with Nephrectomy and Kidney Neoplasm, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Prospective, randomized trial comparing surgical, functional and oncological outcomes between clamp and clamp-less robot assisted partial nephrectomy. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Nephrectomy, Kidney Neoplasm, Glomerular Filtration Rate
What is being tested?: Clamp Robotic partial nephrectomy and Clampless Robotic partial nephrectomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteItaly
Study dates: Oct 2014to Oct 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

Clinical Department of Urology, university Hospital Spedali Civili di Brescia
Brescia, 25123

Other trials in Italy

About this study

Official title: Prospective Randomized Trial Comparing Clamp Versus Clampless Robot Assisted Partial Nephrectomy

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

Conditions: Nephrectomy, Kidney Neoplasm, Glomerular Filtration Rate
Being tested: Clamp Robotic partial nephrectomy, Clampless Robotic partial nephrectomy
Keywords: Renal function, Off-clamp, Partial nephrectomy, Robotic, Hylar clamping
Medical subject headings: Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clamp Robotic partial nephrectomyProcedure or surgery
Renal artery clamping during partial nephrectomy
Clampless Robotic partial nephrectomyProcedure or surgery
Robotic partial nephrectomy without renal artery clamping

Study groups in NCT02287987
Study group	Role	What they receive
Clamp	Active comparator	Laparoscopic robot-assisted partial nephrectomy with clamping the renal pedicle during the resection of the tumor Receives: Procedure: Clamp Robotic partial nephrectomy
Off clamp	Experimental	Laparoscopic robot-assisted partial nephrectomy without clamping the renal pedicle during the resection of the tumor Receives: Procedure: Clampless Robotic partial nephrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

Glomerular Filtration Rate (GFR) variation
difference between pre and post operative Glomerular Filtration Rate (GFR)
Measured: 3-6 months

Secondary outcomes (3)

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.
Measured: Duration of the surgical procedure
Morbidity of clampless robotic partial nephrectomy
Estimated blood loss; pre/post operative variation of hemoglobin value; overall complications rate; bleeding complications rate
Measured: 90 days
Oncological safety of clampless robotic partial nephrectomy
positive surgical margins rate
Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Oct 2016

First posted11 Nov 2014 (estimated)
Study startOct 2014
Primary completionOct 2016 (estimated)
Study completionOct 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for NephrectomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02287987
Sponsor's protocol ID: CLOCKBS 1.1
Acronym: CLOCK
Status last verified: Jan 2016
First submitted: 10 Oct 2014
Last updated: 5 Jan 2016
Results posted: No
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Trial Comparing Clamp Versus Clampless Robot Assisted Partial Nephrectomy
ClinicalTrials.gov ID: NCT02287987
Acronym / sponsor ID: CLOCK / CLOCKBS 1.1
Conditions: Nephrectomy, Kidney Neoplasm, Glomerular Filtration Rate
Keywords: Renal function, Off-clamp, Partial nephrectomy, Robotic, Hylar clamping
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 200 participants (estimated)
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
Study start: Oct 2014
Primary completion: Oct 2016 (estimated)
Study completion: Oct 2016 (estimated)
First posted: 11 Nov 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Clamp	Active comparator	Procedure: Clamp Robotic partial nephrectomyLaparoscopic robot-assisted partial nephrectomy with clamping the renal pedicle during the resection of the tumor
Off clamp	Experimental	Procedure: Clampless Robotic partial nephrectomyLaparoscopic robot-assisted partial nephrectomy without clamping the renal pedicle during the resection of the tumor

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clamp Robotic partial nephrectomyRenal artery clamping during partial nephrectomy	Procedure or surgery	Clamp
Clampless Robotic partial nephrectomyRobotic partial nephrectomy without renal artery clamping	Procedure or surgery	Off clamp

Primary outcome

Glomerular Filtration Rate (GFR) variation
Time frame: 3-6 months
difference between pre and post operative Glomerular Filtration Rate (GFR)

3 secondary outcomes

Feasibility of clampless robotic partial nephrectomy
Time frame: Duration of the surgical procedure
Morbidity of clampless robotic partial nephrectomy
Time frame: 90 days
Oncological safety of clampless robotic partial nephrectomy
Time frame: 15 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
Background: PubMed 20825756Thompson 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.
Background: PubMed 24219227Ficarra 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.
Background: PubMed 24013181Minervini 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.
Background: PubMed 17998077Borm 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.
Background: PubMed 23122834Kaczmarek 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.
Background: PubMed 19616235Kutikov 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.
Background: PubMed 24954792Minervini 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.
Derived from this study: PubMed 38245480Bertolo 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.
Derived from this study: PubMed 36506251Bertolo 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.
Derived from this study: PubMed 31342246Antonelli 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.
EAU guidelines 2014Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alessandro Antonelli, Doctor principal investigator

Spedali Civili di Brescia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glomerular Filtration Rate (GFR) variation (time frame: 3-6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02287987, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.