Unrecognized ConditionNCT03395379

Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma

An observational study of Unrecognized Condition, run by Centre Hospitalier Universitaire de Nice.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The investigators aimed to evaluate the feasibility and safety of using ambient air to protect against thermal injury during RadioFrequency Ablation (RFA) for Renal Cell Carcinoma (RCC) based on data from cases at their institute. Read more about this study

Who is it for?: Any age
Conditions the study is for: Unrecognized Condition
What is being tested?: RFA
Type of treatment: Surgery or procedure
How many people: 90 participants
Where: No sites listed yet
Study dates: 11 Jan 2012to 15 May 2016
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The study cohort is selected from our institution. Patients with a single SRM of <4 cm, confirmed as RCC on biopsy, are offered RFA as an alternative to open resection. In cases in which vital tissues are located within 10 mm of the target treatment area, air dissection are planned if the patient provide his consent.

Who may be able to join

Patients with Renal Cell Carcinoma (RCC)
Patients with a single SRM of <4 cm, confirmed as RCC on biopsy
RCC status : pT1a
Eligible patients for an RadioFrequency Ablation (RFA) treatment

Who cannot join

Patients who have already received a RFA treatment for an other tissu or tumor
Patients who have a bleeding tumor or prior local treatment

About this study

Read the detailed description

The incidence of renal cell carcinoma (RCC) has been increasing, particularly among patients >65 years of age. As older individuals are at higher risk for surgical complications, the use of radiofrequency ablation (RFA) for small renal masses (SRM) <4 cm in size, which include T1a tumors,may be a compelling treatment option for elderly patients. However, RFA uses heat to destroy abnormal tissue, with the risk of thermal injury to tissues and organs, including gastric tissue and nerve roots, which are in proximity to the targeted treatment zone. The incidence rate of major complication with RFA, including thermal wounds, has been reported to vary between 3.2% and 5.2%. Different thermal protection methods have been developed to lower the risk of injury to adjacent tissues during ablation, such as air dissection using CO2 injection and hydrodissection using G5% for shielding. Although both of these options are effective, they are expensive. To lower the cost of thermal protection, the investigators have been using ambient air instead of CO2 for air dissection prior to RFA for SRM-RCCs.

Conditions: Unrecognized Condition
Being tested: RFA
Keywords: Radiofrequency, Thermal Protection, Percutaneous thermal ablation, Kidney neoplasms
Medical subject headings: Kidney Neoplasms

What participants receive

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

RFAProcedure or surgery
Radiofrequency ablation (RFA) is a medical procedure in which part of the electrical conduction system of the tumor is ablated using the heat generated from medium frequency alternating current.

Study groups in NCT03395379
Study group	Role	What they receive
Group 1		RFA without air dissection protection Receives: Procedure: RFA
Group 2		RFA with air dissection protection Receives: Procedure: RFA

What is being measured

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

Failure rate of the air dissection procedure
The failure rate of the air dissection procedure is defined as the need for another dissection method, the inability to create sufficient space for successful dissection and/or damage to surrounding vital tissues.
Measured: 6 weeks post-operative

Secondary outcomes (1)

Post-operative complications
Minor and major complications are recorded, corresponding to Clavien Dindo classification
Measured: 6 weeks post-operative

Timeline

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

11 Jan 201215 May 2016

First posted10 Jan 2018
Study start11 Jan 2012
Primary completion15 Mar 2016
Study completion15 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Unrecognized ConditionStudies of the same condition, open and under way.
More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03395379
Sponsor's protocol ID: URO-BASE01
Status last verified: Dec 2017
First submitted: 4 Jan 2018
Last updated: 10 Jan 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Submission at several congress: WCE2016, EAU2017, AUA2017 Publication at the Journal of Urology in December 2017

Publications

Luciani LG, Cestari R, Tallarigo C. Incidental renal cell carcinoma-age and stage characterization and clinical implications: study of 1092 patients (1982-1997). Urology. 2000 Jul;56(1):58-62. doi: 10.1016/s0090-4295(00)00534-3.
PubMed 10869624
Turrentine FE, Wang H, Simpson VB, Jones RS. Surgical risk factors, morbidity, and mortality in elderly patients. J Am Coll Surg. 2006 Dec;203(6):865-77. doi: 10.1016/j.jamcollsurg.2006.08.026.
PubMed 17116555
Boss A, Clasen S, Kuczyk M, Anastasiadis A, Schmidt D, Claussen CD, Schick F, Pereira PL. Thermal damage of the genitofemoral nerve due to radiofrequency ablation of renal cell carcinoma: a potentially avoidable complication. AJR Am J Roentgenol. 2005 Dec;185(6):1627-31. doi: 10.2214/AJR.04.1946.
PubMed 16304025
Joniau S, Tsivian M, Gontero P. Radiofrequency ablation for the treatment of small renal masses: safety and oncologic efficacy. Minerva Urol Nefrol. 2011 Sep;63(3):227-36.
PubMed 21993321
Pieper CC, Fischer S, Strunk H, Meyer C, Thomas D, Willinek WA, Hauser S, Nadal J, Schild H, Wilhelm K. Percutaneous CT-Guided Radiofrequency Ablation of Solitary Small Renal Masses: A Single Center Experience. Rofo. 2015 Jul;187(7):577-83. doi: 10.1055/s-0034-1399340. Epub 2015 Apr 21.
PubMed 25962750
Arellano RS, Garcia RG, Gervais DA, Mueller PR. Percutaneous CT-guided radiofrequency ablation of renal cell carcinoma: efficacy of organ displacement by injection of 5% dextrose in water into the retroperitoneum. AJR Am J Roentgenol. 2009 Dec;193(6):1686-90. doi: 10.2214/AJR.09.2904.
PubMed 19933665
Laeseke PF, Sampson LA, Brace CL, Winter TC 3rd, Fine JP, Lee FT Jr. Unintended thermal injuries from radiofrequency ablation: protection with 5% dextrose in water. AJR Am J Roentgenol. 2006 May;186(5 Suppl):S249-54. doi: 10.2214/AJR.04.1240.
PubMed 16632684
Farrell MA, Charboneau JW, Callstrom MR, Reading CC, Engen DE, Blute ML. Paranephric water instillation: a technique to prevent bowel injury during percutaneous renal radiofrequency ablation. AJR Am J Roentgenol. 2003 Nov;181(5):1315-7. doi: 10.2214/ajr.181.5.1811315. No abstract available.
PubMed 14573426
Zlotta AR, Wildschutz T, Raviv G, Peny MO, van Gansbeke D, Noel JC, Schulman CC. Radiofrequency interstitial tumor ablation (RITA) is a possible new modality for treatment of renal cancer: ex vivo and in vivo experience. J Endourol. 1997 Aug;11(4):251-8. doi: 10.1089/end.1997.11.251.
PubMed 9376843

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT03395379
Acronym / sponsor ID: URO-BASE01
Conditions: Unrecognized Condition
Keywords: Radiofrequency, Thermal Protection, Percutaneous thermal ablation, Kidney neoplasms
Study type: Observational
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Centre Hospitalier Universitaire de NiceUniversity, hospital or other
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
Study start: 11 Jan 2012 (actual)
Primary completion: 15 Mar 2016 (actual)
Study completion: 15 May 2016 (actual)
First posted: 10 Jan 2018 (actual)
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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Group 1	–	Procedure: RFARFA without air dissection protection
Group 2	–	Procedure: RFARFA with air dissection protection

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The study cohort is selected from our institution. Patients with a single SRM of <4 cm, confirmed as RCC on biopsy, are offered RFA as an alternative to open resection. In cases in which vital tissues are located within 10 mm of the target treatment area, air dissection are planned if the patient provide his consent.

Key inclusion criteria (4 listed)

Patients with Renal Cell Carcinoma (RCC)
Patients with a single SRM of <4 cm, confirmed as RCC on biopsy
RCC status : pT1a
Eligible patients for an RadioFrequency Ablation (RFA) treatment

Key exclusion criteria (2 listed)

Patients who have already received a RFA treatment for an other tissu or tumor
Patients who have a bleeding tumor or prior local treatment

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
RFARadiofrequency ablation (RFA) is a medical procedure in which part of the electrical conduction system of the tumor is ablated using the heat generated from medium frequency alternating current.	Procedure or surgery	Group 1, Group 2

Primary outcome

Failure rate of the air dissection procedure
Time frame: 6 weeks post-operative
The failure rate of the air dissection procedure is defined as the need for another dissection method, the inability to create sufficient space for successful dissection and/or damage to surrounding vital tissues.

1 secondary outcome

Post-operative complications
Time frame: 6 weeks post-operative

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
Background: PubMed 10869624Luciani LG, Cestari R, Tallarigo C. Incidental renal cell carcinoma-age and stage characterization and clinical implications: study of 1092 patients (1982-1997). Urology. 2000 Jul;56(1):58-62. doi: 10.1016/s0090-4295(00)00534-3.
Background: PubMed 17116555Turrentine FE, Wang H, Simpson VB, Jones RS. Surgical risk factors, morbidity, and mortality in elderly patients. J Am Coll Surg. 2006 Dec;203(6):865-77. doi: 10.1016/j.jamcollsurg.2006.08.026.
Background: PubMed 16304025Boss A, Clasen S, Kuczyk M, Anastasiadis A, Schmidt D, Claussen CD, Schick F, Pereira PL. Thermal damage of the genitofemoral nerve due to radiofrequency ablation of renal cell carcinoma: a potentially avoidable complication. AJR Am J Roentgenol. 2005 Dec;185(6):1627-31. doi: 10.2214/AJR.04.1946.
Background: PubMed 21993321Joniau S, Tsivian M, Gontero P. Radiofrequency ablation for the treatment of small renal masses: safety and oncologic efficacy. Minerva Urol Nefrol. 2011 Sep;63(3):227-36.
Background: PubMed 25962750Pieper CC, Fischer S, Strunk H, Meyer C, Thomas D, Willinek WA, Hauser S, Nadal J, Schild H, Wilhelm K. Percutaneous CT-Guided Radiofrequency Ablation of Solitary Small Renal Masses: A Single Center Experience. Rofo. 2015 Jul;187(7):577-83. doi: 10.1055/s-0034-1399340. Epub 2015 Apr 21.
Background: PubMed 19933665Arellano RS, Garcia RG, Gervais DA, Mueller PR. Percutaneous CT-guided radiofrequency ablation of renal cell carcinoma: efficacy of organ displacement by injection of 5% dextrose in water into the retroperitoneum. AJR Am J Roentgenol. 2009 Dec;193(6):1686-90. doi: 10.2214/AJR.09.2904.
Background: PubMed 16632684Laeseke PF, Sampson LA, Brace CL, Winter TC 3rd, Fine JP, Lee FT Jr. Unintended thermal injuries from radiofrequency ablation: protection with 5% dextrose in water. AJR Am J Roentgenol. 2006 May;186(5 Suppl):S249-54. doi: 10.2214/AJR.04.1240.
Background: PubMed 14573426Farrell MA, Charboneau JW, Callstrom MR, Reading CC, Engen DE, Blute ML. Paranephric water instillation: a technique to prevent bowel injury during percutaneous renal radiofrequency ablation. AJR Am J Roentgenol. 2003 Nov;181(5):1315-7. doi: 10.2214/ajr.181.5.1811315. No abstract available.
Background: PubMed 9376843Zlotta AR, Wildschutz T, Raviv G, Peny MO, van Gansbeke D, Noel JC, Schulman CC. Radiofrequency interstitial tumor ablation (RITA) is a possible new modality for treatment of renal cancer: ex vivo and in vivo experience. J Endourol. 1997 Aug;11(4):251-8. doi: 10.1089/end.1997.11.251.
Recommandations en onco-urologie 2013 du CCAFU: Cancer du reinLink provided by the sponsor.
Guidelines on renal cell carcinoma. European Association of UrologyLink provided by the sponsor.
Thermal protection during percutaneous thermal ablation procedures: interest of carbon dioxide dissection and temperature monitoring.Link provided by the sponsor.
Minimizing diaphragmatic injury during radiofrequency ablation: efficacy of intra-abdominal carbon dioxide insufflationLink provided by the sponsor.
Thermal protection during percutaneous thermal ablation of renal cell carcinoma.Link provided by the sponsor.
Thermal protection with 5% dextrose solution blanket during radiofrequency ablation.Link provided by the sponsor.
Individual participant dataSharing planned: No. Submission at several congress: WCE2016, EAU2017, AUA2017 Publication at the Journal of Urology in December 2017

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Unrecognized Condition, run by Centre Hospitalier Universitaire de Nice.

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 4 inclusion and 2 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: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Failure rate of the air dissection procedure (time frame: 6 weeks post-operative). 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 NCT03395379, which also lists 9 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 10 Jan 2018.