Cryoablation-Assisted Surgery for Kidney Cancer

(RCAPN Trial)

Overseen By Eusebio J Luna, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Urological Research Network, LLC

Disqualifiers: Prior renal surgery, M1 disease

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1-2 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for kidney cancer surgery. Instead of the usual technique to limit blood flow during surgery, doctors will use cryoablation, which freezes the tumor area to control bleeding. This method is part of a procedure called Cryoablation Assisted Partial Nephrectomy. The study aims to determine if this approach is safe and effective compared to traditional techniques. Suitable candidates for this trial include those with a kidney tumor that is 7 cm or smaller and protrudes from the kidney by more than half. As an unphased trial, this study offers an opportunity to contribute to innovative surgical techniques that could enhance future kidney cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this technique is safe for kidney cancer surgery?

Research has shown that cryoablation, a method that freezes and destroys cancer cells, is generally safe for treating kidney tumors. One study found that cryoablation is effective and safe for kidney tumors up to 7 cm in size. Another study reported a complication rate of about 23% within 90 days for both cryoablation and partial nephrectomy (surgery to remove part of the kidney), with serious complications being rare at only 3%.

Research comparing cryoablation to surgery indicated that both methods led to similar, small decreases in kidney function after six months. Importantly, long-term survival rates for patients treated with cryoablation were similar to those who underwent surgery, with a 10-year survival rate of 94% for kidney cancer.

Overall, these studies suggest that cryoablation is a well-tolerated option for people with kidney tumors, offering a safety profile similar to traditional surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cryoablation-assisted partial nephrectomy is unique because it combines the precise freezing power of cryoablation with traditional kidney surgery to treat kidney cancer. While typical treatments involve surgical removal of the tumor or the entire kidney, this approach specifically targets and freezes cancer cells, potentially preserving more healthy kidney tissue. Researchers are excited because this method could offer a less invasive option with fewer side effects and a quicker recovery time, while still effectively controlling the cancer.

What evidence suggests that cryoablation-assisted surgery is effective for kidney cancer?

Research has shown that cryoablation in surgery can be a promising way to treat kidney tumors. In this trial, participants will undergo Cryoablation-Assisted Partial Nephrectomy. One study found that cryoablation offers similar long-term survival rates to traditional surgery, with both showing about 89% survival over ten years. Cryoablation typically results in shorter surgery times and hospital stays, with fewer major complications compared to some other surgical methods. Another study suggested that the health benefits of cryoablation are almost the same as other treatments over five years. Overall, cryoablation appears to provide effective and safe results for kidney cancer patients. ^{3 6 7 8 9}

Who Is on the Research Team?

FERNANDO J BIANCO, MD

Principal Investigator

Urological research Network

Are You a Good Fit for This Trial?

This trial is for individuals aged 45-90 with kidney tumors that are less than 7 cm large and mostly on the outside of the kidney. It's not suitable for those who've had previous kidney surgery or have metastatic disease, where cancer has spread to other parts of the body.

Inclusion Criteria

I am between 45 and 90 years old.

My kidney tumor is 7 cm or smaller and mostly on the outside of the kidney.

Exclusion Criteria

My cancer has spread to distant parts of my body.

I have had kidney surgery in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo cryotherapy-assisted partial nephrectomy to manage renal masses without arterial ischemia.

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety, efficacy, and oncological control, including imaging studies at fixed intervals.

10 years

Regular visits every 6 months to 1 year

Long-term Monitoring

Participants are evaluated for survival, CKD progression, and incidence of metastatic disease over a 10-year period.

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Cryoablation Assisted Partial Nephrectomy

Trial Overview The study tests a new method called Cryoablation Assisted Partial Nephrectomy in patients with renal masses. This technique might help control blood loss during surgery without stopping blood flow to the kidney, which is usually done by arterial ischemia.

How Is the Trial Designed?

Group I: Treatment group Experimental Treatment 1 Intervention

Patients underwent Cryotheapy assisted partial nephrectomy

Who Is Running the Clinical Trial?

Urological Research Network, LLC

Lead Sponsor

Trials

5

Recruited

10,200+

Published Research Related to This Trial

Cryoablation of small renal tumors followed by laparoscopic partial nephrectomy (K-LPN) is feasible and does not increase the risk of complications or negatively impact surgical outcomes, based on a study of 16 patients with a follow-up of 9 to 42 months.

While K-LPN had a longer operative time compared to standard procedures, it did not show any advantages in terms of tumor excision or postoperative recovery, indicating that while cryoablation is safe, it may not enhance the effectiveness of the surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a prospective study comparing the clinical efficacy of cryoablation of renal cell cancer followed by immediate partial nephrectomy. Khoder, WY., Siegert, S., Stief, CG., et al.[2014]

Cryoablation is a safe and effective treatment for stage T1 renal cell carcinoma (RCC), with a low complication rate of 11% and a disease-free survival rate of 98% at one year for T1a tumors.

The study indicates that tumor characteristics, such as stage and number of needles used during the procedure, are more important for treatment outcomes than the patient's overall health, highlighting the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, efficacy, and mid-term oncological outcomes of computed tomography-guided cryoablation of T1 renal cancer. Duus, LA., Junker, T., Rasmussen, BS., et al.[2023]

Percutaneous cryoablation is a safe and effective treatment for locally recurrent renal cell carcinoma after partial nephrectomy, with a median follow-up of 32 months showing no significant complications for most patients.

Among five patients treated, one experienced a second recurrence that was successfully managed with repeat cryoablation, indicating that this method can effectively control recurrent disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cryoablation for recurrent low grade renal cell carcinoma after failed nephron-sparing surgery. Morgan, MA., Roberts, NR., Pino, LA., et al.[2013]

Laparoscopic partial nephrectomy, while associated with greater blood loss and a higher rate of delayed complications, is currently the preferred minimally invasive procedure for small renal tumors due to its established oncological effectiveness.

Laparoscopic cryoablation shows advantages like lower blood loss and fewer complications, but it lacks long-term follow-up data to confirm its effectiveness in preventing tumor recurrence compared to partial nephrectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic partial nephrectomy versus laparoscopic cryoablation for the small renal tumor. Desai, MM., Aron, M., Gill, IS.[2006]

A review of 239 cases of renal cryoablation revealed that while the procedure generally has low perioperative morbidity, 78.6% of complications were minor, with 21.4% classified as major, indicating a need for careful patient selection.

Major complications were more frequently associated with non-device related issues, such as patient comorbidities and technical errors, rather than device malfunctions, suggesting that optimizing patient health and tumor complexity is crucial for improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device-related complications during renal cryoablation: insights from the Manufacturer and User Facility Device Experience (MAUDE) database. Kotamarti, S., Michael, Z., Silver, D., et al.[2022]

Laparoscopic cryoablation for small renal tumors offers improved perioperative outcomes, including shorter operative times, less blood loss, and shorter hospital stays compared to laparoscopic partial nephrectomy, based on a review of 13 studies.

However, laparoscopic cryoablation is associated with a significantly higher risk of local and metastatic tumor progression, suggesting that while it may be less invasive, it may not be as effective for long-term cancer control as surgical resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of perioperative and oncologic outcomes of laparoscopic cryoablation versus laparoscopic partial nephrectomy for the treatment of small renal tumors. Klatte, T., Shariat, SF., Remzi, M.[2018]

Both partial nephrectomy and percutaneous cryoablation for treating cT1 renal cell carcinoma showed similar overall complication rates within 90 days, at 23% for both procedures, indicating comparable safety profiles.

However, major complications were more frequent after cryoablation (10%) compared to partial nephrectomy (3%), and factors like tumor complexity and the use of double-J stents were linked to higher complication rates in cryoablation patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partial Nephrectomy versus Percutaneous Cryoablation of Small Renal Cell Carcinomas: A Comparison of Adverse Events in a Prospective Multicenter Cohort Study. Junker, T., Duus, L., Rasmussen, BSB., et al.[2023]

Laparoscopic (LAP) and percutaneous (PERC) renal cryoablation both show similar short-term outcomes in treating renal tumors, with 100% disease-specific survival at 1, 2, and 3 years for both methods.

The PERC approach resulted in shorter hospital stays, less need for postoperative narcotics, and lower rates of atelectasis compared to LAP, suggesting it may be a more favorable option for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single center comparison of laparoscopic cryoablation and CT-guided percutaneous cryoablation for renal tumors. Derweesh, IH., Malcolm, JB., Diblasio, CJ., et al.[2016]

Percutaneous cryoablation of renal tumors smaller than 7 cm has a low overall complication rate of 8.3%, indicating it is a safe treatment option for patients.

Tumors larger than 4 cm are associated with a higher risk of major complications, highlighting the importance of tumor size in assessing treatment risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of percutaneous renal cryoablation: an international multicentre experience from the EuRECA retrospective percutaneous database. Garnon, J., Van Strijen, MJ., Nielsen, TK., et al.[2020]

The study evaluated 19 patients with renal cell carcinoma tumors ≥3 cm, finding that percutaneous cryoablation combined with transcatheter arterial embolization (TAE) was safe, with only four grade 3 hematologic adverse events and no symptomatic severe complications.

The treatment showed favorable survival outcomes, with 100% overall survival and 95% progression-free survival at 3 years, indicating its efficacy for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cryoablation combined with prior transcatheter arterial embolization for renal cell carcinomas of 3 cm or larger: a prospective study. Gobara, H., Matsui, Y., Uka, M., et al.[2022]

Percutaneous renal cryoablation is a technically feasible and minimally invasive treatment for locally recurrent or new tumors in the kidney after partial nephrectomy, with a low major complication rate of 5.7% and no perioperative deaths among 48 patients treated.

The procedure showed acceptable short-term oncologic outcomes, with only 9.3% of patients experiencing local tumor recurrence, while also preserving renal function with a minimal median change in estimated glomerular filtration rate of -1.5 ml per minute.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous renal cryoablation after partial nephrectomy: technical feasibility, complications and outcomes. Hegg, RM., Schmit, GD., Boorjian, SA., et al.[2013]

Laparoscopic renal cryoablation and open partial nephrectomy have similar rates of perioperative complications and renal function outcomes, making both procedures relatively safe options for treating renal tumors.

However, laparoscopic cryoablation has a significantly higher local recurrence risk (17% after 3 years) compared to open partial nephrectomy, suggesting it should be considered primarily for high-risk patients with shorter life expectancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative, oncologic, and functional outcomes of laparoscopic renal cryoablation and open partial nephrectomy: a matched pair analysis. Klatte, T., Mauermann, J., Heinz-Peer, G., et al.[2016]

Citations

1. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12917-z

Comparative efficacy of cryoablation versus robot-assisted ... This study utilizes a meta-analytic approach to investigate the effects of cryoablation and robot-assisted partial nephrectomy on perioperative outcomes.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40481379/

Percutaneous cryoablation versus robot-assisted partial ... PCA was associated with a significantly shorter procedure time and hospitalization duration with fewer major complications than those associated with RAPN.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429525007460

Long-Term Outcomes of Partial Nephrectomy Versus ... Ten-year survival rates were similar across groups (partial nephrectomy: 89.4%, cryoablation: 89.2%, heat-based ablation: 87.8%; p>0.05).

4. news.bostonscientific.eu news.bostonscientific.eu/study-finds-cryoablation-is-an-effective-and-affordable-option-for-treating-kidney-cancer

New study finds cryoablation is an effective and more ... The results show near-identical health benefits over a five-year period: there were no significant differences between focused cryotherapy and ...

5. clinicalimagingscience.org clinicalimagingscience.org/renal-functional-outcomes-after-robot-assisted-partial-nephrectomy-and-percutaneous-cryoablation-of-clinical-t1-renal-cell-carcinoma-a-prospective-study/

Renal functional outcomes after robot-assisted partial ... This study found a small, similar decrease in renal function 6 months after RAPN or PCA, despite significant differences in baseline patient characteristics.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10584313/

Efficacy and safety of cryoablation for localized renal tumor as ... This study showed a good efficacy and safety of cryoablation for renal tumors up to 7 cm (T1b). Our results were consistent with a rather sparse literature.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1051044322010636

Partial Nephrectomy versus Percutaneous Cryoablation of ... The complication rate within 90 days was 23% after partial nephrectomy and cryoablation (P = .98), with major complication rates of 3% after partial nephrectomy ...

8. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.2020192325

Percutaneous Cryoablation for Stage 1 Renal Cell ... Percutaneous cryoablation yielded a 10-year disease-specific survival of 94%, equivalent to that reported after radical or partial nephrectomy.

9. mdpi.com mdpi.com/2072-6694/16/6/1175

Systematic Review and Meta-Analysis The aim of this meta-analysis was to compare PCA and PN in terms of complications, renal function and survival outcomes.