Cryoablation-Assisted Surgery for Kidney Cancer
(RCAPN Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Urological Research Network, LLC
Disqualifiers: Prior renal surgery, M1 disease
No Placebo Group
Trial Summary
What is the purpose of this trial?Patients with renal masses eligible to partial nephrectomy often require arterial ischemia to control or prevent blood loss during this surgical procedure. This study aims to determine the safety and efficacy of renal cryoablation at the tumor bed, as a substitute measure or technique vs total or selective arterial renal ischemia.
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 data supports the effectiveness of the treatment Cryoablation Assisted Partial Nephrectomy for kidney cancer?
Research shows that cryoablation (freezing treatment) is effective for treating small kidney tumors and can be used when surgery alone is not enough. It has been compared to other surgical methods and found to be a useful alternative, especially for small tumors.
12345Is cryoablation-assisted surgery for kidney cancer safe?
Cryoablation for kidney tumors is generally considered safe, with less risk of complications compared to more invasive surgeries. Studies show it has a good safety profile, especially for small tumors, but device-related complications can occur.
678910How is Cryoablation Assisted Partial Nephrectomy different from other kidney cancer treatments?
Cryoablation Assisted Partial Nephrectomy is unique because it combines cryoablation (freezing the tumor to kill cancer cells) with partial nephrectomy (surgically removing part of the kidney), offering a minimally invasive option that may help preserve more kidney function compared to traditional surgery alone.
1231112Eligibility Criteria
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.
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Treatment groupExperimental Treatment1 Intervention
Patients underwent Cryotheapy assisted partial nephrectomy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Urological Research NetworkMiami Lakes, FL
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Who Is Running the Clinical Trial?
Urological Research Network, LLCLead Sponsor
References
Percutaneous cryoablation for recurrent low grade renal cell carcinoma after failed nephron-sparing surgery. [2013]Partial nephrectomy has a 3%-4% incidence of local treatment failure. This study is to present a series of percutaneous cryoablation for locally recurrent renal cell carcinoma after partial nephrectomy.
Systematic review and meta-analysis of perioperative and oncologic outcomes of laparoscopic cryoablation versus laparoscopic partial nephrectomy for the treatment of small renal tumors. [2018]For the minimally invasive treatment of small renal tumors, laparoscopic cryoablation has emerged as an alternative procedure to minimally invasive partial nephrectomy (laparoscopic, robot-assisted laparoscopic) for selected patients, but there are still limited data regarding its safety and oncologic efficacy. We compare perioperative and oncologic outcomes of laparoscopic cryoablation and laparoscopic partial nephrectomy/robot-assisted laparoscopic partial nephrectomy.
Results of a prospective study comparing the clinical efficacy of cryoablation of renal cell cancer followed by immediate partial nephrectomy. [2014]Evaluation if cryoablation of small renal tumours (RT) would facilitate the technique of laparoscopic partial nephrectomy (LPN) in a prospective study.
Laparoscopic partial nephrectomy versus laparoscopic cryoablation for the small renal tumor. [2006]We sought to compare perioperative and short-term outcomes of laparoscopic partial nephrectomy versus laparoscopic cryoablation in patients with peripheral small renal tumors. Prospectively accrued data of patients with a small renal tumor (
Single center comparison of laparoscopic cryoablation and CT-guided percutaneous cryoablation for renal tumors. [2016]Cryoablation has demonstrated therapeutic effectiveness for selected renal tumors. We compared our perioperative and short-term outcomes of laparoscopic (LAP) v percutaneous (PERC) renal cryoablation.
Device-related complications during renal cryoablation: insights from the Manufacturer and User Facility Device Experience (MAUDE) database. [2022]Cryoablation offers a treatment option for small renal masses ideally suited ≤3 cm. In well-selected candidates, it is associated with less perioperative morbidity compared to more invasive options, such as partial or radical nephrectomy. However, little is known regarding device-related complications associated with the procedure. We provide an analysis of reports on renal cryoablation from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.
Percutaneous cryoablation combined with prior transcatheter arterial embolization for renal cell carcinomas of 3 cm or larger: a prospective study. [2022]We prospectively evaluated the safety and efficacy of percutaneous cryoablation combined with transcatheter renal arterial embolization for the treatment of tumors ≥ 3 cm in diameter.
Perioperative, oncologic, and functional outcomes of laparoscopic renal cryoablation and open partial nephrectomy: a matched pair analysis. [2016]To directly compare perioperative, oncologic, and functional outcomes of laparoscopic renal cryoablation and open partial nephrectomy using a matched pair analysis.
Safety of percutaneous renal cryoablation: an international multicentre experience from the EuRECA retrospective percutaneous database. [2020]To investigate the safety profile of percutaneous cryoablation of renal tumours
Partial Nephrectomy versus Percutaneous Cryoablation of Small Renal Cell Carcinomas: A Comparison of Adverse Events in a Prospective Multicenter Cohort Study. [2023]To assess and compare complications and readmissions after partial nephrectomy and percutaneous cryoablation of cT1 renal cell carcinoma (RCC).
Safety, efficacy, and mid-term oncological outcomes of computed tomography-guided cryoablation of T1 renal cancer. [2023]Cryoablation is a promising minimally invasive, nephron-sparing treatment of small renal carcinoma (RCC) in co-morbid patients.
Percutaneous renal cryoablation after partial nephrectomy: technical feasibility, complications and outcomes. [2013]Treatment of locally recurrent or de novo tumors in the ipsilateral kidney after partial nephrectomy represents a management dilemma. Percutaneous renal cryoablation offers a minimally invasive treatment option in such cases. We review our single institution experience with percutaneous cryoablation of renal tumors after partial nephrectomy for technical feasibility, complications and outcomes.