Coverage Policy Manual
Policy #: 2000041
Category: Surgery
Initiated: November 2000
Last Review: July 2018
  Cryosurgical Ablation of Renal Tumors

Description:
Cryosurgery has been shown to be effective in the ablation of primary and metastatic cancer of the liver, and cryosurgery is an accepted, but less well proven alternative for the treatment of carcinoma of the prostate.  Several preliminary studies have appeared indicating a possible role of cryosurgery for the ablation of renal malignancy, primary or metastatic tumors.
 
The instruments for cryosurgery are FDA approved.  No specific approval has been granted for cryosurgery of renal tumors, but there is no FDA requirement for such approval.
 
Coding
There are CPT codes for cryosurgical ablation of renal mass lesions:
 
50250 Ablation, open, one or more renal mass lesion(s), cryosurgical, including intraoperative ultrasound guidance and monitoring, if performed
50593 Ablation, renal tumor(s), unilateral, percutaneous, cryotherapy
 
CPT 50542 may be used for ablation of renal tumors by cryosurgery or radiofrequency. Radiofrequency of renal tumors is addressed in policy # 2004007.
 

Policy/
Coverage:
Cryoablation of benign tumors measuring 4.0 cm or less meets primary coverage criteria that there be scientific evidence of effectiveness.
 
Cryoablation of neoplastic renal tumors meets primary coverage criteria for effectiveness and is covered for patients who cannot tolerate nephron-sparing surgery or nephrectomy when:
    • the tumor is equal to or less than 4 cm,
    • the tumor is not located in the medullary portion of the kidney, and
    • the tumor is not adjacent to a significant vessel.
 
The use of cryoablation to treat renal tumors in any circumstance other than those noted above is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For those contracts that do not contain Primary Coverage Criteria the use of cryoablation to treat renal tumors in any circumstance other than those noted above is considered investigational and is not covered.  Investigational services are an exclusion in the member certificate of coverage.

Rationale:
A variety of case series have reported on the role of cryosurgery in the treatment of small renal tumors. Three reports described results of cryosurgery in 61 patients with renal cell carcinoma.  For half of these patients, cryosurgery was performed laparoscopically and for half during an open procedure. With a median follow-up of 16 months, 91% of the 29 patients treated by Rukstalis et al reportedly had complete radiographic responses but the authors did not report data on long-term outcomes (e.g., survival).  The study cites “five serious adverse events” with 1 considered directly related to the procedure, a persistent renal cell carcinoma. The other adverse events included congestive heart failure in 1 patient and chronic renal failure requiring dialysis in 3. Gill and colleagues have reported outcomes for a series of patients treated at 2 Cleveland Clinic hospitals: an initial report on a series of 10 patients, and a later report with longer term outcomes on 32 patients that likely included the original 10. Results of cryosurgery were reported as 1) a magnetic resonance imaging (MRI) response in 20 patients with 1 or more years of follow-up, and 2) as histologic analyses of biopsies on 23 patients obtained 3 to 6 months post-procedure. The report did not indicate whether these were overlapping patient groups or the number of patients who underwent MRI but not biopsy or vice versa. Based on MRI, the cryoablated lesion fully resolved in 25% of the patients examined. For the remaining 15, the cryoablated lesions decreased a mean 66% in size. Biopsy results showed no evidence of viable tumor in any lesion. However, needle biopsies before cryosurgery confirmed the diagnosis of renal cell carcinoma in only 13 of these patients. Thus, it is unclear whether these patients were tumor-free or the post-procedure biopsy missed residual tumor. Postoperative adverse effects included herpes esophagitis in 1 patient and spontaneously resolving perirenal hemorrhage in another. The authors did not indicate whether these were or were not specifically related to the cryosurgery procedure.
 
Nadler and colleagues summarized their institution’s experience in 15 patients who underwent laparoscopic renal cyroablation of peripheral, exophytic unifocal renal lesions.  There was 1 treatment failure, and 1 patient was discovered to have disease outside the ablated area. Shingleton and colleagues reported on the 6-month follow-up of 14 patients with renal cancer in a solitary kidney.  Two patients were lost to follow-up. Of the remaining 12 patients, 3 required retreatment for incomplete tumor ablation.
 
2006 Update
A literature search of the MEDLINE database was performed for the period of 2005 through February 2006. No additional literature was identified that would prompt reconsideration of the policy statement, which remains unchanged.
 
2007 Update
A number of studies are reporting intermediate term outcomes for cryoablation with renal cell cancer. Weld and colleagues reported on 3-year follow-up of 36 renal tumors (22 were malignant) treated with laparoscopic cryoablation.  In this series, the 3-year cancer-specific survival rate was 100%, and no patient developed metastatic disease. The authors concluded that these intermediate-term data seemed equivalent to results obtained with extirpative therapy.  Studies are also reporting results with small numbers of patients comparing laparoscopic cryoablation with laparoscopic partial nephrecomy for treatment of renal masses. (O'Malley, et.al.)
 
2010 Update
The policy was updated based on a literature search through September 2010.  None of the identified publications prompt a change in the coverage statement.
 
Kunkle and Uzzo (Kunkle, 2008) conducted a comparative meta-analysis evaluating cryoablation and RFA as primary treatment for small renal masses. Forty-seven case series representing 1,375 renal tumors were analyzed. Of 600 lesions treated with cryoablation, 494 were biopsied before treatment vs 482 of 775 treated with RFA. The incidence of RCC with known pathology was 72% in the cryoablation group and 90% in the RFA group. The mean duration of follow-up after cryoablation was 22.5 months. Most studies used contrast enhanced imaging to determine treatment effect. Local tumor progression was reported in 31 of 600 (5%) lesions after cryoablation and in 100 of 775 (13%) lesions after RFA. Progression to metastatic disease was described in 6 of 600 (1%) lesions after cryoablation vs. 19 of 775 (2.5%) after RFA. The authors caution that minimally invasive ablation generally has been performed selectively on older patients with smaller tumors, possibly resulting in selection bias; series of ablated lesions tend to have shorter post-treatment follow-up compared with tumors managed by surgical excision or active surveillance, and treatment efficacy may be overestimated in series that include tumors with unknown pathology.
 
Matin and Ahrar (Matin, 2008) reviewed studies of cryoablation and radiofrequency ablation with at least 12-month follow-up and found that recently published 3- and 5-year outcomes show 93–98% cancer-specific survival in small cohorts. They caution that, while studies suggest satisfactory outcomes, given the limitations of imaging and the indolent nature of the tumors, stringent selection criteria and rigorous follow-up is required. Finley and colleagues (Finley, 2008) report on a retrospective comparison of 37 patients (43 lesions) who underwent laparoscopic or percutaneous cryoablation of small renal masses. Among patients with biopsy-proven renal cell carcinoma, cancer-specific survival was 100% in both groups at median follow-up of 11.3 and 13.4 months, respectively. Nguyen et al. (30) evaluated options for salvage of ipsilateral tumor recurrence after previous ablation. Recurrence rates at their center were 13 of 175 (7%) after cryoablation and 26 of 104 (25%) after radiofrequency ablation. Extensive perinephric scarring was encountered in all salvage operations following cryoablation, and the authors conclude that cryoablation in particular can lead to extensive perinephric fibrosis which can complicate attempts at salvage. The National Comprehensive Cancer Network (NCCN) practice guidelines for kidney cancer state that, based on lower level evidence and uniform NCCN consensus, “patients in satisfactory medical condition should undergo surgical excision of stage I through III tumors. However, a small set of elderly or infirm patients with small tumors may be offered surveillance alone or energy ablative, minimally invasive techniques, such as RFA or cryoablation.”  
 
2011 Update
A literature search was conducted through July 2011.  In a 2010 Cochrane review, Nabi and colleagues review the evidence on the management of localized renal cell carcinoma (RCC) (Nabi, 2010). No randomized trials comparing cryoablation to open radical or partial nephrectomy were identified.
 
Long et al. reported on a 2011 systematic review comparing percutaneous cryoablation to surgical cryoablation of small renal masses (Long, 2011). A total of 42 studies treating small renal masses (pooled total of 1,447 lesions) were reviewed including 28 articles on surgical cryoablation and 14 articles on percutaneous cryoablation. The authors concluded percutaneous and surgical cryoablation for small renal masses have similar, acceptable short-term oncologic outcomes, and each technique is relatively equivalent. Long-term data are needed to ultimately compare ablation techniques to the gold standard of partial or radical nephrectomy.
 
In a prospective, single institution study, Rodriguez et al. reported on 113 patients consecutively treated with percutaneous cryoablation for 117 renal lesions (Rodriguez, 2011). The average size of renal lesions in the study was 2.7 + 2.4 cm (83 or 71% were RCC). Patients were selected for cryoablation over surgery when tumors were equal to or less than 4 cm and percutaneously approachable or if the patient could not tolerate surgery when tumors were greater than 4–7 cm. Technical success was reported to be 100% with 93% of patients having no complications or only mild complications. At a median follow-up of 2 years with 59 patients, efficacy was 98.3% and 92.3% at 3 years with 13 patients. Metastatic disease did not occur in any of the patients during the follow-up period, and cancer specific survival was 100%.
 
A search of online site ClinicalTrials.gov in June 2011 revealed the following registry:  “Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry to observe patients for 5 years from the date of their cryoablation procedure”. (NCT01117779)
 
The 2009 guidelines from the American Urological Association on stage 1 renal masses indicate percutaneous or laparoscopic cryoablation “is an available treatment option for the patient at high surgical risk who wants active treatment and accepts the need for long-term radiographic surveillance after treatment. The guidelines also indicate cryoablation “should be discussed as a less-invasive treatment option” in healthy patients with a renal mass equal to or less than 4.0 cm and clinical stage T1a. Patients should be informed that “local tumor recurrence is more likely than with surgical excision, measures of success are not well defined, and surgical salvage may be difficult.” These recommendations are based on review of the data and “appreciable” majority consensus.
 
The National Comprehensive Cancer Network (NCCN) practice guidelines for kidney cancer state that based on lower level evidence and uniform NCCN consensus, cryosurgery “can be considered for patients with clinical stage T1 renal lesions who are not surgical candidates. Biopsy of small lesions may be considered to obtain or confirm a diagnosis of malignancy and guide surveillance, cryosurgery … [and] ablation strategies.” The NCCN guidelines also note “rigorous comparison with surgical resection (i.e., total or partial nephrectomy by open or laparoscopic techniques) has not been done and [t]hermal ablative techniques are associated with a higher local recurrence rate than conventional surgery.”
 
This information does not prompt a change in the coverage statement.
 
2012 Update
A literature search conducted through September 2012 did not reveal any information that would prompt a change in the coverage statement.  A summary of the key identified literature is as follows:
 
In a 2011 systematic review, Klatte and colleagues reviewed 98 studies published through December 2010 to compare treatment of small renal masses with laparoscopic cryoablation or partial nephrectomy (Klatte, 2011). Partial nephrectomy was performed in 5,347 patients and laparoscopic cryoablation was performed in 1,295 patients. Renal cell carcinoma was proven in 159 (2.9%) of patients. After cryoablation, local tumor progression of the renal cell carcinoma occurred at a rate of 8.5% (70 of 821; range: 0–17.7%). After partial nephrectomy, 1.9% (89 of 4,689; range: 0–4.8%), experienced local tumor progression. Distant metastasis occurred more frequently in partial nephrectomy patients than cryoablation patients although not significantly (91 vs. 9 patients, respectively; p=0.126). However, mean tumor size for cryoablation patients was smaller than the partial nephrectomy patients (2.4 vs. 3.0 cm; p<0.001). Fewer patients receiving cryoablation experienced perioperative complications than partial nephrectomy patients (17% [range: 0-42%] vs. 23.5% [range: 8-66%]; p<0.001).
 
In 2011, Van Poppel et al. conducted a review of the literature on localized renal cell carcinoma treatment published between 2004 and May 2011 (Van Poppel, 2011). In this review, the authors concluded cryoablation is a reasonable treatment option for low-grade renal tumors less than 4 cm (mostly less than 3 cm) in patients who are not candidates for surgical resection or active surveillance. The authors noted the need for long-term prospective studies to compare ablative techniques for renal ablation, such as RFA versus cryoablation.
 
In 2012, El Dib and colleagues conducted a meta-analysis evaluating cryoablation and radiofrequency ablation (RFA) for small renal masses (El Dib, 2012). Included in the review were 20 cryoablation (totaling 457 patients) and 11 RFA (totaling 426 patients) case series studies published through January 2011. Mean tumor size was 2.5 cm (range from 2 to 4.2 cm) in the cryoablation group and 2.7 cm (range from 2 to 4.3 cm) in the RFA group. Mean follow-up times for the cryoablation group and RFA group were 17.9 and 18.1 months, respectively. Clinical efficacy, defined as cancer-specific survival rate, radiographic success, no evidence of local tumor progression, or distant metastases, was not significantly different between groups. The pooled proportion of clinical efficacy for cryoablation was 89% (95% confidence interval [CI]: 0.83–0.94) and 90% (95% CI: 0.86–0.93) for RFA.
 
2013 Update
A literature search was conducted using the MEDLINE database through September 2013.  No new information was identified that would prompt a change in the coverage statement. One relevant study, described below, was identified.
 
 
2014 Update
A literature search conducted through June 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2014, Klatte et al reported on a systematic review and meta-analysis of laparoscopic cryoablation versus laparoscopic partial nephrectomy for small renal tumors (Klatte, 2014). Thirteen non-randomized studies were included in the analysis which found laparoscopic cryoablation was associated with better perioperative outcomes than laparoscopic partial nephrectomy. Oncologic outcomes, however, were inferior with cryoablation which was significantly associated with greater risk of local and metastatic tumor progression with relative risks of 9.39 and 4.68, respectively. Tang et al also reported on a systematic review and meta-analysis of laparoscopic cryoablation versus laparoscopic partial nephrectomy for small renal tumors in 2014 (Tang, 2014). This review included 2 prospective and 7 retrospective studies. Similar results to the Klatte analysis were found including better perioperative outcomes and inferior oncologic outcomes occurring with laparoscopic cryoablation than laparoscopic partial nephrectomy. Local recurrence and distant metastasis rates were significantly lower with laparoscopic partial nephrectomy [odds ratio (OR) 13.03; 95% CI, 4.20-40.39; p<0.001 and OR 9.05; 95% CI, 2.31-35.51; p=0.002, respectively].
 
Martin and Athreya reported on a meta-analysis of cryoablation versus microwave ablation for small renal tumors in 2013 (Martin, 2013). The analysis included 51 studies and did not reveal any significant differences between microwave ablation and cryoablation in primary effectiveness (93.75% vs. 91.27%, respectively; p=0.4), cancer-specific survival (98.27% vs. 96.8%, respectively; p=0.47), local tumor progression (4.07% vs. 2.53%, respectively; p=0.46), or progression to metastases (0.8% vs. 0%, respectively; p=0.12). In the microwave ablation group, the mean tumor size was significantly larger (p=0.03) and open access was used more often than in the cryoablation group (12.20% vs. 1.04%, respectively; p<0.001). In the cryoablation group, percutaneous access was used more often than in the microwave ablation group (88.64% vs. 37.20%, respectively; p=0.0021).
     
2015 Update
A literature search conducted through May 2015 did not reveal any new information that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
Renal Cell Carcinoma
In 2014, Tang et al reported on a systematic review and meta-analysis of laparoscopic renal cryoablation versus laparoscopic partial nephrectomy for the treatment of small renal masses (Tang, 2014). The study identified nine eligible trials (2 prospective, 7 retrospective) in which the 2 techniques were assessed, and included 555 cases and 642 controls. Laparoscopic cryoablation was associated with statistically significant shorter operative time, less blood loss and fewer overall complications, however, it was estimated that laparoscopic partial nephrectomy may still have a significantly lower local recurrence rate (odds ratio, [OR], 13.03; 95% confidence interval [CI], 4.20 to 40.39; p<.001) and lower distant metastasis rate (OR=9.05; 95% CI, 2.31 to 35.51; p=.002).
 
2018 Update
A literature search was conducted through June 2018.  There was no new information identified that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
Renal Cell Carcinoma
There are a relatively large number of studies on cryoablation for renal cell carcinoma (RCC). However, there is also a lack of prospective controlled trials to determine comparative efficacy vs alternatives. There are also numerous systematic reviews and meta-analyses of these case series, some of which have indirectly compared cryosurgery outcomes with alternative strategies.
 
Systematic Reviews
Pessoa et al reported on the results of a systematic review of studies comparing the use of laparoscopic cryoablation (LCA) with PCA for the treatment of small renal masses (Pessoa, 2017). Eleven studies were identified through March 2016 and represented a total of 1725 kidney cryoablation cases: 921 (53.4%) LCA and 804 (46.6%) PCA. All cases were obtained from observational retrospective case-control studies. No significant differences were found for baseline population characteristics including the rate of premalignant histology and tumor size. Moreover, PCA was performed more frequently for posterior renal tumors. The rate of successful biopsies obtained did not differ significantly between techniques (88.5% for LCA vs 76.3% for PCA; p=0.59). The interventions were also comparable in operating times as well as intraoperative and postoperative complications.
 
Residual disease was defined as a persistent imaging study enhancement in 7 of 8 studies, and only one study relied on histopathology to confirm residual disease. Recurrent disease was defined as imaging enhancement after an initial negative imaging in 4 of 7 studies. Imaging and confirmatory biopsy to confirm recurrence was reported in 3 studies. A PCA approach resulted in a higher likelihood of residual disease (odds ratio [OR], 2.6; 95% CI, 1.31 to 3.57; p=0.003) and a seemingly paradoxical lower likelihood of tumor recurrence (OR=0.62; 95% CI, 0.41 to 0.94; p=0.02). This systematic review provided some evidence, albeit low level, of the minimally invasive interventions emerging in clinical practice. The lack of pathologic confirmation of residual and recurrent lesions is a significant limitation.
 
Matin and Ahrar reviewed studies of cryoablation and RFA with at least 12-month follow-up and found that 3- and 5-year outcomes showed 93% to 98% cancer-specific survival in small cohorts Matin, 2008). They cautioned that, while studies suggested satisfactory outcomes, given the limitations of imaging and the indolent nature of the tumors, stringent selection criteria and rigorous follow-up were required.
 
In a 2010 Cochrane review, Nabi et al assessed evidence on the management of localized RCC (Nabi, 2010). No randomized trials comparing cryoablation with open radical or partial nephrectomy were identified. One nonrandomized study, comparing laparoscopic partial nephrectomy with LCA using a matched-paired analysis, and 3 retrospective studies were selected (O’Malley, 2007). Reviewers noted PCA can successfully destroy small RCC and may be considered a treatment option in patients with serious comorbidities that pose surgical risks. Reviewers concluded that high-quality randomized controlled trials are required for the management of localized RCC and that an area of emphasis should be the comparative efficacy of renal surgery with minimally invasive techniques for small tumors (<4 cm). This review was withdrawn and replaced by another with a narrower scope. The 2017 Cochrane review replacement focused on partial nephrectomy and radical nephrectomy as the relevant surgical therapy options for localized RCC (Kunath, 2017). Only 1 randomized controlled trial was identified (n=541 participants) that compared partial nephrectomy with radical nephrectomy. The median follow-up was 9.3 years. The trial was judged to demonstrate a time-to-death of any cause that favored using partial nephrectomy (HR=1.50; 95% CI, 1.03 to 2.18). No other analyses were performed. Study limitations were lack of blinding and imprecision (a substantial proportion of patients were ultimately found not to have a malignant lesion).

CPT/HCPCS:
50250Ablation, open, 1 or more renal mass lesion(s), cryosurgical, including intraoperative ultrasound guidance and monitoring, if performed
50542Laparoscopy, surgical; ablation of renal mass lesion(s), including intraoperative ultrasound guidance and monitoring, when performed
50593Ablation, renal tumor(s), unilateral, percutaneous, cryotherapy

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