Cryosurgical ablation (cryosurgery) involves freezing of target tissues, most often by inserting into the tumor a probe through which coolant is circulated. This policy focuses on the use of cryosurgery as a treatment of prostate cancer and other solid tumors outside the liver. 

Note:  Cryosurgical ablation of primary and metastatic liver tumors are addressed in  SURG.00065 Locally Ablative Techniques for Treating Primary and Metastatic Liver Malignancies.  

See also  SURG.00050 Radiofrequency Ablation to Treat Tumors Outside the Liver.

Medically Necessary:

Cryosurgical ablation for cancer of the prostate is considered medically necessary as an initial treatment of clinically localized prostate cancer or as a salvage therapy of clinically localized prostate cancer recurring after prior radiation therapy.

Note: Clinically localized prostate cancer is defined by one or more of the following situations:

• The tumor is an incidental finding at prostatic surgery.
• The tumor is not palpable or visible by imaging.
• The tumor is confined to the prostate gland.
• The tumor extends through the prostatic capsule.

Investigational/Not Medically Necessary:

Cryosurgical ablation is considered investigational/not medically necessary as a treatment of benign or malignant breast tumors, renal cell carcinomas, pancreatic cancer, or other solid tumors outside the prostate.

Rationale

Cryosurgical ablation for treatment of prostate cancer has been demonstrated to be a safe and effective treatment modality for clinically localized prostate cancer. Data from many small non-randomized uncontrolled trials have established that cryoablation of prostate tumors demonstrates similar complication rates in terms of erectile dysfunction, obstruction, incontinence, and urethral stricture as does external beam radiation therapy. The efficacy of cryoablation, as noted by post-operative biopsy results and recurrence rates, is similar to external beam radiation when treating prostate cancer. While the data supporting this procedure for use as a salvage technique is not extensive, there is data to demonstrate that this is a useful and safe therapeutic modality for patients who have previously failed radiation therapy. The level of evidence supporting this conclusion includes multiple case series studies.

Breast cancer:

Three studies described the outcome of cryosurgery for advanced primary or recurrent breast cancer in 72 patients.  Cryosurgery was performed percutaneously with ultrasound guidance (n=15) or during an open surgical procedure (n=57). Patients were treated for advanced primary disease (44%) or recurrent tumors (56%). Tanaka reported the largest retrospective series: 9 patients with advanced primary tumors and 40 with recurrent disease. The author reported 44% survival of primary breast cancer patients (n=9) at 3 and 5 years, but did not report survival duration or other outcome for those with recurrent or metastatic disease. The report also did not adequately describe selection criteria for those enrolled in the study, details of the procedure, and procedure-related adverse events. The other studies were smaller series of patients and also were inadequate with respect to study design, analysis, and reporting of results. Furthermore, the study by Pfleiderer (2002) was a pilot trial to evaluate technical limitations of the procedure. Tumors were excised and evaluated by pathology days to weeks after cryosurgery and the authors reported incomplete necrosis in tumors greater than 23mm in diameter. Because of these limitations, studies published to date do not permit conclusions regarding the effects of cryosurgery on health outcomes of patients with breast cancer.

One study described the use of office-based ultrasound-guided cryoablation as a treatment of breast fibroadenomas in 57 patients in whom a prior biopsy had confirmed the presence of a fibroadenoma. While this study reported that the procedure was technically feasible, only 20 of the 57 patients treated were followed up for 6 months after cryosurgery and only 3 were followed up for 12 months. Thus, longer follow-up and further studies are required.  Additionally, uncontrolled case series published in 2004 (and funded by the device manufacturer) suggested that cryoablation may be safe and initially effective in treating breast fibroadenomas (Edwards, 2004; Kaufman 2005). However, a 2005 analysis of 444 treated fibroadenomas from a multi-center registry cautioned that palpability of the treated site may persist for months after the procedure in a significant percentage of patients, and urged that surgeons, especially in patients with larger fibroadenomas, consider this factor carefully with their patients when deciding between cryoablation or open surgical removal of the lesion. The paper cautions that, even though patient satisfaction with cosmesis appeared generally high, longer term follow-up is necessary to better understand the time course for resolution of both radiographic and physical findings in such patients (Nurko, 2005).

Renal cell carcinoma:

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 (2001) 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 one considered directly related to the procedure, a persistent renal cell carcinoma. The other adverse events included congestive heart failure in one patient and chronic renal failure requiring dialysis in three.

The other studies reported outcomes for a series of patients treated at two 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 (a) MRI response in 20 patients with one or more years of follow-up, and (b) 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 one 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.

In recent articles, published in 2005 and 2006, the initial or short-term data on laparoscopic renal cryoablation is promising and suggests that the procedure is relatively safe with a low complication rate and reduces tumor bulk. The primary drawback remains the lack of long-term oncologic outcome data (Desai, 2005). In several studies (Aron, 2005; Hegarty, 2006; Kaouk, 2006; Schwartz, 2006) the authors concluded that long-term radiologic and histologic data are needed to determine the most appropriate candidates for renal cryoablation; the optimal modality for tumor targeting and monitoring therapy; the appropriate follow-up strategy and to confirm the durability of the results. This data must be compared with outcomes after partial nephrectomy, which remains the “gold standard” treatment. There is less data on renal cryoablation using the percutaneous approach. More data is needed to determine patient selection, appropriate radiological monitoring during the procedure and long-term efficacy (Permpongkosol, 2006).

Pancreatic cancer:

Kovach (2002) reported 10 cryosurgical ablations in 9 patients with unresectable pancreatic cancer using intraoperative ultrasound guidance during laparotomy. The authors report no intraoperative morbidity or mortality and that all patients had adequate pain control postoperatively. At the time of publication, all patients had expired at an average of 5 months postoperatively (range: 1–11 months). Because this pilot feasibility study did not include a control group or compare outcomes of cryosurgery to alternative strategies for managing similar patients, no conclusions are possible on effects of cryosurgery for pancreatic cancer.

Background/Overview

Cryosurgery, also called cryotherapy or cryosurgical ablation, is the use of extreme cold produced by liquid nitrogen (or argon gas) to destroy abnormal tissue. Cryosurgery may be used to treat tumors on the skin (external tumors), such as basal cell carcinoma, or tumors inside the body (internal tumors), such as prostate cancer. 

When cryosurgery is used to treat tumors inside the body, liquid nitrogen or argon gas is circulated through a hollow instrument called a cryoprobe, which is placed in contact with the tumor. The doctor uses imaging procedures such as ultrasound or MRI to guide the cryoprobe to the tumor location and monitor the freezing process. The monitoring process is important so freezing of the cells is limited to the tumor and its immediate area, limiting the amount of damage to nearby healthy tissue. The cryoprobe may be inserted into the tumor during an open or laparoscopic surgical procedure or may be inserted through the skin (percutaneously) and guided to the tumor using an imaging technique. During a cryosurgical procedure a ball of ice crystals forms around the probe, freezing nearby cells and killing them. The probe is then removed from the tumor and the frozen tissue thaws. The dead tissue is then naturally absorbed by the body. Sometimes more than one probe is used to deliver the liquid nitrogen to various parts of the tumor.

Cryosurgery does have side effects; however, they may be less severe than those associated with conventional surgery or radiation therapy. The effects depend on the location of the tumor but may include bleeding, and in the case of treatment for prostate cancer, incontinence and urinary retention. In rare cases, cryosurgery may interact adversely with certain types of chemotherapy.

Cryosurgery may offer advantages over other methods of cancer treatment. It is less invasive than surgery, involving only a small incision or insertion of the cryoprobe through the skin. Consequently, complications of surgery such as pain and bleeding may be minimized. Cryosurgery may require a shorter recovery time and a shorter hospital stay, or no hospital stay at all. Sometimes cryosurgery can be done using only local anesthesia.

Because physicians can focus cryosurgical treatment on a limited area, they may be able to avoid the destruction of nearby healthy tissue. The treatment may be safely repeated and may be used along with standard treatments such as surgery, chemotherapy, hormone therapy, and radiation. Cryosurgery may offer an option for treating cancers that are considered inoperable or that do not respond to standard treatments. Furthermore, it may be used for patients who are not good candidates for conventional surgery because of their age or other medical conditions.

Cryosurgery of Prostate Cancer:

Treatment options for prostate cancer include watchful waiting, surgical prostatectomy, various forms of radiation therapy and cryosurgery. Cryosurgery of the prostate is a minimally invasive alternative for the management of localized prostate cancer (i.e., prostate cancer that has not spread beyond the prostate gland itself.). The goal of prostate cryoablation is the destruction of the entire gland.

Cryosurgery for Breast Fibroadenomas:

Fibroadenomas of the breast are a common benign tumor, which are typically surgically excised. Cryosurgery has been proposed as a surgical alternative. 

Cryosurgery for Renal Cell Carcinoma:
 
Localized renal cell carcinoma (RCC) is treated by radical nephrectomy or nephron-sparing surgery. Cryosurgery has been proposed as an alternative to surgical excision, with the potential advantage of preserving functioning renal tissue.

Definitions

Cryosurgical ablation (cryotherapy or cryoablation): a surgical procedure where cancerous or diseased cells are destroyed using extreme cold

Solid tumors: tumors that appear in body tissues other than blood, bone marrow, or the lymphatic system; examples include tumors of the liver, lung, or colon

Tumor: an abnormal mass of tissue that results from excessive cell division that is uncontrolled and progressive, also called a neoplasm

Unresectable: a property of a tumor that makes it unable to be removed surgically

Coding

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Medically Necessary:

CPT

ICD-9 Procedure

ICD-9 Diagnosis

When services are Investigational/Not Medically Necessary:

For the procedure codes listed above, for all other diagnoses not listed; or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

When services are also Investigational/Not Medically Necessary:

CPT

ICD-9 Diagnosis

References

Peer Reviewed Publications:

1. Aron M, Gill IS. Renal tumor ablation. Curr Opin Urol. 2005; 15(5):298-305.
2. Aus G, Pileblad E, Hugosson J. Cryosurgical ablation of the prostate: 5-year follow-up of a prospective study.  Eur Urol. 2002; 42(2):133-138. 
3. Bhayani SB, Belani JS, Hidalgo J, et al. Trends in nephron-sparing surgery for renal neoplasia. Urology. 2006; 68(4):732-736. 
4. Cestari A, Guazzoni G, dell’Acqua V, et al. Laparoscopic cryoablation of solid renal masses: intermediate term followup. J Urol. 2004; 172(4 Pt 1):1267-1270. 
5. Davol PE, Fulmer BR, Rukstalis DB. Long-term results of cryoablation for renal cancer and complex renal masses. Urology. 2006; 68(1 Suppl):2-6.
6. Deane LA, Clayman RV. Review of minimally invasive renal therapies: needle-based and extracorporeal. Urology. 2006; 68(1 Suppl):26-37.
7. De la Taille A, Hayek O, Benson MC, et al. Salvage cryotherapy for recurrent prostate cancer after radiation therapy: the Columbia experience. Urology. 2000; 55(1):79-84. 
8. Desai MM, Aron M, Gill IS. Laparoscopic partial nephrectomy versus laparoscopic cryoablation for the small renal tumor. Urology. 2005; 66(5 Suppl):23-28. 
9. Donnelly BJ, Saliken JC, Ernst DS, et al. Prospective trial of cryosurgical ablation of the prostate: five-year results. Urology. 2002; 60(4):645-649. 
10. Drachenberg DE. Treatment of prostate cancer: watchful waiting, radical prostatectomy, and cryoablation.  Semin Surg Oncol. 2000; 18(1):37-44.  
11. Edwards MJ, Broadwater R, Tafra L, et al. Progressive adoption of cryoablative therapy for breast fibroadenoma in community practice. Am J Surg. 2004; 188(3):221-224. 
12. Fergany A. Current status and advances in nephron-sparing surgery. Clin Genitourin Cancer. 2006; 5(1):26-33.
13. Gill IS, Novick AC, Meraney AM, et al. Laparoscopic renal cryoablation in 32 patients. Urology. 2000; 56(5):748-753.  
14. Gill IS, Remer EM, Hasan WA, et al. Renal cryoablation: outcome at 3 years. J Urol. 2005; 173(6):1903-1907. 
15. Hegarty NJ, Gill IS, Desai MM, et al. Probe-ablative nephron-sparing surgery: cryoablation versus radiofrequency ablation. Urology. 2006; 68(1 Suppl):7-13. 
16. Hruby G, Reisiger K, Venkatesh R, et al. Comparison of laparoscopic partial nephrectomy and laparoscopic cryoablation for renal hilar tumors. Urology. 2006; 67(1):50-54.
17. Huston TL, Simmons RM. Ablative therapies for the treatment of malignant diseases of the breast. Am J Surg. 2005; 189(6):694-701. 
18. Johnson DB, Solomon SB, Su LM, et al. Defining the complications of cryoablation and radio frequency ablation of small renal tumors: a multi-institutional review. J Urol. 2004; 172(3):874-877. 
19. Kaouk JH, Aron M, Rewcastle JC, Gill IS. Cryotherapy: clinical end points and their experimental foundations. Urology. 2006; 68(1 Suppl):38-44. 
20. Kaufman CS, Littrup PJ, Freeman-Gibb LA, et al. Office-based cryoablation of breast fibroadenomas with long-term follow-up. Breast J. 2005; 11(5):344-350.  
21. Kaufman CS, Bachman B, Littrup PJ, et al. Office-based ultrasound-guided cryoablation of breast fibroadenomas. Am J Surg. 2002; 184(5):394-400.  
22. Koppie TM, Shinohara K, Grossfeld GD, et al. The efficacy of cryosurgical ablation of prostate cancer: the University of California, San Francisco experience. J Urol. 1999; 162(2):427-432. 
23. Kovach SJ, Hendrickson RJ, Cappadona CR, et al. Cryoablation of unresectable pancreatic cancer. Surgery. 2002; 131(4):463-464. 
24. Lawatsch EJ, Langenstroer P, Byrd GF, et al. Intermediate results of laparoscopic cryoablation in 59 patients at the Medical College of Wisconsin. J Urol. 2006; 175(4):1225-1229. 
25. Littrup PJ, Freeman-Gibb L, Andea A, et al. Cryotherapy for breast fibroadenomas. Radiology. 2005; 234(1):63-72.
26. Long JP, Bahn D, Lee F, et al. Five-year retrospective, multi-institutional pooled analysis of cancer-related outcomes after cryosurgical ablation of the prostate. Urology. 2001; 57(3):518-523. 
27. Lowry PS, Nakada SY. Renal cryotherapy: 2003 clinical status. Curr Opin Urol. 2003; 13(3):193-197. 
28. Moon TD, Lee FT Jr, Hedican SP, et al. Laparoscopic cryoablation under sonographic guidance for the treatment of small renal tumors. J Endourol. 2004; 18(5):436-440.
29. Nadler RB, Kim SC, Rubenstein JN, et al. Laparoscopic renal cryosurgery: the Northwestern experience. J Urol. 2003; 170(4 Pt 1):1121-1125. 
30. Nurko J, Mabry CD, Whitworth P, et al. Interim results from the FibroAdenoma Cryoablation Treatment Registry. Am J Surg. 2005; 190(4):647-651. 
31. O’Malley RL, Berger AD, Kanofsky JA, et al. A matched-cohort comparison of laparoscopic cryoablation and laparoscopic partial nephrectomy for treating renal masses. BJU Int. 2007; 99(2):395-398.
32. Permpongkosol S, Link RE, Kavoussi LR, Solomon SB. Percutaneous computerized tomography guided cryoablation for localized renal cell carcinoma: factors influencing success. J Urol. 2006; 176(5):1963-1968.
33. Permpongkosol S, Nielsen ME, Solomon SB. Percutaneous renal cryoablation. Urology. 2006; 68(1 Suppl):19-25. 
34. Pfleiderer SO, Freesmeyer MG, Marx C, et al. Cryotherapy of breast cancer under ultrasound guidance: initial results and limitations. Eur Radiol. 2002; 12(12):3009-3014.  
35. Rivoire M, De Cian F, Meeus P, et al. Cryosurgery as a means to improve surgical treatment of patients with multiple unresectable liver metastases. Anticancer Res. 2000; 20(5C):3785-3790.  
36. Robinson D, Halperin N, Nevo Z. Two freezing cycles ensure interface sterilization by cryosurgery during bone tumor resection. Cryobiology. 2001; 43(1):4-10. 
37. Robinson JW, Donnelly BJ, Saliken JC, et al. Quality of life and sexuality of men with prostate cancer 3 years after cryosurgery. Urology. 2002; 60(2 Suppl 1):12-18.
38. Rodriguez R, Chan DY, Bishoff JT, et al. Renal ablative cryosurgery in selected patients with peripheral renal masses. Urology. 2000; 55(1):25-30.  
39. Rukstalis DB, Khorsandi M, Garcia FU, et al. Clinical experience with open renal cryoablation. Urology. 2001; 57(1):34-39. 
40. Russo R. Renal cryoablation: study with care—proceed with caution. Urology. 2005; 65(3):419-421.
41. Sabel MS, Kaufman CS, Whitworth P, et al. Cryoablation of early-stage breast cancer: work-in-progress report of a multi-institutional trial. Ann Surg Oncol. 2004; 11(5):542-549.
42. Schwartz BF, Rewcastle JC, Powell T, et al. Cryoablation of small peripheral renal masses: a retrospective analysis. Urology. 2006; 68(1 Suppl):14-18. 
43. Silverman SG, Tuncali K, vanSonnenberg E, et al. Renal tumors: MR imaging-guided percutaneous cryotherapy—initial experience in 23 patients. Radiology. 2005; 236(2):716-724.
44. Warlick CA, Lima GC, Allaf ME, et al. Clinical sequelae of radiographic iceball involvement of collecting system during computed tomography-guided percutaneous renal tumor cryoablation. Urology. 2006; 67(5):918-922.
45. Weld KJ, Figenshau RS, Venkatesh R, et al. Laparoscopic cryoablation for small renal masses: three-year follow-up. Urology. 2007; 69(3):448-451.
46. Weld KJ, Landman J. Comparison of cryoablation, radiofrequency ablation and high-intensity focused ultrasound for treating small renal tumours. BJU Int. 2005; 96(9):1224-1229. 
47. Whitworth PW, Rewcastle JC. Cryoablation and cryolocalization in the management of breast disease. J Surg Oncol. 2005; 90(1):1-9.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Society of Breast Surgeons. Consensus Statement on Management of Fibroadenomas of the Breast. Revised December 8, 2005. Available at: www.breastsurgeons.org. Accessed on April 4, 2007.
2. Centers for Medicare and Medicaid Services. National Coverage Determination for Cryosurgery of Prostate.  NCD #230.9. Effective July 1, 2001. Available at:   http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd#PC. Accessed on April 13, 2007. 
3. Hayes Inc. Hayes Medical Technology Directory. Cryoablation for Prostate Cancer. Lansdale, PA: Hayes, Inc.; November 2006. 
4. Hayes Inc. Hayes Medical Technology Directory. Cryoablation for Treatment of Breast Fibroadenomas. Lansdale, PA: Hayes, Inc.; January 2007. 
5. Hayes Inc. Hayes Health Technology Brief. Percutaneous Cryoablation for the Treatment of Renal Cell Cancer. Lansdale, PA: Hayes, Inc.; March 2007.
   

Web Sites for Additional Information

1. American Cancer Society. Available at: http://www.cancer.org. Accessed on April 10, 2007. 
2. National Cancer Institute. Cancer Facts: Cryosurgery in Cancer Treatment: Questions and Answers. Available at: http://www.cancer.gov/cancertopics/factsheet/Therapy/cryosurgery. Accessed on April 10, 2007.
   

Index

Policy History

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

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