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Clinical Policy Bulletin:
Ethanol Injection for Thyroid Lesions
Number: 0395


Policy

  1. Aetna considers ethanol injection sclerotherapy medically necessary for the treatment of thyroglossal duct cysts when all of the following selection criteria are met:

    1. A monocystic lesion is present; and
    2. Cystographic studies indicate that there is no extravasation; and
    3. Cytologic studies show that the lesion is benign.

    Note: It may be medically necessary to repeat injections after 1 month in cases of recurrence of cyst.

  2. Aetna considers ethanol injection sclerotherapy of thyroglossal duct cysts experimental and investigational when these criteria are not met.

  3. Aetna considers percutaneous ethanol injection experimental and investigational for the treatment of thyroid cancer because its effectiveness for this indication has not been established.



Background

The thyroglossal duct cyst (TGDC) is the commonest congenital neck mass and the second commonest of all childhood cervical masses.  An anterior midline neck mass presenting before the age of 20 and displaying vertical movement with tongue protrusion and swallowing is the hallmark of this lesion.  For recurrent or persistently infected TGDC, the traditional treatment is a Sistrunk operation -- excision of the cyst, the tract connecting it to the foramen cecum, and the central portion of the hyoid bone.

Another approach in treating TGDC is ethanol injection sclerotherapy.  Injection is performed under sonographic guidance.  Studies have shown that ethanol sclerotherapy is safe and effective in treating benign, monocystic TGDC.

Guidelines on thyroid nodules from the American Association of Clinical Endocrinologists and the Associazione Medici Endocrinologi (2006) stated that percutaneous ethanol injection is useful in the treatment of benign cystic thyroid lesions.

Surgery is the gold standard for the treatment of patients with recurrent well-differentiated thyroid cancer (WTC).  Percutaneous ethanol injection is a new minimally invasive surgical option for the treatment of this disease.  Monchik and colleagues (2006) evaluated the long-term effectiveness of radiofrequency ablation (RFA) and percutaneous ethanol injection in the treatment of patients with local recurrence or focal distant metastases of WTC.  A total of 20 patients underwent treatment of biopsy-proven recurrent WTC in the neck: 16 of these patients had lesions treated by ultrasound (US)-guided RFA (mean size, 17.0 mm; range of 8 to 40 mm), while 6 had US-guided ethanol injection treatment (mean size, 11.4 mm; range of 6 to 15 mm).  A total of 4 patients underwent RFA treatment of focal distant metastases from WTC: 3 of these patients had CT-guided RFA of bone metastases (mean size, 40.0 mm; range of 30 to 60 mm), and 1 patient underwent RFA for a solitary lung metastasis (size, 27 mm).  Patients were then followed with routine US, whole body scan, and/or serum thyroglobulin levels for recurrence at the treatment site.  No recurrent disease was detected at the treatment site in 14 of the 16 patients treated with RFA and in all 6 patients treated with ethanol injection at a mean follow-up of 40.7 and 18.7 months, respectively.  Two of the 3 patients treated for bone metastases are free of disease at the treatment site at 44 and 53 months of follow-up, respectively.  The patient who underwent RFA for a solitary lung metastasis is free of disease at the treatment site at 10 months of follow-up.  No complications were experienced in the group treated by ethanol injection, while 1 minor skin burn and 1 permanent vocal cord paralysis occurred in the RFA treatment group.  The authors concluded that RFA and ethanol ablation show promise as alternatives to surgical treatment of recurrent WTC in patients with difficult re-operations.  They stated that further long-term follow-up studies are needed to ascertain the precise role these therapies should play in the treatment of recurrent WTC and if certain more invasive surgical procedures can be replaced.

Lim et al (2007) evaluated the local therapeutic effect of percutaneous ethanol injection therapy (PEIT) in recurrent thyroid cancers.  These researchers performed ultrasound-guided PEIT on 24 recurrent lesions (8 in thyroid beds and 16 in neck nodes) of 16 papillary thyroid carcinoma patients.  Ethanol was injected at 3-month intervals under sonographic guidance.  All patients tolerated PEIT well with only mild local pain, although 1 patient complained of transient hoarseness after the procedure.  The median diameter of lesions was significantly reduced, from 9.9 mm (range of 5.5 to 25.0 mm) to 5.3 mm (range of 0.0 to 17.0 mm) by PEIT.   Four recurrent lesions disappeared sonographically.  The authors concluded that PEIT may be an alternative treatment option for locally recurrent thyroid carcinomas in properly selected patients.  However, a prospective, long-term follow-up study is needed to determine the effect of PEIT on patient survival and tumor recurrence.

Verges et al (2011) described a new procedure of ethanol sclerotherapy without US guidance for the treatment of pure thyroid cysts.  A total of 9 patients with recurrent large thyroid cysts following aspiration, and showing symptoms of compression and/or cosmetic complaints were treated by ethanol injection without US guidance and followed for up to 11 years.  After ethanol injection, mean cyst volume was significantly reduced (9.9 +/- 13.6 versus 31.3 +/- 34.1 ml, p = 0.007) and the mean percentage volume reduction was 72.7 %.  A size reduction of the thyroid lesion more than 50 % was achieved in 8 of the 9 patients (89 %).  Compressive symptoms and cosmetic complaints totally disappeared after sclerotherapy in all patients.  During a mean follow-up of 48 months (ranging from 12 to 135 months), no recurrences were observed.  The treatment was well-tolerated with no major side effects.  The authors concluded that non-US-guided ethanol sclerotherapy is a safe and "easy-to-use" procedure to treat benign thyroid cysts effectively.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
There is no specific code for ethanol injection sclerotherapy for thyroglossal duct cyst:
Other CPT codes related to the CPB:
60300
76942
77012
ICD-9 codes covered if selection criteria are met:
759.2 Anomalies of other endocrine glands [thyroglossal duct cyst]
ICD-9 codes not covered for indications listed in the CPB:
193 Malignant neoplasm of thyroid gland


The above policy is based on the following references:
  1. Yasuda K, Ozaki O, Sugino K, et al. Treatment of cystic lesions of the thyroid by ethanol instillation. World J Surg. 1992;16(5):958-961.
  2. Fukumoto K, Kojima T, Tomonari H, et al. Ethanol injection sclerotherapy for Baker's cyst, thyroglossal duct cyst, and brachial cleft cyst. Ann Plast Surg. 1994;33(6):615-619.
  3. Antonelli A, Campatelli A, Di Vito A, et al. Comparison between ethanol sclerotherapy and emptying with injection of saline in treatment of thyroid cysts. Clin Investig. 1994;72(12):971-974.
  4. Monzani F, Lippi F, Goletti O, et al. Percutaneous aspiration and ethanol sclerotherapy for thyroid cyst. J Clin Endocrinol Metab. 1994;78(3):800-802.
  5. Cho YS, Lee HK, Ahn IM, et al. Sonographically guided ethanol sclerotherapy for benign thyroid cysts: Results in 22 patients. AJR Am J Roentgenol. 2000;174(1):213-216.
  6. Lohela P. Ultrasound-guided drainages and sclerotherapy. Eur Radiol. 2002;12(2):288-295.
  7. Chu CH, Chuang MJ, Wang MC, Sclerotherapy of thyroid cystic nodules. J Formos Med Assoc. 2003;102(9):625-630.
  8. Bennedbaek FN, Hegedüs L. Treatment of recurrent thyroid cysts with ethanol: A randomized double-blind controlled trial. J Clin Endocrinol Metab. 2003; 12: 5773-5777.
  9. Kim DW, Rho MH, Kim HJ, et al. Percutaneous ethanol injection for benign cystic thyroid nodules: Is aspiration of ethanol-mixed fluid advantageous? AJNR Am J Neuroradiol. 2005;26(8):2122-2127.
  10. Hegedus L. Clinical practice. The thyroid nodule. N Engl J Med. 2004;351(17):1764-1771.
  11. AACE/AME Task Force on Thyroid Nodules. American Association of Clinical Endocrinologists and Associazione Medici Endocrinologi medical guidelines for clinical practice for the diagnosis and management of thyroid nodules. Endocr Pract. 2006;12(1):63-102.
  12. Monchik JM, Donatini G, Iannuccilli J, Dupuy DE. Radiofrequency ablation and percutaneous ethanol injection treatment for recurrent local and distant well-differentiated thyroid carcinoma. Ann Surg. 2006;244(2):296-304.
  13. Lim CY, Yun JS, Lee J, et al. Percutaneous ethanol injection therapy for locally recurrent papillary thyroid carcinoma. Thyroid. 2007;17(4):347-350.
  14. Kim BM, Kim MJ, Kim EK, et al. Controlling recurrent papillary thyroid carcinoma in the neck by ultrasonography-guided percutaneous ethanol injection. Eur Radiol. 2008;18(4):835-842.
  15. Tarantino L, Francica G, Sordelli I, et al. Percutaneous ethanol injection of hyperfunctioning thyroid nodules: Long-term follow-up in 125 patients. AJR Am J Roentgenol. 2008;190(3):800-808.
  16. Verges B, Buffier P, Baillot-Rudoni S, et al. Non-ultrasound-guided ethanol sclerotherapy for the treatment of thyroid cysts. Ann Endocrinol (Paris). 2011;72(3):203-207.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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