Contact Dissolution for Gallstones

Number: 0509

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

Policy

Scope of Policy

This Clinical Policy Bulletin addresses contact dissolution for gallstones.

Experimental, Investigational, or Unproven

Aetna considers contact dissolution (also known as direct solvent dissolution or litholysis) experimental, investigational, or unproven for the treatment of gallstones because none of the agents used for contact dissolution – ethyl propionate, isopropyl acetate, methyl tertiary butyl ether – has been approved by the U.S. Food and Drug Administration for this indication and the safety and effectiveness of this approach has not been established.

Table:

CPT Codes / HCPCS Codes / ICD-10 Codes
Code Code Description

There are no specific codes for contact dissolution of gallstones:

ICD-10 codes not covered for indications listed in the CPB:
K80.00 - K80.81 Cholelithiasis

Background

Gallstone (cholelithiasis) is a common disease in this country and is associated with significant morbidity. Open and laparoscopic cholecystectomy remains the mainstay in the methods of treating patients with symptomatic disease. For selected patients, non-invasive treatment such as Actigall (ursodiol) therapy may be appropriate. The management of acute cholecystitis in nonsurgical candidates remains a challenge, with protocols varying based on physician preference and expertise. A considerable number of patients are managed by percutaneous and endoscopic techniques, however current literature is limited to evaluate these evolving management techniques. Contact dissolution by means of ethyl propionate (EP), isopropyl acetate (IA), or methyl tertiary butyl ether (MTBE), has also been used in high-risk patients such as the elderly, patients who are too ill to undergo surgery, and individuals with idiosyncratic reactions to anesthesia.

In contact dissolution of gallstones, the solvent is usually introduced through a percutaneous trans-hepatic catheter into the gallbladder. A catheter is inserted through a small needle puncture into the gallbladder under fluoroscopic or ultrasonographic guidance. The catheter is then connected to a computerized peristaltic pump that delivers small amounts of solvent continuously to slowly dissolve the stones and removes any remaining stone fragments. Gallstones can usually be cleared in hours to days. Care must be taken to limit the time of contact between instillation and drainage to avoid discharge of this potentially toxic agent into the bile duct or the duodenum. Failure to do so may result in transient abdominal pain and duodenitis.

There is a significant risk of complications with contact dissolution of gallstones. As one commentator noted, "none [of the several contact solvents available] is a simple, safe, and effective method of treating gallstones" (Lee, 1999). Complications of use of contact solvents include those caused by the percutaneous puncture procedure and side effects if the solvent drains into the duodenum (e.g., hemolytic anemia, erosive or hemorrhagic duodenitis, aspiration pneumonia, and somnolence).

Although there is preliminary evidence that contact dissolution is effective in treating cholesterol gallstones, this is considered an investigational procedure. None of the agents used (EP, IA, and MTBE) has been approved by the Food and Drug Administration for the treatment of gallstones. As one authority commented regarding direct contact dissolution of gallstones, "this investigational therapy has not gained sufficient acceptance" and, with the introduction of laparoscopic cholecystectomy, contact dissolution has been "practically abandoned" (Paumgartner, 1998). In a review on cholesterol gallstone disease, Portincasa et al. (2006) stated that the "contact" method for stone dissolution by MTBE via percutaneous puncture of the gallbladder or extracorporeal shockwave lithotripsy have been abandoned.

References

The above policy is based on the following references:

  1. Baron TH, Jorge I, Husnain A, et al. Comprehensive review of the management of patients with acute cholecystitis who are ineligible for surgery. Ann Surg. 2026;283(1):72-81.
  2. Bellows CF, Berger DH, Crass RA. Management of gallstones. Am Fam Physician. 2005;72(4):637-642.
  3. Hellstern A, Leuschner M, Frenk H, et al. Gall stone dissolution with methyl tert-butyl ether: How to avoid complications. Gut. 1990;31(8):922-925.
  4. Hofmann AF. Bile acids: Trying to understand their chemistry and biology with the hope of helping patients. Hepatology. 2009;49(5):1403-1418.
  5. Hofmann AF, Amelsberg A, Esch O, et al. Successful topical dissolution of cholesterol gallbladder stones using ethyl propionate. Dig Dis Sci. 1997;42(6):1274-1282.
  6. Janowitz P, Schumacher KA, Swobodnik W, et al. Transhepatic topical dissolution of gallbladder stones with MTBE and EDTA. Results, side effects, and correlation with CT imaging. Dig Dis Sci. 1993;38(11):2121-2129.
  7. Lee SP, Ko CW. Gallstones. In: Textbook of Gastroenterology. DH Alpers. et al. eds. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 1999: 2273.
  8. McNulty J, Chua A, Keating J, et al. Dissolution of cholesterol gall stones using methyltertbutyl ether: A safe effective treatment. Gut. 1991;32(12):1550-1553.
  9. Patient Care Committee, Society for Surgery of the Alimentary Tract. Treatment of gallstone and gallbladder disease. SSAT patient care guidelines. J Gastrointest Surg. 2004;8(3):363-364.
  10. Paumgartner G. Nonsurgical management of gallstone disease. In: Sleisenger & Fordtran's Gastrointestinal and Liver Disease. M Feldman, et al.,eds. 6th ed. Philadelphia, PA: WB Saunders Co; 1998: 98.
  11. Portincasa P, Moschetta A, Palasciano G. Cholesterol gallstone disease. Lancet. 2006;368(9531):230-239.
  12. Ransohoff DF, Gracie WA. Treatment of gallstones. Clinical Practice Guidelines.1995 ed. Philadelphia, PA: American College of Physicians; 1995: IV-22 - IV-37.
  13. Thistle JL, May GR, Bender CE, et al. Dissolution of cholesterol gallbladder stones by methyl tert-butyl ether administered by percutaneous transhepatic catheter. N Engl J Med. 1989;320(10):633-639.
  14. Zakko SF, Scirica JC, Guttermuth MC, et al. Ethyl propionate is more effective and less cytotoxic than methyl tert-butyl ether for topical gallstone dissolution. Gastroenterology. 1997;113(1):232-237.