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A report by the National Health Technology Advisory Panel (NHTAP).
Extracorporeal shock wave lithotripsy (ESWL) is now being applied to treatment of stones in the gallbladder and bile duct. At least five types of machine designed for lithotripsy of stones in the biliary tract have become available.
ESWL of gallbladder stones is followed by a period of oral bile acid therapy (ranging from 8 to 30 months) to achieve clearance of stone fragments.
Bile acid therapy is not used with ESWL of bile duct stones. Fragments pass spontaneously, especially if endoscopic sphincterotomy has been performed, or are removed endoscopically.
As yet only limited data are available from clinical trials of gallstone ESWL with bile acid therapy. Further information is needed before firm conclusions can be established on success rates, complications, duration of bile acid therapy, rate of recurrence of stones, and costs.
In comparison with surgical removal of the gallbladder, gallstone lithotripsy has the advantages that:
It has the disadvantages that:
The cost of lithotripsy of g allbladder stones can fall within a wide range (on a pireliminary estimate, $1,900-$8,100 if there is only one ESWL treatment). Major factors affecting costs are the duration and dosage rates required for the bile acid therapy.
Preliminary estimates suggest that in many cases it would have a cost advantage over cholecystectomy. The advantage would be lost if an extended period of treatment with bile acids were required.
Estimates based on a model with very preliminary assumptions suggest that compared with cholecystectomy, ESWL of gallbladder stones will have an overall cost advantage for a population of patients unless there is a significant rate of repeat treatment.
If gallstone lithotripsy is used to treat patients who would not be considered for cholecystectomy, it will be and additional cost to health care.
The cost of lithotripsy of bile duct stones may fall within the range $2,100-3,300. It would have a cost advantage over surgery but not over endoscopic removal of- stones. It may have a useful role in the treatment of stones which cannot be removed endoscopically.
The routine clinical use of ESWL for gallbladder or bile duct stones in Australia would be premature, at this stage, given the limited data available.
The Panel considers that this technology should not yet be used in Australia except in the context of a clinical trial with a well designed assessment protocol. No more than one unit would be justified in the trial phase.
The unit should be sited in a major hospital with expertise in biliary disorders, experience in clinical evaluation, and adequate back-up facilities.
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