Objectives: To determine the effectiveness of extracorporeal shock-wave lithotripsy (ESWL) and adjuvant bile-salt therapy for the treatment of symptomatic cholelithiasis.
Design: A prospective case study. Follow-up ranged from 3 to 54 months.
Setting: A university teaching hospital.
Patients: Two hundred and twenty-three patients with symptomatic cholelithiasis, a gallbladder that opacified at oral cholecystography and three or fewer radiolucent stones with a maximum total dimension of 3 cm. Of these patients, 197 were given bile salts (ursodeoxycholic acid or chenodeoxycholic acid, 8 to 10 mg/kg daily) and underwent ESWL. Twenty-eight were excluded because of noncompliance with the protocol or treatment failure before termination of the ESWL procedure.
Intervention: ESWL with a piezoelectric lithotripter.
Main outcome measures: The success rate of the intervention, the causes of failure, associated complications and the recurrence rate of cholelithiasis.
Results: Of the 197 patients who underwent ESWL, 85 (43%) were free of stones after treatment. Treatment failure was caused by the following: unsatisfactory fragmentation (9%), increase in fragment size during bile-salt therapy (8%), severe diarrhea due to bile salts (3%), nonvisualization of fragments after the first ESWL (3%), acute cholecystitis (2%), persistence of small fragments at the end of the treatment protocol (2%) and acute pancreatitis (0.5%). Complications included biliary colic (21%), diarrhea (15%), acute cholecystitis (2.5%), acute pancreatitis (2%), macroscopic hematuria (2%), perirenal hematoma (0.5%) and vagal shock (0.5%). The recurrence rate was 18%. Causes of noncompliance with treatment (26%) were the length of treatment, the occurrence of biliary colic during this period and the high cost of bile salts.
Conclusion: ESWL with bile salts as treatment for symptomatic cholelithiasis is not recommended for routine use.