Twenty years ago, in January 1985, extracorporeal shock wave lithotripsy (ESWL) was first applied successfully in a patient with gallbladder stones at our institution . During the following years, ESWL in combination with adjuvant bile acid therapy attracted worldwide attention as non-invasive treatment for selected patients with gallstone disease. At this time laparoscopic cholecystectomy was not on the horizon. ESWL had to compete with open cholecystectomy, which met with limited acceptance by many patients mainly because of postoperative pain and the relatively long stay in hospital. In this setting, ESWL was hailed as a patient friendly and safe procedure.
The conditions that influence the success rates of ESWL have been investigated in various studies. It was shown that the characteristics of the stones are the most important factor for the clearance of all fragments from the gallbladder after ESWL . The highest success rates were observed in patients with radiolucent solitary gallbladder stones less than 20 mm in diameter. In this group of patients, stone-free rates amounted to 60–84% at 6–12 months after treatment [2–4]. With an increase in the number and size of stones, or the presence of calcifications, rates of complete stone clearance decreased [2–10]. In addition, when patients were grouped according to the size of the largest fragment observed 24 h after lithotripsy, stone clearance occurred at a higher rate in patients with fragments smaller than 3 mm than in those with fragments 4–5 mm or larger than 5 mm . Gallbladder emptying proved to be a further determinant for successful treatment. In patients with one radiolucent stone 20 mm in diameter, patients with an ejection fraction >60% after a test meal achieved complete gallstone clearance more rapidly than patients having an ejection fraction <60% . In published experience in the treatment of several thousands of patients, side effects directly related to ESWL were minimal. Petechiae of the skin at the site of shock wave entry were observed in 8–12% of patients, transient haematuria in 4–24% and liver haematoma in less than 1%. Approximately one third of patients experienced one or more episodes of biliary pain during the first 3–4 months after ESWL, which was mainly related to the passage of stone fragments. Mild biliary pancreatitis developed in 1–2% of patients, transient cholestasis in 1%, and emergency or elective cholecystectomy was performed in 2% . No deaths related to the procedure were reported. ESWL plus bile acid therapy for gallstones has been found to be marginally cost-effective compared with open cholecystectomy . Cost-effectiveness increased in the elderly patient, but was lower with multiple than with single stones [12,13].
The paper by Rabenstein et al. in this issue of European Journal of Gastroenterology and Hepatology reports the results of ESWL in 408 out of 774 patients treated with piezoelectric ESWL and adjuvant bile acid therapy. This represents one of the largest studies performed in a single centre over 10 years. It confirms previous results published in the literature with different lithotripters (hydraulic, piezoelectric, electromagnetic) showing that stone characteristics and fragmentation efficacy are key determinants for complete clearance of stones from the gallbladder after ESWL. Among all patients who had become stone free, the authors report stone recurrence in almost half of the patients after 5 years. The Achilles heel of ESWL, namely recurrence of stones, was recognized early on. Recurrence rates between 11% and 29% at 2 years, 27% and 49% at 5 years, and 60% and 80% at 10 years, respectively, have been reported [14–20]. Unfortunately, the number of patients lost from follow-up remains unclear in many studies. Since patients with recurrent stones and pain are more likely to seek medical advice, some of these studies might not be free from a selection bias and true recurrence rates may be somewhat lower. In addition, recurrence rates in certain subgroups of patients may differ considerably from these average values. For instance, differences in bile acid metabolism may influence the rate of stone recurrence. Patients with increased conversion of cholic to deoxycholic acid by the intestinal bacteria flora have been found to have considerably increased risk of gallstone recurrence after successful ESWL . Moreover, in a prospective follow-up study from our group in patients with solitary stones, the recurrence rate in patients with good gallbladder function (ejection fraction >60%) was significantly lower than in patients with an ejection fraction of <60% after a test meal (53% vs 13%, respectively; P=0.002) .
When open cholecstectomy and ESWL were the only alternatives in the treatment of symptomatic gallstone disease, the recurrence rates as observed by our group in selected patients with single gallstones and normal gallbladder emptying appeared acceptable. Many patients who wanted to avoid laparotomy opted for ESWL even after being informed of the risk of stone recurrence. With the advent of laparoscopic cholecystectomy, the situation has changed and the balance between the non-surgical and the surgical approach has shifted towards laparoscopic cholecystectomy. Postoperative pain and the number of days in hospital are no longer arguments against the surgical approach, so that longer treatment time, lower success rate (defined as complete stone elimination) and, above all, stone recurrence turned doctors and patients away from ESWL towards laparoscopic cholecystectomy. Laparoscopic cholecystectomy has become the standard therapy of symptomatic gallbladder stones. It is well accepted by patients and appears to be more cost-effective than ESWL combined with adjuvant bile acid therapy when long-term costs are included . ESWL has kept its role in the treatment of bile duct stones resistant to endoscopic extraction [1,24], but is there still a place for ESWL in patients with gallbladder stones?
We agree with the conclusion of Rabenstein and collegues that ESWL has little chance of surviving in the era of laparoscopic cholecystectomy if recurrence cannot be decreased by better patient selection and/or measures to prevent the recurrence of gallstones. The selection of patients could be improved by considering not only the number of stones but also gallbladder motility. Genetic tests may come along to exclude patients in whom genetic factors play a major role in gallstone formation. Patients in whom environmental factors, such as diet and life style, dominate may have a lower risk of gallstone recurrence if these factors can be removed. One day, it might be possible to give better predictions of the risk of gallstone recurrence in an individual patient or to develop a cost-effective prophylaxis against stone recurrence. Then ESWL may evolve as an acceptable therapeutic option again. At present, laparoscopic cholecystectomy must be regarded as the standard procedure for the treatment of symptomatic gallbladder stones.
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