Search

Twenty years ago, in January 1985, extracorporeal shock wave lithotripsy (ESWL) was first applied successfully in a patient with gallbladder stones. In the following years, the conditions which influence the success rate of ESWL have been extensively investigated. It was shown that the characteristics of the stones, gallbladder emptying and the degree of stone fragmentation are the most important factors which determine the clearance of all fragments from the gallbladder after ESWL. Severe side effects, such as biliary pancreatitis and liver haematoma, were found to be rare and no deaths related to the procedure have been reported. One or more episodes of biliary pain were observed in about one third of patients within the first 3-4 months after ESWL. Follow-up studies after successful treatment, however, have shown that stone recurrence is considerable, limiting the use of ESWL as a non-invasive therapeutic option. Stone recurrence varies between different subgroups of patients indicating that gallbladder motor function and other less well defined factors may be of importance. The recurrence of stones after ESWL is one of the reasons why laparoscopic cholecystectomy has become the standard treatment of symptomatic gallbladder stones today. ESWL has kept its role only in the treatment of bile duct stones resistant to endoscopic extraction. Unless stone recurrence can be decreased by better patient selection and/or other measures to prevent gallstone recurrence, ESWL of gallbladder stones has little chance of surviving.

Background: Endoscopic extraction of bile duct stones after sphincterotomy has a success rate of up to 95%. Failures occur in patients with extremely large stones, intrahepatic stones, and bile duct strictures. This study examined the efficacy and the safety of extracorporeal shock-wave lithotripsy in a large cohort of patients in whom routine endoscopic measures including mechanical lithotripsy had failed to extract bile duct stones., Methods: Out of 1587 consecutive patients, endoscopic stone extraction including mechanical lithotripsy was unsuccessful in 313 (20%). These 313 patients (64% women, median age, 73 years) underwent high-energy extracorporeal shock-wave lithotripsy. Stone targeting was performed fluoroscopically (99%) or by ultrasonography (1%)., Results: Complete clearance of bile duct calculi was achieved in 281 (90%) patients. In 80% of the patients, the fragments were extracted endoscopically after shock-wave therapy; spontaneous passage was observed in 10%. For patients with complete clearance compared with those without there were no differences with regard to size or number of the stones, intrahepatic or extrahepatic stone location, presence or absence of bile duct strictures, or type of lithotripter. Cholangitis (n = 4) and acute cholecystitis (n = 1) were the rare adverse effects., Conclusions: In patients with bile duct calculi that are difficult to extract endoscopically, high-energy extracorporeal shock-wave lithotripsy is a safe and effective therapy regardless of stone size, stone location, or the presence of bile duct stricture.

Background & Aims: The value of adjuvant bile acid dissolution therapy after extracorporeal shockwave lithotripsy (ESWL) of gallbladder stones is under debate. A double-blind, randomized, multicenter trial was conducted to determine the safety and efficacy of repeated ESWL with and without adjuvant bile acid therapy., Methods: At five centers, 153 patients with gallstones and good gallbladder emptying were randomized to undergo up to six high-energy lithotripsy sessions combined with ursodeoxycholic acid (UDCA, 750 mg/day; n = 77) or placebo (n = 76)., Results: Six months after the initial treatment, 77% of patients with small single stones (< or = 20 mm in diameter), 60% with large single stones (> 20 mm in diameter), and 41% with multiple stones were free of stones. Administration of UDCA had no effect on stone disappearance in the whole study group but tended to improve stone disappearance rates in patients with large single stones and tended to decrease biliary adverse effects in patients with multiple stones., Conclusions: Repeated high-energy ESWL without adjuvant bile acid therapy represents a safe and effective treatment in patients with small single stones and good gallbladder emptying. In patients with large single stones and multiple stones, adjuvant bile acid therapy may be beneficial.

Efficient fragmentation is the most important prerequisite for successful treatment of gallstones by extracorporeally induced shock waves. No data are available on the amount of energy necessary for stone disintegration and on the threshold energy below which no further fragmentation occurs. We therefore performed an in vitro investigation on human cholesterol gallstones to elucidate physical laws governing shock-wave lithotripsy. First, the focal pressure of the lithotripter was measured to calculate the energy traversing a stone. Second, 96 gallstones from 16 gall bladders were analysed with respect to physicochemical composition, radiological features and ultrasound before fragmentation was performed. Energy for stone disintegration was constant within each stone family but varied between 4.6 mL-1 and 36.8J mL-1 in different families. This energy correlated linearly with stone volume. None of the radiological and physicochemical factors revealed a clear-cut correlation of the different energies necessary for similar stone disintegration. The threshold energy differed between 0.26 mJ and 1.04 mJ per pulse. In conclusion, stone volume was the best parameter predicting stone fragmentation. However, in cholesterol stones with a similar composition the required energy per volume varies considerably together with the threshold energy. Radiological and ultrasound parameters appear to be of minor importance in explaining these differences.

Inhibitors of the HMG-CoA reductase have been shown to further reduce the biliary cholesterol saturation in patients treated with oral bile acids for cholesterol gallbladder stones. It was the aim of our study to evaluate the efficacy of simvastatin in addition to ursodeoxycholic acid in the dissolution of gallstone fragments after shock wave lithotripsy and adjuvant bile acid dissolution therapy. Eighteen patients with a single radiolucent gallbladder stone and a serum cholesterol of more than 250 mg/dl were randomly assigned to receive either ursodeoxycholic acid alone (750 mg per day, group A, n = 9) or in combination with simvastatin (20 mg per day, group B, n = 9) for the dissolution of the gallstone fragments generated by extracorporeal shock wave lithotripsy. The two groups were well matched regarding their baseline characteristics. At the primary end point of the study 6 months after lithotripsy, there was no difference between the groups in the rate of gallstone disappearance with 4 of 9 patients being stone free in each group. As evaluated by life table analysis, even further follow-up showed no significant difference between the groups (P = 0.8). In group B, serum cholesterol levels decreased by 22% at 3 months (P = 0.01 vs. baseline) and by 24% at six months (P = 0.02) during treatment while no significant change was observed in group A. With both regiments, no adverse effects were observed. While simvastatin added to ursodeoxycholic acid resulted in a decrease of elevated serum cholesterol levels in gallstone patients, it did not enhance stone disappearance after shock wave lithotripsy and adjuvant bile acid dissolution therapy.

Background and Study Aims: Endoscopic extraction of bile duct stones may be complicated by impaction of the Dormia basket with captured stones, or rupture of the traction wire of the basket during mechanical lithotripsy. In an attempt to release impacted baskets by nonoperative means, we studied the efficacy of extracorporeal shock-wave lithotripsy in this dangerous clinical situation., Patients and Methods: Fourteen extracorporeal shock-wave treatments were performed in 12 consecutive patients (eight women and four men; mean age 73.2 +/- 13.2 years, range 46-86 years) with an electrohydraulic shock-wave lithotriptor, using fluoroscopy (n = 13) or ultrasound (n = 1) for targeting. A total of 1845 +/- 334 (mean +/- SD) shock-wave discharges at a voltage of 22 +/- 4 kV were delivered per treatment. Nine treatment sessions (64%) were performed while patients were under general anesthesia. An attempt to extract the Dormia basket was made after disintegration of the captured stone had been confirmed by fluoroscopy., Results: It was possible to remove the Dormia basket by nonsurgical means in 11 of the 12 patients (92%) after one treatment session, and after three treatment sessions in the remaining patient. Thus, disintegration of the stones allowed extraction of the Dormia basket in all patients. None of the patients needed surgical intervention. All patients were rendered free of bile duct stones after extracorporeal shock-wave lithotripsy and subsequent endoscopic removal of the fragments. No adverse effects of shock-wave therapy with subsequent extraction of the Dormia baskets were observed., Conclusion: Shock-wave therapy represents a primary nonsurgical therapeutic option in patients with either impacted Dormia baskets or broken devices which cannot be extracted by endoscopic means.

Background/aims: Disappearance of gallbladder stones after shock-wave lithotripsy combined with bile acid therapy depends on mechanical evacuation and dissolution of fragments. Many patients with gallstones have impaired gallbladder emptying and may show delayed stone clearance after lithotripsy., Methods: The effect of gallbladder emptying on gallstone clearance after lithotripsy was prospectively studied in 57 patients with one radiolucent gallbladder stone < or = 20 mm. Gallbladder emptying was assessed sonographically before and after 2 weeks of ursodeoxycholic acid (UDCA) treatment., Results: UDCA increased gallbladder fasting and residual volume and decreased ejection rate but did not affect ejection fraction. Patients with an ejection fraction > 60% achieved complete gallstone clearance after lithotripsy in a higher percentage than patients with smaller ejection fractions (1 month, 31% vs. 7%, P = 0.022; 2 months, 55% vs. 18%, P = 0.003; 3 months, 66% vs. 29%, P = 0.005). Patients who became stone-free within 1 month showed larger ejection fractions than patients with retained fragments (67% +/- 4% vs. 56% +/- 3% before UDCA, P = 0.032; 65% +/- 4% vs. 53% +/- 3% with UDCA, P = 0.017). Further, ejection rate during UDCA therapy was larger in patients with complete gallstone disappearance within 1 month than in patients with delayed fragment clearance (1.57%/min +/- 0.36%/min vs. 0.76%/min +/- 0.09%/min; P = 0.002)., Conclusions: Gallbladder emptying is a major determinant of early gallstone clearance after lithotripsy.

Background/aims: The long-term outcome of nonoperative gallstone therapy depends on both absence of stones and absence of biliary pain. The aim of the present study was to determine the rate of stone recurrence and the rate of symptoms within 5 years after successful shock wave lithotripsy combined with bile acid therapy., Methods: One hundred consecutive patients (single stones, n = 89; 2 or 3 stones, n = 11) were followed up for a median of 4.3 years after stone disappearance and discontinuation of bile acids., Results: Twenty-three of the 100 patients developed recurrent stones. Calculated by actuarial analysis, the recurrence rate was 7% +/- 3%, 11% +/- 3%, 13% +/- 4%, 20% +/- 5%, and 31% +/- 7% (mean +/- SD) at 1, 2, 3, 4, and 5 years, respectively. The recurrent stones were small (6 +/- 5 mm) and were associated with recurrent biliary pain in 14 (61%) of the 23 patients. Repeated shock wave lithotripsy and/or bile acid medication resulted in stone disappearance in only 10 of 20 patients with recurrence., Conclusions: The long-term rate of stone recurrence after lithotripsy of primarily solitary gallbladder calculi is lower than expected from post-bile acid dissolution trials. Recurrence of stones frequently is associated with recurrence of biliary pain.

We conducted a prospective randomized study in gallstone patients to determine whether a combination of extracorporeal shock-wave lithotripsy and subsequent dissolution with methyl tert-butyl ether increases the success rate of methyl tert-butyl ether dissolution and shortens treatment time compared with monotherapy with methyl tert-butyl ether. Fifty patients were randomized into two groups. Twenty-five patients underwent extracorporeal shock-wave lithotripsy before contact dissolution with methyl tert-butyl ether, and 25 patients were treated with methyl tert-butyl ether alone. All patients had at least three stones or stones larger than 30 mm that were radiolucent on x-ray and had densities of less than 140 Hounsfield Units (HU) on computed tomography. Overall, the combined approach neither shortened the treatment time significantly vs. monotherapy with methyl tert-butyl ether nor reduced the time of hospitalization. The success rate was slightly but not significantly increased compared with that of methyl tert-butyl ether therapy alone. The recurrence rate was similar in the two groups after a median follow-up of 1 yr. However, when subgroups of patients with at least one stone larger than 15 mm or with stones with densities of more than 60 HU were analyzed, the clearance rate after 5 mo was significantly higher (p < 0.005 and p < 0.025, respectively) in patients subjected to a combination of extracorporeal shock-wave lithotripsy and methyl tert-butyl ether dissolution. Extracorporeal shock-wave lithotripsy and methyl tert-butyl ether did not expose patients to more adverse effects than did treatment with methyl tert-butyl ether alone.

Bile acid dissolution therapy alone or in combination with extracorporeal shock-wave lithotripsy continues to be a safe and effective non-surgical treatment for highly selected patients with cholesterol gallstone disease. Its disadvantages are the duration of drug treatment and potential stone recurrence. Its advantages, however, are non-invasiveness, low rate of morbidity, and lack of mortality. Considering the variety of options in modern gallstone therapy, the careful selection of treatment should be tailored to the individual patient's clinical and personal situation. This will involve the patient in the decision-making process.

The role of gallbladder emptying in fragment disappearance following shock wave lithotripsy of gallstones is poorly understood. We studied gallbladder motility in two groups of patients who had been treated by electrohydraulic shock wave lithotripsy and bile acid dissolution therapy. Group I (n = 20) consisted of patients with fragment disappearance within 18 months after lithotripsy, while patients in group II (n = 20) still harboured fragments in the gallbladder 18 months after lithotripsy. Fasting gallbladder volume was 19 +/- 10 ml (mean +/- S.D.) in group I, and 24 +/- 12 ml in group II (not significant). The residual volume was 8 +/- 9 ml in group I, but 18 +/- 14 ml in group II (p < 0.005). Thus, patients in group I ejected nearly twice as much of the fasting gallbladder volume as patients in group II. This difference in gallbladder emptying was still present if only the patients with single stones were compared in both groups. From the results of this retrospective study we conclude that gallbladder emptying is an important factor for complete fragment disappearance after gallstone disintegration by extracorporeally generated shock waves. Further prospective studies are needed to confirm these observations.

Shock wave lithotripsy is a noninvasive treatment for gallstone disease, suitable for about 20% of the patients, and does not require anesthesia. Clearance of the fragments depends on: stone number and size, sufficient fragmentation and bile acid dissolution therapy. Several months are required for complete fragment disappearance. The recurrence rate is relatively low.

Extracorporeal shock wave lithotripsy of pancreatic duct stones (largest stone 12 (SD) 6 mm) was performed in 24 patients with abdominal pain and a dilated duct system (main pancreatic duct 10 (3) mm). The procedure was well tolerated in all but two patients, who had a mild pancreatitic attack immediately after lithotripsy. Disintegration of the stones was achieved in 21 patients. This allowed complete clearance of the duct system by an endoscopic approach in 10 (42%) patients and partial clearance in 7 (29%) patients. Within a mean follow up period of 24 (14) months half of the patients showed complete or considerable relief of pain and alleviation of symptoms was achieved in seven patients. Relief of pain occurred more often after complete ductal clearance. There were no fatalities within the follow up period. These findings underline the value of a combined non-surgical approach, using endoscopy and adjuvant shock wave lithotripsy to patients with large pancreatic calculi and pain attacks.

In 97 patients with radiolucent solitary gallbladder stones, the density of the calculi was evaluated by computed tomography (CT) prior to extracorporeal shock wave lithotripsy (ESWL). Sixty-three percent of the stones were isodense to bile (mean 48 +/- SD 11 HU), and 37% could be identified on CT-sections (maximal density 105 +/- 46 HU, mean density at the largest cross-section 53 +/- 31 HU). There was a slight trend toward better stone fragmentation and higher clearance rate in patients with isodense stones. However, the probability of complete fragment clearance was not significantly different in stones with a high or low CT-density. From these data we conclude that stone selection for ESWL and adjuvant bile acid therapy in patients with radiolucent solitary stones as assessed by oral cholecystography is only marginally improved by computed tomography.

Over 5 yr, 103 elderly patients (mean age = 70 yr) with bile duct stones (mainly not amenable to endoscopic extraction) underwent adjuvant extracorporeal shock-wave lithotripsy using a first-generation kidney lithotripter. Disintegration of stones was achieved after a mean of 1.4 sessions in 92% of the patients. Spontaneous passage of fragments into the duodenum occurred in one fourth of the patients, and endoscopic extraction of fragments was necessary in 75% of the patients, resulting in complete clearance of the bile duct stones in 91 (88%) of 103 patients. The most important adverse effect was septic disease after extracorporeal shock-wave lithotripsy in 4% of the patients. The 30-day mortality rate was 1% (one patient), and another 15 patients died during a mean follow-up of 26 +/- 14 mo (mainly of causes unrelated to biliary tract disease). Two of 91 patients who had been rendered stone free were readmitted because of recurrent stone disease during the follow-up period. Of the 43 patients who still had their gallbladders during extracorporeal shock-wave lithotripsy, 14% subsequently underwent cholecystectomy. These data show that extracorporeal shock-wave lithotripsy of bile duct stones is a useful and safe adjunct to nonsurgical procedures for the removal of calculi in the biliary tree.

Twenty-four patients with symptomatic gallbladder stones (12 radiolucent and 12 calcified) were treated by a combined approach of extracorporeal shock-wave lithotripsy (ESWL) and subsequent instillation of methyl tert-butyl ether (MTBE). The patients received a mean of 1500 +/- 185 shock-wave discharges. The mean instillation time of MTBE was 13 +/- 4.2 hr. Treatment was tolerated without major adverse effects. Within a time period of three to five days eight of 12 patients with pure radiolucent stones and four of 12 with calcified stones became stone-free. After a median follow-up of five months (range: one week to 26 months), a total of 11 patients (92%) with radiolucent stones and of eight patients (66%) of those with calcified stones were free of stones, fragments, or debris. These clearance rates appear high when compared with reports on monotherapy with ESWL or MTBE, suggesting a positive effect of a combined approach in selected patients. Two patients exhibited recurrent stones after six and seven months, respectively.

A comparative study of the effectiveness of two types of lithotripter in fragmenting gall bladder stones is reported. The machines used were a Piezolith 2300, which generates shock waves by the piezoceramic principle, and a Dornier MPL 9000, which produces the shock waves by underwater spark discharge. With each machine, corresponding stones of 45 pairs of weight and volume matched calculi (median volume 0.5 cm3, median diameter 10.5 mm) obtained at cholecystectomy were treated. All stones were successfully disintegrated (fragments smaller than 2 mm) with up to 5400 (median 628) shocks with the Piezolith and 3450 (median 428) shocks with the MPL 9000 lithotripters. With the Piezolith, operating at the highest power setting, a 1.65 fold median higher number of shocks was required for stone fragmentation than with the MPL 9000 at a medium power setting. Stone volume seemed to be the only determinant which affected ease of fragmentation; composition and density of the stones as assessed by computed tomography did not seem to be governing factors.

Objective: To evaluate the long-term results of three types of shock wave treatment in patients with radiolucent gallbladder stones., Design: Cohort study., Setting: Single-center trial., Patients: Of 5824 patients with gallstones, 19% were eligible; 711 patients were treated., Interventions: Patients received extracorporeal shock wave lithotripsy as well as adjuvant therapy with bile acids., Results: Lithotripsy was done in three ways, using a water-tank lithotriptor (group A), a water-cushion lithotriptor at low energy levels (group B), and a water-cushion lithotriptor at high energy levels (group C). The rate of complete fragment clearance 9 to 12 months after lithotripsy was done differed significantly among the three groups: Among patients with single stones of 20 mm or less in diameter, the rate of fragment clearance for group A was 76%; for group B, it was 60%; and for group C, it was 83% (P = 0.03). Among patients with single stones of 21 to 30 mm, the rate of fragment clearance for group A was 63%; for group B, it was 32%; and for group C, it was 58% (P less than 0.005). Among patients with two or three stones, the rate of fragment clearance for group A was 38%; for group B, it was 16%; and for group C, it was 46% (P = 0.01). Patients with fragments of 3 mm or less 24 hours after lithotripsy was done showed a higher probability of fragment disappearance than did those with larger fragments (P less than 0.001). The clearance rate was higher in patients who were compliant than in those who were noncompliant with bile acid therapy (P less than 0.001). Adverse effects included liver hematoma in 1 patients, biliary pain attacks in 253 patients (36%), mild biliary pancreatitis in 13 patients (2%), and cholestasis in 7 patients (1%). Elective cholecystectomy was done in 16 patients (2%), and endoscopic sphincterotomy was done in 4 patients (1%)., Conclusions: The rate of complete disappearance of stones after shock wave therapy depends on the size and the number of the initial stones, the diameter of the largest fragment, and the mode of shock wave treatment. Adjuvant therapy with bile acids appears to be important for complete fragment clearance.

Extracorporeal shock-wave lithotripsy combined with adjuvant bile-acid dissolution therapy results in complete clearance of stone fragments in a high percentage of selected patients with radiolucent gallbladder calculi. With the gallbladder in situ, these patients are at risk of stone recurrence. Therefore, the early rate of stone recurrence after successful lithotripsy was evaluated. Fifty-eight of the first 60 consecutive patients who became stone free underwent follow-up examinations at least 1 yr (range, 12-37 mo; mean +/- SD, 18 +/- 6) after discontinuation of adjuvant bile-acid therapy. Five patients reported recurrent biliary pain within 1 yr after lithotripsy, and recurrent gallstones were detected. Fifty-three patients were asymptomatic during the first yr, and no recurrence was detected. Thus, the rate of gallstone recurrence was 9% within 1 yr. The rate of gallstone recurrence up to 3 yr was estimated by actuarial analysis. The probability of stone recurrence was 11% (+/- 4%) at 1.5 yr, and no further increase was observed up to 3 yr. Gallstone recurrence within 1 yr after successful shock-wave therapy has to be expected in approximately the same percentage of patients as has been reported in earlier postdissolution trials. It causes recurrent biliary pain in most cases.

In summary, 10% to 20% of all symptomatic and uncomplicated gallbladder stones can be treated by ESWL under the current entry criteria. Further, ESWL is suitable for patients with bile duct stones in whom the primary endoscopic approach is not successful (about 10%). The algorithm in Figure 7 shows the therapeutic modalities that may be employed if the least invasive therapy is chosen. The different methods shown in this diagram are usually carried out by different specialists including surgeons, gastroenterologists, or radiologists. Therefore, an interdisciplinary approach is desirable. The technology of shock wave therapy of gallbladder stones will be improved in the future, for example the efficacy of stone fragmentation while maintaining a low level of discomfort for the patient. Moreover, repeated shock wave treatments may increase the success rate in patients with multiple stones and possibly in those with slightly calcified stones as well. Repeated procedures for recurrent stones appear feasible. Long-term follow-up studies are needed to define the place of ESWL in the management of gallstone disease. Surgery of the gallbladder remains the "gold standard" of curative therapy of gallbladder stones, against which ESWL and other nonsurgical techniques have to be evaluated. For the therapy of bile duct stones, ESWL is a helpful and effective nonsurgical adjunct.

Extracorporeal shock-wave lithotripsy combined with adjuvant litholytic therapy (ursodeoxycholic acid and chenodeoxycholic acid) is a relatively safe and effective noninvasive therapy for selected patients with symptomatic radiolucent gallbladder stones. The best results (80% stone-free patients within 1 year) are obtained with radiolucent solitary stones with a diameter of less than 20 mm. Shock-wave lithotripsy achieves rapid clearance of stones in about 80% of patients with bile duct calculi in whom endoscopic procedures fail.

Extracorporeal shock wave lithotripsy of pancreatic stones was performed in eight patients with chronic pancreatitis and a dilated duct system harbouring stones 5 to 20 mm (means 10 (SD) 5 mm) in diameter. After endoscopic sphincterotomy of the pancreatic orifice the stones were disintegrated by shock waves under fluoroscopic control using a kidney lithotripter (Dornier HM3). The procedure was well tolerated by all but one patient, who had a mild pancreatitic attack immediately after lithotripsy. Clearance of the pancreatic duct systems from the larger stones was achieved in seven of eight patients. Half of the patients showed no improvement in the intensity and frequency of pain. The other patients had a marked amelioration of symptoms, however, both immediately and during a mean follow up interval of 11 (eight) months. A selective combined approach by endoscopy and extracorporeal shock wave lithotripsy for the treatment of pancreatic stones seems promising.

Extracorporeal shock-wave lithotripsy has been introduced as a novel nonsurgical therapy for gallstone disease. To substantiate the initial results, more than 400 patients with biliary calculi have been treated. In selected patients with gallbladder stones, complete clearance of all stone fragments can be expected within 1 year in about 80%. In patients with bile-duct stones not amenable to endoscopic measures, sufficient stone fragmentation by extracorporeal shock waves was achieved in about 80%. Extracorporeal shock-wave lithotripsy is a safe and efficient therapy for selected patients with gallbladder calculi. For patients with bile-duct stones not amenable to endoscopic measures it offers a nonsurgical alternative.

Today, several methods of treatment for gall stone disease exist besides standard surgical procedures: endoscopy, lithotripsy, litholysis or a combination of the above. During the last four years 1786 patients were treated using an interdisciplinary approach. Cholecystectomy was still the most frequent method of treatment for symptomatic cholecystolithiasis (n = 1369) with low morbidity (4.3%) and lethality (0.28%). Probably less than 20% of all cases fulfill the strict selection criteria for extracorporeal shock wave lithotripsy (ESWL). All alternative methods of treatment in which the gallbladder is preserved have an increased risk for gall stone recurrence. Only after the long-term follow-up results of ESWL are known, the recurrence rate can be assessed. In most cases, bile duct stones (n = 417) were removed by endoscopy, if necessary in combination with ESWL (n = 310, stone removal: 95%, lethality: 0.3%). However, in low risk patients with concurrent cholecystolithiasis surgery was still the method of choice (n = 107, stone removal: 96%, lethality: 0/107). It seems not so important as to who performs the non-surgical procedures in the treatment of gall stones - the surgeon, internist or radiologist. Moreover, an interdisciplinary approach should be sought.

To determine whether extracorporeal shock-wave lithotripsy of gallbladder stones alters gallbladder motility, gallbladder contraction in response to intravenous cholecystokinin was investigated by ultrasound. Twenty-one patients with symptomatic gallstones were studied before and after shock-wave lithotripsy, 12 with and 9 without concomitant litholytic therapy (combination of ursodeoxycholic acid and chenodeoxycholic acid). Gallbladder emptying was significantly delayed and less complete in both groups of patients before shock-wave treatment (with bile salts: residual volume, 51% +/- 10% and half-ejection time, 40 +/- 5 min; without bile salts: residual volume, 46% +/- 7%; half-ejection time, 30 +/- 4 min) compared with healthy controls (residual volume, 15% +/- 4%; half-ejection time, 18 +/- 2 min). Gallbladder motility was not altered in either group 1 day and 1 yr after lithotripsy. The findings indicate (a) that extracorporeal shock-wave lithotripsy has no immediate or long-term adverse effects on gallbladder motility and (b) that the defect of gallbladder motility associated with gallstone disease is not abolished by removal of the stone.

1206 patients with gallstone disease were treated between January 1985 and December 1987, using an interdisciplinary concept that included surgery, endoscopic sphincterotomy, and extracorporeal shock-wave lithotripsy (ESWL). Twenty-five per cent of the patients who were admitted for gallbladder stones were treated by ESWL, whereas 75% underwent surgery. Mortality of elective treatment for gallbladder stones amounted to 0.25% (0.4% in surgery, 0% in ESWL). Postoperative complication rate was low (4.2% in surgery, 7.0% in ESWL). After ESWL treatment, 80% of the patients were free of stones after a follow-up period of 1 year. Recurrence rate in these patients amounted up to 10%; in seven of 70 patients, mean follow-up period was 6 months after complete disappearance of stones. Twenty-seven per cent of all patients who were admitted for bile duct stones underwent surgery, whereas in the other 73%, calculi were removed via endoscopy. ESWL treatment was used additionally, if necessary. Fragments were left behind in three of 75 patients (4.0%) after surgical treatment, and in 7 of 200 patients (3.5%) after endoscopic and ESWL treatment, respectively. In the latter group, three patients (1.5%) required an additional operation. There were no deaths in either of the groups. The use of ESWL for treatment of gallbladder stones needs to be evaluated in long-term follow-up studies. Thus far, surgery remains the dominating method. Endoscopic procedures, eventually combined with ESWL, represent the preferred treatment for patients with bile duct stones.

A patient with gastric outlet syndrome (Bouveret's syndrome) caused by a large gallstone impacted in the duodenal bulb was successfully treated by extracorporeal shock-wave lithotripsy. Thus, open abdominal surgery could be avoided. For disintegration of the stone, three consecutive lithotripsy procedures were necessary. Thereafter, stone fragments could be extracted endoscopically. Extracorporeal shock-wave lithotripsy could become a non-surgical alternative in patients with obstruction of the duodenum caused by a gallstone.

We report the case of a 33-year-old woman with chronic calcifying pancreatitis in whom an intraductal pancreatic stone with a diameter of 8 mm was successfully disintegrated with extracorporeal shock waves, permitting subsequent endoscopic extraction of the fragments. The patient had a mild attack of pancreatitis after the treatment. We conclude that shockwave lithotripsy of a pancreatic duct stone in patients with chronic pancreatitis is possible. It should, however, be viewed with reservation until further experience has been gained.

Five cases of surgical intervention following extracorporeal shock wave lithotripsy (ESWL) of gallbladder and bile duct stones are reported. This represents an incidence of surgical intervention in 1% of patients with gallbladder stones and in 9% of patients with common bile duct stones who underwent ESWL during a two-and-a-half-year investigation period. There was no mortality. In 2 patients with gallbladder stones and persistent colic after ESWL, elective cholecystectomy was performed. There was no evidence of macroscopic or microscopic damage or bleeding within the wall of the gallbladder. Furthermore, no damage to the liver, common bile duct, duodenum, or stomach was noted. ESWL was applied in 34 patients with common bile duct stones in whom endoscopic sphincterotomy and stone extraction had proved ineffective. Three (9%) of these patients required surgery. In 1 patient, a Dormia basket got stuck and the basket, together with the stone, were removed by choledochotomy. In a second patient, rupture of a juxtapapillary diverticulum occurred 10 days after ESWL and 2 days after endoscopic extraction of stone fragments. At laparotomy, the retroperitoneum was drained. In a third patient with gallbladder and common bile duct stones, acute cholecystitis developed after lithotripsy of common bile duct stones. Cholecystectomy was performed and a t-tube was inserted in the bile duct. In all patients, the postoperative course was uneventful. In our experience, ESWL is a safe procedure with no mortality and an infrequent need for surgical intervention.

Eighty in vitro experiments were performed with single (n = 51) or multiple (n = 29) gallstones in order to find out which parameters are of prime importance for their disintegration by extracorporeal shock waves. A Dornier lithotripter and an upper limit of 1,500 discharges were employed. Although computed tomography density was significantly lower in cholesterol stones than in the noncholesterol stones (p less than 0.0001) and although the latter were significantly more often radiopaque (p less than 0.0001), we found no clear-cut correlation between the cholesterol content or computed tomography density and the degree of fragmentation of the stones. The most important variable which limited successful disintegration was the total stone volume. In stones with a mean total volume of 0.83 ml +/- 0.25 S.E. (diameter for single stones = 11.5 +/- 0.9 mm), none of the fragments exceeded 2 mm, whereas in stones with a mean volume of 3.6 ml +/- 0.64 (diameter = 17.2 +/- 1.5 mm) at least one fragment larger than 2 mm remained (p less than 0.002). Under the in vitro conditions, fragmentation was similar in multiple and solitary stones, provided the volume of the stones was comparable. These data show that, in general, the number and size of the stones, i.e. their total volume, and much less significantly their chemical composition are the major determinants of fragmentation by extracorporeal shock waves.

In order to test whether shock wave fragmentation of human gallstones increases their dissolution rates in a bile acid-lecithin solution, we carried out in vitro experiments. Stones comparable in size, weight and cholesterol content (86%) from the same human gallbladder were disintegrated by shock waves. A glycoursodeoxycholic acid (GUDC)-lecithin solution served as solvent. After 10 days incubation in this solvent, intact stones had lost only 4% of their cholesterol. This value increased to 92% after disintegration of the stones by 300 shock wave discharges. Fragments with a size of less than 2 mm had lost 55% of their cholesterol after day 1 and 99% after day 10. A large stone fragment cleaved off by shock waves lost much more cholesterol (42% after 10 days) than an intact untreated stone (4% after 10 days) comparable in size, weight and cholesterol content. These data show that shock wave lithotripsy of cholesterol gallstones considerably accelerates their dissolution rate in a GUDC-lecithin solvent, the desirable fragment size being 2 mm or less. However, even large fragments may lose much more cholesterol than comparable intact stones as a result of changes in surface structure as documented by scanning electron microscopy. The experiments favor the concept of a combined treatment of gallbladder stones by extracorporeally generated shock waves and bile salt therapy.

We treated nine patients with functioning gallbladders containing one to three symptomatic radiolucent stones not larger than 25 mm in diameter, as well as five patients with stones in the common bile duct that were not removable by endoscopic procedures, by means of extracorporeally generated shock waves during general anesthesia. The patients with gallbladder stones received adjuvant treatment with a combination of ursodeoxycholic acid and chenodeoxycholic acid. All gallbladder stones were disintegrated into sludge or fragments with diameters of no more than 8 mm. In six of the nine patients the fragments disappeared completely within 1 to 25 weeks. No adverse effects were detected during a follow-up period of 10 to 34 weeks, except transient biliary pain in two patients, with mild pancreatitis in one. In four of the five patients with common-bile-duct stones, shock-wave treatment permitted stone disintegration and successful endoscopic extraction or spontaneous passage of fragments. We conclude that gallstone disease may be treated successfully and without serious adverse effects by extracorporeally generated shock waves in selected patients.