Liver fibrosis after extracorporeal shock-wave lithotripsy of gallbladder stones. A case report.

We encountered significant liver fibrosis in a healthy young patient undergoing laparoscopic cholecystectomy for symptomatic gallstone disease. Twelve months prior to cholecystectomy the patient underwent multiple extracorporeal shock-wave lithotripsy (ESWL) sessions with adjuvant oral bile-acid therapy. Since the site of fibrosis corresponded clearly to the shock-wave transmission path, which was in accordance with animal studies, it was concluded that this liver fibrosis was a side effect of biliary ESWL. Based on these findings and the literature, we conclude that further assessment of the long-term safety of ESWL is still warranted, especially in patients undergoing multiple ESWL sessions.

Quality of life after treatment of gallstones: results of a randomised study of lithotripsy and open cholecystectomy.

OBJECTIVE: To compare quality of life after extracorporeal shock wave lithotripsy (ESWL) and open cholecystectomy for symptomatic gallstones. DESIGN: Randomised study. SETTING: University hospital, The Netherlands. SUBJECTS: 49 Patients, 23 of whom were randomized to undergo ESWL and 26 to undergo open cholecystectomy. INTERVENTIONS: Health questionnaires were filled out before, and at 3, 6 and 12 months after treatment. MAIN OUTCOME MEASURE: Improvements of quality of life after one year. RESULTS: Both treatments improved quality of life. Open cholecystectomy improved quality of life significantly better than ESWL (median percentage gains in Nottingham Health Profile scores at 1 year 17.1 and 10.5, respectively, p = 0.003). CONCLUSION: Open cholecystectomy is superior to ESWL in improving quality of life, so cholecystectomy remains the treatment of choice for symptomatic gallstones. For patients who are unfit or unwilling to undergo operation, however, ESWL is adequate because most patients have some benefit from it in terms of quality of life.

Extracorporeal shock-wave lithotripsy of pancreatic duct stones: immediate and long-term results.

To study the efficacy of extracorporeal shock-wave lithotripsy (ESWL) of pancreatic duct stones, seventeen patients (mean age: 42 years) with recurrent attacks of abdominal pain as a result of chronic calcifying pancreatitis were treated with this method. In all cases, endoscopic removal of the stones proved impossible. When there was fragmentation, the remaining calculi and fragments either evacuated spontaneously, or attempts were made to extract them endoscopically, followed by flushing. In 13 patients (76%), fragmentation of stones was achieved, and 11 of these patients had dramatic pain relief directly after ESWL (65%). However, complete ductal clearance of stones was achieved in only seven patients (41%); at the last follow-up (12-59 months after ESWL, mean: 30 months), all seven were free of symptoms. Of the six patients with stone fragmentation without ductal clearance, three were operated on because of recurrent complaints. The only complication due to the procedure was an exacerbation of pancreatitis in one patient, which was treated conservatively. If pancreatic stones cannot be removed endoscopically, ESWL seems to be preferable to surgery, which may still be performed in case of failure. It seems important to achieve ductal clearance and not merely stone disintegration in order to obtain the desired long-term clinical effects.

Unexpected difficulties in randomizing patients in a surgical trial: a prospective study comparing extracorporeal shock wave lithotripsy with open cholecystectomy.

Shortly after extracorporeal shock wave lithotripsy (ESWL) was introduced as a promising new treatment modality for gallstone disease, a randomized controlled study was performed to assess the cost-effectiveness of ESWL compared to open cholecystectomy, the gold standard. During the performance of this study it was found that during a 3-year intake period only 8.3% (37 of 448) of the patients could be entered into the trial. Three factors were identified that hampered patient accrual: (1) restricted eligibility for ESWL (and thus for the study), which could not have been predicted on the data provided in the literature; (2) the introduction of laparoscopic cholecystectomy; and (3) strong patient preference, inhibiting randomization. All three mechanisms could not have been predicted during the design phase of the study. It is concluded that it is not always feasible to conduct a randomized study in surgery due to unforeseen circumstances. Entering patients into surgical trials is difficult in quickly evolving fields of surgery, such as the management of gallstone disease. Acquiring informed consent is also difficult when treatment characteristics are divergent. A randomized controlled study on the effects of laparoscopic cholecystectomy will therefore probably never be performed.

Gallstone lithotripsy: the Rotterdam experience.

In the period between September 1988 and September 1992, 133 patients (34 males and 99 females; mean age 49 years [range 24-81]) underwent 299 extracorporeal shockwave lithotripsy sessions with adjuvant oral bile acid therapy. The mean number of extracorporeal shockwave lithotripsy sessions was 2.5 (1-7) and the mean number of shock waves 2,817 (75-4000), while the mean duration per session was 62 minutes (35-210). Ninety-eight patients (73.7%) required intravenous analog-sedation. At last follow-up (mean: 17.7 months [2-46]), 37 patients (27.8%) were free of stones and 30 (22.6%) had undergone cholecystectomy. At 1 year after the first session of extracorporeal shockwave lithotripsy, 51.0% of the patients with a solitary stone and 8.3% of the patients with 2-10 stones were free of concrements (p < 0.0001). Fourteen per cent [6/43] of the patients developed recurrent stones. Major complications comprised pancreatitis (n = 4; 3.0%) and acute cholecystitis (n = 1; 0.8%). Our results reconfirm that extracorporeal shockwave lithotripsy is safe and moderately effective in selected patients. Because of the wide acceptance of the laparoscopic cholecystectomy, extracorporeal shockwave lithotripsy should be restricted to patients at increased surgical risk and patients who refuse surgery. In view of the poor results in multiple stones, extracorporeal shockwave lithotripsy should be performed only on solitary stones.

The course of biliary and gastrointestinal symptoms after treatment of uncomplicated symptomatic gallstones: results of a randomized study comparing extracorporeal shock wave lithotripsy with conventional cholecystectomy.

OBJECTIVES: We performed a randomized study that compared extracorporeal shock wave lithotripsy (ESWL) with conventional cholecystectomy for uncomplicated symptomatic gallstones. The primary outcome of the study was the influence of therapy on biliary colic and gastrointestinal symptoms. METHODS: In the period October 1989-March 1992, 26 patients were randomized for cholecystectomy and 23 for ESWL. Pain diaries and symptom questionnaires were taken before, and 3, 6, 12, 18, and 24 months after therapy. ESWL patients regularly underwent ultrasound examination for determining stone clearance. Median follow-up was 18 months (12-24). RESULTS: Biliary colic was cured in 90.9% and 45.4% of the patients within 3 months after cholecystectomy or ESWL, respectively (p < 0.01). Stomach swelling, fatty food upset, and nausea responded to cholecystectomy after 6, 12, and 18 months, respectively. Nausea responded to ESWL after 6 months. Vomiting, pyrosis, ructus, diarrhea and constipation did not respond to gallstone therapy. When the two treatment arms were compared, only fatty food upset responded significantly better to cholecystectomy than to ESWL at 18 months (p < 0.05). With regard to the other gastrointestinal symptoms, no significant differences could be detected. CONCLUSIONS: We conclude that cholecystectomy is superior to ESWL in improving biliary colic and fatty food upset. Furthermore, because ESWL is not able to clear all stones and harbors the possibility of stone recurrence, cholecystectomy remains the preferred treatment modality in healthy patients with uncomplicated symptomatic gallstones.

Extracorporeal shock wave lithotripsy of common bile duct stones in patients with increased operative risk.

OBJECTIVE: Assessment of efficacy of extracorporeal shock wave lithotripsy (ESWL) of stones in the common bile duct. DESIGN: Prospective clinical study. SETTING: Department of Surgery, University Hospital Rotterdam, Rotterdam, The Netherlands. SUBJECTS: 90 patients with stones in the common bile duct and at increased operative risk (median age 73 years, range 27-95). INTERVENTIONS: After failure of endoscopic measures, the first 13 patients were treated under general anaesthesia with a first generation lithotriptor. Of the next 77 patients, treated with a second generation lithotriptor, only one required general anaesthesia and 68 intravenous analgesia and sedation. Eight patients needed no analgesia at all. MAIN OUTCOME MEASURES: Fragmentation, clearance, and recurrence of stones. RESULTS: Fragmentation of stones was achieved in all the first 13 patients and 63 of the 90 patients (69%). There were minor complications (macroscopic haematuria and subcapsular haematoma of the right kidney) in 13 and serious complications (bacteraemia) in 2. At follow-up (median 28 months), 2 patients had recurrent stones. CONCLUSION: ESWL of stones in the common bile duct is safe and effective and should be considered in high risk patients.

[Shockwave lithotripsy in the pancreas; the first 16 patients treated in Rotterdam-Dijkzigt]. / Schokgolfvergruizing van stenen in het pancreas; de eerste 16 in Rotterdam-Dijkzigt behandelde patiënten.

Sixteen patients, 7 women and 9 men, with a mean age of 42 years and with recurrent attacks of abdominal pain as a result of chronic calcifying pancreatitis, were treated with extracorporeal shock wave lithotripsy (ESWL), after endoscopical removal of one or more stones from the main pancreatic duct had proved impossible. In all patients fragmentation by ESWL of the stone situated farthest distally was attempted, after which the remaining calculi and fragments could be voided spontaneously or could be flushed via a drain placed endoscopically in the main pancreatic duct. In 12 patients (75%) fragmentation of stones was achieved, 11 of them had a dramatic relief of pain immediately after ESWL. In 7 patients (44%) stone clearance was achieved; at follow-up (1-38 months after ESWL) none of these had complaints. Of the 5 patients with stone fragmentation without stone clearance, 2 were operated on because of recurrent symptoms. The only complication seen after ESWL, was an exacerbation of pancreatitis in 1 patient, which could be treated conservatively. If pancreatic stones cannot be removed endoscopically, ESWL appears to be an attractive alternative to an operation. It is important to achieve stone clearance.

[Results of 4 years of gallstone lithotripsy]. / De resultaten van 4 jaar galsteenvergruizing.

OBJECTIVE: Determination of the efficacy of extracorporeal shock wave lithotripsy (ESWL) of gallbladder stones and adjuvant treatment with oral bile acids. SETTING: Department of Surgery, University Hospital Dijkzigt, Rotterdam, the Netherlands. DESIGN: Descriptive clinical research. PATIENTS AND METHODS: In 4 years, 133 patients (34 males and 99 females, mean age 49 years (range 24-81)) underwent 299 ESWL sessions, on an outpatient basis except for the first 16. All patients received adjuvant oral bile acid therapy (7-8 mg/kg body weight urso- and chenodeoxycholic acid, starting one day after ESWL). The number of ESWL sessions was 2.5 (mean; range: 1-7) with 2817 shock waves (75-4000), a session duration of 62 min (35-210). 73.7% of the patients (n = 98) required intravenous analgesic sedation. RESULTS: At a mean follow-up of 13.8 months (1-45), 27.6% of the patients were free of stones. At 1 year after the first ESWL session, 51.0% of the patients with a solitary stone and 8.3% of the patients with 2-10 stones were free of stones (p < 0.0001). Of the 43 patients who had become free of stones 6 developed recurrent stones (14.0%). Fifty-seven patients (42.9%) suffered from colic, 9 (6.8%) from obstruction of the common bile duct, including 4 who developed pancreatitis. Two patients had transient haematuria and one acute cholecystitis; 15 (11.3%) suffered from an oral bile acid-related diarrhoea, which could easily be resolved by lowering the dose of chenodeoxycholic acid. 30 patients (22.6%) underwent cholecystectomy. CONCLUSIONS: Our results reconfirm that ESWL is safe and moderately effective in selected patients. Nowadays most patients choose laparoscopic cholecystectomy, which implies that ESWL will be confined to patients with an increased operative risk and to those who refuse surgery. ESWL should be limited to patients with solitary stones.

The value of ultrasound in the follow-up of patients treated with biliary lithotripsy. Implications for monitoring patients after nonsurgical therapy of gallbladder stones.

To establish the value of ultrasound (US) in the follow-up of patients treated with extracorporeal shockwave lithotripsy (ESWL), the results of 484 US examinations of 87 patients were analyzed and related to the results of ESWL. Reliability of US in assessing efficacy was investigated by comparing consecutive US examinations. Unreliable US results were found in 36 patients (41%); in 7 patients US failed to demonstrate fragments. In nine patients (10%) unreliable US findings contributed to delayed retreatment with ESWL. To prevent errors in treatment regimen, verification of US findings is advised in case no fragments or fragments < 5 mm are found. In 22 patients (25%) US findings appeared indicative of hampered stone migration. Only 2 of these 22 patients (9.1%) became free of stones, compared with 32 of the remaining 65 patients (49.3%) (p < 0.01), even though both groups had similar initial stone characteristics and similar time of follow-up. US findings such as a contracted gallbladder or a common bile duct > 7 mm therefore indicate poor efficacy of ESWL.

Eligibility for extracorporeal shock wave lithotripsy of gallbladder stones using different entry criteria.

Extracorporeal shock wave lithotripsy (ESWL) was introduced as a nonsurgical treatment for uncomplicated, symptomatic gallstone disease. Due to its limited results and the possibility of stone recurrence, ESWL is mainly indicated for patients who reject or cannot tolerate cholecystectomy. For budgetary and planning purposes, it is essential to know what percentage of patients are eligible for this form of therapy. In the literature suitability is either reported variably (ranging from 10% to 53%) or not mentioned. We respectively assessed eligibility for ESWL for different entry criteria, based on the histories of 694 consecutive patients, who were referred for gallstone therapy from April 1, 1988 to October 1, 1991. Only 10.3%-46.9% of symptomatic patients were found eligible for ESWL, depending on the entry criteria used. When the overall results are compared with eligibility, there is no inverse relationship. This suggests that patient selection is not the only factor determining the results of therapy. It is concluded, therefore, that other factors, such as treatment schemes, the lithotripters used, and experience of the treating physicians, are important factors for the outcome of ESWL therapy.

[3-year results of 'gallstone outpatient clinic' in an academic hospital]. / Ervaringen van 3 jaar 'galsteenpolikliniek' in een academisch ziekenhuis.

On April 1st 1988 an outpatient clinic solely for patients with gallstones was started. 594 patients visited the gallstone outpatient clinic during the first three years of its existence and the data of all these patients were collected and examined retrospectively. Mean age was 49.0 years (SD: 15; range: 20-88), male-female ratio was 0.34 and the majority of patients were symptomatic (86.9%). 60.3% were referred by their general practitioners, 21.7% by another specialist en 18.0% sought help on their own initiative. In 8.1% of the cases there were acute biliary problems and 2.4% had an increased surgical mortality risk. Cholecystectomy was advised in the majority of patients (51.9%), expectant management in 20.2%, analysis was stopped in 2.5% and the others (25.4%) were advised a treatment alternative to cholecystectomy. Medical, but most of all public interest in the different therapeutic modalities for symptomatic cholelithiasis has a trend-sensitive character which is reflected in patterns of referral, diagnostic procedures and therapeutic advice given.

Electromagnetic shock wave lithotripsy of gallbladder stones: a wide range of inclusion criteria.

From April 1988 until November 1990, 83 patients with symptomatic gallbladder stones were treated in the University Hospital "Dijkzigt" Rotterdam with extracorporeal shock wave lithotripsy (ESWL) followed by oral administration of bile acids (urso- and chenodeoxycholic acid). According to our inclusion criteria, patients with up to 10 stones without any limit to the size of the stone(s) were accepted for treatment. On average, these patients underwent two sessions of ESWL with an electromagnetic lithotriptor (Lithostar and Lithostar Plus, Siemens AG, Erlangen, Germany). Fragmentation of stones was achieved in 70/83 (84% patients). The best results were achieved in patients with a solitary gallstone (50% of these patients were stone-free 12 months after ESWL). Four percent of the patients with two to three stones, and 12% of the patients with four to 10 stones were free of stones 12 months after ESWL. Twenty-eight (34%) patients suffered from biliary colics after ESWL, and three patients (3.5%) developed pancreatitis. The administration of oral bile acids was complicated by transient diarrhoea in 15 (18%) patients. ESWL followed by oral bile acid therapy is a relatively effective and safe therapy for a highly select population of patients with gallbladder stones, which can be performed on an outpatient basis. Although the results for multiple stones were poor, the usage of wide inclusion criteria (up to 10 stones of any size) did not affect the success rate of ESWL for multiple stones.

Extracorporeal shock wave lithotripsy of pancreatic duct stones.

Chronic calcifying pancreatitis presents a major clinical problem, often requiring extensive surgery. Extracorporeal shock wave lithotripsy (ESWL) offers a new therapeutic option. We applied ESWL after endoscopic sphincterotomy of the pancreatic orifice in eight patients with impacted pancreatic duct stones. An electromagnetic lithotriptor (Siemens Lithostar, Erlangen, FRG) was used. Patients were treated in prone position under fluoroscopic control. A mean of 6,813 shock waves (range 1,500-10,000) was delivered in one or two sessions. Disintegration of stones was achieved in 6/8 patients, initial relief of pain in 7/8 patients, and total clearance of the pancreatic duct in 3/8 patients. One patient had an exacerbation of her pancreatitis one day after ESWL, which resolved rapidly with medical treatment. No other complications were observed. Four of five patients with fragmented stones had no abdominal complaints at follow-up (mean 17 months, range 3-27). Three patients in whom ESWL was not completely successful (two without and one with partial fragmentation) underwent an operation according to Puestow. Two of them still have abdominal complaints after surgery. From these data, we conclude that ESWL of pancreatic duct stones is a promising new alternative for surgery, when endoscopic stone extraction fails.

Extracorporeal shock wave treatment of common bile duct stones: experience with two different lithotriptors at a single institution.

Extracorporeal shock wave lithotripsy (ESWL) is a new treatment modality for retained common bile duct stones. Sixty-two patients (mean age 75 years, range 27-95 years) with retained common bile duct stones were treated with two different lithotriptors. One of the lithotriptors operated on the electrohydraulic principle (Dornier HM-3) (n = 13), the other on the electromagnetic principle (Siemens Lithostar) (n = 49). All HM-3 patients were treated under general anaesthesia, whereas with the Lithostar one patients was treated under general anaesthesia, 43 received analgesia and sedation and five had no analgesia at all. Patients treated with the Lithostar had more sessions (mean 1.9 versus 1.3, P less than 0.05) and needed more stock waves (mean 8611 versus 2534, P less than 0.001) than patients treated with the HM-3. Fragmentation was achieved in all patients treated with the HM-3 and in 42 (86 per cent) patients treated with the Lithostar. In this latter group ten patients underwent common bile duct exploration without complications. Eleven patients had transient haematuria after treatment with the HM-3 and two patients (one in each group) had a subcapsular haematoma of the right kidney, all without clinical sequelae. At follow-up (median: HM-3 43 months, Lithostar 18 months), none of the patients had biliary complaints. We conclude that ESWL of retained common bile duct stones in safe and effective with both lithotriptors and should be considered before surgery in the elderly or high-risk patient.

Euro-Collins solution versus UW-solution for long-term liver preservation in the isolated rat-liver perfusion model.

To compare UW-solution (UW) and Euro-Collins (EC) for long-term liver preservation we investigated the morphology and metabolic capacity of rat liver after 18 and 42-hours cold-storage in either UW or EC. After harvesting the rat liver was transferred to a perfusion chamber where it was perfused for 10 min with UW or EC at 4 degrees C. Thereafter livers were stored at 4 degrees C in UW or EC for 18 hours (both groups n = 6) or for 42 hours (both groups n = 8). After 18-hr or 42-hr cold-storage a 2-hr warm perfusion (37 degrees C) was started with Krebs-Ringer solution with carbogen to which 125Iodine-triiodothyronine (T3) was added. Control livers (n = 8) were immediately perfused with Krebs-Ringer without cold-storage. The following parameters were assessed: ASAT-levels in the perfusate, T3-metabolites in the bile and the perfusate, the perfusion pressure, the volume of bile secreted and light-microscopical morphology at the end of the warm perfusion period. After cold storage in UW-solution the ASAT-levels in the perfusate were lower than after storage in EC as well as the perfusion pressures. These livers demonstrated a better T3-metabolism and secreted more bile than EC-stored livers. Histological examination showed more tissue damage in the EC-stored livers than in the UW stored livers. We conclude that cold-storage of rat liver in UW-solution resulted in a better morphology and metabolic capacity as compared with EC-solution.

[Shock wave lithotripsy of gallbladder stones: the initial 54 patients treated in Rotterdam-Dijkzigt]. / Schokgolfvergruizing van stenen in de galblaas; de eerste 54 in Rotterdam-Dijkzigt behandelde patiënten.

From April 1988 till May 1990 54 patients with symptomatic gallbladder stones were treated in the University Hospital Rotterdam-Dijkzigt with extracorporeal shock wave lithotripsy (ESWL) followed by oral administration of bile acids (urso- and chenodeoxycholic acid). These patients on average underwent 2 sessions of ESWL with an electromagnetic lithotriptor (Lithostar and Lithostar Plus, Siemens AG, Erlangen, FRG). Ultimate disintegration of stones was achieved in 50/54 (93%) patients. The best results were achieved in patients with a solitary gallstone (56% of these patients were stone-free 12 months after ESWL). Four per cent of the patients with 2-10 stones were free of stones 12 months after ESWL). Thirty-seven per cent of the patients suffered from biliary colics after ESWL and three patients developed pancreatitis. The administration of oral bile acids were complicated by transient diarrhoea in 20% of the patients. ESWL followed by oral bile acid therapy is a relatively effective and safe therapy for a highly selected population of patients with gallbladder stones.