Routine testing of liver function after biliary-enteric anastomosis has no clinical relevance.

BACKGROUND/AIMS: Patients who had a biliary-enteric anastomosis often have elevated liver function tests. The aim of this study was to investigate whether elevated liver function tests are associated with recurrent episodes of cholangitis. METHODOLOGY: Thirty-two patients, who received a biliary-enteric anatomosis for benign biliary disease were evaluated. Follow-up consisted of the patient's history, physical examination, determination of liver function tests, ultrasonography and hepatobiliary scintigraphy using 99mTc-HIDA. RESULTS: Median duration of follow-up was 45 months (range: 1-192) and liver function tests were elevated in 22 patients (69%) at some time during follow-up. Dilated intrahepatic ducts were found in 3 of 30 patients (10%), all of whom had elevated liver function tests at follow-up. Delayed passage from the liver was observed using scintigraphy in 10 (31%) of the patients. Seven patients (22%) experienced one episode of cholangitis and none experienced more than one episode. Multivariate analysis showed that male sex was an independent risk factor for elevated liver function tests (odds ratio: 10.9; P < 0.05). For cholangitis, no risk factors could be identified. CONCLUSIONS: It is concluded that elevated liver function tests are relatively common after a biliary-enteric anastomosis for benign biliary tract disease and are not predictive of the occurrence of cholangitis. We, therefore, recommend omitting routine laboratory screening for elevated liver function tests in the follow-up of a biliary-enteric anastomosis.

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.

Proximal cholangiocarcinoma: a multidisciplinary approach.

OBJECTIVE: To evaluate our diagnosis and treatment of proximal cholangiocarcinoma. DESIGN: Retrospective clinical study. SETTING: Department of Surgery, University Hospital. SUBJECTS: 66 patients with proximal cholangiocarcinoma [median age (range): 64 years (28-87)]. INTERVENTIONS: Ultrasonography (n = 65), computed tomography (n = 55), endoscopic retrograde cholangio-pancreaticography [ERCP] (n = 54), percutaneous transhepatic cholangiography [PTC] (n = 32), angiography (n = 19) and cytology (n = 13) were used in diagnosis. Treatment consisted of: insertion of a stent (n = 37), resection of the tumour (n = 16), and biliary-enteric anastomosis (n = 9). Twenty-eight patients received radiotherapy, 3 patients received no active treatment. MAIN OUTCOME MEASURES: Usefulness of diagnostic methods, survival. RESULTS: Ultrasonography, ERCP and PTC were helpful whereas computed tomography, angiography, and cytology added little additional information. Mean (SEM) survival after resection was 35.8 months (7.4) and after conservative treatment 10.4 months (1.5) (p < 0.001). CONCLUSION: A multidisciplinary approach is necessary and the tumour should be resected if possible.

Current role of extracorporeal shockwave therapy in surgery.

In urology the introduction of extracorporeal shockwave therapy brought a revolutionary change to the management of urinary calculi. This inspired the introduction of shockwave therapy in several fields of surgery; it has been applied as a potential alternative to several operative procedures but is still experimental. So far, the major application of shockwave therapy has been lithotripsy of stones in the gallbladder, common bile duct, pancreatic duct and salivary gland ducts. Other applications are in the non-operative management of bone healing disturbances and in the inhibition of tumour growth. Steps towards selective thrombus ablation and pretreatment of heavily calcified arteries have also been made. In this review, the applications of extracorporeal shockwave therapy in several areas of surgery are discussed. It is concluded that, for selected patients, shockwave treatment may serve as a useful addition to the surgical armamentarium.

Radiographic features of oral cholecystograms of 448 symptomatic gallstone patients: implications for nonsurgical therapy.

Since radiographic findings on oral cholecystography (OCG) have implications for the eligibility for nonsurgical therapy of elderly patients, we investigated the OCGs of 448 symptomatic gallstone patients (109 male, 339 female; mean age, 49.8 +/- 14 (range, 21-88)). Opacification of the gallbladder was found in 323 cases (72.1%). Calcifications of gallstones were found in 85 opacified gallbladders (26.3%). Solitary and multiple stones were calcified in 35.3% and 18.2%, respectively (P < 0.0005). When divided into two groups (< or = 40 years and > 40 years), there was a significant increase in calcifications (P < 0.02) and a non-significant increase in opacification with increasing age. It is concluded that age is a determinant for calcification of gallstones and not opacification of the gallbladder. Since multiple stones are proportionately observed more in clinical studies than in epidemiologic studies, it is suggested that multiplicity of stones predisposes to biliary complaints. That solitary stones are more likely to be calcified than multiple stones, adds to the hypothesis that solitary and multiple stones have a different pathogenesis. Elderly patients, in whom non-surgical therapy is most likely to be indicated and cost-effective, are less likely to be suitable for this form of treatment, since age is a determinant for stone calcification.

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.

Role of extracorporeal shock wave lithotripsy in hepato-biliary-pancreatic surgery.

Since the early 1980s extracorporeal shock wave lithotripsy (ESWL) has partially replaced major operative procedures in various fields of surgery. In the interest of the patient, it is important to determine the exact role of ESWL in surgery. Comparing our own prospectively followed patients with other patient series, we have tried to assess this role. We treated 133 patients with cholecystolithiasis, 80 patients with choledocholithiasis, and 17 patients with pancreatic stones using a second-generation lithotriptor, the Siemens Lithostar (Siemens, Erlangen, Germany). The results suggest a limited role of ESWL for cholecystolithiasis, in which it is reserved for patients with high operative risk and patients who reject an operation. For choledocholithiasis ESWL seems to become an integral part of the treatment in the elderly patient in whom endoscopic stone removal proved impossible. Finally, ESWL could become a first option for the treatment of intractable pain in patients with chronic calcifying pancreatitis.

Current treatment modalities for symptomatic gallstones.

Gallstone disease is an important clinical problem: approximately 10% of all adults in the western population have gallstones. Most gallstones, however, remain asymptomatic, and from various disciplines there is consensus that only symptomatic gallstones require therapy. Since the first gallbladder extirpation in 1882, cholecystectomy has been considered the gold standard. Nowadays, this operation is performed laparoscopically in most hospitals. Despite relatively low morbidity and mortality rates, a number of alternative therapies have been developed in the past few years. These alternative treatment modalities are especially indicated in high risk patients and in patients rejecting surgery. In this review article, the currently available treatment modalities are discussed.

[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.