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In Germany, the use of quality data to support hospital capacity planning was introduced in 2017. On behalf of the Federal Joint Committee, IQTIG suggested 11 quality indicators and developed a program on how to collect, evaluate and report data for the clinical areas gynaecological surgery, obstetrics and breast surgery. By analysing data from 2015 to 2021, effects of the introduction of the program on indicator results, statistical discrepancies and impact on care quality are examined. Effects on capacity planning are discussed. Since the program started, indicator results improved in all clinical areas, and statistical discrepancies and the number of assessments with insufficient quality decreased due to enhanced adherence to quality standards and data validity. Effects on capacity planning or the allocation of hospitals have not occurred. Thus, a change of the legal basis to allow a better link between quality and hospital planning is recommended. The approach to use quality data on hospital regulation in Germany is evolving. The current hospital reform in Germany also addresses other approaches to quality-based regulation. Already now, there have been clear improvements in specific indicators as well as lessons for quality assurance and its link to capacity planning provided by the program, which are also applicable to other countries., Competing Interests: Declaration of Competing Interest None, (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: The number of catheter related bloodstream infections (CRBSI) could be reduced and the outcome improved if specific standards in the quality of care were maintained. Therefore, the development of quality assurance (QA) procedures was commissioned to be included in the national mandatory QA programme in Germany., Methods: Indicators representing quality deficiencies and potential for improvement of quality in relation to prevention and management of central venous catheters (CVC) were developed by (1) evidence-based literature searches and the compiling of an indicator register; (2) a multi-professional expert panel including patient representatives who selected indicators from this register by using a modified RAND/UCLA Appropriateness Method; (3) defining methods for data assessment, risk adjustment and feedback of indicator results to service providers; and (4) consulting all relevant medical societies and other stakeholders with regard to the QA procedures that had been developed., Results: Thirty-two indicators for CRBSI prevention and management were eventually approved by the expert panel. These indicators represent quality of care at predefined points with regard to indication, insertion and care of CVCs, management of sepsis, general hygiene and training of health care personnel. Fourteen indicators represent processes, together with 7 representing structures and 11 outcomes. For assessing these indicators, data was obtained from four sources: claims data from health insurance funds, routine claims data from hospital electronic information systems, case specific longitudinal documentation from service providers and cross-sectional annual assessment of structures., Conclusions: It was possible to develop indicators for mandatory QA procedures on CRBSI that take into account the different perspectives of all stakeholders involved. Despite efforts to use routine data for documentation wherever possible, most indicators required extra documentation.

Since 2001, statutory external quality assurance (QA) for hospital care has been in place in the German health system. In 2009, the decision was taken to expand it to cross-sectoral procedures. This novel and unprecedented form of national QA aims at (1) making the quality procedures comparable that are provided both in inpatient and outpatient care, (2) following-up outcomes of hospital care after patients' discharge and (3) measuring the quality of complex treatment chains across interfaces. As a pioneer procedure a QA procedure in cataract surgery QA was developed. Using this as an example, challenges of cross-sectoral QA are highlighted. These challenges relate, in particular, to three technical problems: triggering cases for documentation, following-up patients' after hospital discharge, and the burden of documentation in outpatient care. These problems resulted finally in the haltering of the development of the QA procedure. However, the experiences gained with this first development of cross-sectoral QA inspired the reorientation and further development of the field in Germany. Future cross-sectoral QA will rigorously aim at keeping burden of documentation small. It will draw data for QA mainly at three sources: routine data, patient surveys and peer reviews using indicators. Policy implications of this reorientation are discussed., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Objectives: Evaluation of the classification of the patients with coronary procedures [CP: coronary angiography (CA) and/or percutaneous coronary intervention (PCI)] in Germany to provide valid data as a basis for the evaluation of resource planning and comparison of results from other countries., Background: In the case of CP, most data are restricted to procedures related to acute coronary syndrome (ACS), either STEMI or NSTEMI, and does not cover the whole range of coronary angiographies and therapeutic procedures. To contribute to the clarification of this situation, our analysis was performed., Methods: The data of all patients with CP documented according to § 137 German Social Security Code V (SGB V) by hospitals registered under the requirements of § 108 SGB V were analyzed. By cluster analysis, the most important predictors for four short-term clinical outcomes (intra-procedural and post-procedural events, death, length of hospital stay) were identified. Differences were analyzed on a national, federal state and interstate level., Results: In 2012, 764,233 CP were performed in 733,337 patients (64.7 % males) in 890 hospitals. In 88.2 % of all patients, a cardiac disease was detected; in 11.3 %, it was excluded. 5 clusters were identified which were based on the following parameters: ACS, invasive coronary procedure, cardiac disease (i.e., hypertensive cardiac disease, cardiomyopathy, aortic aneurysm, cardiac valve disease), exclusion of CHD. There were significant differences between the five patient clusters: percentages of patients with diabetes, renal insufficiency and CHF varied between 14.1 and 32.9 %, 9.5 and 31.6 %, and 7.0 and 16.9 %, respectively; average duration of hospitalization and death rates varied between 5.5 (without ACS) and 8 days (ACS) and 0.3 and 4.5 %, respectively. The distribution of patient clusters varied significantly between the German federal states as well as within a federal state., Conclusions: Five patient clusters with CP showed significantly differing profiles of risk, outcome and resource consumption as well as a regional distribution. This has to be considered for comparisons between hospitals as well as on a regional and international level and hospital planning.

Background: The database of the German programme for quality in healthcare including data of every hospitalised patient with community-acquired pneumonia (CAP) during a 2-year period (n = 388 406 patients in 2005 and 2006) was analysed., Methods: End points of the analysis were: (1) incidence; (2) outcome; (3) performance of the CRB-65 (C, mental confusion; R, respiratory rate >or=30/min; B, systolic blood pressure <90 mm Hg or diastolic blood pressure or=65 years) score in predicting death; and (4) lack of ventilatory support as a possible indicator of treatment restrictions. The CRB-65 score was calculated, resulting in three risk classes (RCs)., Results: The incidence of hospitalised CAP was 2.75 and 2.96 per 1000 inhabitants/year in 2005 and 2006, respectively, higher for males (3.21 vs 2.52), and strongly age related, with an incidence of 7.65 per 1000 inhabitants/year in patients aged >or=60 years over 2 years. Mortality (13.72% and 14.44%) was higher than reported in previous studies. The CRB-65 RCs accurately predicted death in a three-class pattern (mortality 2.40% in CRB-65 RC 1, 13.43% in CRB-65 RC 2 and 34.39% in CRB-65 RC 3). The first days after admission were consistently associated with the highest risk of death throughout all risk classes. Only a minority of patients who died had received mechanical ventilation during hospitalisation (15.74%)., Conclusions: Hospitalised CAP basically is a condition of the elderly associated with a higher mortality than previously reported. It bears a considerable risk of early mortality, even in low risk patients. CRB-65 is a simple and powerful tool for the assessment of CAP severity. Hospitalised CAP is a frequent terminal event in chronic debilitated patients, and a limitation of treatment escalation is frequently applied.

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.

The pathogenesis of cholesterol gallstones is now recognized as a multifactorial process, including saturation of bile with cholesterol, destabilization of bile leading to cholesterol crystals and hypomotility permitting crystal growth, and agglomeration and retention of microstones which then grow to macroscopic gallstones. In the last 15 years meticulous research has demonstrated convincing evidence that many patients with cholesterol gallstone disease have a distinct defect in gall-bladder motor function that is induced by bile saturated with cholesterol.

A 47-year-old male patient with alcoholic cirrhosis Child-Pugh grade C was admitted to our center for evaluation of liver transplantation. Serum creatinine had increased from 1.6 to 4.3 mg/100 ml within the previous two weeks, creatinine clearance was 12 ml/min, and urinary sodium 12 mmol/24 h. The diagnosis of HRS type I was established. Diuretic treatment was discontinued. Following albumin infusion, central venous pressure was increased to above 10 cm H2O and dopamine (2 micrograms/kg/min) infusion was started. However, renal function did not improve. An i.v. infusion of ornipressin (POR8, Sandoz; 6 IU/h) was started and dopamine infusion continued. During a four-hour interval, urinary volume and sodium excretion doubled. Therefore treatment was continued for three weeks. After 22 days, renal function had normalized (creatinine 1.2 mg/100 ml, creatinine clearance 65 ml/min, urinary sodium 62 mmol/24 h) and diuretic therapy was resumed. No adverse effects were observed. Ornipressin/dopamine infusion was discontinued and renal function remained normal. Three weeks later, the patient underwent liver transplantation with normal renal function. Ornipressin infusion had no effect on circulating endothelin, but decreased the activation of the renin-aldosterone system and of the sympathetic activity. So far, no noninvasive therapy of hepatorenal syndrome has been established. This is the first report of successful medical treatment of HRS type I with a three-week infusion of the vasopressin-l-receptor agonist ornipressin.

Background & Aims: Gallbladder emptying is reduced in many patients with cholesterol gallstones. To clarify the role of impaired gallbladder motility in recurrent gallstone disease, the effect of gallbladder emptying on the formation of recurrent stones was studied prospectively., Methods: In 54 consecutive patients with single radiolucent gallbladder stones, postprandial gallbladder emptying was assessed sonographically before lithotripsy and 1.8 +/- 0.1 years (mean +/- SE) after gallstone disappearance. Patients were followed up for gallstone recurrence for 0.6-4.1 years (median, 2.6 years)., Results: After gallstone disappearance, gallbladder fasting volume (33.7 +/- 3.4 vs. 27.8 +/- 3.0 mL; P = 0.007) and residual volume (12.6 +/- 1.9 vs. 9.7 +/- 1.3 mL; P = 0.010) decreased, whereas the ejection fraction remained unchanged. However, gallbladder volume did not differ whether initial or recurrent stones were present. Gallbladder emptying was more impaired in patients with than patients without later recurrence (47% +/- 5% vs. 63% +/- 2%; P = 0.001). Cox analysis showed that gallbladder emptying was an independent determinant of the risk of gallstone recurrence (P = 0.002). Within 3 years, recurrent stones formed in 53% (actuarial analysis) of patients with an ejection fraction of < 60% but in only 13% of patients with an ejection fraction of > or = 60%., Conclusions: Gallbladder emptying is an important factor in the formation of recurrent gallstones.

To overcome the geometrical limitations of current methods to calculate gallbladder volume from two-dimensional sonographic images, we evaluated the accuracy and precision of a novel three-dimensional ultrasound system (3D). In vitro accuracy of 3D volumetry (10 mL to 55 mL) was 98.1 +/- 7.1% (mean+/-SD) with a mean difference of 0.7 mL between the measured and the true volume (p < 0.003). Compared with the sum-of-cylinders (SC) and the ellipsoid (EL) methods, 3D was characterized by a significantly smaller systematic bias and closer limits of agreement with the true volume. The variation coefficient was smallest with 3D (2.4%, p < 0.02) and largest with EL (4.2%). In vivo, gallbladder volumes were on average 1.4 mL (9%) smaller with 3D than with SC (p < 0.0001) and 2.4 mL (14%) larger with EL than with SC (p < 0.0001). 3D ultrasonography accurately measures gallbladder volume and emptying.

Background: Although it has been shown that chronic administration of ursodeoxycholic acid increases gallbladder fasting and residual volume, it is unknown whether ursodeoxycholic acid exerts an acute effect on gallbladder volume. We therefore evaluated the effect of a single oral dose of ursodeoxycholic acid on gallbladder volume in healthy volunteers., Methods: After the volunteers had fasted overnight, gallbladder volume was measured sonographically every 15 min for 5 h. Following a 1-h control period group I (n = 8) received ursodeoxycholic acid (1000 mg) orally with 100 ml of water, whereas group II (n = 8) received 100 ml of water (placebo) only. Gallbladder volumes were calculated, applying the sum-of-cylinders method. Serum levels of ursodeoxycholic acid were determined by gas chromatography at 1-h intervals., Results: Gallbladder fasting volumes before ursodeoxycholic acid were similar in both groups (24.0 +/- 2.3 ml versus 25.4 +/- 3.3 ml; NS). After ingestion of ursodeoxycholic acid (group I) gallbladder volume increased rapidly, reaching 27.6 +/- 3.1 ml (p < 0.04) 1 h and 38.4 +/- 3.4 ml (p < 0.02) 4 h after ingestion of ursodeoxycholic acid. The individual gallbladder volumes after ingestion of ursodeoxycholic acid in group I increased to 146%-211% of pretreatment values. Ursodeoxycholic acid serum levels increased from 0.94 +/- 0.38 mumol/l to 10.51 +/- 1.36 mumol/l (p < 0.001) and correlated closely with gallbladder volumes (r = 0.80; p < 0.05). After ingestion of water only (group II) gallbladder volume decreased transiently from 15 min to 30 min after water intake and then remained at pretreatment values throughout the study period., Conclusion: Administration of a single oral dose of ursodeoxycholic acid causes a rapid increase in gallbladder volume, which reaches 163 +/- 10% of pretreatment volume at 4 h and is closely correlated with ursodeoxycholic acid serum levels.

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.

To determine the rate and characteristics of gallstone recurrence after direct contact dissolution with methyl tert-butyl ether, 60 consecutive patients were followed for up to 4.5 years (median 2.2 years) after complete disappearance of all stone residues and debris and cessation of adjuvant bile acid therapy. Initial gallstones had been multiple in all but four patients. Twenty-eight of the 60 patients developed recurrent gallstones. The cumulative risk of gallstone recurrence (actuarial analysis) was 23 +/- 6%, 34 +/- 7%, 55 +/- 8%, and 70 +/- 9% at one, two, three, and four years, respectively. The recurrent stones were usually multiple and small (6 +/- 4 mm). Gallstone recurrence was associated with recurrent biliary pain in two patients, one of whom developed acute cholecystitis. Recurrent stones were cleared completely by bile acid medication with or without shock-wave lithotripsy in 61 +/- 15% of patients at one year (actuarial analysis). In conclusion, gallstone recurrence after successful contact dissolution of multiple stones with methyl tert-butyl ether has to be expected in a high percentage of patients. Most patients, however, remain free of biliary pain during long-term follow-up.

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: Impaired gallbladder emptying is a pathogenetic factor in gallstone formation. To test whether gallbladder motility can be improved by high-dose cholecystokinin (CCK), gallbladder emptying was measured sonographically in 21 patients with cholesterol gallstone disease and 6 healthy controls., Methods: The effects of CCK infusions of 0.06 IDU/kg.min (group A, n = 11) and 0.12 IDU/kg.min (group B, n = 10) were compared with the response to a standard CCK infusion (0.02 IDU/kg.min). Controls received CCK at all infusion rates., Results: The ejection fraction was smaller after CCK infusion of 0.06 IDU/kg.min than after the standard stimulus (group A, 52 +/- 10 versus 64 +/- 10%, p < 0.05; controls, 66 +/- 10 versus 91 +/- 3%, p < 0.05). After infusion of 0.12 IDU/kg.min CCK ejection fractions decreased even more (group B, 44 +/- 16 versus 65 +/- 12%, p < 0.05; controls, 54 +/- 12 versus 91 +/- 3%, p < 0.05). High-dose CCK infusions shortened the ejection period markedly, whereas the ejection rate remained unaltered., Conclusions: High-dose CCK does not improve gallbladder motility but blocks the ejection process early, leading to reduced gallbladder emptying in gallstone patients and healthy subjects.

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.

Three-dimensional reconstruction of ultrasonographic images was used to visualize hepatobiliary and pancreatic lesions and stones, and to measure gallbladder emptying. The initial experience shows that these reconstructions may be of some help in the identification of the extension of tumors and the invasion into surrounding tissues. Stones and stone fragments in the pancreas and in the gallbladder as well as the wall of the gallbladder were visualized well. If further studies will reveal a benefit for the patient, three-dimensional ultrasonography may be added to the noninvasive methods used in the diagnosis of several hepatobiliary and pancreatic diseases.

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.

To evaluate whether the extent of postprandial gall bladder emptying is correlated with gall bladder fasting volume, gall bladder motility was studied in 56 patients with cholesterol gall stone and 19 control patients. Gall bladder volumes were determined sonographically, while cholecystokinin plasma values were measured radioimmunologically. Twenty three per cent of gall stone patients were classified as pathological contractors (residual fraction > mean +2SD of controls) and 77% as normal contractors. Normal but not pathological contractor patients exhibited larger gall bladder fasting volumes (mean (SEM)) (24.7 (1.7) ml) than controls (15.3 (1.2) ml, p < 0.001). In normal contractor patients and controls fasting volume was closely related with ejection volume (r = 0.97, p < 0.001) and residual volume (r = 0.80, p < 0.001). Although ejection volume was enlarged in normal contractor patients it did not compensate the increase in fasting volume. Thus, residual volumes were considerably increased not only in pathological contractors (12.7 (2.5) ml, p < 0.001) but also in normal contractor patients (7.0 (0.5) v 4.6 (0.6) ml, p < 0.001). Postprandial cholecystokinin secretion did not differ between patients and controls. It is concluded, that in normal contractor patients gall bladder fasting volume is closely correlated with ejection and residual volume. Thus, fasting volume may be an essential factor affecting postprandial gall bladder emptying. Large fasting volumes in cholesterol gall stone disease could thereby contribute to bile retention, which facilitates gall stone growth.

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.

Beneficial effects of ursodeoxycholic acid in chronic cholestatic liver diseases have been attributed to displacement of hydrophobic bile acids from the endogenous bile acid pool. To test this hypothesis, we determined pool sizes, fractional turnover rates, synthesis/input rates and serum levels of deoxycholic acid and chenodeoxycholic acid before and 1 mo after the start of treatment with ursodeoxycholic acid (13 to 15 mg/kg body wt/day) in four healthy volunteers and five patients with chronic cholestatic liver diseases (three with primary biliary cirrhosis and two with primary sclerosing cholangitis). Bile acid kinetics were determined by combined capillary gas chromatography-isotope ratio mass spectrometry in serum samples after administration of [2H4] deoxycholic acid and [13C]chenodeoxycholic acid. In healthy volunteers, deoxycholic acid pool sizes decreased during administration of ursodeoxycholic acid by 72%. In patients with cholestatic liver diseases, deoxycholic acid pool sizes before ursodeoxycholic acid treatment were only 13% of those in healthy volunteers and were unaffected by ursodeoxycholic acid treatment. Chenodeoxycholic acid pool sizes were not different in healthy volunteers and in patients with cholestatic liver disease, and were not altered by ursodeoxycholic acid treatment. In both healthy volunteers and patients with cholestatic liver disease, synthesis/input rates and serum levels of deoxycholic acid and chenodeoxycholic acid were not altered by ursodeoxycholic acid treatment. Because in our patients improvement of serum liver tests during short-term ursodeoxycholic acid treatment was noted without a decrease of the pool sizes of the major hydrophobic bile acids, we conclude that displacement of hydrophobic endogenous bile acids is not the mechanism of action of ursodeoxycholic acid in chronic cholestatic liver disease.

Sixty patients undergoing shock wave lithotripsy of gallbladder stones (ESWL) were randomly assigned to receive alfentanil either by infusion controlled by the attending anesthesiologist (standard treatment group, n = 31) or by analgesia controlled by the patient (PCA group, n = 29). Patients using PCA were allowed to self-administer 0.25 mg of alfentanil i.v. every minute as required. Data collected during treatment included the total dose of drug required, transcutaneous pCO2 values, verbal pain and sedation scores, visual analogue scale (VAS) patient satisfaction scores, and the incidence of nausea or vomiting. PCA patients used less alfentanil than the standard treatment group (PCA group: 12.8 micrograms/kg; standard treatment group: 44.3 micrograms/kg; mean values, P = 0.0001), tolerated significantly higher pain intensities and self-administered the narcotic only to moderate levels of pain but not to pronounced analgesia. Standard treatment patients reported lower levels of pain, were more sedated (P less than 0.05) and showed significantly higher transcutaneous pCO2 values. There was a trend towards a lower incidence of nausea or vomiting in PCA patients without reaching statistical significance. No significant difference with regard to patient satisfaction with pain relief could be demonstrated. Self-administered alfentanil during ESWL of gallbladder stones provided adequate analgesia with minimal side effects and high patient satisfaction. ESWL may represent a new and useful indication for PCA.

Safety and efficacy of shock-wave lithotripsy and bile acid dissolution therapy of patients with gallbladder calculi with a radiopaque rim were evaluated. Eighty-six patients with symptomatic solitary stones were treated by this noninvasive therapy and were followed up to 18 months. Three different lithotripsy treatment modalities were used. Up to 1600 shock wave discharges were applied. Patients in group A (n = 20) were treated with an electrohydraulic water-bath lithotripter at a discharge voltage of 18 +/- 1 kV (mean +/- SD), group B patients (n = 25) were treated with an electrohydraulic water-cushion lithotripter at 19 +/- 2 kV, and group C patients were treated (n = 41) with the same lithotripter at 22 +/- 2 kV. Five to eight months after lithotripsy, 15% in group A were free of fragments compared with only 4% in group B (NS vs. group A), and 38% in group C had no stones (NS vs. group A; P = 0.007 vs. B). Thirteen to eighteen months after lithotripsy, the respective results were 59% in group A, 37% in group B (NS vs. group A), and 68% in group C (NS vs. group A; P = 0.05 vs. group B). Patients with fragments of less than or equal to 3 mm in diameter showed significantly better fragment clearance than those with larger fragments. The frequency of adverse effects was not significantly different between the three groups. Biliary colic occurred in 43% of the patients and mild biliary pancreatitis in 3 patients. Endoscopic sphincterotomy was required in 1 patient, and elective cholecystectomy was performed in 6 patients. Using a water-cushion lithotripter at high-power setting, selected patients with solitary gallbladder stones with a radiopaque rim may be treated safely and successfully by shock-wave lithotripsy combined with bile acid dissolution therapy.

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.

A prospective, double-blind, randomized, single-center study was conducted to compare ursodeoxycholic acid alone with the combination of ursodeoxycholic acid and chenodeoxycholic acid for dissolution therapy of gallstone fragments after shock wave lithotripsy. Patients with single radiolucent gallstones up to 30 mm in diameter or up to three stones of similar total volume received either 750 mg ursodeoxycholic acid alone (group A, n = 138) or the combination of 500 mg ursodeoxycholic acid and 500 mg chenodeoxycholic acid (group B, n = 144) in a single bedtime dose. The bile acids were administered from 2 wk before electrohydraulic lithotripsy until 3 mo beyond complete disappearance of all fragments. Patient's characteristics, stones (group A, 82% single stones, maximum diameter 19 +/- 5 mm, mean +/- S.D.; group B, 82% single stones, 18 +/- 5 mm), lithotripsy treatment and follow-up period were not different between the two groups. Between the two groups, no statistically significant difference was found in the time required for complete clearance of the fragments (group A, median time = 15 mo; group B, median time = 13 mo; p = 0.7). At 12 mo after lithotripsy, the probability of complete clearance was 46% +/- 5% in group A and 49% +/- 5% in group B. Diarrhea occurred significantly more often in group B than in group A (p less than 0.001) and was the main reason for withdrawal of randomized medication. Severe adverse effects of the bile acids were not observed. It is concluded that monotherapy with ursodeoxycholic acid is as efficient as the combination of ursodeoxycholic acid and chenodeoxycholic acid for fragment dissolution after lithotripsy.(ABSTRACT TRUNCATED AT 250 WORDS)

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.

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.

Decreased levels of serum cholesterol are a well-recognized finding in hyperthyroidism. Since the conversion to bile acids is an important pathway for the elimination of cholesterol, we studied primary bile acid kinetics in seven hyperthyroid patients before and after medical treatment. Pool sizes, fractional turnover and synthesis rates of cholic acid and chenodeoxycholic acid were determined after oral administration of 50 mg [13C]cholic acid and 50 mg [13C]chenodeoxycholic acid. 13C/12C isotope ratios in serum were measured by capillary gas chromatography/electron impact mass spectrometry. Compared with the euthyroid state, serum cholesterol levels were distinctly lower in hyperthyroidism (150 +/- 33 vs. 261 +/- 51 mg per dl, p less than 0.01). Thyroid hormone excess caused a 34% reduction in cholic acid synthesis (5.8 +/- 2.8 vs. 7.9 +/- 4.2 mu moles per kg per day, p less than 0.02), which was associated with a 47% decrease in cholic acid pool size (11.7 +/- 3.4 vs. 22.0 +/- 5.2 mu moles per kg, p less than 0.01). Chenodeoxycholic acid kinetics exhibited no apparent changes. Thus, total primary bile acid synthesis was diminished by 20% in hyperthyroidism. After normalization of thyroid function, the ratio of cholic acid/chenodeoxycholic acid pool size increased in all patients. This was paralleled by a rise in the ratio of concentrations of cholic acid/chenodeoxycholic acid in serum. The depression of cholic acid synthesis in the presence of unaltered subjects is compatible with an inhibition of hepatic 12 alpha-hydroxylation by thyroid hormone. Furthermore, evidence is provided that, in man, the low serum cholesterol levels found during hyperthyroidism are not caused by an increased conversion of cholesterol to bile acid.