Routine versus selective intraoperative cholangiography during cholecystectomy: systematic review, meta-analysis and health economic model analysis of iatrogenic bile duct injury.

BACKGROUND: Bile duct injury (BDI) is a severe complication following cholecystectomy. Early recognition and treatment of BDI has been shown to reduce costs and improve patients' quality of life. The aim of this study was to assess the effect and cost-effectiveness of routine versus selective intraoperative cholangiography (IOC) in cholecystectomy. METHODS: A systematic review and meta-analysis, combined with a health economic model analysis in the Swedish setting, was performed. Costs per quality-adjusted life-year (QALY) for routine versus selective IOC during cholecystectomy for different scenarios were calculated. RESULTS: In this meta-analysis, eight studies with more than 2 million patients subjected to cholecystectomy and 9000 BDIs were included. The rate of BDI was estimated to 0.36 per cent when IOC was performed routinely, compared with to 0.53 per cent when used selectively, indicating an increased risk for BDI of 43 per cent when IOC was used selectively (odds ratio 1.43, 95 per cent c.i. 1.22 to 1.67). The model analysis estimated that seven injuries were avoided annually by routine IOC in Sweden, a population of 10 million. Over a 10-year period, 33 QALYs would be gained at an approximate net cost of €808 000 , at a cost per QALY of about €24 900. CONCLUSION: Routine IOC during cholecystectomy reduces the risk of BDI compared with the selective strategy and is a potentially cost-effective intervention.

Self-Expandable Metallic Stent Is More Cost Efficient Than Plastic Stent in Treating Anastomotic Biliary Stricture.

BACKGROUND: Anastomotic bile duct stricture (ABS) is one of the most common complications after liver transplantation. Current practice of endoscopic retrograde cholangiopancreatography (ERCP) with multiple plastic stent (MPS) insertion often requires multiple sessions before achieving stricture resolution. We aimed to compare the efficacy of fully covered self-expandable metallic stent (FCSEMS) with MPS method while simultaneously analyzing the relative healthcare cost between the two methods in the management of ABS. METHODS: Liver transplant patients with ABS who received ERCP with stent placement were identified by query of our endoscopic database. Comparative analyses between the group of patients treated with ERCP with MPS and the group treated with FCSEMS were performed. The costs to achieve stricture resolution, and the rates of stricture resolution, recurrence and complications were also compared. RESULTS: A total of 158 patients underwent ERCP with stent insertion for the management of ABS. Of those, 49 patient received FCSEMS for their ABS while 109 patients were treated with MPS only. Our cost analysis showed early utilization of FCSEMS can deliver up to 25% savings in the total procedure cost while providing comparable rates of stricture resolution. The rates of technical success, stricture recurrence and adverse outcomes, and stricture free durations were also comparable between the two groups. CONCLUSION: While providing efficacy and safety rates comparable to ERCP-MPS, the incorporation of FCSEMS at early stage of ABS management could provide a substantial savings by reducing the number of ERCP session to achieve stricture resolution. Optimization of the timing and duration of FCSEMS indwelling time needs further validation.

A comprehensive evaluation of the long-term economic impact of major bile duct injury.

BACKGROUND: Complications and litigation after bile duct injury (BDI) result in clinical and economic burden. The aim of this study was to comprehensively evaluate the long-term clinical and economic impact of major BDI. METHOD: Patients with long-term follow-up after Strasberg E BDI were identified. Costs of treatment and litigation were the primary outcome. Relationships between these outcomes and repair factors, like timing of repair and surgeon expertise, were secondary outcomes. RESULTS: Among 139 patients with a median follow up of 10.7 years, 40% of patients developed biliary complications. Repairs by non-specialist surgeons had significantly higher follow up and treatment costs than those by specialists (£25,814 vs. £14,269, p < 0.001). Estimated litigation costs were higher in delayed than immediate repairs (£23,295 vs. £12,864). As such, the lowest average costs per BDI are after immediate specialist repair and the highest after delayed non-specialist repair (£27,133 vs. £49,109, ×1.81 more costly, p < 0.001). Repair by a non-specialist surgeon (HR: 4.00, p < 0.001) and vascular injury (HR: 2.35, p = 0.013) were significant independent predictors of increased complication rates. CONCLUSION: Costs of major BDI are considerable. They can be reduced by immediate on-table repair by specialist surgeons. This must therefore be considered the standard of care wherever possible.

Routine intraoperative cholangiography during cholecystectomy is a cost-effective approach when analysing the cost of iatrogenic bile duct injuries.

BACKGROUND: The total cost of bile duct injuries (BDIs) in an unselected national cohort of patients undergoing cholecystectomy are unknown. The aim was to evaluate costs associated with treatment of cholecystectomy-related BDIs and to calculate cost effectiveness of routine vs. on-demand intraoperative cholangiography (IOC). METHODS: Data from Swedish patients suffering a BDI during a 5 year period were analysed. Questionnaires to investigate loss-of-production and health status (EQ-5D) were distributed to patients who suffered a BDI during cholecystectomy and who underwent uneventful cholecystectomy (matched control group). Costs per quality-adjusted-life-year (QALY) gained by intraoperative diagnosis were estimated for two strategies: routine versus on-demand IOC during cholecystectomy. RESULTS: Intraoperative diagnosis, immediate intraoperative repair, and minor BDI were all associated with reduced direct treatment costs compared to postoperative diagnosis, delayed repair, and major BDI (all p < 0.001). No difference was noted in loss-of-production for minor versus major BDIs or between different treatment strategies. The cost per QALY gained with routine intraoperative cholangiography (ICER-incremental cost-effectiveness ratio) to achieve intraoperative diagnosis was €50,000. CONCLUSIONS: Intraoperative detection and immediate intraoperative repair is the superior strategy with less than half the cost and superior functional patient outcomes than postoperative diagnosis and delayed repair. The cost per QALY gained (ICER) using routine IOC was considered reasonable.

A cost analysis of operative repair of major laparoscopic bile duct injuries.

BACKGROUND: Major bile duct injuries occur infrequently after laparoscopic cholecystectomy, but may result in life-threatening complications. Few data exist on the financial implications of duct repair. This study calculated the costs of operative repair in a cohort of patients who underwent reconstruction of the bile duct after major ductal injury. OBJECTIVE: To calculate the total in-hospital cost of surgical repair of patients referred with major bile duct injuries. METHODS: A prospective database was reviewed to identify all patients referred to the University of Cape Town Private Academic Hospital, South Africa, between 2002 and 2013 for assessment and repair of major laparoscopic bile duct injuries. The detailed clinical records and billing information were evaluated to determine all costs from admission to discharge. Total costs for each patient were adjusted for inflation between the year of repair and 2013. Results. Forty-four patients (33 women, 11 men; median age 48 years, range 30 - 78) underwent reconstruction of a major bile duct injury. First-time repairs were performed at a median of 24.5 days (range 1 - 3,662) after initial surgery. Median hospital stay was 15 days (range 6 - 86). Mean cost of repair was ZAR215,711 (range ZAR68,764 - 980,830). Major contributors to cost were theatre expenses (22%), admission to intensive care (21%), radiology (17%) and specialist fees (12%). Admission to a general ward (10%), consumables (7%), pharmacy (5%), endoscopy (3%) and laboratory costs (3%) made up the balance. CONCLUSIONS: The cost of repair of a major laparoscopic bile duct injury is substantial owing to prolonged hospitalisation, complex surgicalintervention and intensive imaging requirements.

Cost analysis and effectiveness comparing the routine use of intraoperative fluorescent cholangiography with fluoroscopic cholangiogram in patients undergoing laparoscopic cholecystectomy.

BACKGROUND: Despite the standardization of laparoscopic cholecystectomy (LC), the rate of bile duct injury (BDI) has risen from 0.2 to 0.5%. Routine use of intraoperative cholangiography (IOC) has not been widely accepted because of its cost and a lack of evidence concerning its use in preventing BDI. Fluorescent cholangiography (FC), which has recently been advocated as an alternative to IOC, is a novel intraoperative procedure involving infrared visualization of the biliary structures. This study evaluated costs and effectiveness of routinely implemented FC and IOC during LC. MATERIALS AND METHODS: Between February and June 2013, the authors prospectively collected the data of all patients undergoing laparoscopic cholecystectomy. We retrospectively reviewed and compared the use of FC and IOC. Procedure time, procedure cost, and effectiveness of the two methods were analyzed and compared. The surgeons involved in the cases completed a survey on the usefulness of each method. RESULTS: A total of 43 patients (21 males and 22 females) were analyzed during the study period. Mean age was 49.53 ± 14.35 years and mean body mass index was 28.35 ± 8 kg/m(2). Overall mean operative time was 64.95 ± 17.43 min. FC was faster than IOC (0.71 ± 0.26 vs. 7.15 ± 3.76 min; p < 0.0001). FC was successfully performed in 43 of 43 cases (100%) and IOC in 40 of 43 cases (93.02%). FC was less expensive than IOC (US$14.10 ± 4.31 vs. US$778.43 ± 0.40; p < 0.0001). According to the survey, all surgeons found routine use of FC useful. CONCLUSION: In this study, FC was effective in delineating important anatomic structures. It required less time and expense than IOC, and was perceived by the surgeons to be easier to perform, and at least as useful as IOC. Further prospective studies are warranted to evaluate the effectiveness of FC in decreasing BDI.

A cost-effectiveness analysis of early vs late reconstruction of iatrogenic bile duct injuries.

BACKGROUND: Controversy exists regarding the optimal timing of repair after iatrogenic bile duct injuries (BDI). Several studies advocate late repair (≥6 weeks after injury) with mandatory drainage and resolution of inflammation. Others indicate that early repair (<6 weeks after injury) produces comparable or superior clinical outcomes. Additionally, although most studies have reported inferior outcomes with primary surgeon repair, this practice continues. With disparate published recommendations and rising health care costs, decision analysis was used to examine the cost-effectiveness of BDI repair. STUDY DESIGN: A Markov model was developed to evaluate primary surgeon repair (PSR), late repair by a hepatobiliary surgeon (LHBS), and early repair by a hepatobiliary surgeon (EHBS). Baseline values and ranges were collected from the literature. Sensitivity analsyses were conducted to test the strength of the model and variability of parameters. RESULTS: The model demonstrated that EHBS was associated with lower costs, earlier return to normal activity, and better quality of life. Specifically, 1 year after repair, PSR yielded 0.53 quality adjusted life years (QALYs) ($120,000/QALY) and LHBS yielded 0.74 QALYs ($74,000/QALY); EHBS yielded 0.82 QALYs ($48,000/QALY). Sensitivity analyses supported these findings at clinically meaningful probabilities. CONCLUSIONS: This cost-effectiveness model demonstrates that early repair by a hepatobiliary surgeon is the superior strategy for the treatment of BDI in properly selected patients. Although there is little clinical difference between early and late repair, there is a great difference in cost and quality of life. Ideally, costs and quality of life should be considered in decisions regarding strategies of repair of injured bile ducts.

The impact of complications on costs of major surgical procedures: a cost analysis of 1200 patients.

OBJECTIVE: To assess the impact of postoperative complications on full in-hospital costs per case. BACKGROUND: Rising expenses for complex medical procedures combined with constrained resources represent a major challenge. The severity of postoperative complications reflects surgical outcomes. The magnitude of the cost created by negative outcomes is unclear. PATIENTS AND METHODS: Morbidity of 1200 consecutive patients undergoing major surgery from 2005 to 2008 in a tertiary, high-volume center was assessed by a validated, complication score system. Full in-hospital costs were collected for each patient. Statistical analysis was performed using a multivariate linear regression model adjusted for potential confounders. RESULTS: This study population included 393 complex liver/bile duct surgeries, 110 major pancreas operations, 389 colon resections, and 308 Roux-en-Y gastric bypasses. The overall 30-day mortality rate was 1.8%, whereas morbidity was 53.8%. Patients with an uneventful course had mean costs per case of US$ 27,946 (SD US$ 15,106). Costs increased dramatically with the severity of postoperative complications and reached the mean costs of US$ 159,345 (SD US$ 151,191) for grade IV complications. This increase in costs, up to 5 times the cost of a similar operation without complications, was observed for all types of investigated procedures, although the magnitude of the increase varied, with the highest costs in patients undergoing pancreas surgery. CONCLUSION: This study demonstrates the dramatic impact of postoperative complications on full in-hospital costs per case and that complications are the strongest indicator of costs. Furthermore, the study highlights a relevant savings capacity for major surgical procedures, and supports all efforts to lower negative events in the postoperative course.

A cost-effectiveness analysis of intraoperative cholangiography in the prevention of bile duct injury during laparoscopic cholecystectomy.

BACKGROUND: Recent population-based studies have demonstrated that the use of intraoperative cholangiography (IOC) during laparoscopic cholecystectomy (LC) is associated with a decrease in the rate of common bile duct (CBD) injury. The cost implications of a management strategy involving routine IOC use have not been adequately evaluated. STUDY DESIGN: Decision analytic models were developed to analyze costs and benefits of routine IOC use during LC. The models were used to calculate the cost per life saved, cost per CBD injury avoided, and incremental cost of IOC when used routinely. Transition probabilities, costs, and outcomes were derived from published sources. Sensitivity analyses were used to account for uncertainty in these estimates. RESULTS: Using base-case estimates, management of patients undergoing LC with routine IOC would cost 100 dollars more per LC. Routine IOC would prevent 2.5 deaths for every 10,000 patients at a cost of 390,000 dollars per life saved (13,900 dollars per life year saved). The cost per CBD injury avoided with IOC use is 87,143 dollars. The cost per CBD injury avoided is less for procedures done in high-risk patients (approximately 8,000 dollars) or by less experienced surgeons (approximately 61,000 dollars). CONCLUSIONS: These models describe settings where the cost of IOC and the reduction in CBD injury rates make routine IOC use cost effective. Routine IOC use among less experienced surgeons and in high-risk operations is the most cost effective, but the cost implications of routine use for the general population should also be considered cost effective.

Clinical pathway implementation improves outcomes for complex biliary surgery.

BACKGROUND: Complex biliary surgery is associated with significant morbidity, prolonged hospital stay, and high cost. Clinical pathway implementation has the potential to standardize treatment and improve outcomes. Therefore the aim of this analysis was to determine whether clinical pathway implementation and/or feedback of outcome data would alter hospital stay, charges, and mortality rates for complex biliary surgery at an academic medical center METHODS: Pre- and postoperative length of stay, hospital charges, and mortality rates were monitored for 36 months before (period 1) and for 2 18-month periods (periods 2 and 3) after implementation of a clinical pathway for hepaticojejunostomy. Outcome data were provided to the surgeons 18 months after pathway implementation to determine whether further clinical practice improvement was possible. RESULTS: From 1991 to 1997, 339 patients underwent hepaticojejunostomy at The Johns Hopkins Hospital for malignant and benign biliary obstruction. Total length of stay was 13.3 +/- 0.9 days for period 1 compared with 12.5 +/- 0.8 days for period 2 (not significant) and 10.1 +/- 0.3 days for period 3 (P < .01 vs period 1; P < .03 vs period 2). Hospital charges averaged $24,446 during period 1 compared with $23,338 during period 2 and $20,240 during period 3 (P < .01 vs periods 1 and 2). Hospital mortality rate was 4.5% during period 1 compared with 0.7% during periods 2 and 3 (P < .05). CONCLUSIONS: These data suggest that implementation of a clinical pathway for hepaticojejunostomy reduces hospital mortality rates and that feedback of outcome data to surgeons results in further clinical practice improvement. Thus clinical pathway implementation and feedback are effective methods to control costs at an academic medical center.