Evaluating a preoperative protocol that includes magnetic resonance imaging for lymph node metastasis in the Cholangiocarcinoma Screening and Care Program (CASCAP) in Thailand.

BACKGROUND: Treatment planning especially liver resection in cholangiocarcinoma (CCA) depends on the extension of tumor and lymph node metastasis which is included as a key criterion for operability. Magnetic resonance imaging (MRI) offers a rapid and powerful tool for the detection of lymph node metastasis (LNM) and in the current manuscript is assessed as a critical tool in the preoperative protocol for liver resection for treatment of CCA. However, the accuracy of MRI to detect LNM from CCA had yet to be comprehensively evaluated. METHODS: The accuracy of MRI to detect LNM was assessed in a cohort of individuals with CCA from the Cholangiocarcinoma Screening and Care Program (CASCAP), a screening program designed to reduce CCA in Northeastern Thailand by community-based ultrasound (US) for CCA. CCA-positive individuals are referred to one of the nine tertiary centers in the study to undergo a preoperative protocol that included enhanced imaging by MRI. Additionally, these individuals also underwent lymph node biopsies for histological confirmation of LNM (the "gold standard") to determine the accuracy of the MRI results. RESULTS: MRI accurately detected the presence or absence of LNM in only 29 out of the 51 CCA cases (56.9%, 95% CI 42.2-70.7), resulting in a sensitivity of 57.1% (95% CI 34.0-78.2) and specificity of 56.7% (95% CI 37.4-74.5), with positive and negative predictive values of 48.0% (95% CI 27.8-68.7) and 65.4% (95% CI 44.3-82.8), respectively. The positive likelihood ratio was 1.32 (95% CI 0.76-2.29), and the negative likelihood ratio was 0.76 (95% CI 0.42-1.36). CONCLUSIONS: MRI showed limited sensitivity and a poor positive predictive value for the diagnosis of LNM for CCA, which is of particular concern in this resource-limited setting, where simpler detection methods could be utilized that are more cost-effective in this region of Thailand. Therefore, the inclusion of MRI, a costly imaging method, should be reconsidered as part of protocol for treatment planning of CCA, given the number of false positives, especially as it is critical in determining the operability for CCA subjects.

Factors and Outcomes Associated with MRCP Use prior to ERCP in Patients at High Risk for Choledocholithiasis.

Background. Consensus guidelines recommend that patients at high risk for choledocholithiasis undergo endoscopic retrograde cholangiopancreatography (ERCP) without additional imaging. This study evaluates factors and outcomes associated with performing magnetic resonance cholangiopancreatography (MRCP) prior to ERCP among patients at high risk for choledocholithiasis. Methods. An institutional administrative database was searched using diagnosis codes for choledocholithiasis, cholangitis, and acute pancreatitis and procedure codes for MRCP and ERCP. Patients categorized as high risk for choledocholithiasis were evaluated. Results. 224 patients classified as high risk, of whom 176 (79%) underwent ERCP only, while 48 (21%) underwent MRCP prior to ERCP. Patients undergoing MRCP experienced longer time to ERCP (72 hours versus 35 hours, p < 0.0001), longer length of stay (8 days versus 6 days, p = 0.02), higher hospital charges ($23,488 versus $19,260, p = 0.08), and higher radiology charges ($3,385 versus $1,711, p < 0.0001). The presence of common bile duct stone(s) on ultrasound was the only independent factor associated with less use of MRCP (OR 0.09, p < 0.0001). Conclusions. MRCP use prior to ERCP in patients at high risk for choledocholithiasis is common and associated with greater length of hospital stay, higher radiology charges, and a trend towards higher hospital charges.

Comparison Costs of ERCP and MRCP in Patients with Suspected Biliary Obstruction Based on a Randomized Trial.

BACKGROUND: The optimal management of patients with suspected biliary obstruction remains unclear, and includes the possible performance of magnetic resonance cholangiopancreatography (MRCP) and endoscopic retrograde cholangiopancreatography (ERCP). OBJECTIVES: To complete a cost analysis based on a medical effectiveness randomized trial comparing an ERCP-first approach with an MRCP-first approach in patients with suspected bile duct obstruction. METHODS: The management strategies were based on a medical effectiveness trial of 257 patients over a 12-month follow-up period. Direct and indirect costs were included, adopting a societal perspective. The cost values are expressed in 2012 Canadian dollars. RESULTS: Total per-patient direct costs were Can$3547 for ERCP-first patients and Can$4013 for MRCP-first patients. Corresponding indirect costs were Can$732 and Can$694, respectively. Causes for differences in direct costs included a more frequent second procedure and a greater mean number of hospital days over the year in patients of the MRCP-first group. In contrast, it is the ERCP-first patients whose indirect costs were greater, principally due to more time away from activities of daily living. Choosing an ERCP-first strategy rather than an MRCP-first strategy saved on average Can$428 per patient over the 12-month follow-up duration; however, there existed a large amount of overlap when varying total cost estimates across a sensitivity analysis range based on observed resources utilization. CONCLUSIONS: This cost analysis suggests only a small difference in total costs, favoring the ERCP-first group, and is principally attributable to procedures and hospitalizations with little impact from indirect cost measurements.

A cost analysis of a pancreatic cancer screening protocol in high-risk populations.

BACKGROUND: Pancreatic cancer is the 4th leading cause of cancer death in the United States. A screening protocol is needed to catch early-stage, resectable disease. This study suggests a protocol for high-risk individuals and assesses the cost in the context of the Affordable Care Act. METHODS: Medicare and national average pricing were used for cost analysis of a protocol using magnetic resonance imaging/MRCP biannually in high-risk groups. RESULTS: Costs per year of life added" based on Medicare and national average costs, respectively, are as follows: $638.62 and $2,542.37 for Peutz-Jeghers syndrome, $945.33 and $3,763.44 for hereditary pancreatitis, $1,141.77 and $4,545.45 for familial pancreatic cancer and "p16-Leiden" mutations, and $356.42 and $1,418.92 for new-onset diabetes over age 50 with weight loss or smoking. CONCLUSIONS: A screening program using magnetic resonance imaging/MRCP is affordable in high-risk populations. The United States Preventive Services Task Force must re-evaluate its pancreatic cancer screening guidelines to make screening more cost-effective for the individual.

Cost-effectiveness analysis of endoscopic ultrasound versus magnetic resonance cholangiopancreatography in patients with suspected common bile duct stones.

BACKGROUND: Patients with suspected common bile duct (CBD) stones are often diagnosed using endoscopic retrograde cholangiopancreatography (ERCP), an invasive procedure with risk of significant complications. Using endoscopic ultrasound (EUS) or Magnetic Resonance CholangioPancreatography (MRCP) first to detect CBD stones can reduce the risk of unnecessary procedures, cut complications and may save costs. AIM: This study sought to compare the cost-effectiveness of initial EUS or MRCP in patients with suspected CBD stones. METHODS: This study is a model based cost-utility analysis estimating mean costs and quality-adjusted life years (QALYs) per patient from the perspective of the UK National Health Service (NHS) over a 1 year time horizon. A decision tree model was constructed and populated with probabilities, outcomes and cost data from published sources, including one-way and probabilistic sensitivity analyses. RESULTS: Using MRCP to select patients for ERCP was less costly than using EUS to select patients or proceeding directly to ERCP ($1299 versus $1753 and $1781, respectively), with similar QALYs accruing to each option (0.998, 0.998 and 0.997 for EUS, MRCP and direct ERCP, respectively). Initial MRCP was the most cost-effective option with the highest monetary net benefit, and this result was not sensitive to model parameters. MRCP had a 61% probability of being cost-effective at $29,000, the maximum willingness to pay for a QALY commonly used in the UK. CONCLUSION: From the perspective of the UK NHS, MRCP was the most cost-effective test in the diagnosis of CBD stones.

MRCP is not a cost-effective strategy in the management of silent common bile duct stones.

BACKGROUND: Few formal cost-effectiveness analyses simultaneously evaluate radiographic, endoscopic, and surgical approaches to the management of choledocholithiasis. STUDY DESIGN: Using the decision analytic software TreeAge, we modeled the initial clinical management of a patient presenting with symptomatic cholelithiasis without overt signs of choledocholithiasis. In this base case, we assumed a 10 % probability of concurrent asymptomatic choledocholithiasis. Our model evaluated four diagnostic/therapeutic strategies: universal magnetic resonance cholangiopancreatography (MRCP), universal endoscopic retrograde cholangiopancreatography (ERCP), laparoscopic cholecystectomy (LC), or laparoscopic cholecystectomy with universal intraoperative cholangiogram (LCIOC). All probabilities were estimated from a review of published literature. Procedure and intervention costs were equated with Medicare reimbursements. Costs of hospitalizations were derived from median hospitalization reimbursement for New York State using diagnosis-related groups (DRG). Sensitivity analyses were performed on all cost and probability variables. RESULTS: The most cost-effective strategy in the diagnosis and management of symptomatic cholelithiasis with a 10 % risk of asymptomatic choledocholithiasis was LCIOC. This was followed by LC alone, MRCP, and ERCP. LC was preferred only when the probability that a retained CBD stone would eventually become symptomatic fell below 15 % or if the probability of technical success of an intraoperative cholangiogram (IOC) was less than 35 %. Universal MRCP and ERCP were both more costly and less effective than surgical strategies, even at a high probability of asymptomatic choledocholithiasis. Within the tested range for both procedural and hospitalization-related costs for any of the surgical or endoscopic interventions, LCIOC and LC were always more cost-effective than universal MRCP or ERCP, irrespective of the presence or absence of complications. Varying the cost, sensitivity, and specificity of MRCP had no effect on this outcome. CONCLUSIONS: LC with routine IOC is the preferred strategy in a cost-effectiveness analysis of the management of symptomatic cholelithiasis with asymptomatic choledocholithiasis. MRCP was both more costly and less effective under all tested scenarios.

Concordance of imaging modalities and cost minimization in the diagnosis of pediatric choledochal cysts.

PURPOSE: Given evolving imaging technologies, we noted significant variation in the diagnostic evaluation of pediatric choledochal cysts (CDC). To streamline the diagnostic approach to CDC, and minimize associated expenses, we compared typing accuracy and costs of ultrasound (US), intraoperative cholangiography (IOC), and magnetic resonance cholangiopancreatography (MRCP). METHODS: Records of 30 consecutive pediatric CDC patients were reviewed. Blinded to all clinical data, two pediatric radiologists reviewed all US, MRCPs, and IOCs to type CDCs according to the Todani classification. When compared with pathologic findings, the concordance between and accuracy of each diagnostic test were determined. Inflation-adjusted procedure charges and collections for imaging modalities were analyzed. RESULTS: Mean typing accuracy overlapped for US, IOC, and MRCP. Inter-rater reliability was 87 % for US (κ = 0.77), 80 % for IOC (κ = 0.62), and 60 % for MRCP (κ = 0.37). MRCP procedure charges ($1204.69) and collections ($420.85) exceeded IOC and US combined ($264.80 charges, p = 0.0002; $93.40 collections, p = 0.0021). CONCLUSION: Our data support the use of US alone in the diagnosis of pediatric CDC when no intrahepatic biliary ductal dilatation is visualized. However, when dilated intrahepatic ducts are encountered on US, MRCP should be utilized to distinguish a type I from a type IV CDC, which may alter the operative approach.

Contrast-free air cholangiography-assisted unilateral plastic stenting in malignant hilar biliary obstruction.

BACKGROUND: Endoscopic palliation in malignant hilar biliary obstruction requires endoscopic retrograde cholangiopancreatography (ERCP), whereas contrast injection leads to cholangitis. Contrast-free metal stenting with or without magnetic resonance cholangiopancreatography (MRCP) has shown encouraging results, but MRCP and metal stents are costly. There have been no reports on the use of air cholangiography. METHODS: We prospectively evaluated the role of air cholangiography-assisted unilateral plastic stenting in 10 patients with type II malignant hilar biliary obstruction. A retrospectively analysed group of 10 patients treated with contrast-free unilateral metal stenting served as historical controls. RESULTS: Ten patients with unresectable type II malignant hilar biliary obstruction were studied. Air cholangiography detected type II obstruction in all patients, similar to MRCP. The patients underwent unilateral stenting. Successful endoscopic drainage was achieved in all patients. The mean patency of the stent was 95.8+/-17.5 days in the study group and 143.9+/-115.1 days in the control group (P=0.20). The mean survival was 121.8+/-41.6 days in the study group and 154.9+/-122.5 days in the control group (P=0.42). Kaplan-Meier analysis showed an estimated median survival of 100:95% CI (65.9, 134.1) days in the study group and 98:95% CI (84.1, 111.9) days in the control group (P=0.62). Cholangitis occurred in none of the patients and there were no 30-day deaths nor major complications. Air cholangiography-assisted unilateral plastic stenting was cheaper than contrast-free unilateral metal stenting. CONCLUSION: Air cholangiography-assisted unilateral plastic stenting is as safe and effective as contrast-free unilateral metal stenting in type II malignant hilar biliary obstruction for palliating patients, but it is cheaper.

The roles of magnetic resonance and endoscopic retrograde cholangiopancreatography (MRCP and ERCP) in the diagnosis of patients with suspected sclerosing cholangitis: a cost-effectiveness analysis.

BACKGROUND AND STUDY AIMS: The optimal approach for diagnosing sclerosing cholangitis remains unclear in the face of competing imaging technologies. We aimed to determine the most cost-effective strategy. PATIENTS AND METHODS: A decision model compared three approaches in the work-up of patients with suspected sclerosing cholangitis; all included an initial test, with, if unsuccessful, performance of a second cholangiographic method. They were magnetic resonance cholangiopancreatography (MRCP) and endoscopic retrograde cholangiopancreatography (ERCP), termed "MRCP_ERCP", ERCP and MRCP ("ERCP_MRCP"), or ERCP and a repeat ERCP ("ERCP_ERCP"). The implications of true and false positive and negative results with regard to costs and procedural complications were considered, including that of a liver biopsy, if indicated as a result of a negative work-up in the face of persistent clinical suspicion. The unit of effectiveness adopted was that of a correct diagnosis. Probability assumptions were derived from published literature, while cost estimates were derived from time-motion microanalyses or a national database, and expressed in Canadian dollars at 2004 values. Sensitivity analyses, including clinically relevant threshold analyses, were carried out. RESULTS: The average cost-effectiveness ratios were $414 for MRCP_ERCP, $1101 for ERCP_MRCP and $1123 for ERCP_ERCP, per correct diagnosis. The ERCP_MRCP strategy was dominated (more expensive and less effective) by MRCP_ERCP, while ERCP_ERCP was more effective and more costly than MRCP_ERCP, at $289,292 per additional correct diagnosis. Sensitivity and threshold analyses confirmed the robustness of these findings. CONCLUSIONS: Based on the model assumptions, a strategy of initial MRCP, followed, if negative, by ERCP is currently the most cost-effective approach to the work-up of patients with suspected sclerosing cholangitis.

Value of magnetic resonance cholangiopancreatography in the diagnosis of biliary abnormalities in postcholecystectomy patients: a probabilistic cost-effectiveness analysis of diagnostic strategies.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard for imaging of the biliary tract but is associated with complications. Less invasive imaging techniques, such as magnetic resonance cholangiopancreatography (MRCP), have a much lower complication rate. The accuracy of MRCP is comparable to that of ERCP, and MRCP may be more effective and cost-effective, particularly in cases for which the suspected prevalence of disease is low and further intervention can be avoided. A model was constructed to compare the effectiveness and cost-effectiveness of MRCP and ERCP in patients with a previous history of cholecystectomy, presenting with abdominal pain and/or abnormal liver function tests. METHODS: Diagnostic accuracy estimates came from a systematic review of MRCP. A decision analytic model was constructed to represent the diagnostic and treatment pathway of this patient group. The model compared the following two diagnostic strategies: (i) MRCP followed with ERCP if positive, and then management based on ERCP; and (ii) ERCP only. Deterministic and probabilistic analyses were used to assess the likelihood of MRCP being cost-effective. Sensitivity analyses examined the impact of prior probabilities of common bile duct stones (CBDS) and test performance characteristics. The outcomes considered were costs, quality-adjusted life years (QALYs), and cost per additional QALY. RESULTS: The deterministic analysis indicated that MRCP was dominant over ERCP. At prior probabilities of CBDS, less than 60 percent MRCP was the less costly initial diagnostic test; above this threshold, ERCP was less costly. Similarly, at probabilities of CBDS less than 68 percent, MRCP was also the more effective strategy (generated more QALYs). Above this threshold, ERCP became the more effective strategy. Probabilistic sensitivity analyses indicated that, in this patient group for which there is a low to moderate probability of CBDS, there was a 59 percent likelihood that MRCP was cost-saving, an 83 percent chance that MRCP was more effective with a higher quality adjusted survival, and an 83 percent chance that MRCP had a cost-effectiveness ratio more favorable than dollars 50,000 per QALY gained. CONCLUSIONS: Costs and cost-effectiveness are dependent upon the prior probability of CBDS. However, probabilistic analysis indicated that, with a high degree of certainty, MRCP was the more effective and cost-effective initial test in postcholecystectomy patients with a low to moderate probability of CBDS.

Noninvasive vs. selective invasive biliary imaging for acute biliary pancreatitis: an economic evaluation by using decision tree analysis.

BACKGROUND: ERCP is used selectively in patients with acute biliary pancreatitis (ABP). In patients with ABP, ERCP often is difficult and has the potential to cause further damage. In addition, the prevalence of residual choledocholithiasis in ABP is low (<30%). EUS and MRCP accurately diagnose choledocholithiasis, but the performance of MRCP may be inferior in ABP. EUS, with ERCP when a stone is seen, has been shown to be feasible. This study assessed the relative costs and outcomes of EUS and MRCP in patients with ABP compared with standard care involving selective ERCP. METHODS: A decision tree was constructed, modeling standard care for nonsevere ABP (selective ERCP) and severe ABP (ERCP with sphincterotomy and balloon sweep). The other arms included either EUS or MRCP first, with the conversion to or the addition of ERCP when a bile-duct stone was seen. Probabilities and accuracy of EUS and MRCP were taken from published data. Costs were locally quantified in Canadian dollars (CDN), including nursing/technical/professional personnel, equipment maintenance, and disposable equipment. The robustness of assumptions was tested by sensitivity analyses. RESULTS: Overall, EUS in all patients with ABP was marginally dominant compared with standard care with selective ERCP ($58 CDN per patient less expensive; 0.9% fewer cases of pancreatitis [ERCP-related or recurrent]). In the severe ABP subgroup, EUS was more clearly dominant ($742 CDN per patient less expensive; 3% fewer cases of pancreatitis), and the nonsevere subgroup had an incremental cost-effectiveness ratio of $17,000 per case of pancreatitis avoided. MRCP was more expensive than EUS in both subgroups. CONCLUSIONS: EUS is dominant in severe ABP. In nonsevere ABP, it is slightly more costly but is associated with fewer ERCPs and ERCP-related complications. A randomized trial would help to quantify the benefits of avoiding ERCP in these patients.