Management of occluded self-expanding biliary metal stents in malignant biliary disease.

BACKGROUND: Occlusion of self-expanding metal stents (SEMS) in malignant biliary obstruction occurs in up to 40% of patients. This study aimed to compare the different techniques to resolve stent occlusion in our collective of patients. METHODS: Patients with malignant biliary obstruction and occlusion of biliary metal stent at a tertiary referral endoscopic center were retrospectively identified between April 1, 1994 and May 31, 2014. The clinical records were further analyzed regarding the characteristics of patients, malignant strictures, SEMS, management strategies, stent patency, subsequent interventions, survival time and case charges. RESULTS: A total of 108 patients with biliary metal stent occlusion were identified. Seventy-nine of these patients were eligible for further analysis. Favored management was plastic stent insertion in 73.4% patients. Second SEMS were inserted in 12.7% patients. Percutaneous transhepatic biliary drainage and mechanical cleansing were conducted in a minority of patients. Further analysis showed no statistically significant difference in median overall secondary stent patency (88 vs. 143 days, P = 0.069), median survival time (95 vs. 192 days, P = 0.116), median subsequent intervention rate (53.4% vs. 40.0%, P = 0.501) and median case charge (€5145 vs. €3473, P = 0.803) for the treatment with a second metal stent insertion compared to plastic stent insertion. In patients with survival time of more than three months, significantly more patients treated with plastic stents needed re-interventions than patients treated with second SEMS (93.3% vs. 57.1%, P = 0.037). CONCLUSIONS: In malignant biliary strictures, both plastic and metal stent insertions are feasible strategies for the treatment of occluded SEMS. Our data suggest that in palliative biliary stenting, patients especially those with longer expected survival might benefit from second SEMS insertion. Careful patient selection is important to ensure a proper decision for either management strategy.

Liver transplant-related anastomotic biliary strictures: a novel, rapid, safe, radiation-sparing, and cost-effective management approach.

BACKGROUND AND AIMS: Biliary strictures after orthotopic liver transplantation (OLT) are typically managed by sequential ERCP procedures, with incremental dilation of the stricture and stent exchange (IDSE) and placement of new stents. This approach resolves >80% of strictures after 12 months but requires costly, lengthy ERCPs with significant patient radiation exposure. Increasing awareness of the harmful effects of radiation, escalating healthcare costs, and decreasing reimbursement for procedures mandate maximal efficiency in performing ERCP. We compared the traditional IDSE protocol with a sequential stent addition (SSA) protocol, in which additional stents are placed across the stricture during sequential ERCPs, without stent removal/exchange or stricture dilation. METHODS: Patients undergoing ERCP for OLT-related anastomotic strictures from 2010 to 2016 were identified from a prospectively maintained endoscopy database. Procedure duration, fluoroscopy time, stricture resolution rates, adverse events, materials fees, and facility fees were analyzed for IDSE and SSA procedures. RESULTS: Seventy-seven patients underwent 277 IDSE and 132 SSA procedures. Mean fluoroscopy time was 64.5% shorter (P < .0001) and mean procedure duration 41.5% lower (P < .0001) with SSA compared with IDSE. SSA procedures required fewer accessory devices, resulting in significantly lower material (63.8%, P < .0001) and facility costs (42.8%, P < .0001) compared with IDSE. Stricture resolution was >95%, and low adverse event rates did not significantly differ. CONCLUSIONS: SSA results in shorter, cost-effective procedures requiring fewer accessory devices and exposing patients to less radiation. Stricture resolution rates are equivalent to IDSE, and adverse events do not differ significantly, even in this immunocompromised population.

Comparison of patency and cost-effectiveness of self-expandable metal and plastic stents used for malignant biliary strictures: a Polish single-center study.

INTRODUCTION: Most patients with malignant biliary obstruction are suited only for palliation by endoscopic drainage with plastic stents (PS) or self-expandable metal stents (SEMS). OBJECTIVE: To compare the clinical outcome and costs of biliary stenting with SEMS and PS in patients with malignant biliary strictures. PATIENTS AND METHODS: A total of 114 patients with malignant jaundice who underwent 376 endoscopic retrograde biliary drainage (ERBD) were studied. RESULTS: ERBD with the placement of PS was performed in 80 patients, with one-step SEMS in 20 patients and two-step SEMS in 14 patients. Significantly fewer ERBD interventions were performed in patients with one-step SEMS than PS or the two-step SEMS technique (2.0±1.12 vs. 3.1±1.7 or 5.7±2.1, respectively, P<0.0001). The median hospitalization duration per procedure was similar for the three groups of patients. The patients' survival time was the longest in the two-step SEMS group in comparison with the one-step SEMS and PS groups (596±270 vs. 276±141 or 208±219 days, P<0.001). Overall median time to recurrent biliary obstruction was 89.3±159 days for PS and 120.6±101 days for SEMS (P=0.01). The total cost of hospitalization with ERBD was higher for two-step SEMS than for one-step SEMS or PS (1448±312, 1152±135 and 977±156&OV0556;, P<0.0001). However, the estimated annual cost of medical care for one-step SEMS was higher than that for the two-step SEMS or PS groups (4618, 4079, and 3995&OV0556;, respectively). CONCLUSION: Biliary decompression by SEMS is associated with longer patency and reduced number of auxiliary procedures; however, repeated PS insertions still remain the most cost-effective strategy.

Endoscopic stenting for inoperable malignant biliary obstruction: A systematic review and meta-analysis.

AIM: To analyze through meta-analyses the benefits of two types of stents in the inoperable malignant biliary obstruction. METHODS: A systematic review of randomized clinical trials (RCT) was conducted, with the last update on March 2015, using EMBASE, CINAHL (EBSCO), MEDLINE, LILACS/CENTRAL (BVS), SCOPUS, CAPES (Brazil), and gray literature. Information of the selected studies was extracted in sight of six outcomes: primarily regarding dysfunction, complication and re-intervention rates; and secondarily costs, survival, and patency time. The data about characteristics of trial participants, inclusion and exclusion criteria and types of stents were also extracted. The bias was mainly assessed through the JADAD scale. This meta-analysis was registered in the PROSPERO database by the number CRD42014015078. The analysis of the absolute risk of the outcomes was performed using the software RevMan, by computing risk differences (RD) of dichotomous variables and mean differences (MD) of continuous variables. Data on RD and MD for each primary outcome were calculated using the Mantel-Haenszel test and inconsistency was qualified and reported in χ (2) and the Higgins method (I (2)). Sensitivity analysis was performed when heterogeneity was higher than 50%, a subsequent assay was done and other findings were compiled. Student's t-test was used for the comparison of weighted arithmetic means regarding secondary outcomes. RESULTS: Initial searching identified 3660 studies; 3539 were excluded through title, repetition, and/or abstract, while 121 studies were fully assessed and were excluded mainly because they did not compare self-expanding metal stents (SEMS) and plastic stents (PS), leading to thirteen RCT selected, with 13 articles and 1133 subjects meta-analyzed. The mean age was 69.5 years old, that were affected mostly by bile duct (proximal) and pancreatic tumors (distal). The preferred SEMS diameter used was the 10 mm (30 Fr) and the preferred PS diameter used was 10 Fr. In the meta-analysis, SEMS had lower overall stent dysfunction compared to PS (21.6% vs 46.8%, P < 0.00001) and fewer re-interventions (21.6% vs 56.6%, P < 0.00001), with no difference in complications (13.7% vs 15.9%, P = 0.16). In the secondary analysis, the mean survival rate was higher in the SEMS group (182 d vs 150 d, P < 0.0001), with a higher patency period (250 d vs 124 d, P < 0.0001) and a lower cost per patient (4193.98 vs 4728.65 Euros, P < 0.0985). CONCLUSION: SEMS are associated with lower stent dysfunction, lower re-intervention rates, better survival, and higher patency time. Complications and costs showed no difference.

Endoscopic Biliary Stenting Versus Percutaneous Transhepatic Biliary Stenting in Advanced Malignant Biliary Obstruction: Cost-effectiveness Analysis.

BACKGROUND/AIMS: This study aims to compare the clinical outcomes and costs between endoscopic biliary stenting (EBS) and percutaneous transhepatic biliary stenting (PTBS). METHODOLOGY: We randomly assigned 112 patients with unresectable malignant biliary obstruction 2006 and 2011 to receive EBS or PTBS with self-expandable metal stent (SEMS) as palliative treatment. PTBS was successfully performed in 55 patients who formed the PTBS group (failed in 2 patients). EBS was successfully performed in 52 patients who formed the EBS group (failed in 3 patients). The effectiveness of biliary drainage, hospital stay, complications, cost, survival time and mortality were compared. RESULTS: Patients in PTBS group had shorter hospital stay and lower initial and overall expense than the BBS group (P < 0.05). There was no significant difference in effectiveness of biliary drainage (P = 0.9357) or survival time between two groups (P = 0.6733). Early complications occurred in PTBS group was significantly lower than in EBS group (3/55 vs 11/52, P = 0.0343). Late complications in the EBS group did not differ significantly from PTBS group (7/55 vs 9/52, P = 0.6922). The survival curves in the two groups showed no significant difference (P = 0.5294). Conclusions: 3.

Do the benefits of metal stents justify the costs? A systematic review and meta-analysis of trials comparing endoscopic stents for malignant biliary obstruction.

BACKGROUND: A variety of stent designs has been studied for endoscopic stenting of the bile duct in patients with malignant biliary obstruction. Although metal stents are associated with longer patency, their costs are significantly higher than plastic stents. AIMS: To compare clinical outcome and cost-effectiveness of endoscopic metal and plastic stents for malignant biliary obstruction by a systematic review and meta-analysis of all randomized controlled trials in this area. METHODS: We conducted searches to identify all randomized controlled trials in any language from 1966 to 2006 using electronic databases and hand-searching of conference abstracts. Meta-analysis was performed with RevMan software [Review Manager (RevMan) version 4.2 for Windows. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2003]. RESULTS: Seven randomized controlled trials were identified that met the inclusion criteria, and 724 participants were randomized to either metal or plastic endoscopic stents. No significant difference between the two stent types in terms of technical success, therapeutic success, 30-day mortality or complications was observed. Metal stents were associated with a significantly less relative risk (RR) of stent occlusion at 4 months than plastic stents [RR, 0.44; 95% confidence interval (CI) 0.3, 0.63; P<0.01]. The overall risk of recurrent biliary obstruction was also significantly lower in patients treated with metal stents (RR, 0.52; 95% confidence interval 0.39, 0.69; P<0.01). The median incremental cost-effectiveness ratio of metal stents was $1820 per endoscopic retrograde cholangiopancreatography prevented. CONCLUSION: Endoscopic metal stents for malignant biliary obstruction are associated with significantly higher patency rates than plastic stents as early as 4 months after insertion. Metal stents will be cost-effective if the unit cost of additional endoscopic retrograde cholangiopancreatographies per patient exceeds $1820.

An analysis of cost and clinical outcome in palliation for advanced pancreatic cancer.

BACKGROUND: The optimal palliative method for patients with unresectable pancreatic cancer remains controversial. METHODS: A retrospective chart review evaluated patients who underwent exploration for presumed resectable pancreatic cancer. Cost-based analysis was performed using relative value units (RVUs) that included the initial surgical procedure and any additional procedure required to achieve satisfactory palliation. RESULTS: Of 96 patients (1993--2002), 6% had biliary bypass, 42% had duodenal bypass, 40% had double bypass, and 13% had no procedure with equivalent clinical outcomes. If biliary bypass was not initially performed, there was a significant incidence of biliary complications before definitive endoscopic stenting (P=.01). If duodenal bypass was not initially performed, 11% developed duodenal obstruction (P=.04). Total RVUs was highest for a double bypass and lowest for no initial surgical palliative procedure. CONCLUSIONS: Although surgical bypass procedures at initial exploration provide durable palliation, these procedures are associated with greater costs.

Percutaneous self-expanding metal stents versus endoscopic polyethylene endoprostheses for treating malignant biliary obstruction: randomized clinical trial.

PURPOSE: To compare percutaneous self-expanding metal stents with conventional endoscopic polyethylene endoprostheses for treatment of malignant biliary obstruction by means of a prospective randomized clinical trial. MATERIALS AND METHODS: Patients with biliary obstruction due to inoperable primary carcinoma of the pancreas, gallbladder, or bile ducts or regional lymph node metastases were included. Evaluated outcomes included technical and therapeutic success rates, morbidity and 30-day mortality rates, hospital stay length and readmission, biliary reobstruction, and overall survival rates. Data were analyzed according to both the intention-to-treat principle and the treatment actually administered. Univariate (Kaplan-Meier method) and multivariate (Cox model) analyses were performed. RESULTS: After randomization, 28 patients were assigned to receive a percutaneous self-expanding metal stent and 26 patients to receive a 12-F endoscopic polyethylene prosthesis. The technical success rates of both implantation procedures were similar (percutaneous, 75% [21 of 28 patients]; endoscopic, 58% [15 of 26 patients]; P =.29), whereas therapeutic success was higher in the percutaneous group (71% [20 of 28 patients] vs 42% [11 of 26 patients]; P =.03). However, major complications were more common in the percutaneous group (61% [17 of 28 patients] vs 35% [nine of 26 patients]; P =.09) but did not account for differences in 30-day mortality rates (percutaneous, 36% [10 of 28 patients]; endoscopic, 42% [11 of 26 patients]; P =.83). Overall median survival was significantly higher in the percutaneous group than in the endoscopic group (3.7 vs 2.0 months; P =.02). Cox regression analysis enabled identification of placement of the percutaneous self-expanding metal stent as the only independent predictor of survival (relative risk, 2.19; 95% CI: 1.11, 4.31; P =.02). CONCLUSION: Placement of a percutaneous self-expanding metal stent is an alternative to placement of an endoscopic polyethylene endoprosthesis in patients with malignant biliary obstruction.

Cost-effectiveness analysis of alternative strategies for palliation of distal biliary obstruction after a failed cannulation attempt.

OBJECTIVES: Occasionally alternative techniques such as precut sphincterotomy or percutaneous transhepatic cholangiography (PTC) are required to achieve access to the common bile duct. Tradeoffs exist, however, with respect to their complications and costs. Some experts believe that precut sphincterotomy should not be performed at all. We aimed to compare the cost-effectivenesses of metallic biliary stent placement after an initial failed cannulation attempt at ERCP utilizing precut sphincterotomy and placement utilizing PTC for palliation of jaundice. A cost-effectiveness analysis was performed, as viewed from the societal perspective. METHODS: A decision analysis model was designed comparing precut sphincterotomy and PTC approaches for placement of a metallic biliary stent for palliation of jaundice in a patient with inoperable malignant distal biliary obstruction in whom an initial attempt at ERCP cannulation had failed. Baseline probabilities, obtained from the published literature, were varied through plausible ranges using sensitivity analysis. Charges were based on Medicare professional plus facility fees or diagnosis-related group rates for out- and inpatients, respectively. The outcome measured was cost per year of life. RESULTS: Sensitivity analysis showed that precut sphincterotomy with subsequent PTC, if necessary, was the most cost-effective strategy provided the precut complication rate was <51% ($9,033/yr), versus $14,741/yr for PTC. CONCLUSIONS: Precut sphincterotomy followed by PTC (if necessary) is the most cost-effective strategy for palliative biliary stenting in the setting of malignant distal biliary obstruction after a failed ERCP attempt. The endoscopic approach is best practiced by experienced endoscopists who minimize precut complication rates.

Biliary stents in malignant obstructive jaundice due to pancreatic carcinoma: a cost-effectiveness analysis.

OBJECTIVES: Obstructive jaundice frequently complicates pancreatic carcinoma and is associated with complications such as malabsorption, coagulopathy, progressive hepatocellular dysfunction, and cholangitis in addition to disabling pruritus, which greatly interferes with terminal patients' quality of life. Endoscopic placement of biliary stents decreases the risk of these complications and is considered the procedure of choice for palliation for patients with unresectable tumors. We used decision analysis with Markov modeling to compare the cost-effectivenesses of plastic stents and metal stents in patients with unresectable pancreatic carcinoma. METHODS: A model of the natural history of unresectable pancreatic carcinoma was constructed using probabilities derived from the literature. Cost estimates were obtained from Medicare reimbursement rates and supplemented by the literature. Two strategies were evaluated: 1) initial endoscopic plastic stent placement and 2) initial endoscopic metal stent placement. We compared total costs and performed cost-effectiveness analysis in these strategies. The outcome measures were quality-adjusted life months. Sensitivity analyses were performed on selected variables. RESULTS: Our baseline analysis showed that initial plastic stent placement was associated with a total cost of $13,879/patient and 1.799 quality-adjusted life months. Initial placement of a metal stent cost $13,466/patient and conferred 1.832 quality-adjusted life months. Among the variables examined, expected patient survival was demonstrated by sensitivity analyses to have the most influence on the results of the model. CONCLUSION: Initial endoscopic placement of a metal stent is a cost-saving strategy compared to initial plastic stent placement, particularly in patients expected to survive longer than 6 months.

Cost analysis of magnetic resonance cholangiography in the management of inoperable hilar biliary obstruction.

OBJECTIVE: Palliation of patients with Klatskin tumors involving both hepatic ducts is usually performed with bilateral biliary stent placement. Magnetic resonance cholangiopancreatography (MRCP) offers the ability to visualize the hepatic ducts without injection of contrast, thereby reducing the patient's risk of developing postprocedure bacterial cholangitis. We used decision analysis techniques to quantitate the cost-effectiveness of MRCP before stent placement versus routine placement of bilateral biliary stents in the setting of inoperable malignant hilar obstruction. In addition to determining which strategy was most economical, we used sensitivity analysis to identify the critical factors defining relative costs. METHODS: A decision analysis model was designed comparing MRCP with subsequent unilateral biliary stent placement and double biliary stent placement approaches for palliation of jaundice in a patient with inoperable malignant hilar obstruction, as viewed from the societal perspective. Baseline probabilities, obtained from the published literature, were varied through plausible ranges using sensitivity analysis. Charges were based on Medicare professional plus facility fees or diagnosis-related group rates for out- and inpatients, respectively. RESULTS: MRCP with subsequent directed unilateral stent placement was the least costly approach ($3806) compared with bilateral stent placement ($4275), provided the bilateral biliary stent complication rate was >3%. Bilateral stent placement needed to confer a survival advantage of at least 7 days over unilateral stent placement to become the more cost-effective approach. CONCLUSIONS: The use of MRCP to guide biliary stent placement in a patient with inoperable hilar obstruction reduces the overall cost of treatment. The uncertainty of any survival advantage that bilateral biliary stent placement confers over unilateral stent placement makes cost-effectiveness difficult to assess.

Cost comparison of endoscopic stenting vs surgical treatment for unresectable cholangiocarcinoma.

BACKGROUND: Total lifetime costs of endoscopic vs surgical treatment for obstructive jaundice due to cholangiocarcinoma are difficult to assess. The purpose of this study was to compare total costs in these two groups, including all treatment and retreatments. METHODS: This retrospective study identified patients with biopsy-proven cholangiocarcinoma treated this decade with either endoscopic biliary stenting or surgical biliary-enteric bypass with or without resection. Outcomes and hospital charges were recorded. Ten matched control patients were compared from each group. Costs included those for cost of repeat endoscopy in the endoscopic group and for the management of recurrent obstructive jaundice in the surgical group. RESULTS: The groups were similar in age and gender ratio. The surgical approach was frequently for cure; therefore, surgical patients were by and large at an earlier stage of their disease than those in the endoscopic group. Mean survival for the endoscopic group was 19 months vs 16.5 months for the surgical group. The median total lifetime cost for surgical therapy was $60,986 vs $24,251 for endoscopic therapy. CONCLUSION: Endoscopic therapy is an effective palliative therapy for unresectable cholangiocarcinoma. Endoscopic therapy for this entity costs significantly less than surgical treatment. The cost benefit of endoscopic stenting over standard surgical bypass in the management of patients with unresectable cholangiocarcinoma, when considered along with its minimally invasive approach, makes this the procedure of choice for palliative therapy.

EUS with EUS-guided fine-needle aspiration as the first endoscopic test for the evaluation of obstructive jaundice.

BACKGROUND: This study assesses the cost savings associated with using endoscopic ultrasound (EUS) before endoscopic retrograde cholangiopancreatography (ERCP) for evaluating patients with suspected obstructive jaundice. METHODS: One hundred forty-seven patients with obstructive jaundice of unknown or possibly neoplastic origin had EUS as their first endoscopic procedure. With knowledge of the final diagnosis and actual management for each patient, their probable evaluation and outcomes and their additional costs were reassessed assuming that ERCP would have been performed as the first endoscopic procedure. Also calculated were the additional costs incurred if EUS were unavailable for use after ERCP and had to be replaced by computed tomography or other procedures. RESULTS: The final diagnoses in these patients included malignancies (65%), choledocholithiasis or cholecystitis (18%), "medical jaundice" (11%), and miscellaneous benign conditions (6%). Fifty-four percent had EUS-guided fine-needle aspiration but only 53% required ERCP after EUS. An EUS-first approach saved an estimated $1007 to $1313/patient, but the cost was $2200 more if EUS was unavailable for use after ERCP. Significant savings persisted through sensitivity analysis. CONCLUSIONS: Performing EUS with EUS-guided fine-needle aspiration as the first endoscopic procedure in patients suspected to have obstructive jaundice can obviate the need for about 50% of ERCPs, helps direct subsequent therapeutic ERCP, and can substantially reduce costs in these patients.

ERCP and stent therapy for progressive jaundice in hepatocellular carcinoma: which patients benefit, which patients don't?

Jaundice in hepatocellular carcinoma (HCC) can be due to biliary obstruction. Endoscopic retrograde cholangiopancreatography (ERCP) can be both diagnostic and therapeutic. Biliary stenting can relieve jaundice and allow further chemotherapy, but at additional expense and potential morbidity. We sought to determine whether CT scan or ultrasound (US) could identify which patients with HCC and jaundice would benefit from endoscopic stenting. We retrospectively analyzed 26 patients with HCC and jaundice who underwent ERCP after CT or US. We compared biliary dilation on CT or US with the dominant biliary stricture seen on ERCP, and with response to biliary stenting. Eleven of 26 patients had dominant biliary stricture on ERCP; 11 underwent stenting. Six of 11 (55%) stented patients had a significant decline in bilirubin; three became eligible for further chemotherapy. All six responders to stenting had biliary dilation on prior CT or US. Procedure-related complications occurred in 1/11 (9%) who underwent stent placement. In conclusion, in selected patients, stenting can safely relieve jaundice and allow subsequent chemotherapy. CT or US accurately predicted lesions that responded to stenting. ERCP and stenting provided no benefit in the absence of biliary dilation on CT or US.

Comparative costs of metal versus plastic biliary stent strategies for malignant obstructive jaundice by decision analysis.

BACKGROUND: For palliation of patients with malignant obstructive jaundice, expansile metal stents provide longer patency than plastic stents but are more expensive. The optimal cost-effective strategy has not been established. Our aim was to compare the relative costs of 3 strategies: (1) plastic stent, with exchange on occlusion; (2) metal stent initially, with coaxial plastic stent insertion in the event of occlusion; or (3) plastic stent initially, with metal stent exchange in the event of occlusion. METHODS: A decision analysis model was created using DATA 2.6 software to assess the relative costs of the three strategies. Values for variables including the probabilities of reintervention and patient survival were obtained from published data. Costs were based on Medicare reimbursements of hospital charges, and the model was evaluated from the perspective of a third-party payer. One-way and two-way sensitivity analysis of the variables was performed over a wide range. RESULTS: The outcome is highly sensitive to the ratio of metal stent cost relative to endoscopic retrograde cholangiopancreatography cost (cost ratio M:ERCP) and to the length of survival of the patient. The most economical strategies were (2), (3) and (1) for M:ERCP cost ratios of <0.5, 0.5 to 0.7, and >0.7, respectively. CONCLUSIONS: The choice of stent should be guided by the relative local costs of ERCP and metal stents and by the prognosis of the patient. At current metal stent costs and Medicare reimbursement rates, initial placement of a plastic stent, followed by metal stent placement at first occlusion in longer survivors, is an economical option. If metal stent cost is less than half of ERCP cost, then initial insertion of a metal stent would be most economical. Use of plastic stents is preferable for patients surviving less than 4 months, whereas metal stents are more economical for patients with longer survival.

Single-specimen bile cytology: a prospective study of 80 patients with obstructive jaundice.

PURPOSE: To determine the sensitivity, specificity, and charges associated with single-specimen bile cytologic study in patients with obstructive jaundice. MATERIALS AND METHODS: Eighty consecutive patients with presumed malignant biliary strictures underwent percutaneous biliary drainage (PBD). Cytologic evaluation was performed on a single bile specimen from each patient collected at the time of the PBD. Final diagnoses were obtained from either percutaneous (n = 14) or surgical (n = 66) histologic specimens (gold standard). Both data sets were then compared to determine the sensitivity and specificity of bile cytology. The charges associated with bile cytodiagnosis were compared to those for other biopsy procedures utilized in the same setting. RESULTS: Eighty bile specimens were obtained with a mean of 14 mL (range, 3-65 mL) per patient with 79 (99%) specimens adequate for cytologic processing. Eleven (13%) specimens were acellular. The overall sensitivity was 15% and specificity was 100%; these values were not dependent on the volume of the bile specimen (P > .10) or type of malignancy (P = .10). For bile cytodiagnosis, the mean charge was $160 and the successful biopsy rate (true-positive plus true-negative results/total number procedures) was 27%. CONCLUSION: Single-specimen bile cytology has a low sensitivity; however, because of its convenience, simplicity, atraumatic nature, and low relative charge versus comparable procedures, it may be useful as an adjunct to PBD in patients with suspected malignant biliary disease.

Malignant obstructive jaundice. Evaluation and management.

A large number of laboratory tests, radiologic studies, and endoscopic techniques are available for the evaluation of the jaundiced patient. Similarly, the therapeutic options have increased with the development and improvement of endoscopic, percutaneous, and laparoscopic procedures, and the morbidity and mortality rates associated with open surgery have decreased. The challenge is to select, on an individual basis, the most efficient and cost-effective evaluation as well as the management with the lowest morbidity and mortality rates and the best short- and long-term goals.