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Competing Interests: The authors declare that they have no conflict of interest.

Background and Study Aim: Endoscopic retrograde cholangiopancreatography (ERCP) has evolved as the main therapeutic intervention for hepatobiliary disorders. Palliative stenting for inoperable cases is associated with better morbidity and mortality than surgery. This work aimed at assessing the effect of insertion of two plastic stents in inoperable malignant biliary stricture among cirrhotic patients regarding stent patency, quality of life (QOL), and cost., Patients and Methods: This multicenter study included 72 cirrhotic patients presented for ERCP with an inoperable malignant biliary stricture. All patients underwent ERCP after preoperative optimization with sphincterotomy, balloon dilatation, and insertion of two plastic stents of 10 Fr. Evaluation included stent patency at 6 months, effect on the QOL using EORTC QLQ-C30 (version 3), adverse events, and the cost., Results: Patients included 67% of males and had an age range of 48-88 years (mean: 70 years). In all, 92% of stents were patent at 6 months. Significant improvement in serum total bilirubin and all items of QOL questionnaire at 6 months after the procedure was reported. Cholangitis and pancreatitis were reported in 25 and 8% of cases, respectively. The cost of insertion of two plastic stents and the daily cost of the procedure regarding the effect on QOL were low., Conclusion: Double plastic stenting of the common bile duct seems effective at 6 months of follow-up among cirrhotic patients with inoperable malignant biliary obstruction. Furthermore, it seems also valuable in improving laboratory findings and QOL among those patients with an acceptable cost.

Background: ASGE and ESGE guidelines recommend endoscopic metal stent placement for pancreatic carcinoma patients with biliary obstruction, and whose estimated life expectancy is greater than 6 months. Because median overall survival (OS) of metastatic pancreatic adenocarcinoma until recently has been less than 6 months, plastic biliary stents were preferentially placed rather than metal due to the greater upfront cost of the latter. Recent advances in the treatment of metastatic pancreatic cancer have extended median OS beyond the 6-month range. Given this improvement in OS, we performed a cost-effectiveness analysis of initial metal biliary versus plastic stent placement in metastatic pancreatic cancer patients with biliary obstruction., Methods: A Markov model was developed to predict lifetime costs, quality-adjusted life years (QALYs), and cost effectiveness of metal compared with plastic stents. Adult patients entered the model with locally advanced cancer and underwent endoscopic retrograde cholangiopancreatography (ERCP) with placement of metal or plastic stents. A targeted literature search was conducted to identify published sources, which were used to estimate clinical, cost, utility, and event rate inputs to the model. Results were estimated from the third-party payer perspective in 2012 US dollars per QALY. One-way and probabilistic sensitivity analyses were conducted to assess the impact on model outcomes resulting from uncertainty among inputs., Results: Our analysis found that initial placement of metal stents was more cost effective than plastic biliary stents with lower overall costs due to lower restenting rates while at the same time associated with a better quality of life. Based on model projections, placement of metal stents could save approximately $1450 per patient over a lifetime, while simultaneously improving quality of life. These findings were robust in sensitivity analyses., Conclusions: Placement of metal biliary stents at initial onset of obstructive jaundice in adult patients with metastatic pancreatic carcinoma with an expected OS greater than 6 months was found to be a more cost-effective strategy than plastic stents. These results reinforce guidelines' suggestions for metal stent placement.

Background: Pancreatitis is the most frequent complication due to ERCP. Pancreatic duct stent placement has been described as a preventive measure. There is also evidence pointing towards the preventive effect that early precut may provide., Aim: To determine and compare the cost-effectiveness of an early precut approach versus pancreatic duct stent placement for the prevention of post-ERCP pancreatitis., Methods: This was a multicenter, randomized-controlled pilot study with a cost-effectiveness analysis performed between early precut (group A) and pancreatic duct stent (group B) for the prevention of pancreatitis in high-risk patients. Patients with a difficult biliary cannulation and at least one other risk factor for post-ERCP pancreatitis were enrolled and randomized to one of the treatment arms. Both effectiveness and costs of the procedures and their complications were analyzed and compared., Results: From November 2011 to November 2013, 101 patients were enrolled; 50 subjects were assigned to group A and 51 to group B. There were no significant differences in terms of baseline characteristics of patients between groups. Two cases of mild pancreatitis were observed in each group. The overall costs were U$ 1,242.6 per patient in group A and U$ 1,606.5 per patient in group B. The cost in group B was 29.3% higher (p < 0.0001)., Conclusion: Early precut showed a better cost-effectiveness profile when compared to pancreatic duct stent placement.

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.

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.

Objectives: The aim of the present study was to perform a comparative cost-effectiveness analysis of the different strategies used to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) acute pancreatitis., Methods: We performed a cost-effectiveness decision analysis of 4 prophylactic strategies (nonsteroidal anti-inflammatory drugs or NSAIDs, pancreatic stent, stent plus rectal indomethacin, and no prophylaxis) in a simulated cohort of 300 patients during 1 year. Treatment effectiveness was defined as the number of patients who did not develop post-ERCP pancreatitis., Results: The baseline costs of each strategy were as follows: rectal NSAID $359,098, pancreatic stent $426,504, stent plus rectal indomethacin $479,153, and no prophylaxis $491,275. The mean number of cases developing post-ERCP pancreatitis was 16, 21, 23, and 37 for the strategies rectal NSAID, pancreatic stent, stent plus rectal indomethacin, and no prophylaxis, respectively. Taking rectal NSAID prophylaxis as the reference strategy, the odds ratio of an episode of post-ERCP acute pancreatitis after pancreatic stent placement was 1.33 (95% confidence interval [CI], 0.68-2.61); after stent plus indomethacin, it was 1.40 (95% CI, 0.72-2.73), and after no prophylaxis, it was 2.49 (95% CI, 1.35-4.59)., Conclusions: Rectal NSAID administration proved to be the most cost-effective prophylactic strategy used to prevent post-ERCP pancreatitis. The strategy of no prophylaxis for this complication should be avoided.

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.

Objectives: A recent large-scale randomized controlled trial (RCT) demonstrated that rectal indomethacin administration is effective in addition to pancreatic stent placement (PSP) for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. We performed a post hoc analysis of this RCT to explore whether rectal indomethacin can replace PSP in the prevention of PEP and to estimate the potential cost savings of such an approach., Methods: We retrospectively classified RCT subjects into four prevention groups: (1) no prophylaxis, (2) PSP alone, (3) rectal indomethacin alone, and (4) the combination of PSP and indomethacin. Multivariable logistic regression was used to adjust for imbalances in the prevalence of risk factors for PEP between the groups. Based on these adjusted PEP rates, we conducted an economic analysis comparing the costs associated with PEP prevention strategies employing rectal indomethacin alone, PSP alone, or the combination of both., Results: After adjusting for risk using two different logistic regression models, rectal indomethacin alone appeared to be more effective for preventing PEP than no prophylaxis, PSP alone, and the combination of indomethacin and PSP. Economic analysis revealed that indomethacin alone was a cost-saving strategy in 96% of Monte Carlo trials. A prevention strategy employing rectal indomethacin alone could save approximately $150 million annually in the United States compared with a strategy of PSP alone, and $85 million compared with a strategy of indomethacin and PSP., Conclusions: This hypothesis-generating study suggests that prophylactic rectal indomethacin could replace PSP in patients undergoing high-risk ERCP, potentially improving clinical outcomes and reducing healthcare costs. A RCT comparing rectal indomethacin alone vs. indomethacin plus PSP is needed.

Background: Although self-expandable metal stents (SEMS) are widely used for distal malignant biliary obstruction, one-step SEMS (direct placement without a prior plastic stent) and two-step SEMS (placement at second endoscopic retrograde cholangiopancreatography [ERCP] following plastic stent placement) have not been fully compared., Methods: In this multicenter retrospective study, patients were included who underwent first-time endoscopic SEMS placement between September 1994 and December 2010. We compared the one-step and two-step strategies using a propensity analysis., Results: In total, 370 patients were identified and one-step SEMS was performed in 59 patients. After adjustment using propensity scores, the median times to dysfunction were 116 and 219 days, respectively, for one-step and two-step SEMS (P = 0.058). Stent migration was more frequently observed in one-step SEMS as compared with two-step SEMS (25 vs. 11 %, P = 0.031). In one-step SEMS, the number of days of hospitalization associated with first-time SEMS placement was shorter compared with that in two-step SEMS (21 vs. 30 days, P = 0.001), and the total costs of SEMS-related interventions within 6 months were lower (6510 and 8100 USD, P = 0.004). The pathological diagnosis rates for pancreatic and biliary tract cancer at initial ERCP were 52 and 61 %. After failed diagnosis at initial ERCP, pathological diagnosis rates for pancreatic cancer were 32 versus 76 % (P = 0.005) by repeated ERCP versus endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA)., Conclusions: One-step SEMS was associated with increased stent migration, despite having potential cost-effectiveness. The additional yield of pathological diagnosis at repeated ERCP was low compared with that yielded by EUS-guided FNA.

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.

Background: In countries where ERCP costs are low relative to those of metal stents (eg, Korea), initial endoscopic retrograde biliary drainage (ERBD) with a plastic stent is thought to be more economical., Objective: We conducted this study to compare metal and plastic stent-based ERBD in efficacy, complications, and total cost of biliary drainage., Design: Retrospective study., Setting: Tertiary referral center., Patients: A total of 112 patients who had not undergone previous biliary drainage procedures and who underwent ERBD for unresectable malignant biliary obstruction., Interventions: Endoscopic sphincterotomy was performed, and covered or uncovered Wallstents were used in 56 patients and plastic stents in 56 patients., Results: Stent occlusion occurred in 31 patients after a mean of 278 days in the metal stent group and in 39 patients after a mean of 133 days in the plastic stent group (P = .0004). The incidence of and length of hospitalization for cholangitis were significantly lower in the metal stent group. There was no difference in the total number of drainage procedures between the 2 groups. There was no statistical difference in the mean cost of the relief of jaundice between the 2 groups ($1488.77 in the metal stent group vs $1319.26 in the plastic stent group, P = .422)., Limitations: Nonrandomized, retrospective study., Conclusion: Even in countries where ERCP costs are lower than those of metal stents, ERBD with metal biliary stents as the first-line treatment may offer better palliation without a significant increased cost in patients with unresectable malignant biliary obstruction.

Background: A significant number of self-expandable metal stents (SEMSs) placed to palliate malignant biliary obstruction will occlude. Few data exist as to what constitutes optimal management., Objective: Our purpose was to review the management and outcomes of patients with biliary SEMS occlusion., Design and Setting: Retrospective chart review at a single tertiary care hospital., Patients: From January 1999 to October 2005, a total of 90 patients had SEMSs placed for malignant biliary obstruction, and 27 of these occluded., Main Outcome Measurements: Technical success of treating SEMS occlusion, stent patency and need for reintervention, and incremental cost analysis., Results: A total of 60 ERCPs were performed to treat SEMS occlusions in 27 patients. The success rate was 95%; however, 52% of patients eventually required more than 1 intervention. Placing a second SEMS through the existing SEMS (n = 14) provided the lowest reocclusion rate (43% vs 55% and 100%), the longest time to reintervention (172 days vs 66 and 43 days, P = .03), and a trend toward longer survival (285 days vs 188 and 194 days) compared with plastic stent and mechanical balloon cleaning, respectively. Incremental cost analysis showed both uncovered SEMSs and plastic stents to be cost effective strategies., Limitations: Small number of patients, retrospective study., Conclusions: Treatment of biliary SEMS occlusion with SEMS insertion provides for longer patency and survival, decreases the number of subsequent ERCPs by 50% compared with plastic stents, and is cost-effective.

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.

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.

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.

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.