Clinical and cost effectiveness of endoscopic bipolar radiofrequency ablation for the treatment of malignant biliary obstruction: a systematic review.

Background: Early evidence suggests that using radiofrequency ablation as an adjunct to standard care (i.e. endoscopic retrograde cholangiopancreatography with stenting) may improve outcomes in patients with malignant biliary obstruction. Objectives: To assess the clinical effectiveness, cost-effectiveness and potential risks of endoscopic bipolar radiofrequency ablation for malignant biliary obstruction, and the value of future research. Data sources: Seven bibliographic databases, three websites and seven trials registers were searched from 2008 until 21 January 2021. Review methods: The study inclusion criteria were as follows: patients with biliary obstruction caused by any form of unresectable malignancy; the intervention was reported as an endoscopic biliary radiofrequency ablation to ablate malignant tissue that obstructs the bile or pancreatic ducts, either to fit a stent (primary radiofrequency ablation) or to clear an obstructed stent (secondary radiofrequency ablation); the primary outcomes were survival, quality of life or procedure-related adverse events; and the study design was a controlled study, an observational study or a case report. Risk of bias was assessed using Cochrane tools. The primary analysis was meta-analysis of the hazard ratio of mortality. Subgroup analyses were planned according to the type of probe, the type of stent (i.e. metal or plastic) and cancer type. A de novo Markov model was developed to model cost and quality-of-life outcomes associated with radiofrequency ablation in patients with primary advanced bile duct cancer. Insufficient data were available for pancreatic cancer and secondary bile duct cancer. An NHS and Personal Social Services perspective was adopted for the analysis. A probabilistic analysis was conducted to estimate the incremental cost-effectiveness ratio for radiofrequency ablation and the probability that radiofrequency ablation was cost-effective at different thresholds. The population expected value of perfect information was estimated in total and for the effectiveness parameters. Results: Sixty-eight studies (1742 patients) were included in the systematic review. Four studies (336 participants) were combined in a meta-analysis, which showed that the pooled hazard ratio for mortality following primary radiofrequency ablation compared with a stent-only control was 0.34 (95% confidence interval 0.21 to 0.55). Little evidence relating to the impact on quality of life was found. There was no evidence to suggest an increased risk of cholangitis or pancreatitis, but radiofrequency ablation may be associated with an increase in cholecystitis. The results of the cost-effectiveness analysis were that the costs of radiofrequency ablation was £2659 and radiofrequency ablation produced 0.18 quality-adjusted life-years, which was more than no radiofrequency ablation on average. With an incremental cost-effectiveness ratio of £14,392 per quality-adjusted life-year, radiofrequency ablation was likely to be cost-effective at a threshold of £20,000 per quality-adjusted life-year across most scenario analyses, with moderate uncertainty. The source of the vast majority of decision uncertainty lay in the effect of radiofrequency ablation on stent patency. Limitations: Only 6 of 18 comparative studies contributed to the survival meta-analysis, and few data were found concerning secondary radiofrequency ablation. The economic model and cost-effectiveness meta-analysis required simplification because of data limitations. Inconsistencies in standard reporting and study design were noted. Conclusions: Primary radiofrequency ablation increases survival and is likely to be cost-effective. The evidence for the impact of secondary radiofrequency ablation on survival and of quality of life is limited. There was a lack of robust clinical effectiveness data and, therefore, more information is needed for this indication. Future work: Future work investigating radiofrequency ablation must collect quality-of-life data. High-quality randomised controlled trials in secondary radiofrequency ablation are needed, with appropriate outcomes recorded. Study registration: This study is registered as PROSPERO CRD42020170233. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 7. See the NIHR Journals Library website for further project information.

The bile and pancreatic ducts transport fluids to the intestines to help people digest their food properly. Some types of cancer can cause these ducts to become totally or partially blocked. We wanted to know if endoscopic radiofrequency ablation is safe and works well to treat people who have one of these blockages that cannot be removed by surgery. Radiofrequency ablation burns away a blockage by hitting it with radio waves. Endoscopic means that the radio waves are directed to the blockage using a thin, tube-like wire with a camera at the end. During radiofrequency ablation, a person might have a small tube called a stent put into their bile or pancreatic duct to keep it open or to replace an already blocked stent.

We searched for research studies that looked at (1) whether or not radiofrequency ablation was able to remove blockages from the ducts, (2) if radiofrequency ablation allowed people to live longer, (3) if patients had a better quality of life after radiofrequency ablation, (4) if radiofrequency ablation caused any side effects and (5) how much it costs to treat people with radiofrequency ablation.

We found that treatment with radiofrequency ablation before giving a person a stent helped them to live a little longer with their cancer. We did not find any evidence that radiofrequency ablation increased pain or swelling in the bile duct or pancreatic duct. Radiofrequency ablation might cause more swelling in the gall bladder than having a stent without radiofrequency ablation, but there was not enough research available for us to be certain of this.

Radiofrequency ablation before inserting a stent could be a safe option to add to treatment of bile and pancreatic duct blockages caused by cancer. There is limited research evidence and so we are unable to recommend radiofrequency ablation as a treatment for standard clinical practice.

Costs of pediatric liver transplantation among commercially insured and Medicaid-insured patients with cholestasis in the US.

Children with rare cholestatic liver diseases, such as Alagille syndrome, progressive familial intrahepatic cholestasis, and biliary atresia typically require liver transplantation (LT). The objective of this analysis was to assess the economic burden of LT on these patients. Health care resource utilization and costs associated with pediatric LT were retrospectively assessed using insurance claims data from the US IBM MarketScan Commercial and Medicaid databases collected between October 2015 and December 2019. Inclusion criteria were as follows: ≥1 procedure code for LT, <18 years old at transplant, and ≥6 months of insurance eligibility at baseline. A cholestatic liver disease population who received LT was selected in the absence of specific diagnosis codes by excluding other severe liver conditions (ie, acute liver failure, malignancy) and by excluding severely decompensated individuals requiring ICU admission before LT. Annualized rates were reported. Over a mean study duration of 1.8 years, 53 commercially insured and 100 Medicaid-insured children received LT, with mean (SD) ages at baseline of 6.9 (6.0) and 5.7 (5.4) years, respectively. During this period, commercially insured and Medicaid-insured patients had annualized means of 65.3 and 52.8 medical visits, respectively. Most were outpatient visits, although the burden of inpatient visits was also high, with mean inpatient stays (inclusive of LT stay) of 37.2 and 31.6 days per year, respectively. Commercially insured and Medicaid-insured patients averaged US$512,124 and $211,863 in medical costs and $26,998 and $15,704 in pharmacy costs, respectively. These costs remained substantial throughout the first year after transplant. Overall, pediatric LT resulted in substantial health care resource utilization and cost burden in both commercially- and Medicaid-insured patients. Novel targeted medications that negate the need for pediatric LT could decrease the associated morbidity and costs.

Comparison of therapeutic efficacy and treatment costs of self-expandable metal stents and plastic stents for management of malignant biliary obstruction.

BACKGROUND: According to the European Society of Gastrointestinal Endoscopy guidelines, self-expandable metal stents (SEMSs) are preferable to plastic stents (PSs) in the management of pancreatic cancer, regardless of cancer stage. The aim of this study was to compare the therapeutic efficacy and treatment costs of SEMS and PS in the management of malignant biliary obstruction. METHODS: One hundred and thirty-five patients who underwent endoscopic stent placement were retrospectively enrolled and divided into PS (41 patients), primary SEMS (39 patients) and secondary SEMS (55 patients) groups. We determined the technical and functional success rate, stent patency, and cumulative treatment cost. RESULTS: A total of 111 SEMSs and 153 PSs were placed with similar technical (100% vs. 98.69%) and functional success rate (90.10% vs. 86.27%) but with different stent patency (10.28 vs. 22.16 weeks; p < 0.001). Multiple PS implantations and larger stent diameter increased the length of stent patency compared to 7-Fr PSs (10.88 vs. 10.55 vs. 7.63 weeks, respectively). The cumulative treatment cost of patients with different survival times did not differ significantly between groups, however, among patients surviving 2-4 months it was higher in PS group than primary SEMS and secondary SEMS groups (2888€ vs. 2258€ vs. 2144€, respectively, p = 0.3369) due to increased number of biliary reintervention (2.08 ± 1.04 vs. 1.20 ± 0.42 vs. 1.50 ± 0.53; p < 0.0274) and longer hospital stay (15.77 ± 10.14 vs. 8.70 ± 7.70 vs. 8.50 ± 6.17 days, p = 0.0527). CONCLUSIONS: In view of treatment costs, the consequences of illness, and the processes of the health care system, SEMS implantation is recommended regardless of patients' life expectancy.

Fully Covered Self-expanding Stents are Cost-effective at Remediating Biliary Strictures in Patients With Chronic Pancreatitis.

Benign biliary strictures (BBS) develop in up to 10% to 30% of patients with chronic pancreatitis (CP).1 Endoscopic endoprosthetics via endoscopic retrograde cholangiopancreatography (ERCP) has become the standard of care for remediating these strictures. Seventy percent to eighty percent of these strictures resolve with sequential or concurrent placement of multiple plastic stents (MPS).1,2 More recently, placement of fully covered self-expanding metal stents (FCSEMS) have been shown to have similar outcomes as MPS.3-6 FCSEMS provide a larger radial diameter and require fewer procedures, but may have drawbacks, including a higher risk of migration, cholecystitis, delamination, and tissue ingrowth. A recent study demonstrated that FCSEMS with a 12-month indwell had similar outcomes to MPS with fewer ERCP needed.7 However, the cost-effectiveness of either strategy for managing BBS has not been assessed previously nor has the impact of additional reimbursement to cover the cost of FCSEMS on the cost-effectiveness of FCSEMS utilization.

Assessing the incidence of complications and malignancies in the long-term management of benign biliary strictures with a percutaneous transhepatic drain.

ABSTRACT: Percutaneous drainage catheters (PDCs) are required for the management of benign biliary strictures refractory to first-line endoscopic treatment. While biliary patency after PDC placement exceeds 75%, long-term catheterization is occasionally necessary. In this article, we assess the outcomes of patients at our institution who required long-term PDC placement.A single-institution retrospective analysis was performed on patients who required a PDC for 10 years or longer for the management of a benign biliary stricture. The primary outcome was uncomplicated drain management without infection or complication. Drain replacement was performed every 4 to 12 weeks as an outpatient procedure.Nine patients (three males and six females; age range of 48-96 years) required a long-term PDC; eight patients required the long-term PDC for an anastomotic stricture and one for iatrogenic bile duct stenosis. A long-term PDC was required for residual stenosis or patient refusal. Drain placement ranged from 157 to 408 months. In seven patients, intrahepatic stones developed, while in one patient each, intrahepatic cholangiocarcinoma or hepatocellular carcinoma occurred.Long-term PDC has a high rate of complications; therefore, to avoid the need for using long-term placement, careful observation or early surgical interventions are required.

Metal stents are safe and cost-effective for preoperative biliary drainage in resectable pancreaticobiliary tumours.

BACKGROUNDS: To compare the complication rates and overall costs of self-expandable metal stents (SEMS) and plastic stents (PS) in clinically indicated preoperative biliary drainage (PBD) prior to a pancreatoduodenectomy (PD). METHODS: We conducted an Australian multicentre retrospective cohort study using the databases of four tertiary hospitals. Adult patients who underwent clinically indicated endoscopic PBD prior to PD from 2010 to 2019 were included. Rates of complications attributable to PBD, surgical complications and pre-operative endoscopic re-intervention were calculated. Costing data were retrieved from our Financial department. RESULTS: Among the 157 included patients (mean age 66.6 ± 9.8 years, 45.2% male), 49 (31.2%) received SEMS and 108 received PS (68.8%). Baseline bilirubin was 187.5 ± 122.6 µmol/L. Resection histopathology showed mainly adenocarcinoma (93.0%). Overall SEMS was associated less complications (12.2% vs. 28.7%, p = 0.02) and a lower pre-operative endoscopic re-intervention rate (4.3 vs. 20.8%, p = 0.03) compared with PS. There was no difference in post-PD complication rates. On multivariate logistic regression analysis, stent type was an independent risk factor of PBD complication (OR of SEMS compared to PS 0.24, 95% CI 0.07-0.79, p = 0.02) but not for any secondary outcome measures. Upfront material costs were $56USD for PS and $1991USD for SEMS. Accounting for rates of complications, average costs were similar ($3110USD for PS and $3026USD for SEMS). CONCLUSION: In resectable pancreaticobiliary tumours, SEMS for PBD was associated with reduced risk of overall PBD-related complications and pre-surgical endoscopic reintervention rates and was comparable to PS in terms of overall cost.

Palliative endoscopic retrograde biliary drainage for malignant biliary obstruction in Korea: A nationwide assessment.

BACKGROUND: Malignant biliary obstruction (MBO) is usually caused by biliary tract cancer or pancreatic cancer. This study was performed to summarize the current situation regarding palliative endoscopic retrograde biliary drainage (ERBD) for MBO in Korea and to determine its clinical significance by analyzing representative nationwide data. METHODS: Patients that underwent palliative ERBD for MBO between 2012 and 2015 were identified using the Health Insurance Review and Assessment database, which covers the entire Korean population. We assessed clinical characteristics and complications and compared the clinical impacts of initial metal and plastic stenting in these patients. RESULTS: A total of 9,728 subjects (mean age, 65 ± 11.4 years; male, 61.4%) were identified and analyzed. The most common diagnosis was malignant neoplasm of liver and intrahepatic bile ducts (32.1%) and this was followed by extrahepatic or Ampulla of Vater cancer and pancreatic cancer. Initial plastic stent(s) placement was performed in 52.9% of the study subjects, and metal stent(s) placement was performed in 23.3%. The number of sessions of endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD) was significantly higher in patients that underwent initial plastic stenting than in patients that underwent metal stenting (2.2 ± 1.7 vs 1.8 ± 1.4, P < 0.0001), but rates of post-ERCP pancreatitis, hospital days, and time to second ERCP or PTBD were not significantly different. CONCLUSION: This nationwide assessment study suggests that initial metal stenting is associated with fewer sessions of total ERCP or PTBD following the initial procedure, despite the preference for initial plastic stenting in Korea.

EUS-guided biliary drainage in patients with distal malignant biliary obstruction requires fewer interventions and has a lower cost compared to ERCP biliary drainage.

INTRODUCTION: Endoscopic retrograde cholangiopancreatography (ERCP) biliary drainage is considered the reference standard in patients with biliary obstruction, but it is not free of complications. EUS-guided biliary drainage (EUS-BD) is considered an alternative in patients with failed ERCP; however, data are scarce as to whether EUS-BD could be considered a first option. OBJECTIVE: The aim of our study was to compare the need for reintervention and cost between ERCP biliary drainage vs. EUS-BD. MATERIAL AND METHODS: We conducted a retrospective and comparative study of patients with distal malignant biliary obstruction with biliary drainage with ERCP + plastic stent (ERCP-PS) vs. ERCP + metal stent (ERCP-MS) vs. EUS-BD. RESULTS: 124 patients were included, divided into three groups: ERCP-PS, 60 (48.3%) patients; ERCP-MS, 40 (32.2%) patients; and EUS-BD, 24 (19.3%) patients. The need for reinterventions (67 vs. 37 vs. 4%, respectively), the number of procedures [3 (1-10) vs. 2 (1-7) vs. 1 (1-2)], and the costs (4550 ± 3130 vs. 5555 ± 3210 vs. 2375 ± 1020 USD) were lower in the EUS-BD group. No differences in terms of complications were detected. CONCLUSION: EUS-BD requires fewer reinterventions and has a lower cost compared to drainage by ERCP with metal or plastic stents.

Radiologic Assessment for Endoscopic US-guided Biliary Drainage.

Endoscopic US-guided biliary drainage (BD) is performed for various types of biliary obstruction and is mainly indicated for unsuccessful conventional transpapillary endoscopic retrograde cholangiodrainage. In endoscopic US BD, an extra-anatomic drainage route between the gastrointestinal (GI) tract and the biliary system is created with a covered metallic stent or plastic stent. Procedural types of endoscopic US BD include hepaticogastrostomy, hepaticojejunostomy (after gastrectomy), choledochoduodenostomy, hepaticoduodenostomy, and endoscopic US-guided gallbladder drainage. The technical and clinical success rates of endoscopic US BD are reported to be 94%-97% and 88%-100%, respectively. CT is crucial both in preprocedural assessment and postprocedural monitoring. CT is used to determine the indications for endoscopic US BD, which include the type of biliary obstruction, collateral vessels in the puncture route, ascites, the volume of the liver segment, the distribution of an intrahepatic tumor, and GI tract patency. After endoscopic US BD, common subclinical findings are a small amount of intraperitoneal gas, localized edematous change in the GI tract, a notch in the placed stent, and localized biliary dilatation caused by stent placement. Stent malfunction after endoscopic US BD is caused by impaction of debris and/or food, stent migration into the GI tract, or tumor overgrowth and/or hyperplasia. Complications that can occur include internal stent migration, intraperitoneal biloma, arterial bleeding or pseudoaneurysm, perforation of the GI tract, and portobiliary fistula. The incidence of clinical endoscopic US BD-related complications is 11%-23%. ©RSNA, 2020.

Double plastic stenting for inoperable malignant biliary stricture among cirrhotic patients as a possible cost-effective treatment: a pilot study.

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.

Transhepatic forceps biopsy after PTCD for histological assessment of bile duct stenoses or occlusions.

PURPOSE: The goal of this study was to evaluate the experience of 11 years of wire-guided forceps biopsy via PTCD in patients with obstructive jaundice. MATERIALS AND METHODS: In a retrospective approach, 56 biopsies in 51 patients were analyzed (22 female, 29 male). Data was collected from 2006 to 2016. Mean age was 71 years (range: 34 - 86 years). Data was extracted from dig. Patients' records (KIS, PACS, RIS) to be analyzed in Microsoft Excel. RESULTS: All 56 procedures were technically successful. Stenosis in anastomoses were benign due to scarring in 7 patients and in 9 due to papillitis or others. In 4 patients, results in anastomosis were malignant. In 19 patients without anastomosis, CCC was the diagnosis, thereof 10 klatskin, 9 stenosis in other locations, followed by gastric, pancreatic, and colon carcinoma in 5, 3, and 2 patients. Three patients had a CUP (multimetering in case of more than 1 related category). Overall results were 35 mal. and 16 benign, 76.8 % of all proc. had a correct histopathologic result, and 23.2 % were false negative. Sensitivity was 65.8 %, which results in negative predictive value of 58.1 %. There was no false positive and so specificity was 100 %, as was the positive predictive value. False negative results (no malignancy but clinically and imaging suspect) were corrected by rerunning the procedure, by CT-guided biopsy or by 1 PET-CT. In 1 case the surg. sample brought the result. Minor complications occurred in 8 patients: shivering in 1 case, distinct but hemodynamically not relevant hemobilia in 5 cases, 2 portovenal bleedings. All bleedings were short-term and self-limiting. CONCLUSION: Despite good feasibility, low peri- and post-interv. risk and high validity the forceps biopsy via PTCD is not widely used. For experienced interventionalists, it is an effective method for obtaining histology.

The economic impact of using single-operator cholangioscopy for the treatment of difficult bile duct stones and diagnosis of indeterminate bile duct strictures.

BACKGROUND AND STUDY AIM: Conventional endoscopic retrograde cholangiopancreatography (ERCP) combines endoscopy and radiography to diagnose and treat pathological conditions of the bile duct. The aim of the present analysis was to evaluate the clinical and economic impact of the use of single-operator intraductal cholangioscopy (IDC), which allows for direct visualization of the bile duct, as an alternative to ERCP for the treatment of difficult bile duct stones and the diagnosis of bile duct strictures. PATIENTS AND METHODS: The clinical and economic consequences of single-operator IDC use were evaluated using two decision-tree models, one for management of difficult-to-remove stones and one for stricture diagnosis. A hospital perspective was adopted. Data to populate the models were derived from two Belgian hospitals that specialize in endoscopic procedures of the bile duct. Overall, the examined population consisted of 62 patients with difficult stones and 49 patients with indeterminate strictures. RESULTS: In the model for difficult stone management, the use of IDC determined a decrease in the number of procedures (- 27 % relative reduction) and costs (- €73 000; - 11 % relative reduction) when compared with ERCP. In the model for stricture diagnosis, the use of IDC determined a decrease in the number of procedures (- 31 % relative reduction) and costs (- €13 000; - 5 % relative variation) when compared with ERCP. CONCLUSIONS: The single-operator IDC system performed better than ERCP for the treatment of difficult bile duct stones and the diagnosis of bile duct strictures, and reduced the overall expenditure in hospitals in Belgium.

Assessment of School Readiness in Chronic Cholestatic Liver Disease: A Pilot Study Examining Children with and without Liver Transplantation.

Background. Assessment of school readiness evaluates physical, social-emotional, and neuropsychological domains essential for educational success. Cognitive testing of preschool aged children with chronic liver disease may guide more timely interventions and focused efforts by health care providers. Patients and Methods. Children with chronic cholestatic liver disease diagnosed as an infant and still with their native liver (NL) and children who received a liver transplant (LT) before age of 2 years underwent testing with a battery of well-validated pediatric psychometric measures. Results. Eighteen (13 LT, 5 NL) patients (median age of 4.45 and 4.05 years, resp.) were tested. Median Full-Scale IQ was 98 (range 102-116) for LT and 116 [(range 90-106), p = 0.35, NS] for NL subjects. LT recipients had significantly greater visual based difficulties, poorer caregiver rated daily living skills (p = 0.04), and higher levels of executive function based difficulties (e.g., inattention, inhibition). Conclusion. This pilot study highlights the risk of neuropsychological difficulties in early school age children who were under 2 years of age at time of LT. Comprehensive early school age assessment should integrate psychometric measures to identify children at greatest risk, thus allowing for proactive educational intervention.

Efficacy and safety assessment of ERCP in patients with malignant biliary obstruction.

BACKGROUND: To assess the efficacy and safety of Endoscopic retrograde cholangiopancreatography (ERCP) for malignant biliary obstruction (MBO). MATERIAL AND METHODS: A review of all ERCP-procedures performed at Akershus University Hospital during the six year period between 2009-2014 was analysed. Data for the period 2009- 2013 were obtained retrospectively and prospectively for 2014. Patients with jaundice due to MBO were selected for the present study. RESULTS: A total of 210 patients (51% females), median age of 70 years (range 33-96) were included. The total number of procedures were 314, whereof 218 (69%) were successful and 96 (31%) were failures. 292 procedures were palliative and 22 procedures were intended as 'bridge to surgery' whereof 15 patients underwent surgery. Pancreatic carcinoma occurred in 105 (50%) patients and was the most common reason for MBO. Straight plastic stents (I-stents) were applied in 145 (74%), double-pigtail stents (JJ-stents) in 29 (15%), self-expanding metal stent (SEMS) in 18 (9%) procedures and in 3 procedures (1.5%) an I-stent was inserted through an indwelling SEMS. Median duration of stentpatency in months was 2 (range 0-74) for I-stent, 1 (range 0-29) for JJ-stent and 4 (range 0-29) for SEMS. The rates of complication and mortality due to complication were 8.9% and 1.3% per procedure. CONCLUSION: Adequate drainage of MBO by ERCP was obtained in 69%. The rates of complication and procedure related mortality were at acceptable levels.

Cost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic adenocarcinoma in a randomized controlled trial.

BACKGROUND AND AIMS: The optimal type of stent for the palliation of malignant biliary obstruction in patients with pancreatic adenocarcinoma undergoing neoadjuvant chemoradiotherapy with curative intent is unknown. We performed a prospective trial comparing 3 types of biliary stents-fully covered self-expandable metal (fcSEMS), uncovered self-expandable metal (uSEMS), and plastic-to determine which best optimized cost-effectiveness and important clinical outcomes. METHODS: In this prospective randomized trial, consecutive patients with malignant biliary obstruction from newly diagnosed pancreatic adenocarcinoma who were to start neoadjuvant chemoradiotherapy were randomized to receive fcSEMSs, uSEMSs, or plastic stents during the index ERCP. The primary outcomes were time to stent occlusion, attempted surgical resection, or death after the initiation of neoadjuvant therapy, and the secondary outcomes were total patient costs associated with the stent, including the index ERCP cost, downstream hospitalization cost due to stent occlusion, and the cost associated with procedural adverse event. RESULTS: Fifty-four patients were randomized and reached the primary end point: 16 in the fcSEMS group, 17 in the uSEMS group, and 21 in the plastic stent group. No baseline demographic or tumor characteristic differences were noted among the groups. The fcSEMSs had a longer time to stent occlusion compared with uSEMSs and plastic stents (220 vs 74 and 76 days, P < .01), although the groups had equivalent rates of stent occlusion, attempted surgical resection, and death. Although SEMS placement cost more during the index ERCP (uSEMS = $24,874 and fcSEMS = $22,729 vs plastic = $18,701; P < .01), they resulted in higher procedural AE costs per patient (uSEMS = $5522 and fcSEMS = $12,701 vs plastic = $0; P < .01). Conversely, plastic stents resulted in an $11,458 hospitalization cost per patient due to stent occlusion compared with $2301 for uSEMSs and $0 for fcSEMSs (P < .01). CONCLUSIONS: In a prospective trial comparing fcSEMSs, uSEMSs, and plastic stents for malignant biliary obstruction in patients undergoing neoadjuvant therapy with curative intent for pancreatic adenocarcinoma, no stent type was superior in optimizing cost-effectiveness, although fcSEMSs resulted in fewer days of neoadjuvant treatment delay and a longer time to stent occlusion. (Clincial trial registration number: NCT01038713.).

Assessment of efficacy and safety of EUS-guided biliary drainage: a systematic review.

BACKGROUND AND AIMS: EUS-guided biliary drainage (EUS-BD) has emerged as an alternative procedure after failed ERCP. However, limited data on the efficacy and safety of EUS-BD are available. Therefore, a systematic review was conducted to evaluate the efficacy and safety of EUS-BD and to evaluate transduodenal (TD) and transgastric (TG) approaches. METHODS: PubMed and EMBASE were searched to identify relevant studies published in the English language for inclusion in this systematic review and meta-analysis. Data from eligible studies were combined to calculate the cumulative technical success rate (TSR), functional success rate (FSR), and adverse-event rate of EUS-BD and the pooled odds ratio of TSR, FSR, and adverse-event rate of the TD approach when compared with the TG approach. RESULTS: Forty-two studies with 1192 patients were included in this study, and the cumulative TSR, FSR, and adverse-event rate were 94.71%, 91.66%, and 23.32%, respectively. The common adverse events associated with EUS-BD were bleeding (4.03%), bile leakage (4.03%), pneumoperitoneum (3.02%), stent migration (2.68%), cholangitis (2.43%), abdominal pain (1.51%), and peritonitis (1.26%). Ten studies were included in the meta-analysis for comparative evaluation of TD and TG approaches for EUS-BD. Compared with the TG approach, the pooled odds ratio of the TSR, FSR, and adverse-event rate of the TD approach were 1.36 (95% CI, .66-2.81; P > .05), .84 (95% CI, .50-1.42; P > .05), and .61 (95% CI, .36-1.03; P > .05), respectively, which indicated no significant difference in the TSR, FSR, and adverse-event rate between the 2 groups. CONCLUSIONS: Although it is associated with significant morbidity, EUS-BD is an effective alternative procedure for relieving biliary obstruction. There was no significant difference between the TD and TG approaches for EUS-BD.

Partially covered self-expandable metal stents versus polyethylene stents for malignant biliary obstruction: a cost-effectiveness analysis.

UNLABELLED: BACKGROUND/ OBJECTIVE: Partially covered self-expandable metal stents (SEMS) and polyethylene stents (PES) are both commonly used in the palliation of malignant biliary obstruction. Although SEMS are significantly more expensive, they are more efficacious than PES. Accordingly, a cost-effectiveness analysis was performed. METHODS: A cost-effectiveness analysis compared the approach of initial placement of PES versus SEMS for the study population. Patients with malignant biliary obstruction underwent an endoscopic retrograde cholangiopancreatography to insert the initial stent. If the insertion failed, a percutaneous transhepatic cholangiogram was performed. If stent occlusion occurred, a PES was inserted at repeat endoscopic retrograde cholangiopancreatography, either in an outpatient setting or after admission to hospital if cholangitis was present. A third-party payer perspective was adopted. Effectiveness was expressed as the likelihood of no occlusion over the one-year adopted time horizon. Probabilities were based on a contemporary randomized clinical trial, and costs were issued from national references. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: A PES-first strategy was both more expensive and less efficacious than an SEMS-first approach. The mean per-patient costs were US$6,701 for initial SEMS and US$20,671 for initial PES, which were associated with effectiveness probabilities of 65.6% and 13.9%, respectively. Sensitivity analyses confirmed the robustness of these results. CONCLUSION: At the time of initial endoscopic drainage for patients with malignant biliary obstruction undergoing palliative stenting, an initial SEMS insertion approach was both more effective and less costly than a PES-first strategy.

Racial and ethnic disparities in access to and utilization of living donor liver transplants.

Living donor liver transplantation (LDLT) is a comparable alternative to deceased donor liver transplantation and can mitigate the risk of dying while waiting for transplant. Although evidence exists of decreased utilization of living donor kidney transplants among racial minorities, little is known about access to LDLT among racial/ethnic minorities. We used Organ Procurement and Transplantation Network/United Network for Organ Sharing data from February 27, 2002 to June 4, 2014 from all adult liver transplant recipients at LDLT-capable transplant centers to evaluate differential utilization of LDLTs based on race/ethnicity. We then used data from 2 major urban transplant centers to analyze donor inquiries and donor rule-outs based on racial/ethnic determination. Nationally, of 35,401 total liver transplant recipients performed at a LDLT-performing transplant center, 2171 (6.1%) received a LDLT. In multivariate generalized estimating equation models, racial/ethnic minorities were significantly less likely to receive LDLTs when compared to white patients. For cholestatic liver disease, the odds ratios of receiving LDLT based on racial/ethnic group for African American, Hispanic, and Asian patients compared to white patients were 0.35 (95% CI, 0.20-0.60), 0.58 (95% CI, 0.34-0.99), and 0.11 (95% CI, 0.02-0.55), respectively. For noncholestatic liver disease, the odds ratios by racial/ethnic group were 0.53 (95% CI, 0.40-0.71), 0.78 (95% CI, 0.64-0.94), and 0.45 (95% CI, 0.33-0.60) respectively. Transplant center-specific data demonstrated that African American patients received fewer per-patient donation inquiries than white patients, whereas fewer African American potential donors were ruled out for obesity. In conclusion, racial/ethnic minorities receive a disproportionately low percentage of LDLTs, due in part to fewer initial inquiries by potential donors. This represents a major inequality in access to a vital health care resource and demands outreach to both patients and potential donors.

Recipient factors associated with having a potential living donor for liver transplantation.

Because of a persistent discrepancy between the demand for liver transplantation (LT) and the supply of deceased donor organs, there is an interest in increasing living donation rates at centers trained in this method of transplantation. We examined a large socioeconomically heterogeneous cohort of patients listed for LT to identify recipient factors associated with living donation. We retrospectively reviewed 491 consecutive patients who were listed for LT at our center over a 24-month period. Demographic, medical, and socioeconomic data were extracted from electronic records and compared between those who had a potential living donor (LD) volunteer for assessment and those who did not; 245 patients (50%) had at least 1 potential LD volunteer for assessment. Multivariate logistic regression analysis identified that patients with a LD were more likely to have Child-Pugh C disease (odds ratio [OR], 2.44; P = 0.02), and less likely to be older (OR, 0.96; P = 0.002), single (OR, 0.34; P = 0.006), divorced (OR, 0.53; P = 0.03), immigrants (OR, 0.38; P = 0.049), or from the lowest income quintile (OR, 0.44; P = 0.02). In conclusion, this analysis has identified several factors associated with access to living donation. More research is warranted to define and overcome barriers to living donor liver transplantation through targeted interventions in underrepresented populations.