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Background: Conventional transbronchial needle aspiration (c-TBNA) and endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) are both valuable diagnostic techniques for the diagnosis of hilar/mediastinal lesions. Although a superiority of EBUS-TBNA over c-TBNA may be expected, evidence-based data on a direct comparison between these 2 procedures are still lacking. Objectives: We aimed to test the superiority of EBUS-TBNA over c-TBNA in a randomized trial and to evaluate the cost-effectiveness profile of a staged strategy, including c-TBNA as initial test followed by EBUS-TBNA, in case of inconclusive results at rapid on-site evaluation. Methods: Eligible patients were randomized 1:1 to either the EBUS-TBNA or c-TBNA group. The primary endpoint was to test the superiority of EBUS-TBNA sensitivity over c-TBNA. The secondary endpoints included the sensitivity of the staged strategy, as well as costs and safety related to each procedure and to their sequential combination. Results: A total of 253 patients were randomized to either EBUS-TBNA (n = 127) or c-TBNA (n = 126), and 31 patients of the c-TBNA group subsequently underwent EBUS-TBNA. The sensitivity of EBUS-TBNA was higher, but not significantly superior to that of c-TBNA (respectively. 92% [95% CI 87-97] and 82% [95% CI 75-90], p > 0.05). The sensitivity of the staged strategy was 94% (95% CI 89-98). No major adverse events occurred. Conclusions: EBUS-TBNA was the single best diagnostic tool, although not significantly superior to c-TBNA. Due to the favorable cost-effectiveness profile of their sequential combination, in selected scenarios with a high probability of success from the standard procedure, these should not be necessarily intended as competitive and the staged strategy could be considered in clinical practice.

Numerous guidelines exist for the management of pancreatic cysts. We sought to compare the guideline-directed management strategies for pancreatic cysts by comparing 2 approaches (2017 International Consensus Guidelines and 2015 American Gastroenterological Association Guidelines) that differ significantly in their thresholds for imaging, surveillance, and surgery. We developed a Monte Carlo model to evaluate the outcomes for a cohort of 10,000 patients managed per each guideline. The primary outcome was mortality related to pancreatic cyst management. Secondary outcomes included all-cause mortality, missed cancers, number of surgeries, number of imaging studies, cumulative cost, and quality-adjusted life years. Deaths because of pancreatic cyst management and quality-adjusted life years were similar in both guidelines at a significantly higher cost of $3.6 million per additional cancer detected in the Consensus Guidelines. Deaths from \"unrelated\" causes (1,422) vastly outnumbered deaths related to pancreatic cysts (125). Secondary outcomes included more missed cancers in the American Gastroenterological Association guideline (71 vs 49), more surgeries and imaging studies in the Consensus guideline (711 vs 163; 116,997 vs 68,912), and higher cost in the Consensus guideline ($168.3 million vs $89.4 million). As the rate of malignant transformation increases, a more-intensive guideline resulted in fewer deaths related to pancreatic cyst management. Our study demonstrates trade-offs between more- and less-intensive management strategies for pancreatic cysts. Although deaths related to pancreatic cyst management were similar in each strategy, fewer missed cancers in the more-intensive surveillance strategy is offset by a greater number of surgical deaths and higher cost. In conclusion, our study identifies that if the rate malignant transformation of pancreatic cysts is low (0.12% annually), a less-intensive guideline will result in similar deaths to a more-intensive guideline at a much lower cost.

The negative predictive value of endoscopic ultrasonography-guided fine needle aspiration for the diagnosis of solid pancreatic lesions remains low, and the biopsy specimens are sometimes inadequate for appropriate pathological diagnosis. To evaluate the usefulness of a novel method of contrast-enhanced harmonic endoscopic ultrasonography-guided fine-needle aspiration for the differential diagnosis and adequate sampling of solid pancreatic lesions. Patients with a diagnosis of solid pancreatic lesions who underwent fine-needle aspiration guided by contrast-enhanced harmonic endoscopic ultrasonography or by endoscopic ultrasonography from October 2010 to July 2013 were retrospectively identified and classified into the CH-EUS or EUS group, respectively. Surgical pathology and/or follow-up results were defined as the final diagnosis. Operating characteristics and adequacy of biopsy specimens by fine-needle aspiration were compared between the two groups. Operating characteristics for contrast-enhanced harmonic endoscopic ultrasonography-guided fine-needle aspiration in solid pancreatic lesions were as follows: area under the curve = 0.908, sensitivity = 81.6%, specificity = 100%, positive predictive value = 100%, negative predictive value = 74.1%, and accuracy = 87.9%. The percentage of adequate biopsy specimens in the CH-EUS group (96.6%) was greater than that in the EUS group (86.7%). Simultaneous contrast-enhanced harmonic endoscopic ultrasonography during fine-needle aspiration is useful for improving the diagnostic yield and adequate sampling of solid pancreatic lesions.

Summary The use of endobronchial ultrasound trans‐bronchial needle aspiration (EBUS‐TBNA) as the initial diagnostic and staging procedure in patients with suspected, non‐metastatic lung cancer has gained substantial support, and is now recommended by numerous guidelines. Whereas considerable attention has been pointed to the reductions in costs achieved by EBUS‐TBNA, that has not been the case for some of its more significant benefits, namely the reduction of the diagnostic work‐up time and its ability to accurately assess and restage lymph nodes, which were previously stated incorrectly by CT or PET scan. Both these benefits translate into improved outcomes for patients, as delays are reduced, futile surgeries are prevented and curable operations can be performed on patients previously excluded by CT or PET scan. Indeed, the use of EBUS as the initial diagnostic and staging procedure has been proven to significantly increase survival, compared with conventional diagnostic and staging procedures, in a pragmatic, randomised controlled trial (Navani N. et al, 2015). The instalment of EBUS will have the greatest effect on overwhelmed, suboptimally functioning national healthcare systems, by decreasing the number of required diagnostic and staging procedures, therefore reducing both treatment delays and costs. The improved selection of surgical candidates by EBUS will result in improved patient outcomes. The latest findings regarding the benefits of EBUS are outlined in this review, which, to the best of our knowledge, is the first to emphasise the impact of the procedure, both on timing and costs of lung cancer staging, as well as on survival.

Proponents of the endobronchial ultrasound–guided transbronchial needle aspiration (EBUS-TBNA) propose that in this era of EBUS-TBNA, training for conventional transbronchial needle aspiration (C-TBNA) should be abandoned. The authors of this editorial provide the opposing view. C-TBNA has a short and a steep learning curve and adds to the diagnostic yield of flexible bronchoscopy in a cost-effective fashion. Considering its simplicity, availability, affordability, safety, and several unique indications, C-TBNA continues to contribute to the welfare of patients worldwide. It should remain as an integral part of pulmonary fellowship training programs.

Background: Correct coding is essential for accurate reimbursement for clinical activity. Published data confirm that significant aberrations in coding occur, leading to considerable financial inaccuracies especially in interventional procedures such as endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Previous data reported a 15% coding error for EBUS-TBNA in a UK service. Objectives: We hypothesised that greater physician involvement with coders would reduce EBUS-TBNA coding errors and financial disparity. Methods: The study was done as a prospective cohort study in the tertiary EBUS-TBNA service in Bristol. 165 consecutive patients between October 2009 and March 2012 underwent EBUS-TBNA for evaluation of unexplained mediastinal adenopathy on computed tomography. The chief coder was prospectively electronically informed of all procedures and cross-checked on a prospective database and by Trust Informatics. Cost and coding analysis was performed using the 2010-2011 tariffs. Results: All 165 procedures (100%) were coded correctly as verified by Trust Informatics. This compares favourably with the 14.4% coding inaccuracy rate for EBUS-TBNA in a previous UK prospective cohort study [odds ratio 201.1 (1.1-357.5), p = 0.006]. Projected income loss was GBP 40,000 per year in the previous study, compared to a GBP 492,195 income here with no coding-attributable loss in revenue. Conclusions: Greater physician engagement with coders prevents coding errors and financial losses which can be significant especially in interventional specialties. The intervention can be as cheap, quick and simple as a prospective email to the coding team with cross-checks by Trust Informatics and against a procedural database. We suggest that all specialties should engage more with their coders using such a simple intervention to prevent revenue losses.

Background and Objectives. The ideal type of sedation for endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) is not known. Two previous studies comparing the diagnostic yield between moderate sedation (MS) and deep sedation/general anesthesia (DS/GA) had provided conflicting results with one study clearly favoring the latter. No study had addressed cost. This is concerning for pulmonologists without routine access to anesthesia services. Our objective was to assess the impact of MS and Monitored Anesthesia Care (sedation administered and monitored by an anesthesiologist) on the outcomes and cost of EBUS-TBNA. Materials and Methods. We performed a retrospective review of prospectively collected data on consecutive EBUS-TBNA performed under two different types of sedation in a single academic center. A diagnostic TBNA was defined as an aspirate yielding any specific diagnosis or if subsequent surgery or follow-up of nondiagnostic/normal aspirates showed no pathology. Current Medicare time-based allowances were used for professional charges calculation. Results. There was no difference observed between MS and MAC in regards of the diagnostic yield (92.9% versus 91.9%), procedure duration, number, location, and size of lymph node (LN) sampled, but there were more passes per LN with MAC. The average charges were 74.30 USD for MS and 319.91 for MAC. There were more hypotensive and desaturations episodes with MAC but none required escalation of care. Conclusions. When performed under MS, EBUS-TBNA has similar diagnostic yield as under MAC but may be associated with less side effects. The difference in sedation cost is modest; however, an additional 245$ for each EBUS done under MAC would have significant cost implications on the health system. These findings are of critical importance for bronchoscopists without routine access to anesthesia services and for optimization of healthcare cost and resource utilization.

Background: Rapid on site evaluation (ROSE) allows immediate processing and interpretation of the aspirate in the procedural suite. It improves diagnostic yield and lowers patient care costs. There are limited data on its cost-effectiveness with endobronchial ultrasound (EBUS). Methods: We developed an economic model with two arms, no ROSE (our current practice) and simulated ROSE. To simulate ROSE, a cytopathologist retrospectively identified the first diagnostic slide in each case. Using a decision analytic modeling technique under a hospital diagnostic unit perspective, the benefits of simulated ROSE were estimated as cost-savings. The model input was estimated from actual data, consulting experts, and the literature. The benefits were estimated as cost savings per patient and for the province of Alberta per year. Due to differences in the procedure, sarcoidosis and cancer patients were analyzed separately. The costs are shown in 2012 Canadian dollars, CAD. Results: In our model without ROSE, the procedure cost/patient was CAD 646.00(USD 523.32) for cancer and CAD 1,170.00 (USD 947.73) for sarcoidosis. With simulated ROSE cost savings of CAD 63.00(37.00 to 89.00) [USD 51.04(29.97 to 72.10)], CAD 544.00(490.00 to 598.00) [USD 440.65(397.05 to 484.44)] for cancer and sarcoidosis, respectively. Extrapolating this to provincial data, our model estimates that EBUS with ROSE would lead to savings of CAD 50,000.00(30,000 to 71,000) [USD 40,501.24 (24,300.75 to 57,531.34)] for cancer and CAD 109,000.00 (87,000 to 130,000) [USD 88,337.07 (70,546.45 to 105,313.04) for sarcoidosis. Conclusion: The use of ROSE with EBUS is cost saving. The projected savings were CAD 50,000.00 (USD 40,501.24) and CAD 109,000.00(USD 88,337.07) in cancer and sarcoidosis, respectively, for the province of Alberta, Canada.

Background Neoadjuvant chemoradiotherapy (nCRT) plus surgery is a standard treatment for locally advanced oesophageal cancer. With this treatment, 29% of patients have a pathologically complete response in the resection specimen. This provides the rationale for investigating an active surveillance approach. The aim of this study is to assess the (cost-)effectiveness of active surveillance vs. standard oesophagectomy after nCRT for oesophageal cancer. Methods This is a phase-III multi-centre, stepped-wedge cluster randomised controlled trial. A total of 300 patients with clinically complete response (cCR, i.e. no local or disseminated disease proven by histology) after nCRT will be randomised to show non-inferiority of active surveillance to standard oesophagectomy (non-inferiority margin 15%, intra-correlation coefficient 0.02, power 80%, 2-sided α 0.05, 12% drop-out). Patients will undergo a first clinical response evaluation (CRE-I) 4–6 weeks after nCRT, consisting of endoscopy with bite-on-bite biopsies of the primary tumour site and other suspected lesions. Clinically complete responders will undergo a second CRE (CRE-II), 6–8 weeks after CRE-I. CRE-II will include 18F–FDG-PET-CT, followed by endoscopy with bite-on-bite biopsies and ultra-endosonography plus fine needle aspiration of suspected lymph nodes and/or PET- positive lesions. Patients with cCR at CRE-II will be assigned to oesophagectomy (first phase) or active surveillance (second phase of the study). The duration of the first phase is determined randomly over the 12 centres, i.e., stepped-wedge cluster design. Patients in the active surveillance arm will undergo diagnostic evaluations similar to CRE-II at 6/9/12/16/20/24/30/36/48 and 60 months after nCRT. In this arm, oesophagectomy will be offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant dissemination. The main study parameter is overall survival; secondary endpoints include percentage of patients who do not undergo surgery, quality of life, clinical irresectability (cT4b) rate, radical resection rate, postoperative complications, progression-free survival, distant dissemination rate, and cost-effectiveness. We hypothesise that active surveillance leads to non-inferior survival, improved quality of life and a reduction in costs, compared to standard oesophagectomy. Discussion If active surveillance and surgery as needed after nCRT leads to non-inferior survival compared to standard oesophagectomy, this organ-sparing approach can be implemented as a standard of care.

Aim Comprehensive genomic profiling (CGP) test for solid tumors is now increasingly utilized in clinical practice, especially in pancreatobiliary cancer, and specimens obtained by endoscopic ultrasound‐guided tissue acquisition (EUS‐TA) are often submitted for tissue‐based CGP test. In this study, we evaluated the feasibility of EUS‐TA using a 22‐gauge Franseen needle for the CGP test. Methods Consecutive patients with solid tumors who underwent EUS‐TA using a 22‐gauge Franseen needle, and whose tissue samples were pre‐checked for suitability for CGP test, were included in this single‐center, retrospective analysis. The success rates of appropriate sample collection for CGP evaluated by pathologists (1st quality control) and CGP test (2nd quality control) were evaluated. In addition, The EUS‐TA slides were evaluated for the tissue area and tumor area content, using the image software. Results A total of 50 cases, with 78% of pancreatic cancer, were included in the analysis. A median of 3 passes of EUS‐TA were performed with an adverse event rate of 4%. The success rates for 1st and 2nd quality control for CGP tests were 86% and 76%, respectively. The image analyses suggested EUS‐TA specimen did not always fulfill CGP test criteria, with 18% of tissue area ≥16 mm2 and 38% of tumor area content ≥20%, even in cases with successful CGP tests. The suction method yielded a significantly larger amount of DNA but without a significant difference in the multivariate analysis. Conclusions The present study demonstrated the feasibility of EUS‐TA using a 22‐gauge Franseen needle for CGP test.