Cost-effectiveness Analysis of Radiofrequency Ablation in Patients With Barrett Esophagus and High-grade Dysplasia or Low-grade Dysplasia.

PURPOSE: Clinical guidelines recommend radiofrequency ablation (RFA) for eradication of Barrett esophagus in patients with low-grade dysplasia (LGD) and high-grade dysplasia (HGD), but evidence on whether RFA provides good value for money is still sparse. This study evaluates the cost-effectiveness of RFA in Italy. METHODS: A Markov model was used to estimate lifelong costs and consequences of disease progression with different treatments. RFA was compared with esophagectomy in the HGD group or endoscopic surveillance in the LGD group. Clinical and quality-of-life parameters were derived from a review of the literature and expert opinions, whereas Italian national tariffs were used as a proxy for costs. FINDINGS: RFA dominated esophagectomy in patients with HGD with a probability of 83%. For patients with LGD, RFA was more effective and more costly than active surveillance (incremental cost-effectiveness ratio, €6276 per quality-adjusted life-year). At a cost-effectiveness threshold of €15,272, the probability of RFA being the optimal strategy in this population was close to 100%. Model results were sensitive to the cost of the interventions and utility weights used in the different disease states. IMPLICATIONS: RFA is likely to be the optimal choice for patients with LGD and HGD in Italy. Italy is discussing the implementation of a national program for the health technology assessment of medical devices, requiring more studies to prove value for money of emerging technologies.

White paper of Italian Gastroenterology: delivery of services for digestive diseases in Italy: weaknesses and strengths.

In 2011 the three major Italian gastroenterological scientific societies (AIGO, the Italian Society of Hospital Gastroenterologists and Endoscopists; SIED, the Italian Society of Endoscopy; SIGE, the Italian Society of Gastroenterology) prepared their official document aimed at analysing medical care for digestive diseases in Italy, on the basis of national and regional data (Health Ministry and Lombardia, Veneto, Emilia-Romagna databases) and to make proposals for planning of care. Digestive diseases were the first or second cause of hospitalizations in Italy in 1999-2009, with more than 1,500,000 admissions/year; however only 5-9% of these admissions was in specialized Gastroenterology units. Reported data show a better outcome in Gastroenterology Units than in non-specialized units: shorter average length of stay, in particular for admissions with ICD-9-CM codes proxying for emergency conditions (6.7 days versus 8.4 days); better case mix (higher average diagnosis-related groups weight in Gastroenterology Units: 1 vs 0.97 in Internal Medicine units and 0.76 in Surgery units); lower inappropriateness of admissions (16-25% versus 29-87%); lower in-hospital mortality in urgent admissions (2.2% versus 5.1%); for patients with urgent admissions due to gastrointestinnal haemorrhage, in-hospital mortality was 2.3% in Gastroenterology units versus 4.0% in others. The present document summarizes the scientific societies' official report, which constitutes the "White paper of Italian Gastroenterology".

Risk factors for post-ERCP pancreatitis in high- and low-volume centers and among expert and non-expert operators: a prospective multicenter study.

OBJECTIVES: Prospective studies have identified a number of patient- and procedure-related independent risk factors for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, with different conclusions, so various questions are still open. The endoscopist's expertise, case volume, and case mix can all significantly influence the outcome of ERCP procedures, but have been investigated little to date. METHODS: We identified patient- and procedure-related risk factors for post-ERCP pancreatitis and the impact of the endoscopist's experience and the center's case volume, using univariate and multivariate analysis, in a multicenter, prospective study involving low- and high-volume centers, over a 6-month period. RESULTS: A total of 3,635 ERCP procedures were included; 2,838 (78%) ERCPs were performed in the 11 high-volume centers (median 257 each) and 797 in the 10 low-volume centers (median 45 each). Overall, 3,331 ERCPs were carried out by expert operators and 304 by less-skilled operators. There were significantly more grade 3 difficulty procedures in high-volume centers than in low-volume ones (P<0.0001). Post-ERCP pancreatitis occurred in 137 patients (3.8%); the rates did not differ between high- and low-volume centers (3.9% vs. 3.1%) and expert and non-expert operators (3.8% vs. 5.5%). However, in high-volume centers, there were 25% more patients with patient- and procedure-related risk factors, and the pancreatitis rate was one-third higher among non-expert operators. Univariate analysis found a significant association with pancreatitis for history of acute pancreatitis, either non-ERCP- or ERCP-related and recurrent, young age, absence of bile duct stones, and biliary pain among patient-related risk factors, and >10 attempts to cannulate the Vater's papilla, pancreatic duct cannulation, contrast injection of the pancreatic ductal system, pre-cut technique, and pancreatic sphincterotomy, among procedure-related risk factors. Multivariate analysis also showed that a history of post-ERCP pancreatitis, biliary pain, >10 attempts to cannulate the Vater's papilla, main pancreatic duct cannulation, and pre-cut technique were significantly associated with the complication. CONCLUSIONS: A history of pancreatitis among patient-related factors, and multiple attempts at cannulation among procedure-related factors, were associated with the highest rates of post-ERCP pancreatitis. Pre-cut sphincterotomy, although identified as another significant risk factor, appeared safer when done early (fewer than 10 attempts at cannulating), compared with repeated multiple cannulation. The risk of post-ERCP pancreatitis was not associated with the case volume of either the single endoscopist or the center; however, high-volume centers treated a larger proportion of patients at high risk of pancreatitis and did a significantly greater number of difficult procedures.

Preventing post-ERCP pancreatitis: where are we?

Acute pancreatitis still represents the most common complication after procedures involving Vater's papilla; the reported incidence of this complication varies from less than 1% up to 40%. Attempts at preventing post-ERCP pancreatitis have been carried out using technical measures, pharmacological prophylaxis, or patient selection. Balloon sphincter of Oddi dilatation, difficult papillary cannulation, pancreatic sphincterotomy and multiple pancreatic duct injections have been found to be risk factors for postprocedure pancreatitis. Therefore, technique-related prevention of post-ERCP pancreatitis includes careful pancreatic duct injection, avoiding cannulation trauma, and maintaining adequate pancreatic drainage after the ERCP procedure. Pancreatic stent placement has been shown to be the most effective technique-related prevention of postprocedure pancreatitis. Apart from technique-related risk factors, operator experience also seems to be a potential risk-factor for post-ERCP/ES complications. The experience of the endoscopist rather than other patient- or technique-related conditions could probably constitute the major risk factor for postprocedure pancreatitis. Pharmacological prevention of pancreatitis after ERCP or sphincterotomy has been the topic of several investigations in recent years but still remains a debated question. Pharmacological prevention has been mainly aimed at either reducing the amount of intrapancreatic enzymes, preventing intra-cellular co-localization of enzymes and lysosomal hydrolases or blocking some steps of the enzyme-activated inflammatory cascade. Somatostatin, octreotide, gabexate mesilate and, more recently, recombinant interleukin-10 have been the most investigated drugs. Somatostatin, gabexate mesilate and recombinant interleukin-10, but not octreotide, have been found to be able to prevent post-ERCP pancreatitis in non-selected cases; however, a strategy of routine pharmacological prophylaxis in all patients is not likely to be cost-effective. A strategy of pharmacological prevention only in high-risk cases is cost-effective, but, up to now, only recombinant interleukin-10 has been proven effective. The "on demand" postprocedure treatment should also be of paramount importance, but no data are at present available regarding the potential efficacy of some drugs; on the basis of the mechanism of action, we can argue that recombinant interleukin-10 could be the only drug candidate for such a strategy. Post-ERCP pancreatitis can also be prevented by patient selection. Patient-related risk factors are now well-known, so an increased risk of developing pancreatitis is predictable "a priori" in these subjects, independently of the type of endoscopic procedure performed. Furthermore, the risk of pancreatitis escalates when multiple risk factors occur in the same patient or some technique-related risk factor comes up during the procedure. In these patients diagnostic ERCP should be avoided in routine practice and magnetic resonance cholangio-pancreatography should be used as the first diagnostic step. When either diagnostic or therapeutic ERCP is indicated, these high-risk patients should be informed about their own specific risk of postprocedure pancreatitis.