Telepresence-teleguidance to facilitate training and quality assurance in ERCP: a health economic modeling approach.

Background and study aims The aims of this study was to document the clinical and training relevance of endoscopic retrograde cholangiopancreaticography (ERCP) teleguidance (as a clinical model for applied telemedicine) with health economic modeling methodologies. Methods Probabilities and consequences of complications after ERCP performed by either a novice-trainee or supported through teleguidance (TM) by an expert formed the basis of the health economic model. Results The main clinical and economic outcomes originated from the base case scenario representing a low-volume center. In the cohort the patient age was 62 years, 58 % were females, the expert was doing ≥ 250 ERCPs per year and 50 for the novice-trainee. The expert knowledge transferred was set to 50 % and the average complexity grade to 1.98. Given a willingness to pay threshold of 56,180 USD/ quality-adjusted life years (QALY), the probability of cost-effectiveness of TM assistance was 98.9 %. The probability of a QALY gain for patients having an ERCP, to which was added TM, was 91.6 %. Adding TM saved on an average 111.2 USD (95 % CI 959 to 1021 SEK) per patient, and remained cost-effective basically insensitive to the level of willingness to pay. Conclusion Teleguidance during an ERCP procedure has the potential to be the prefered option in many low- to medium-volume hospitals. The main mechanisms behind these effects are positive impact on several adverse patient outcomes, QALY increase, and decreased costs. TM should be considered for integration into future teaching curriculums in advanced upper gastrointestinal endoscopy.

Nitinol versus steel partially covered self-expandable metal stent for malignant distal biliary obstruction: a randomized trial.

BACKGROUND AND STUDY AIMS: Covered nitinol alloy self-expandable metal stents (SEMSs) have been developed to overcome the shortcomings of steel SEMS in patients with malignant biliary obstruction. In a randomized, multicenter trial, we compared stent patency, patient survival, and adverse events in patients with partly covered stents made from steel or nitinol. PATIENTS AND METHODS: A total of 400 patients with unresectable distal malignant biliary obstruction were randomized at endoscopic retrograde cholangiopancreatography (ERCP) to insertion of a steel or nitinol partially covered SEMS, with 200 patients in each group. The primary outcome was confirmed stent failure during 300 days of follow-up.  RESULTS: At 300 days, the proportion of patients with patent stents was 77 % in the steel group, compared with 89 % in the nitinol group (P = 0.01). Confirmed stent failure occurred more often in the steel SEMS group compared with the nitinol SEMS group, in 30 versus 14 patients (P = 0.02). Stent migration occurred in 13 patients in the steel group and in 3 patients in the nitinol group (P = 0.01). Median patient survival (secondary outcome) was 137 days and 120 days in the steel SEMS and nitinol SEMS groups, respectively (P = 0.59). CONCLUSIONS: The nitinol SEMS showed longer patency time, and the nitinol group had fewer patients with stent failure, compared with the steel SEMS group. We could not detect any differences between the two groups regarding survival time, and regarding adverse event rate.Clinical trial registration : NCT 00980889.

Changes of activity and isoforms of alkaline sphingomyelinase (nucleotide pyrophosphatase phosphodiesterase 7) in bile from patients undergoing endoscopic retrograde cholangiopancreatography.

BACKGROUND: Alkaline sphingomyelinase (NPP7) is an ecto-enzyme expressed in intestinal mucosa, which hydrolyses sphingomyelin (SM) to ceramide and inactivates platelet activating factor. It is also expressed in human liver and released in the bile. The enzyme may have anti-tumour and anti-inflammatory effects in colon and its levels are decreased in patients with colon cancer and ulcerative colitis. Active NPP7 is translated from a transcript of 1.4 kb, whereas an inactive form from a 1.2 kb mRNA was found in colon and liver cancer cell lines. While the roles of NPP7 in colon cancer have been intensively studied, less is known about the function and implications of NPP7 in the bile. The present study examines the changes of NPP7 in bile of patients with various hepatobiliary diseases. METHODS: Bile samples were obtained at endoscopic retrograde cholangiopancreatography (ERCP) in 59 patients with gallstone, other benign disease, tumour, and primary sclerosing cholangitis (PSC). The NPP7 activity was determined. The appearance of the 1.4 and 1.2 kb products in the bile was examined by Western blot. The results were correlated to the diseases and also plasma bilirubin and alkaline phosphatase. RESULTS: NPP7 activity in the tumour group was significantly lower than in the gallstone group (p < 0.05). The activity in the tumour plus PSC group was also lower than in gallstone plus other benign disease group (p < 0.05). Within the tumour group NPP7 activity was lowest in cholangiocarcinoma patients, being only 19% of that in gallstone patients. Bilirubin correlated inversely to NPP7 and was higher in the tumour than in the gallstone group. Western blot identified both the 1.4 kb and the 1.2 kb products in most bile samples. The density ratio for the 1.4/1.2 kb products correlated to NPP7 activity significantly. Two patients (one PSC and one cholangiocarcinoma) lacking NPP7 activity had only the 1.2 kb form in bile. CONCLUSION: NPP7 activity and the ratio of 1.4/1.2 kb products in bile are significantly decreased in malignancy, particularly in cholangiocarcinoma. The implications of the finding in diagnosis of cholangiocarcinoma and 1.2 kb product in hepatobiliary diseases require further investigation.

Diagnostic utility of single-user peroral cholangioscopy in sclerosing cholangitis.

OBJECTIVE: To evaluate the diagnostic utility of single-operator peroral cholangioscopy (SOC) in patients with sclerosing cholangitis. METHODS: All patients with sclerosing cholangitis who underwent SOC procedures due to suspicious biliary strictures, in one Swedish and four UK tertiary centers in 2008-2012, were retrospectively enrolled. For each SOC procedure in sclerosing cholangitis, another one attempted due to a single biliary stricture in the same center and calendar year was randomly selected as control. Patients were followed up until death or last clinic visit until November 2012. RESULTS: Fifty-four SOC procedures were attempted in 52 sclerosing cholangitis patients (48 with primary sclerosing cholangitis, 4 with IgG4-related sclerosing cholangitis). Cannulation with the SOC system failed more frequently in sclerosing cholangitis (15% vs. 2% in controls; p = 0.015). The sensitivity, specificity, and accuracy of SOC (including tissue sampling) for cancer diagnosis were similar in sclerosing cholangitis and controls (50% vs. 55%, 100% vs. 97%, and 88% vs. 80%, respectively) with largely overlapping confidence intervals. Adverse events were more common in sclerosing cholangitis, due to an increased frequency of cholangitis (11% vs. 2% in controls; p = 0.051). CONCLUSIONS: SOC is equally accurate in cancer diagnosis in sclerosing cholangitis and patients with single biliary strictures. However, cholangioscope insertion may be hampered by bile duct narrowing and post-SOC cholangitis is more common in sclerosing cholangitis.

Immediate oral feeding in patients with mild acute pancreatitis is safe and may accelerate recovery--a randomized clinical study.

BACKGROUND & AIMS: In acute pancreatitis, traditional treatment has been initial fasting on purpose to avoid activation of proteolytic enzymes and pancreatic enzyme secretion. The aim of the present study was to evaluate the efficacy and feasibility of immediate oral feeding as compared to traditional fasting in patients with mild acute pancreatitis. METHODS: Sixty patients were randomized to the two treatment groups, fasting or immediate oral feeding. The inclusion criteria were pancreas amylase > or =3 times above normal, onset of abdominal pain within 48 h, acute physiological and chronic health evaluation (APACHE) score<8 and C-reactive protein (CRP) <150 mg/L. Outcome measures were pancreas-specific amylase, systemic inflammatory response, feasibility and length of hospital stay (LOHS). RESULTS: The groups were comparable with respect to age, sex, etiology, APACHE, time from onset of pain and amylase at admission. No significant differences were seen between the groups concerning levels of amylase, CRP, leukocytes, abdominal pain or number of gastrointestinal symptoms. The LOHS was significantly shorter in the oral feeding group (4 vs. 6 days; p<0.05). CONCLUSIONS: No signs of exacerbation of the disease process were seen in terms of significant differences between treatment groups for amylase or systemic inflammatory response. In mild acute pancreatitis, immediate oral feeding was feasible and safe and may accelerate recovery without adverse gastrointestinal events.