IMPORTANCE: Endoscopic placement of multiple plastic stents in parallel is the first-line treatment for most benign biliary strictures; it is possible that fully covered, self-expandable metallic ...stents (cSEMS) may require fewer endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution. OBJECTIVE: To assess whether use of cSEMS is noninferior to plastic stents with respect to stricture resolution. DESIGN, SETTING, AND PARTICIPANTS: Multicenter (8 endoscopic referral centers), open-label, parallel, randomized clinical trial involving patients with treatment-naive, benign biliary strictures (N = 112) due to orthotopic liver transplant (n = 73), chronic pancreatitis (n = 35), or postoperative injury (n = 4), who were enrolled between April 2011 and September 2014 (with follow-up ending October 2015). Patients with a bile duct diameter less than 6 mm and those with an intact gallbladder in whom the cystic duct would be overlapped by a cSEMS were excluded. INTERVENTIONS: Patients (N = 112) were randomized to receive multiple plastic stents or a single cSEMS, stratified by stricture etiology and with endoscopic reassessment for resolution every 3 months (plastic stents) or every 6 months (cSEMS). Patients were followed up for 12 months after stricture resolution to assess for recurrence. MAIN OUTCOMES AND MEASURES: Primary outcome was stricture resolution after no more than 12 months of endoscopic therapy. The sample size was estimated based on the noninferiority of cSEMS to plastic stents, with a noninferiority margin of −15%. RESULTS: There were 55 patients in the plastic stent group (mean SD age, 57 11 years; 17 women 31%) and 57 patients in the cSEMS group (mean SD age, 55 10 years; 19 women 33%). Compared with plastic stents (41/48, 85.4%), the cSEMS resolution rate was 50 of 54 patients (92.6%), with a rate difference of 7.2% (1-sided 95% CI, −3.0% to ∞; P < .001). Given the prespecified noninferiority margin of −15%, the null hypothesis that cSEMS is less effective than plastic stents was rejected. The mean number of ERCPs to achieve resolution was lower for cSEMS (2.14) vs plastic (3.24; mean difference, 1.10; 95% CI, 0.74 to 1.46; P < .001). CONCLUSIONS AND RELEVANCE: Among patients with benign biliary strictures and a bile duct diameter 6 mm or more in whom the covered metallic stent would not overlap the cystic duct, cSEMS were not inferior to multiple plastic stents after 12 months in achieving stricture resolution. Metallic stents should be considered an appropriate option in patients such as these. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01221311
Abstract OBJECTIVE We sought to define the severity and natural history of hypertriglyceridemia induced acute pancreatitis (HTG-AP), specifically whether HTG-AP causes more severe AP than that caused ...by other etiologies. METHODS Systematic review of the English literature. RESULTS Thirty-four studies (15 countries; 1972 to 2015) included 1340 HTG-AP patients (weighted mean prevalence of 9%). The median admission triglyceride concentration was 2622mg/dl (range 1,160 – 9,769). Patients with HTG have a 14% weighted mean prevalence of AP. Plasmapheresis decreased circulating triglycerides, but did not conclusively affect AP mortality. Only 7 reports (n= 392 patients) compared severity of HTG-AP to that of AP from other etiologies. Of these, 2 studies found no difference in severity, while 5 suggested that HTG-AP patients may have increased severity compared to AP of other etiology. CONCLUSIONS 1) hypertriglyceridemia is a relatively uncommon (9%) cause of acute pancreatitis; however, patients with hypertriglyceridemia have a high (14%) incidence of acute pancreatitis; 2) plasmapheresis may offer specific therapy unique to this patient population; and 3) data specifically comparing the severity of HTG-AP with AP caused by other etiologies are heterogeneous and scarce.
Accurate peripheral markers for the diagnosis of pancreatic ductal adenocarcinoma (PDAC) are lacking. We measured the differential expression of select microRNAs (miRNAs) in plasma and bile among ...patients with PDAC, chronic pancreatitis (CP), and controls.
We identified patients (n=215) with treatment-naive PDAC (n=77), CP with bile/pancreatic duct pathology (n=67), and controls (n=71) who had been prospectively enrolled in a Pancreatobiliary Biorepository at the time of endoscopic retrograde cholangiopancreatography or endoscopic ultrasound. Controls were patients with choledocholithiasis but normal pancreata. The sample was separated into training (n=95) and validation (n=120) cohorts to establish and then test the performance of PDAC Signature Panels in diagnosing PDAC. The training cohort (n=95) included age-matched patients with PDAC, CP, and controls. Panels were derived from the differential expression of 10 candidate miRNAs in plasma or bile. We selected miRNAs having excellent accuracy for inclusion in regression models.
Using the training cohort, we confirmed the differential expression of 9/10 miRNAs in plasma (miR-10b, -30c, -106b, -132, -155, -181a, -181b, -196a, and -212) and 7/10 in bile (excluding miR-21, -132, and -181b). Of these, five (miR-10b, -155, -106b, -30c, and -212) had excellent accuracy for distinguishing PDAC. In the training and validation cohorts, the sensitivity/specificity for a PDAC Panel derived from plasma was 95/100% and 100/100%, respectively; in bile, these were 96/100% and 100/100%.
Increased expression of miRNA-10b, -155, and -106b in plasma appears highly accurate in diagnosing PDAC. Additional studies are needed to confirm this Panel and explore its value as a prognostic test.
In this trial involving patients at increased risk for pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP), rectal indomethacin reduced the incidence of this condition, as ...compared with placebo (9% vs. 17%).
Acute pancreatitis is the most common major complication of endoscopic retrograde cholangiopancreatography (ERCP),
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accounting for substantial morbidity, occasional death, and estimated health care expenditures of approximately $150 million annually in the United States.
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Given the magnitude of this problem, more than 35 pharmacologic agents have been studied for the prophylaxis of post-ERCP pancreatitis, and many prospective clinical trials addressing chemoprevention have been conducted. To date, however, no medication has proved to be consistently effective in preventing post-ERCP pancreatitis on the basis of data from high-quality clinical trials, and no pharmacologic prophylaxis for post-ERCP pancreatitis is in widespread clinical use. . . .
Background There are conflicting data on the risk of post-ERCP pancreatitis (PEP) related to self-expandable metallic stents (SEMSs). Objective To compare rates of PEP in patients who undergo biliary ...drainage with SEMSs or polyethylene stents (PSs). Design Retrospective, cohort study. Setting Tertiary-care medical center. Patients This study involved patients undergoing ERCP for malignant biliary obstruction between January 2005 and October 2008. Intervention First-time placement of a SEMS or PS for biliary decompression. Main Outcome Measurements Early post-ERCP complications, particularly PEP. Results We identified 544 eligible patients, 248 SEMSs (102 covered), and 296 PSs. The etiology of malignant biliary obstruction was similar between groups, with 55% from pancreatic cancer. The frequency of PEP was significantly higher in the SEMS group (7.3%) versus the PS group (1.3%) (OR 5.7 95% CI, 1.9-17.1). On univariate analysis, patient age of <40 years, a history of PEP, and at least 1 pancreatic duct injection were also significant predictors of PEP, whereas female sex and having pancreatic cancer were not. When significant variables were added to a multiple-predictor regression model, the odds of PEP from SEMS placement increased to 6.8 (95% CI, 2.2, 21.4). However, the frequency of PEP was similar between covered (6.9%) and uncovered (7.5%) SEMSs (OR 0.9 CI, 0.3-2.4). Purported SEMS-specific risk factors, including the use of cSEMSs, overlapping SEMSs, or having a biliary sphincterotomy were not found to be significant contributors to the higher risk. Limitations Retrospective design. Conclusion After we controlled for confounding variables, the frequency of PEP was significantly higher with placement of a SEMS compared with a PS. Rates of PEP were comparable with use of covered and uncovered SEMSs.
Chronic pancreatitis (CP) has a profound independent effect on quality of life (QOL). Our aim was to identify factors that impact the QOL in CP patients.
We used data on 1,024 CP patients enrolled in ...the three NAPS2 studies. Information on demographics, risk factors, co-morbidities, disease phenotype, and treatments was obtained from responses to structured questionnaires. Physical and mental component summary (PCS and MCS, respectively) scores generated using responses to the Short Form-12 (SF-12) survey were used to assess QOL at enrollment. Multivariable linear regression models determined independent predictors of QOL.
Mean PCS and MCS scores were 36.7±11.7 and 42.4±12.2, respectively. Significant (P<0.05) negative impact on PCS scores in multivariable analyses was noted owing to constant mild-moderate pain with episodes of severe pain or constant severe pain (10 points), constant mild-moderate pain (5.2), pain-related disability/unemployment (5.1), current smoking (2.9 points), and medical co-morbidities. Significant (P<0.05) negative impact on MCS scores was related to constant pain irrespective of severity (6.8-6.9 points), current smoking (3.9 points), and pain-related disability/unemployment (2.4 points). In women, disability/unemployment resulted in an additional 3.7 point reduction in MCS score. Final multivariable models explained 27% and 18% of the variance in PCS and MCS scores, respectively. Etiology, disease duration, pancreatic morphology, diabetes, exocrine insufficiency, and prior endotherapy/pancreatic surgery had no significant independent effect on QOL.
Constant pain, pain-related disability/unemployment, current smoking, and concurrent co-morbidities significantly affect the QOL in CP. Further research is needed to identify factors impacting QOL not explained by our analyses.
Background Accurate preoperative diagnosis and staging of cholangiocarcinoma (CCA) remain difficult. Objective To evaluate the utility of EUS in the diagnosis and preoperative evaluation of CCA. ...Design Observational study of prospectively collected data. Setting Single tertiary referral hospital in Indianapolis, Indiana. Patients Consecutive patients with CCA from January 2003 through October 2009. Interventions EUS and EUS-guided FNA (EUS-FNA). Main Outcome Measurements Sensitivity of EUS for the detection of a tumor and prediction of unresectability compared with CT and magnetic resonance imaging (MRI); sensitivity of EUS-FNA to provide tissue diagnosis, by using surgical pathology as a reference standard. Results A total of 228 patients with biliary strictures undergoing EUS were identified. Of these, 81 (mean age 70 years, 45 men) had CCA. Fifty-one patients (63%) had distal and 30 (37%) had proximal CCA. For those with available imaging, tumor detection was superior with EUS compared with triphasic CT (76 of 81 94% vs 23 of 75 30%, respectively; P < .001). MRI identified the tumor in 11 of 26 patients (42%; P = .07 vs EUS). EUS identified CCA in all 51 (100%) distal and 25 (83%) of 30 proximal tumors ( P < .01). EUS-FNA (median, 5 passes; range, 1-12 passes) was performed in 74 patients (91%). The overall sensitivity of EUS-FNA for the diagnosis of CCA was 73% (95% confidence interval, 62%-82%) and was significantly higher in distal compared with proximal CCA (81% vs 59%, respectively; P = .04). Fifteen tumors were definitely unresectable. EUS correctly identified unresectability in 8 of 15 and correctly identified the 38 of 39 patients with resectable tumors (53% sensitivity and 97% specificity for unresectability). CT and/or MRI failed to detect unresectability in 6 of these 8 patients. Limitation Single-center study. Conclusion EUS and EUS-FNA are sensitive for the diagnosis of CCA and very specific in predicting unresectability. The sensitivity of EUS-FNA is significantly higher in distal than in proximal CCA.
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