Pharmacological prophylaxis versus pancreatic duct stenting plus pharmacological prophylaxis for prevention of post-ERCP pancreatitis in high risk patients: a randomized trial.

BACKGROUND: Acute pancreatitis is a serious complication of endoscopic retrograde cholangiopancreatography (ERCP). The aim of this noninferiority study was to evaluate the effectiveness of pancreatic duct (PD) stenting plus pharmacological prophylaxis vs. pharmacological prophylaxis alone in the prevention of post-ERCP pancreatitis (PEP) in high risk patients. METHODS: In this randomized, controlled, double-blind, noninferiority trial, patients at high risk of developing PEP were randomly allocated to pharmacological prophylaxis (rectal indomethacin, sublingual isosorbide dinitrate, and intravenous hydration with Ringer's lactate) plus PD stenting (group A) or pharmacological prophylaxis alone (group B). The rate and severity of PEP, serum amylase levels, and length of hospital stay after ERCP were assessed. RESULTS: During 21 months, a total of 414 patients (mean age 55.5 ±â€Š17.0 years; 60.2 % female) were enrolled (207 in each group). PEP occurred in 59 patients (14.3 %, 95 % confidence interval [CI] 11.1 % - 17.9 %: 26 patients [12.6 %, 95 %CI 8.6 % - 17.6 %] in group A and 33 [15.9 %, 95 %CI 11.4 % - 21.4 %] in group B). There was no significant difference between the two groups in PEP severity (P = 0.59), amylase levels after 2 hours (P = 0.31) or 24 hours (P = 0.08), and length of hospital stay (P = 0.07). CONCLUSIONS: The study failed to demonstrate noninferiority or inferiority of pharmacological prophylaxis alone compared with PD stenting plus pharmacological prophylaxis in the prevention of PEP in high risk patients.

Diagnostic yield of EUS-guided FNA for malignant biliary stricture: a systematic review and meta-analysis.

BACKGROUND AND AIMS: EUS-guided FNA (EUS-FNA) is increasingly being used for tissue diagnosis of extrahepatic biliary strictures. The aim of this study was to determine the diagnostic yield of EUS-FNA in malignant biliary strictures. METHODS: A comprehensive literature review was carried out by 2 reviewers for studies evaluating the accuracy of EUS-FNA in biliary stricture. A meta-analysis was performed to determine the pooled estimates of sensitivity, specificity, likelihood ratios, and diagnostic odds ratio for EUS-FNA of extrahepatic biliary stricture. A Quality Assessment of Diagnostic Accuracy Studies questionnaire was used to assess the quality of the selected studies. Several sensitivity analyses were performed to assess the effect of the quality of the studies on the accuracy of the final results of the meta-analysis. RESULTS: Twenty studies involving 957 patients met inclusion criteria and were included in the meta-analysis. The pooled sensitivity and specificity of EUS-FNA for diagnosis of malignant biliary stricture were 80% (95% confidence interval [CI], 74%-86%), and 97% (95% CI, 94%-99%), respectively. The pooled positive likelihood ratio was 12.35 (95% CI, 7.37-20.72), and the negative likelihood ratio was 0.26 (95% CI, 0.18-0.38). The pooled diagnostic odds ratio for diagnosing a malignant biliary stricture was 70.53 (95% CI, 38.62-128.82). The area under the receiver-operating characteristic curve was 0.97. Sensitivity analyses showed that the quality of the included studies did not affect the accuracy of the final results of the meta-analysis. CONCLUSION: This meta-analysis demonstrates that EUS-FNA is sensitive and highly specific for diagnosing malignancy in biliary strictures. Further studies are needed to compare EUS--FNA with emerging methods including cholangioscopy-guided biopsy and laser endomicroscopy.

Open-access endoscopy.

OAE is commonly used. The majority of patients referred for OAE are considered appropriate for endoscopy according to ASGE guidelines. Most patients undergoing OAE procedures are knowledgeable about the study and are satisfied with the experience. Several potential problems have been identified, including inappropriate referrals, communication errors, and inadequately prepared or informed patients. OAE can be safely used if preprocedure assessment, informed consent, information transfer, patient safety, and satisfaction are addressed in all cases.

The role of endoscopy in the management of GERD.

We recommend that uncomplicated GERD be diagnosed on the basis of typical symptoms without the use of diagnostic testing, including EGD. We recommend EGD for patients who have symptoms suggesting complicated GERD or alarm symptoms. We recommend that EGD not be routinely performed solely for the assessment of extraesophageal GERD symptoms. We recommend that endoscopic findings of reflux esophagitis be classified according to an accepted grading scale or described in detail. We suggest that repeat EGD be performed in patients with severe erosive esophagitis after at least an 8-week course of PPI therapy to exclude underlying BE or dysplasia. 44BB We recommend against obtaining tissue samples from endoscopically normal tissue to diagnose GERD or exclude BE in adults. We suggest that endoscopy be considered in patients with multiple risk factors for Barrett's esophagus. We recommend that tissue samples be obtained to confirm endoscopically suspected Barrett's esophagus. We suggest that endoscopic antireflux therapy be considered for selected patients with uncomplicated GERD after careful discussion with the patient regarding potential adverse effects, benefits, and other available therapeutic options.

Aspirin Has a Protective Effect Against Adverse Outcomes in Patients with Nonvariceal Upper Gastrointestinal Bleeding.

OBJECTIVE: To determine the effect of aspirin and anticoagulants on clinical outcomes and cause of in-hospital death in patients with nonvariceal upper gastrointestinal bleeding (NVUGIB). METHODS: Patients were identified from a tertiary center database that included all patients with UGIB. Clinical outcomes including (1) in-hospital mortality, (2) severe bleeding, (3) rebleeding, (4) in-hospital complications, and (5) length of hospital stay were examined in patients taking (a) aspirin only, (b) anticoagulants only, and (c) no antithrombotics. RESULTS: Of 717 patients with NVUGIB, 56 % (402) were taking at least one antithrombotic agent. Seventy-eight (11 %) patients died in hospital, and 310 (43 %) had severe bleeding (BP < 90 mmHg, HR > 120 b/min, Hb < 7 g/dL on presentation, or transfusion of >3 units). On multivariate analysis, being on aspirin was protective against in-hospital mortality [OR 0.26 (0.13-0.53)], rebleeding [OR 0.31 (0.17-0.59)], and predictive of a shorter hospital stay (coefficient = -4.2 days; 95 % CI -8.7, 0.3). Similarly, being on nonaspirin antiplatelets was protective against in-hospital mortality (P = 0.03). However, being on anticoagulants was predictive of in-hospital complications [OR 2.0 (1.20-3.35)] and severe bleeding [OR 1.69 (1.02-2.82)]. Compared to those not taking any antithrombotics, patients who bled on aspirin were less likely to die in hospital of uncontrolled gastrointestinal bleeding (3.6 vs 0 %, P ≤ 0.01) and systemic cancer (4.9 vs 0 %, P ≤ 0.002), but equally likely to die of cardiovascular/thromboembolic disease, sepsis, and multiorgan failure. CONCLUSION: Patients who present with NVUGIB on aspirin had reduced in-hospital mortality and fewer adverse outcomes, while those on anticoagulants had increased in-hospital complications.

A Trial of Rectal Indomethacin to Prevent Post-ERCP Pancreatitis in Patients with Suspected Type 3 Sphincter of Oddi Dysfunction.

BACKGROUND AND AIM: Recent data have suggested that rectal indomethacin can also reduce the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). The aim of this study was to determine whether prophylactic rectal indomethacin with PD stenting would reduce the incidence and severity of PEP compared to PD stenting alone in patients undergoing manometry for suspected SOD type 3. PATIENTS AND METHODS: A retrospective review of consecutive patients who underwent an ERCP with manometry for suspected SOD type 3 was performed. Patients were divided into two groups: (a) those who received a prophylactic PD stent (n = 285) and (b) those who received a prophylactic PD stent and a single dose of 100-mg indomethacin suppositories after ERCP (n = 57). The rate of PEP was compared between the two groups. RESULTS: The two patient groups were similar with regard to patient and procedure risk factors for PEP. Post-ERCP pancreatitis developed in 22 % patients. There was no significant difference in the incidence of PEP in the PD stent group compared to the PD stent and indomethacin group (23 vs. 18 %, respectively; p = 0.39). Moderate-to-severe pancreatitis developed in 21 (7 %) patients in the PD stent group compared to 5 (9 %) patients in the PD stent and indomethacin group (p = 0.78). Among patients with PEP, the median length of hospital stay was not significantly longer in the PD stent group compared to the PD stent and indomethacin group (6 vs. 4 days, respectively; p = 0.11). CONCLUSIONS: In patients with suspected SOD type 3, prophylactic rectally administered indomethacin with PD stenting was not observed to affect the incidence or severity of post-ERCP pancreatitis when compared to PD stenting alone.

Utility of endoscopic ultrasound to diagnose remnant stones in symptomatic patients after cholecystectomy.

BACKGROUND AND STUDY AIMS: Stones in the cystic duct stump (CDS) or gallbladder remnant after cholecystectomy are difficult to identify. The aim of this study was to evaluate the utility of endoscopic ultrasound (EUS) in the diagnosis of stones in the CDS or gallbladder remnant in patients with postcholecystectomy syndrome. METHODS: A prospective study was conducted between January 2011 and December 2012 in consecutive patients with pancreaticobiliary-type pain or acute pancreatitis (n = 112) following cholecystectomy. Diagnostic modalities including EUS were used to diagnose the cause of postcholecystectomy syndrome. RESULTS: A total of 11 patients (10 %) were found to have stones in the gallbladder remnant (n = 8), CDS (n = 2), or both (n = 1). In eight patients, EUS was the first imaging procedure to make the diagnosis. Seven patients agreed to undergo repeat surgery, and six of them remained free of symptoms postoperatively after a median follow-up period of 4 months (range 1 - 13 months). CONCLUSION: EUS may be an important procedure to consider in the study of patients with symptoms after cholecystectomy, as the diagnosis of residual stones is frequently missed by other imaging modalities.

Unexplained common bile duct dilatation with normal serum liver enzymes: diagnostic yield of endoscopic ultrasound and follow-up of this condition.

BACKGROUND: There is scant literature about common bile duct (CBD) dilatation with normal liver function tests (LFTs). AIMS: The aims of this study were to assess the diagnostic yield of endoscopic ultrasound (EUS) in patients with CBD dilatation, normal LFTs, and prior inconclusive imaging tests, and to assess the natural history of these subjects. METHODS: We retrospectively reviewed our EUS database for patients referred for evaluation of CBD dilatation, normal LFTs, and prior inconclusive imaging. We excluded patients with a prior endoscopic retrograde cholangiopancreatography or a history of biliary obstruction, pancreatitis, or jaundice. Follow-up data were retrieved from medical records or by calling the general practitioners, referring specialists, patients, or their closest relatives. RESULTS: A total of 57 patients were enrolled. The mean CBD diameter was 12.5±3.6 mm. The majority of patients (50.8%) were asymptomatic. Abnormal EUS findings were recorded in 12 (21%) subjects: 6 patients had a periampullary diverticulum, 2 had ampullary adenoma, 2 had signs of chronic pancreatitis, 1 had a cancer of the pancreatic head, and 1 had a 7 mm CBD stone. Neither age, sex, prior cholecystectomy, clinical presentation, CBD diameter, nor a dilated main pancreatic duct were predictors of abnormal EUS findings. None of the patients complained of biliary symptoms or showed abnormal LFTs on long-term follow-up. CONCLUSIONS: CBD dilatation with normal liver chemistry is not always a benign condition. Even when prior imaging tests are negative, EUS may allow to diagnose conditions overlooked by standard diagnostic imaging.

Objective assessment of an algorithmic approach to EUS-guided FNA and interventions.

BACKGROUND: Despite an increasing number of procedures being performed, there is no consensus on an optimal approach to EUS-guided FNA (EUS-FNA) or interventions. OBJECTIVE: Validate an algorithmic approach to EUS-FNA/interventions with the objective of improving technical outcomes and resource use. DESIGN: Prospective study. SETTING: Tertiary-care referral center. PATIENTS: Consecutive patients undergoing EUS-FNA and/or interventions. INTERVENTION: Phase I was a retrospective analysis of EUS-FNA/interventions performed in 548 patients. The 19-gauge needle was used for interventions, and the 22- or 25-gauge needle was used interchangeably for performing FNAs. At phase I, the technical failure rate was 11.5%. Based on these observations, an algorithm was proposed by which all transduodenal FNAs were performed by using a 25-gauge needle and other FNAs with a 22-gauge needle. All transduodenal interventions were performed with a Flexible 19-gauge needle and others with a standard 19-gauge needle. This algorithm was tested prospectively in phase II on 500 patients. MAIN OUTCOME MEASUREMENTS: Compare technical failure, diagnostic adequacy, procedural complications, and average needle costs between both phases. RESULTS: The technical failure rate was significantly less in phase II compared with that of phase I (1.6% vs 11.5%; P < .001) for both FNA (1.8% vs 10.9%; P < .001) and therapeutic interventions (0% vs 16.4%; P = .001). Although there was no difference in diagnostic adequacy (97.1% vs 98.4%; P = .191) or complications (0.4% vs 0.2%; P = 1.0) between phases I and II, the average cost per case was significantly less in phase II ($199.59 vs $188.30; P = .008). LIMITATIONS: Single-center study. CONCLUSION: An algorithmic approach to EUS-FNA/interventions yielded better technical outcomes and cost savings without compromising diagnostic adequacy.

Outcomes of EUS-guided drainage of debris-containing pancreatic pseudocysts by using combined endoprosthesis and a nasocystic drain.

BACKGROUND: The presence of debris within a pseudocyst may impair success of endoscopic drainage. OBJECTIVE: To compare the clinical outcomes and adverse-event rates of EUS-guided pseudocyst drainage with and without a nasocystic drain for the management of pancreatic pseudocysts with viscous solid debris-laden fluid. DESIGN: Retrospective study. SETTING: Single, tertiary-care referral center. PATIENTS: Consecutive patients with pancreatic pseudocysts managed by EUS-guided drainage: those with solid debris who underwent drainage via nasocystic drains alongside stents (n = 63) and those with solid debris who underwent drainage via transmural stents only (n = 24). INTERVENTION: Drainage via nasocystic drains alongside stents or drainage via transmural stents only. MAIN OUTCOME MEASUREMENTS: The primary outcomes were short-term success and long-term success of the procedures. The secondary outcomes were procedure-related adverse events and reintervention. RESULTS: The patients with viscous solid debris-laden fluid whose pseudocysts were drained by both stents and nasocystic tubes had a 3 times greater short-term success rate compared with those who had drainage by stents alone (P = .03). On 12-month follow-up, complete resolution of pseudocysts with debris drained via stents alone was less (58%) compared with those with debris who underwent drainage via nasocystic drains alongside stents (79%; P = .059). The rate of stent occlusion was higher in cysts with debris drained by stents alone (33%) compared with those drained via nasocystic drains alongside stents (13%; P = .03). LIMITATIONS: Retrospective design; limited sample size. CONCLUSION: In patients with pseudocysts with viscous debris-laden fluid, EUS-guided drainage by using a combination of a nasocystic drain and transmural stents improves clinical outcomes and lowers the stent occlusion rate compared with those who underwent drainage via stents alone.

Patients with obstructive jaundice and biliary stricture ± mass lesion on imaging: prevalence of malignancy and potential role of EUS-FNA.

BACKGROUND: In patients with obstructive jaundice and biliary stricture, the role of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is debated for fear of missing a potentially resectable pancreatobiliary malignancy (PBM). We evaluated the prevalence of (1) PBM; (2) lesions that do not require a potentially curative cancer surgery; and (3) potentially resectable PBMs in patients with false-negative diagnosis by EUS-FNA. PATIENTS AND METHODS: This is a retrospective analysis of 342 patients who underwent EUS/EUS-FNA from 2002 to 2009 after presenting with obstructive jaundice and a biliary stricture. Of these, 170 patients had no definitive mass on computed tomography and 172 patients had definitive mass on computed tomography without evidence of unresectability. Final diagnosis was based on surgical pathology or definitive cytology and clinical follow-up of ≥ 12 months. RESULTS: The mean age of patients (176 male) was 68.0±12.5 years. A final diagnosis of malignancy was made in only 248 patients (72.5%; 95% confidence interval, 67.7, 77.2). The overall accuracy of EUS-FNA for diagnosing malignancy was 92.4% (89.0, 94.8), with 91.5% sensitivity (87.1, 94.5) and 80.9% negative predictive value (72.0, 87.5). Among 21 patients with false-negative diagnosis, 8 had cholangiocarcinoma (2 resectable), 13 had pancreatic cancer (5 resectable). EUS-FNA provided information to potentially modify surgical management in 116 patients (33.9%; 95% confidence interval, 29.1, 39.0): 89 patients diagnosed as true negatives, 24 with distant malignant lymphadenopathy, and 3 with malignant lymphoma. CONCLUSIONS: In above-defined patient subset, the risk of missing resectable tumors by EUS-FNA has been exaggerated because of artifactually low negative predictive value resulting from a high pretest probability of PBM. The actual miss rate for resectable PBM by EUS-FNA is rather small and was 2% in present cohort. Information from EUS-FNA can potentially modify surgical management in up to one third of patients.

Identification of cholangiocarcinoma by using the Spyglass Spyscope system for peroral cholangioscopy and biopsy collection.

BACKGROUND & AIMS: It is a challenge to collect samples from bile duct strictures to diagnose patients with cholangiocarcinoma. We investigated the utility of the Spyglass Spyscope, a single-operator endoscope that is used to perform cholangiopancreatoscopy, to identify extrahepatic cholangiocarcinoma in patients who were not diagnosed with this disorder by endoscopic retrograde cholangiopancreatography (ERCP) cytology or endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) analyses. METHODS: We conducted a retrospective analysis of data from 30 patients (median age, 67 years; 67% male) with indeterminate extrahepatic biliary strictures who were ultimately diagnosed with cholangiocarcinoma but had inconclusive results from initial biliary ductal brush cytology and EUS-FNA analyses. Patients then underwent cholangioscopy by using the Spyglass Spyscope and intraductal biopsy analysis. None of the patients had a definitive mass in abdominal imaging or EUS analyses. RESULTS: The biliary stricture was located in the common bile duct in 13 patients and in the common hepatic duct in 17 patients. The Spyglass Spyscope system had 77% accuracy (23 of 30) in the diagnosis of malignancies that were inconclusive on the basis of ERCP-guided brush or EUS-FNA analyses. CONCLUSIONS: The Spyglass Spyscope for cholangioscopy and biopsy collection identified malignancies with 77% accuracy in patients with suspected cholangiocarcinoma.

Histologic and imaging features of mural nodules in mucinous pancreatic cysts.

BACKGROUND & AIMS: Mural nodules predict malignancy within pancreatic cysts, but it is not clear whether endoscopic ultrasound (EUS) and computed tomography (CT) accurately identify nodules. We assessed images and the histology of mural nodules in branch duct intraductal papillary mucinous neoplasms (BD-IPMNs) and mucinous cystic neoplasms (MCNs) and identified criteria to distinguish mural nodules from mucus. METHODS: We reviewed pathology specimens and EUS and CT images from consecutive patients with resected BD-IPMNs or MCNs. A blinded interobserver study of the EUS images was then conducted to identify features that distinguished nodules from mucus. After education about these features, the raters interpreted the EUS images again. RESULTS: On the basis of histologic analysis, 22 of 57 cases had epithelial nodules. Cancer or high-grade dysplasia was found in 23% of cysts with nodules versus 3% without nodules (P = .02). On the basis of reports, EUS detected epithelial nodules with 75% sensitivity and 83% specificity, whereas these values were 24% and 100%, respectively, for CT. Mucus accounted for 65% of intracystic lesions detected by EUS and was often diagnosed by using change in body position and fine-needle aspiration. Interobserver analysis identified 3 features that were detected by EUS (echogenicity, edge, and rim) that distinguished mucus from epithelial nodules. The diagnostic accuracy of the raters improved from a mean of 57% to 79% after education about these features (P = .004); accuracy was 90% when all 3 features of mucus were present. CONCLUSIONS: Malignancy is associated with epithelial nodules in BD-IPMNs and MCNs, but most echogenic lesions detected in cysts by EUS are mucus. Knowledge of features that discriminate mucus from mural nodules improves the diagnostic accuracy of EUS.

Outcome and complications of endoscopic ultrasound guided pancreatic pseudocyst drainage using combined endoprosthesis and naso-cystic drain.

BACKGROUND AND AIM: Endoscopic ultrasound guided pancreatic pseudocyst drainage (EUS-PPD) is increasingly being used for management of pancreatic pseudocysts. We evaluated the outcome and complications of EUS-PPD with modified combined technique by inserting both endoprosthesis and naso-cystic drain. METHODS: Forty patients referred between August 2007 and January 2010 for EUS-PPD were prospectively studied. EUS-PPD was attempted for symptomatic pancreatic pseudocysts which were; (i) resistant to conservative treatment, (ii) in contact with the gastric or duodenal wall on EUS and (iii) having no bulge seen on endoscopy. Controlled radial expansion wire guided balloon dilation of the puncture tract was performed followed by insertion of a 10 French double pigtail stent and 7-Fr naso-biliary drain. The early and late outcome and complications of EUS-PPD were analyzed. RESULTS: Thirty-two patients had non-infected and eight had infected pseudocysts. EUS-PPD was technically successful in all. Pseudocysts resolved completely in 39 patients, while one with infected pseudocyst underwent surgical resection for bleeding in the cyst. Naso-cystic drain was removed in 39 patients after median duration of 13 days. Thereafter, the double pigtail stent was removed in all cases after median duration of 10 weeks. Pseudocyst recurred in one patient requiring a second session of EUS-PPD. All 32 patients without cystic infection were successfully treated by EUS-PPD. Seven out of eight patients (87%) with cystic infection were successfully treated by EUS-PPD. CONCLUSION: Endoscopic ultrasound guided pancreatic pseudocyst drainage with modified combined technique is safe and is associated with high success rate.

Levels of evidence in endoscopic ultrasonography: a systematic review.

BACKGROUND AND AIMS: A prolific trend currently designates endoscopic ultrasonography (EUS) literature. We aimed to record all EUS-studies published during the past decade and evaluate them in terms of scientific quality, creating a stratification based on levels of evidence (LE). METHODS: All articles on EUS published between January 2001 and December 2010 were retrieved using a Pubmed and Cochrane Library search. Inclusion criteria were: original research papers (randomized controlled trials-RCTs, prospective and retrospective studies), meta-analyses, reviews and surveys pertinent to gastrointestinal EUS. Levels of evidence (LE) were assessed using the North of England evidence-based guidelines. RESULTS: Overall, 1,832 eligible articles were reviewed. The majority (46.1%) of reports comprised retrospective descriptive studies (LE III). Expert reviews and committee reports (LE IV) accounted for 28.9%, well-designed quasi-experimental studies (LE IIb) for 20.1%, RCTs (LE Ib) for 2.4%, prospective controlled trials (LE IIa) for 1.4%, and meta-analyses (LE Ia) for 1.1% of the total. High LE (Ia-Ib) were assigned to loco-regional staging of luminal gastrointestinal cancers; mediastinal staging of lung cancer; diagnostic work-up of solid pancreatic tumors, suspected biliary obstruction and choledocholithiasis; celiac plexus neurolysis; and pancreatic pseudocysts drainage. Intermediate to low LE (IIa-IV) were assigned to submucosal tumors, pancreatic cysts, chronic pancreatitis and novel therapeutic applications (pancreato-biliary drainage, tumor ablation). CONCLUSIONS: Diagnostic and staging EUS has matured and has proven its clinical impact on patient management. Therapeutic or interventional EUS is still evolving and more quality research and data are needed to establish EUS as the best next intervention to perform once firm evidence is available.

Comparison of the influence of plastic and fully covered metal biliary stents on the accuracy of EUS-FNA for the diagnosis of pancreatic cancer.

BACKGROUND AND STUDY AIMS: Prior studies have reported that the presence of prior biliary stent may interfere with EUS visualization of pancreatic tumors. We aimed to compare the influence of the biliary plastic and fully covered self-expanding metal stents (CSEMS) on the accuracy of EUS-FNA cytology in patients with solid pancreatic masses. PATIENTS AND METHODS: We conducted a retrospective study evaluating 677 patients with solid pancreatic head/uncinate lesions and a previous biliary stent in whom EUS-FNA was performed. The patients were stratified into two groups: (1) those with a plastic stents and (2) those with CSEMS. Performance characteristics of EUS-FNA including the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were compared between the two groups. RESULTS: The frequency of obtaining an adequate cytology by EUS-FNA was similar in both the CSEMS group and the plastic stent group (97 vs. 97.1 % respectively; p = 1.0). The sensitivity, specificity, and accuracy of EUS-FNA was not significantly different between patients with CSEMS and plastic stents (96.8, 100, 100 % and 97.3, 98, 99.8 %, respectively). The negative predictive value for EUS-FNA was lower in the CSEMS group compared to the plastic stent group (66.6 vs. 78.1 % respectively; p = 0.42). There was one false-positive cytology in the plastic stent group compared to none in the CSEMS group. CONCLUSIONS: In a retrospective cohort trial, EUS-FNA was found to be highly accurate and safe in diagnosing patients with suspected pancreatic cancer, even in the presence of a plastic or metallic biliary stent. The presence of a stent did not contribute to a higher false-positive cytology rate.