Brian C. Brauer

A multicenter, U.S. experience of single-balloon, double-balloon, and rotational overtube–assisted enteroscopy ERCP in patients with surgically altered pancreaticobiliary anatomy (with video)

BACKGROUND Data on overtube-assisted enteroscopy to facilitate ERCP in patients with surgically altered pancreaticobiliary anatomy, or long-limb surgical bypass, is limited. OBJECTIVE To evaluate and compare ERCP success by using single-balloon (SBE), double-balloon (DBE), or rotational overtube enteroscopy. DESIGN Consecutive patients identified retrospectively. SETTING Eight U.S. referral centers. PATIENTS Long-limb surgical bypass patients with suspected pancreaticobiliary diseases. INTERVENTION Overtube-assisted enteroscopy ERCP. MAIN OUTCOME MEASUREMENTS Enteroscopy success: visualizing the pancreaticobiliary-enteric anastomosis or papilla. ERCP success: completing the intended pancreaticobiliary intervention. Clinical success: greater than 50% reduction in abdominal pain or level of hepatic enzyme elevations or resolution of jaundice. RESULTS From January 2008 through October 2009, 129 patients had 180 enteroscopy-ERCPs. Anatomy was Roux-en-Y: gastric bypass (n = 63), hepaticojejunostomy (n = 45), postgastrectomy (n = 6), Whipple procedure (n = 10), and other (n = 5). ERCP success was 81 of 129 (63%). Enteroscopy success: 92 of 129 (71%), of whom 81 of 92 (88%) achieved ERCP success. Reasons for ERCP failure (n = 48): afferent limb entered but pancreaticobiliary anastomosis and/or papilla not reached (n = 23), cannulation failure (n = 11), afferent limb angulation (n = 8), and jejunojejunostomy not identified (n = 6). Select interventions: anastomotic stricturoplasty (cautery ± dilation, n = 16), stone removal (n = 21), stent (n = 25), and direct cholangioscopy (n = 11). ERCP success rates were similar between Roux-en-Y gastric bypass and other long-limb surgical bypass and among SBE, DBE, and rotational overtube enteroscopy. Complications were 16 of 129, 12.4%. LIMITATIONS Retrospective study. CONCLUSION (1) ERCP is successful in nearly two-thirds of long-limb surgical bypass patients and in 88% when the papilla or pancreaticobiliary-enteric anastomosis is reached. (2) Enteroscopy success in long-limb surgical bypass is similar among SBE, DBE, and rotational overtube enteroscopy methods. (3) Referral of long-limb surgical bypass patients who require ERCP to high-volume institutions may be considered before more invasive percutaneous or surgical alternatives.

ERCP with cholangiopancreatoscopy may be associated with higher rates of complications than ERCP alone: a single-center experience

BACKGROUND Comparative data regarding complications associated with ERCP alone or when performed with cholangiopancreatoscopy (CP) are lacking. OBJECTIVE To determine whether ERCP complications are more frequent when concomitant CP is performed. DESIGN A retrospective query of a prospectively maintained database of ERCP, CP, and complications. MAIN OUTCOME MEASUREMENTS Consensus criteria complications and additional adverse events (AEs), including unplanned medical evaluation, cardiopulmonary/sedation events, and others. SETTING Academic, tertiary referral center. RESULTS A total of 4214 ERCPs were performed (337 sphincter of Oddi manometry cases excluded) during the study period, of which 3475 ERCPs and 402 ERCPs with CP were analyzed. There were 28 of 402 AEs (7.0%) in the ERCP with CP group and 101 of 3475 (2.9%) in the ERCP-only group (odds ratio [OR], 2.50; 95% CI, 1.56-3.89). Subgroup analysis revealed a significantly higher rate of cholangitis in the CP group versus ERCP group (1.0% vs 0.2%; OR, 4.98; 95% CI, 1.06-19.67) and similar rates of pancreatitis (2.2% vs 1.3%; OR, 1.75; 95% CI, 0.74-3.65) and perforation (1.0% vs 0.3%; OR, 3.16; 95% CI, 0.73-10.75). LIMITATIONS Retrospective review of a complications database that relies on physician self-reporting. CONCLUSIONS AEs from CP may be more than double those of ERCP alone (when sphincter of Oddi manometry cases are excluded). CP appears to be associated with a significantly higher rate of cholangitis, possibly because of intermittent intraductal irrigation required during the procedure.

Variation in learning curves and competence for ERCP among advanced endoscopy trainees by using cumulative sum analysis

BACKGROUND AND AIMS There are limited data on learning curves and competence in ERCP. By using a standardized data collection tool, we aimed to prospectively define learning curves and measure competence among advanced endoscopy trainees (AETs) by using cumulative sum (CUSUM) analysis. METHODS AETs were evaluated by attending endoscopists starting with the 26th hands-on ERCP examination and then every ERCP examination during the 12-month training period. A standardized ERCP competency assessment tool (using a 4-point scoring system) was used to grade the examination. CUSUM analysis was applied to produce learning curves for individual technical and cognitive components of ERCP performance (success defined as a score of 1, acceptable and unacceptable failures [p1] of 10% and 20%, respectively). Sensitivity analyses varying p1 and by using a less-stringent definition of success were performed. RESULTS Five AETs were included with a total of 1049 graded ERCPs (mean ± SD, 209.8 ± 91.6/AET). The majority of cases were performed for a biliary indication (80%). The overall and native papilla allowed cannulation times were 3.1 ± 3.6 and 5.7 ± 4, respectively. Overall learning curves demonstrated substantial variability for individual technical and cognitive endpoints. Although nearly all AETs achieved competence in overall cannulation, none achieved competence for cannulation in cases with a native papilla. Sensitivity analyses increased the proportion of AETs who achieved competence. CONCLUSION This study demonstrates that there is substantial variability in ERCP learning curves among AETs. A specific case volume does not ensure competence, especially for native papilla cannulation.

Suboptimal accuracy of carcinoembryonic antigen in differentiation of mucinous and nonmucinous pancreatic cysts: results of a large multicenter study.

BACKGROUND AND AIMS The exact cutoff value at which pancreatic cyst fluid carcinoembryonic antigen (CEA) level distinguishes pancreatic mucinous cystic neoplasms (MCNs) from pancreatic nonmucinous cystic neoplasms (NMCNs) is unclear. The aim of this multicenter retrospective study was to evaluate the diagnostic accuracy of cyst fluid CEA levels in differentiating between MCNs and NMCNs. METHODS Consecutive patients who underwent EUS with FNA at 3 tertiary care centers were identified. Patients with histologic confirmation of cyst type based on surgical specimens served as the criterion standard for this analysis. Demographic characteristics, EUS morphology, FNA fluid, and cytology results were recorded. Multivariate logistic regression analysis to identify predictors of MCNs was performed. Receiver-operating characteristic (ROC) curves were generated for CEA levels. RESULTS A total of 226 patients underwent surgery (mean age, 61 years, 96% white patients, 39% female patients) of whom 88% underwent Whipples procedure or distal pancreatectomy. Based on surgical histopathology, there were 150 MCNs and 76 NMCNs cases. The median CEA level was 165 ng/mL. The area under the ROC curve for CEA levels in differentiating between MCNs and NMCNs was 0.77 (95% confidence interval, 0.71-0.84, P < .01) with a cutoff of 105 ng/mL, demonstrating a sensitivity and specificity of 70% and 63%, respectively. The cutoff value of 192 ng/mL yielded a sensitivity of 61% and a specificity of 77% and would misdiagnose 39% of MCN cases. CONCLUSIONS Cyst fluid CEA levels have a clinically suboptimal accuracy level in differentiating MCNs from NMCNs. Future studies should focus on novel cyst fluid markers to improve risk stratification of pancreatic cystic neoplasms.

Increasing Number of Passes Beyond 4 Does Not Increase Sensitivity of Detection of Pancreatic Malignancy by Endoscopic Ultrasound–Guided Fine-Needle Aspiration

BACKGROUND & AIMS It is not clear exactly how many passes are required to determine whether pancreatic masses are malignant using endoscopic ultrasound–guided fine‐needle aspiration (EUS‐FNA). We aimed to define the per‐pass diagnostic yield of EUS‐FNA for establishing the malignancy of a pancreatic mass, and identify factors associated with detection of malignancies. METHODS In a prospective study, 239 patients with solid pancreatic masses were randomly assigned to groups that underwent EUS‐FNA, with the number of passes determined by an on‐site cytopathology evaluation or set at 7 passes, at 3 tertiary referral centers. A final diagnosis of pancreatic malignancy was made based on findings from cytology, surgery, or a follow‐up evaluation at least 1 year after EUS‐FNA. The cumulative sensitivity of detection of malignancy by EUS‐FNA was calculated after each pass; in the primary analysis, lesions categorized as malignant or suspicious were considered as positive findings. RESULTS Pancreatic malignancies were found in 202 patients (84.5% of the study population). EUS‐FNA detected malignancies with 96% sensitivity (95% confidence interval [CI], 92%–98%); 4 passes of EUS‐FNA detected malignancies with 92% sensitivity (95% CI, 87%–95%). Tumor size greater than 2 cm was the only variable associated with positive results from cytology analysis (odds ratio, 7.8; 95% CI, 1.9–31.6). In masses larger than 2 cm, 4 passes of EUS‐FNA detected malignancies with 93% sensitivity (95% CI, 89%–96%) and in masses ≤2 cm, 6 passes was associated with 82% sensitivity (95% CI, 61%–93%). Sensitivity of detection did not increase with increasing number of passes. CONCLUSIONS In a prospective study, we found 4 passes of EUS‐FNA to be sufficient to detect malignant pancreatic masses; increasing the number of passes did not increase the sensitivity of detection. Tumor size greater than 2 cm was associated with malignancy, and a greater number of passes may be required to evaluate masses 2 cm or less. ClinicalTrials.gov number, NCT01386931.

A Prospective Multicenter Study Evaluating Learning Curves and Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography Among Advanced Endoscopy Trainees: The Rapid Assessment of Trainee Endoscopy Skills Study

BACKGROUND & AIMS: On the basis of the Next Accreditation System, trainee assessment should occur on a continuous basis with individualized feedback. We aimed to validate endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) learning curves among advanced endoscopy trainees (AETs) by using a large national sample of training programs and to develop a centralized database that allows assessment of performance in relation to peers. METHODS: ASGE recognized training programs were invited to participate, and AETs were graded on ERCP and EUS exams by using a validated competency assessment tool that assesses technical and cognitive competence in a continuous fashion. Grading for each skill was done by using a 4‐point scoring system, and a comprehensive data collection and reporting system was built to create learning curves by using cumulative sum analysis. Individual results and benchmarking to peers were shared with AETs and trainers quarterly. RESULTS: Of the 62 programs invited, 20 programs and 22 AETs participated in this study. At the end of training, median number of EUS and ERCP performed/AET was 300 (range, 155–650) and 350 (125–500), respectively. Overall, 3786 exams were graded (EUS, 1137; ERCP‐biliary, 2280; ERCP‐pancreatic, 369). Learning curves for individual end points and overall technical/cognitive aspects in EUS and ERCP demonstrated substantial variability and were successfully shared with all programs. The majority of trainees achieved overall technical (EUS, 82%; ERCP, 60%) and cognitive (EUS, 76%; ERCP, 100%) competence at conclusion of training. CONCLUSIONS: These results demonstrate the feasibility of establishing a centralized database to report individualized learning curves and confirm the substantial variability in time to achieve competence among AETs in EUS and ERCP. ClinicalTrials.gov: NCT02509416.

Interobserver agreement among cytopathologists in the evaluation of pancreatic endoscopic ultrasound- guided fine needle aspiration cytology specimens *

Background and aims: Endoscopic ultrasound with fine needle aspiration (EUS-FNA) has become the standard of care in the evaluation of solid pancreatic lesions. Limited data exist on interobserver agreement (IOA) among cytopathologists in assessing solid pancreatic EUS-FNA specimens. This study aimed to evaluate IOA among cytopathologists in assessing EUS-FNA cytology specimens of solid pancreatic lesions using a novel standardized scoring system and to assess individual clinical and cytologic predictors of IOA. Methods: Consecutive patients who underwent EUS-FNA of solid pancreatic lesions at a tertiary care referral center were included. EUS-FNA slides were evaluated by four blinded cytopathologists using a standardized scoring system that assessed final cytologic diagnosis and quantitative (number of nucleated/diagnostic cells) and qualitative (bloodiness, inflammation/necrosis, contamination, artifact) cytologic parameters. Final clinical diagnosis was based on final cytology, surgical pathology, or 1-year clinical follow-up. IOA was calculated using multi-rater kappa (κ) statistics. Bivariate analyses were performed comparing cases with and without uniform agreement among the cytopathologists followed by logistic regression with backward elimination to model likelihood of uniform agreement. Results: Ninety-nine patients were included (49 % males, mean age 64 years, mean lesion size 26 mm). IOA for final diagnosis was moderate (κ = 0.45, 95 % confidence interval (CI) 0.4 – 0.49) with minimal improvement when combining suspicious and malignant diagnoses (κ = 0.54, 95 %CI 0.49 – 0.6). The weighted kappa value for overall diagnosis was 0.65 (95 %CI 0.54 – 0.76). IOA was slight to fair (κ = 0.04 – 0.32) for individual cytologic parameters. A final clinical diagnosis of malignancy was the most significant predictor of agreement [OR 3.99 (CI 1.52 – 10.49)]. Conclusions: Interobserver agreement among cytopathologists for pancreatic EUS-FNA specimens is moderate-substantial for the final cytologic diagnosis. The final clinical diagnosis of malignancy was the strongest predictor of agreement. These results have significant implications for patient management and need to be validated in future trials.

Peroral pancreatoscopy via the minor papilla for diagnosis and therapy of pancreatic diseases

Direct examination of the pancreaticobiliary system permits mucosal inspection, detection of stones or mucin, and directed tissue sampling. Although peroral pancreatoscopy (POP) is typically performed via the major papilla, the main pancreatic duct (PD) may be inaccessible because of acquired obstruction of the ventral PD (“pseudodivisum”) from strictures or stones. To access the dorsal duct by ERCP in this setting, we and others have reported the technique of minor papilla endotherapy in patients without divisum with patent accessory ducts that communicate with the upstream PD. However, it is largely unknown whether pancreatic endotherapy with POP via the minor papilla is technically feasible because of the less-stable duodenoscope position in the more proximal duodenum. We report our experience of dorsal duct pancreatoscopy (DDP) via the minor papilla.

Increased Incidence of Pseudoaneurysm Bleeding With Lumen-Apposing Metal Stents Compared to Double-Pigtail Plastic Stents in Patients With Peripancreatic Fluid Collections

Background & Aims There have been few studies that compared the effects of lumen‐apposing metal stents (LAMS) and double‐pigtail plastic stents (DPS) in patients with peripancreatic fluid collections from pancreatitis. We aimed to compare technical and clinical success and adverse events in patients who received LAMS vs DPS for pancreatic pseudocysts and walled‐off necrosis. Methods We performed a retrospective study of endoscopic ultrasound–mediated drainage in 149 patients (65% male; mean age, 47 y) with pancreatic pseudocysts or walled‐off necrosis (97 received LAMS and 152 received DPS), from January 2011 through September 2016 at a single center. We collected data on patient characteristics, outcomes, hospitalizations, and imaging findings. Technical success was defined as LAMS insertion or a minimum of 2 DPS. Clinical success was defined as resolution of pancreatic pseudocysts or walled‐off necrosis based on imaging results. The primary outcome was resolution of peripancreatic fluid collection with reduced abdominal pain or obstructive signs or symptoms. Secondary outcomes included the identification and management of adverse events, number of additional procedures required to resolve fluid collection, and the recurrence of fluid collection. Results Patients who received LAMS had larger peripancreatic fluid collections than patients who received DPS prior to intervention (P = .001), and underwent an average 1.7 interventions vs 1.9 interventions for patients who received DPS (P = .93). Technical success was achieved for 90 patients with LAMS (92.8%) vs 137 patients with DPS (90.1%) (odds ratio [OR] for success with DPS, 0.82; 95% CI, 0.33–2.0; P = .67). Despite larger fluid collections in the LAMS group, there was no significant difference in proportions of patients with clinical success following placement of LAMS (82 of 84 patients, 97.6%) vs DPS (118 of 122 patients, 96.7%) (OR for clinical success with DPS, 0.73; 95% CI, 0.13–4.0; P = .71). Adverse events developed in 24 patients who received LAMS (24.7%) vs 27 patients who received DPS (17.8%) (OR for an adverse event in a patient receiving a DPS, 0.82; 95% CI, 0.33–2.0; P = .67). However, patients with LAMS had a higher risk of pseudoaneurysm bleeding than patients with DPS (OR, 10.0; 95% CI, 1.19–84.6; P = .009). Conclusions In a retrospective study of patients undergoing drainage of pancreatic pseudocysts or walled‐off necrosis, we found LAMS and DPS to have comparable rates of technical and clinical success and adverse events. Drainage of walled‐off necrosis or pancreatic pseudocysts using DPS was associated with fewer bleeding events overall, including pseudoaneurysm bleeding, but bleeding risk with LAMS should be weighed against the trend of higher actionable perforation and infection rates with DPS.

Predictors for Surgical Referral in Patients with Pancreatic Cystic Lesions Undergoing Endoscopic Ultrasound: Results from a Large Multicenter Cohort Study

Objective Endoscopic ultrasound (EUS) plays an integral role in the evaluation of pancreatic cysts lesions (PCLs). The aim of the study was to determine predictors of surgical referral in patients with PCLs undergoing EUS. Methods We performed a multicenter retrospective study of patients undergoing EUS for evaluation of PCLs. Demographics, EUS characteristics, and fine-needle aspiration results were recorded. Patients were categorized into surgery or surveillance groups on the basis of post-EUS recommendations. Univariate and multivariate analyses were performed to identify predictors of surgical referral. Results 1804 patients were included. 1301 patients were recommended to undergo surveillance and 503 patients were referred for surgical evaluation, of which 360 patients underwent surgery. Multivariate analysis revealed the following 5 independent predictors of surgical referral: symptoms of weight loss on presentation (odds ratio [OR], 2.69; 95% confidence interval [CI], 1.44–5.03), EUS findings of associated solid mass (OR, 7.34; 95% CI, 3.81–14.16), main duct communication (OR, 4.13; 95% CI, 1.71–9.98), multilocular macrocystic morphology (OR, 2.79; 95% CI, 1.78–4.38), and fine-needle aspiration findings of mucin on cytology (OR, 3.06; 95% CI, 1.94–4.82). Conclusions This study identifies factors associated with surgical referral in patients with PCLs undergoing EUS. Future studies should focus on creation of risk stratification models to determine the need for surgery or enrollment in surveillance programs.