Roy D. Yen

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.

Comparison of endoscopic therapies and surgical resection in patients with early esophageal cancer: a population-based study

BACKGROUND Outcome data comparing endoscopic eradication therapy (EET) and esophagectomy are limited in patients with early esophageal cancer (EC). OBJECTIVE To compare overall survival and EC-related mortality in patients with early EC treated with EET and esophagectomy. DESIGN AND SETTING Population-based study. PATIENTS Patients with early EC (stages T0 and T1) were identified from the Surveillance, Epidemiology, and End Results database (1998-2009). Demographics, tumor specific data, and survival were compared. Cox proportional hazards regression models were used to evaluate the association between treatment and EC-specific mortality. INTERVENTION EET and esophagectomy. MAIN OUTCOME MEASUREMENTS Mid- (2 years) and long- (5 years) term overall survival and EC-specific mortality, outcomes based on histology and stage, treatment patterns, and predictors of cancer-specific mortality. RESULTS A total of 430 (21%) and 1586 (79%) patients underwent EET and esophagectomy, respectively. There was no difference in the 2-year (EET: 10.5% vs esophagectomy: 12.7%, P = .27).and 5-year (EET: 36.7% vs esophagectomy: 42.8%, P = .16) EC-related mortality rates between the 2 groups. EET patients had higher mortality rates attributed to non-EC causes (5 years: 46.6% vs 20.6%, P < .001). Similar results were noted when comparisons were limited to patients with stage T0 and T1a disease and esophageal adenocarcinoma. There was no difference in EC-specific mortality in the EET compared with the surgery group (hazard ratio 1.4; 95% confidence interval, 0.9-2.03). Variables associated with mortality were older age, year of diagnosis, radiation therapy, higher stage, and esophageal squamous cell carcinoma. LIMITATIONS Comorbidities and recurrence rates were not available. CONCLUSIONS This population-based study demonstrates comparable mid- and long-term EC-related mortality in patients with early EC undergoing EET and surgical resection.

The Clinical Impact of Immediate On-Site Cytopathology Evaluation During Endoscopic Ultrasound-Guided Fine Needle Aspiration of Pancreatic Masses: A Prospective Multicenter Randomized Controlled Trial

Objectives:Observational data on the impact of on-site cytopathology evaluation (OCE) during endoscopic ultrasonography-guided fine needle aspiration (EUS–FNA) of pancreatic masses have reported conflicting results. We aimed to compare the diagnostic yield of malignancy and proportion of inadequate specimens between patients undergoing EUS–FNA of pancreatic masses with and without OCE.Methods:In this multicenter randomized controlled trial, consecutive patients with solid pancreatic mass underwent randomization for EUS–FNA with or without OCE. The number of FNA passes in the OCE+ arm was dictated by the on-site cytopathologist, whereas seven passes were performed in OCE− arm. EUS–FNA protocol was standardized, and slides were reviewed by cytopathologists using standardized criteria for cytologic characteristics and diagnosis.Results:A total of 241 patients (121 OCE+, 120 OCE−) were included. There was no difference between the two groups in diagnostic yield of malignancy (OCE+ 75.2% vs. OCE− 71.6%, P=0.45) and proportion of inadequate specimens (9.8 vs. 13.3%, P=0.31). Procedures in OCE+ group required fewer EUS–FNA passes (median, OCE+ 4 vs. OCE− 7, P<0.0001). There was no significant difference between the two groups with regard to overall procedure time, adverse events, number of repeat procedures, costs (based on baseline cost-minimization analysis), and accuracy (using predefined criteria for final diagnosis of malignancy). There was no difference between the two groups with respect to cytologic characteristics of cellularity, bloodiness, number of cells/slide, and contamination.Conclusions:Results of this study demonstrated no significant difference in the diagnostic yield of malignancy, proportion of inadequate specimens, and accuracy in patients with pancreatic mass undergoing EUS–FNA with or without OCE.

Gastroenterology Trainees Can Easily Learn Histologic Characterization of Diminutive Colorectal Polyps With Narrow Band Imaging

BACKGROUND & AIMS Little is known about how teaching gastroenterology trainees polyp patterns by using narrow band imaging (NBI) affects their ability to characterize the histology of diminutive colorectal polyps. We developed and tested a tool to teach trainees to characterize the histology of diminutive polyps by using NBI. METHODS Twelve gastroenterology trainees with varying levels of colonoscopy experience watched a teaching tool that described the NBI criteria to distinguish polyp histology. The trainees then watched 80 videos of NBI examination of diminutive polyps, recording their predictions of polyp histology and their degree of confidence. After each video, an expert provided feedback about actual polyp histology and the NBI criteria that supported each diagnosis. Twelve weeks later, without training or feedback during the interval, the trainees watched the same videos and predicted histologies of the polyps. Performance was evaluated by comparing predicted classification with actual histologic findings. Cumulative sum analysis was used to determine the learning curve for each trainee. RESULTS Trainees made significant improvements in accuracy and the proportion of high-confidence predictions as they progressed through video blocks during the first session (P < .001). With active feedback, all trainees predicted polyp histologies with >90% accuracy, with a negative predictive value >90% for adenomatous histology. A median of 49 videos was required to achieve competency. For diagnoses made with high confidence, trainee performance exceeded 90% during the first and second sessions. Interobserver agreement was substantial (session 1, κ = 0.71; session 2, κ = 0.70). CONCLUSIONS We developed a computer-based tool, combined with short videos and active feedback, to train gastroenterologists to identify polyp histology by using NBI. After training, gastroenterology trainees characterized the histology of diminutive polyps with ≥ 90% accuracy.

ERCP with per-oral pancreatoscopy-guided laser lithotripsy for calcific chronic pancreatitis: a multicenter U.S. experience

BACKGROUND In patients with chronic pancreatitis, laser lithotripsy (LL) permits stone fragmentation and removal during ERCP with some advantages over extracorporeal shock-wave lithotripsy (ESWL) and surgery. OBJECTIVES To evaluate the technical success of LL in pancreatic duct (PD) stones. DESIGN Retrospective cohort. SETTING Four tertiary referral centers. PATIENTS Patients undergoing endotherapy for PD stones. INTERVENTIONS ERCP with per-oral pancreatoscopy (POP)-guided LL. MAIN OUTCOME MEASUREMENT Technical success was defined as complete stone clearance. RESULTS Over 3 years, 28 patients (16 men, 51 years [mean age]) underwent a median of 1 (range, 1-4) POP-LL for PD stones. Baseline parameters included pain requiring hospitalization (n=19, 68%), opiate use (n=14, 50%), or weight loss (n=11, 39%). Before POP-LL, 22 of 28 patients (79%) had a median of 1 (range, 1-5) ERCP, 9 of 28 (32%) underwent a median of 2 (range, 1-3) ESWL sessions, and 5 underwent a median of 1 (range, 1-3) POP-guided electrohydraulic lithotripsy with failed (n=2) or partial (n=3) fragmentation. A median of 2 (range, 1-3) stones sized 15 mm (range, 4-32 mm) were identified in the head (n=9, 32%), neck (n=3, 11%), body (n=9, 32%), tail (n=1, 4%), or multiple sites (n=6, 21%). Technical success occurred in 22 patients (79%) with complete clearance. Partial clearance occurred in 3 (11%). Clinical success at a median of 13 (range, 1-25) months of follow-up was noted in 25 of 28 patients (89%) by improvement in pain (n=25), decreased narcotic use (n=25), or reduced hospitalizations (n=19). Mild adverse events occurred in 8 of 28 (29%). CONCLUSIONS POP-LL is feasible at expert centers in patients with accessible stones. Although intensive endotherapy is required, most patients achieve stone clearance and clinical improvement.

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.

Endoscopic retrograde cholangiopancreatography with per oral pancreatoscopy for calcific chronic pancreatitis using endoscope and catheter-based pancreatoscopes: a 10-year single-center experience.

Objectives Per oral pancreatoscopy (POP) with electrohydraulic lithotripsy (EHL) or laser lithotripsy (LL) permits stone fragmentation and removal during endoscopic retrograde cholangiopancreatography. Our study evaluates the safety and efficacy of POP in patients with main pancreatic duct (PD) stones. Methods This was a cohort study of patients undergoing POP with EHL/LL for PD stones between January 2000 and March 2011. Technical success was defined as complete or partial stone clearance, and clinical success as greater than 50% reduction in opiate use, pain, or hospitalizations. Results Forty-six patients underwent POP for PD stones using a 10F cholangioscope (POP-Endo) (n = 31) or catheter-based system (POP-Cath, n = 15). Electrohydraulic lithotripsy/LL was performed in 39 (85%) of 46 patients. Stone extraction without EHL or LL was performed in 7 (15%) of 46 patients. Technical success for POP-Endo versus POP-Cath was 27 (87%) of 31 versus 15 (100%) of 15 patients (P = 0.29). Complete clearance was achieved in 21 (68%) of 31 versus 11 (73%) of 15 patients, respectively (P = 0.519). Per oral pancreatoscopy–related complications were found in 10%. Follow-up in 43 (93%) of 46 patients was a median of 18 months (range, 1–60 months). Overall clinical success was 74%. Conclusions Per oral pancreatoscopy–guided endotherapy leads to partial or complete stone clearance in most patients with PD stones. The technical success rates between POP-Endo versus POP-Cath systems appear similar and are associated with clinical improvement in most patients.

Endoscopic ultrasonography in esophageal cancer leads to improved survival rates: Results from a population‐based study

The advantages of endoscopic ultrasound (EUS) and computed tomography (CT)–positron emission tomography (PET) with respect to survival for esophageal cancer patients are unclear. This study aimed to assess the effects of EUS, CT‐PET, and their combination on overall survival with respect to cases not receiving these procedures.

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.