Rabindra R. Watson

Colonoscopy With Clipping Is Useful in the Diagnosis and Treatment of Diverticular Bleeding

BACKGROUND & AIMS Diverticular bleeding is the most common cause of acute severe lower gastrointestinal bleeding (LGIB) in Western countries. Diagnostic and therapeutic approaches, including endoscopy, radiology, or surgery, have not been standardized. We investigated colonoscopy as a first-line modality to diagnose and manage patients with LGIB. METHODS We performed a retrospective study of data collected from 2 tertiary Veterans hospitals of 64 patients (61 men, 76 ± 11 years) with acute severe diverticular bleeding, based on colonoscopy examination. We assessed primary hemostasis using endoscopic clipping for diverticular bleeding and described the bleeding stigmata. We measured early (<30 days) and late rebleeding, blood transfusion requirements, hospital stay and complications. RESULTS Patients received 3.1 ± 3.0 and 0.9 ± 2.2 U of blood before and after colonoscopy, respectively. Twenty-four of the 64 patients (38%) had diverticular stigmata of recent hemorrhage; and 21 of these patients (88%) were treated successfully using endoscopic clips, without complication or early rebleeding. Hospital stays averaged 6.4 ± 5.6 days. Endoscopic clipping provided primary hemostasis in 9/12 patients (75%) with active diverticular bleeding. During 35 ± 18 months of follow-up, late recurrent diverticular bleeding occurred in 22% of the patients (14/64) after a mean time period of 22 months; 5 of the patients (21%) with stigmata of recent hemorrhage who received clip treatment had rebleeding at 43 months. Rebleeding was self-limited in 8 patients (57%), was clipped in 4 (29%), or was embolized in 2 (14%). CONCLUSIONS Colonoscopy can be a safe first-line diagnostic and therapeutic approach for patients with severe LGIB. Endoscopic clipping provides hemostasis of active diverticular bleeding. Recurrent bleeding occurs in about 21% of patients who were treated with clips, at approximately 4 years; most bleeding is self-limited or can be retreated by endoscopic clipping.

Yield and Performance Characteristics of Endoscopic Ultrasound-Guided Fine Needle Aspiration for Diagnosing Upper GI Tract Stromal Tumors

Background and AimsEUS-FNA is a means of sampling suspected GI stromal tumors (GIST). However, there are limited published data on factors influencing the sampling yield, and on the performance characteristics of this technique in comparison with resection pathology. We analyzed the yield of EUS-FNA for submucosal lesions of the upper GI tract, and determined the performance characteristics of EUS-FNA for diagnosing GISTs.MethodsWe retrospectively reviewed procedural and pathology data from consecutive patients undergoing EUS-FNA of submucosal lesions from two medical centers over a 4-year period. We analyzed the yield of EUS-FNA, and calculated performance characteristics of EUS-FNA for GIST based on resection pathology.ResultsA total of 65 patients underwent EUS-FNA of 66 submucosal lesions during the study period. EUS-FNA was either diagnostic (68%) or suspicious (12%) in a total of 80%. EUS-FNA yielded the following diagnoses: GIST based on cytology and immunohistochemistry (56%), suspected GIST (12%), leiomyoma (9%), other neoplasm (3%), and non-diagnostic (20%). Larger lesion size, gastric location, and presence of on-site cytopathology were associated with higher yield in univariate analysis. Larger needle size and number of FNA passes were not associated with improved yield. Based on resection pathology from 28 specimens, the EUS-FNA performance characteristics for diagnosing GISTs included a sensitivity of 82%, a specificity of 100%, and an overall accuracy of 86%.ConclusionsEUS-FNA provides a high yield for sampling submucosal lesions and is highly accurate for diagnosing GISTs. EUS-FNA has an important role in the evaluation of suspected GISTs.

Variation in Aptitude of Trainees in Endoscopic Ultrasonography, Based on Cumulative Sum Analysis

BACKGROUND & AIMS Studies have reported substantial variation in the competency of advanced endoscopy trainees, indicating a need for more supervised training in endoscopic ultrasound (EUS). We used a standardized, validated, data collection tool to evaluate learning curves and measure competency in EUS among trainees at multiple centers. METHODS In a prospective study performed at 15 centers, 17 trainees with no prior EUS experience were evaluated by experienced attending endosonographers at the 25th and then every 10th upper EUS examination, over a 12-month training period. A standardized data collection form was used (using a 5-point scoring system) to grade the EUS examination. Cumulative sum analysis was applied to produce a learning curve for each trainee; it tracked the overall performance based on median scores at different stations and also at each station. Competency was defined by a median score of 1, with acceptable and unacceptable failure rates of 10% and 20%, respectively. RESULTS Twelve trainees were included in the final analysis. Each of the trainees performed 265 to 540 EUS examinations (total, 4257 examinations). There was a large amount of variation in their learning curves: 2 trainees crossed the threshold for acceptable performance (at cases 225 and 245), 2 trainees had a trend toward acceptable performance (after 289 and 355 cases) but required continued observation, and 8 trainees needed additional training and observation. Similar results were observed at individual stations. CONCLUSIONS A specific case load does not ensure competency in EUS; 225 cases should be considered the minimum caseload for training because we found that no trainee achieved competency before this point. Ongoing training should be provided for trainees until competency is confirmed using objective measures.

Transpapillary drainage has no added benefit on treatment outcomes in patients undergoing EUS-guided transmural drainage of pancreatic pseudocysts: a large multicenter study.

BACKGROUND AND AIMS The need for transpapillary drainage (TPD) in patients undergoing transmural drainage (TMD) of pancreatic fluid collections (PFCs) remains unclear. The aims of this study were to compare treatment outcomes between patients with pancreatic pseudocysts undergoing TMD versus combined (TMD and TPD) drainage (CD) and to identify predictors of symptomatic and radiologic resolution. METHODS This is a retrospective review of 375 consecutive patients with PFCs who underwent EUS-guided TMD from 2008 to 2014 at 15 academic centers in the United States. Main outcome measures included TMD and CD technical success, treatment outcomes (symptomatic and radiologic resolution) at follow-up, and predictors of treatment outcomes on logistic regression. RESULTS A total of 375 patients underwent EUS-guided TMD of PFCs, of which 174 were pseudocysts. TMD alone was performed in 95 (55%) and CD in 79 (45%) pseudocysts. Technical success was as follows: TMD, 92 (97%) versus CD, 35 (44%) (P = .0001). There was no difference in adverse events between the TMD (15%) and CD (14%) cohorts (P = .23). Median long-term (LT) follow-up after transmural stent removal was 324 days (interquartile range, 72-493 days) for TMD and 201 days (interquartile range, 150-493 days) (P = .37). There was no difference in LT symptomatic resolution (TMD, 69% vs CD, 62%; P = .61) or LT radiologic resolution (TMD, 71% vs CD, 67%; P = .79). TPD attempt was negatively associated with LT radiologic resolution of pseudocyst (odds ratio, 0.11; 95% confidence interval, 0.02-0.8; P = .03). CONCLUSIONS TPD has no benefit on treatment outcomes in patients undergoing EUS-guided TMD of pancreatic pseudocysts and negatively affects LT resolution of PFCs.

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.

A randomized controlled cross-over trial and cost analysis comparing endoscopic ultrasound fine needle aspiration and fine needle biopsy *

Background and study aims: Techniques to optimize endoscopic ultrasound-guided tissue acquisition (EUS-TA) in a variety of lesion types have not yet been established. The primary aim of this study was to compare the diagnostic yield (DY) of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) to endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) for pancreatic and non-pancreatic masses. Patients and methods: Consecutive patients referred for EUS-TA underwent randomization to EUS-FNA or EUS-FNB at four tertiary-care medical centers. A maximum of three passes were allowed for the initial method of EUS-TA and patients were crossed over to the other arm based on on-site specimen adequacy. Results: A total of 140 patients were enrolled. The overall DY was significantly higher with specimens obtained by EUS-FNB compared to EUS-FNA (90.0 % vs. 67.1 %, P = 0.002). While there was no difference in the DY between the two groups for pancreatic masses (FNB: 91.7 % vs. FNA: 78.4 %, P = 0.19), the DY of EUS-FNB was higher than the EUS-FNA for non-pancreatic lesions (88.2 % vs. 54.5 %, P = 0.006). Specimen adequacy was higher for EUS-FNB compared to EUS-FNA for all lesions (P = 0.006). There was a significant rescue effect of crossover from failed FNA to FNB in 27 out of 28 cases (96.5 %, P = 0.0003). Decision analysis showed that the strategy of EUS-FNB was cost saving compared to EUS-FNA over a wide range of cost and outcome probabilities. Conclusions: Results of this RCT and decision analysis demonstrate superior DY and specimen adequacy for solid mass lesions sampled by EUS-FNB.

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.

Initial experience with a novel EUS-guided core biopsy needle (SharkCore): results of a large North American multicenter study.

Background and aims: The ability to safely and effectively obtain sufficient tissue for pathologic evaluation by using endoscopic ultrasound (EUS) guidance remains a challenge. Novel designs in EUS needles may provide for improved ability to obtain such core biopsies. The aim of this study was to evaluate the diagnostic yield of core biopsy specimens obtained using a novel EUS needle specifically designed to obtain core biopsies. Patients and methods: Multicenter retrospective review of all EUS-guided fine-needle biopsies obtained using a novel biopsy needle (SharkCore FNB needle, Medtronic, Dublin, Ireland). Data regarding patient demographics, lesion type/location, technical parameters, and diagnostic yield was obtained. Results: A total of 250 lesions were biopsied in 226 patients (Median age 66 years; 113 (50 %) male). Median size of all lesions (mm): 26 (2 – 150). Overall, a cytologic diagnosis was rendered in 81 % specimens with a median number of 3 passes. When rapid onsite cytologic evaluation (ROSE) was used, cytologic diagnostic yield was 126/149 (85 %) with a median number of 3 passes; without ROSE, cytologic diagnostic yield was 31/45 (69 %, P = 0.03) with a median number of 3 passes. Overall, a pathologic diagnosis was rendered in 130/147 (88 %) specimens with a median number of 2 passes. Pathologic diagnostic yield for specific lesion types: pancreas 70/81 (86 %), subepithelial lesion 13/15 (87 %), lymph node 26/28 (93 %). Ten patients (10/226, 4 %) experienced adverse events: 4 acute pancreatitis, 5 pain, 1 fever/cholangitis. Conclusions: Initial experience with a novel EUS core biopsy needle demonstrates excellent pathologic diagnostic yield with a minimum number of passes.

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.

The efficacy of peroral cholangioscopy for difficult bile duct stones and indeterminate strictures: a systematic review and meta-analysis

Background and study aims: Current evidence supporting the efficacy of peroral cholangioscopy (POC) in the evaluation and management of difficult bile duct stones and indeterminate strictures is limited. The aims of this systematic review and meta-analysis were to assess the following: the efficacy of POC for the therapy of difficult bile duct stones, the diagnostic accuracy of POC for the evaluation of indeterminate biliary strictures, and the overall adverse event rates for POC. Patients and methods: Patients referred for the removal of difficult bile duct stones or the evaluation of indeterminate strictures via POC were included. Search terms pertaining to cholangioscopy were used, and articles were selected based on preset inclusion and exclusion criteria. Quality assessment of the studies was completed with a modified Newcastle-Ottawa Scale. After critical literature review, relevant outcomes of interest were analyzed. Meta-regression was performed to examine potential sources of between-study variation. Publication bias was assessed via funnel plots and Egger’s test. Results: A total of 49 studies were included. The overall estimated stone clearance rate was 88 % (95 % confidence interval [95 %CI] 85 % – 91 %). The accuracy of POC was 89 % (95 %CI 84 % – 93 %) for making a visual diagnosis and and 79 % (95 %CI 74 % – 84 %) for making a histological diagnosis. The estimated overall adverse event rate was 7 % (95 %CI 6 % – 9 %). Conclusions: POC is a safe and effective adjunctive tool with endoscopic retrograde cholangiopancreatography (ERCP) for the evaluation of bile duct strictures and the treatment of bile duct stones when conventional methods have failed. Prospective, controlled clinical trials are needed to further elucidate the precise role of POC during ERCP.