Sachin Wani

The diagnostic accuracy of 22-gauge and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration of solid pancreatic lesions: a meta-analysis

BACKGROUND AND STUDY AIMSnIt is uncertain if needle gauge impacts the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic mass lesions. Our aim was to use meta-analysis to more robustly define the diagnostic accuracy of EUS-FNA for pancreatic masses using 22 G and 25 G needles.nnnPATIENTS AND METHODSnStudies were identified by searching nine medical databases for reports published between 1994 and 2011, using a reproducible search strategy comprised of relevant terms. Only studies comparing the overall diagnostic accuracy of 22 G vs. 25 G EUS needles that used surgical histology or at least 6 months clinical follow up for a gold standard were included. Two reviewers independently scored the identified studies for methodology and abstracted pertinent data. When required, the original investigators were contacted to provide additional data. Pooling was conducted by both fixed-effects and random-effects models. Diagnostic characteristics (sensitivity, specificity, positive and negative likelihood ratios) with 95% confidence intervals (CIs) were calculated.nnnRESULTSnEight studies involving 1292 subjects met the defined inclusion criteria. Of the 1292 patients, 799 were in the 22 G group and 565 were in the 25 G group (both needles were used in 72 patients). The pooled sensitivity and specificity of the 22 G needle were 0.85 (95%CI 0.82-0.88) and 1 (95%CI 0.98-1) respectively. The pooled sensitivity and specificity of the 25 G needle were 0.93 (95%CI 0.91-0.96) and 0.97 (95%CI 0.93-0.99) respectively. The bivariate generalized linear random-effect model indicated that the 25 G needle is associated with a higher sensitivity (P = 0.0003) but comparable specificity (P = 0.97) to the 22 G needle.nnnCONCLUSIONSnThis meta-analysis suggests 25 G needle systems are more sensitive than 22 G needles for diagnosing pancreatic malignancy.

Adverse Events After Radiofrequency Ablation in Patients With Barrett’s Esophagus: A Systematic Review and Meta-analysis

BACKGROUND & AIMSnRadiofrequency ablation (RFA) with or without endoscopic mucosal resection (EMR) is routinely used for treatment of Barretts esophagus with dysplasia. Despite the relative safety of this method, there have been imprecise estimates of the rate of adverse events. We performed a systematic review and meta-analysis to assess the rate of adverse events associated with RFA with and without EMR.nnnMETHODSnWe searched MEDLINE, Embase, Web of Science, and Cochrane Central through October 22, 2014. The primary outcome of interest was the overall rate of adverse events after RFA with or without EMR. We used forest plots to contrast effect sizes among studies.nnnRESULTSnOf 1521 articles assessed, 37 met our inclusion criteria (comprising 9200 patients). The pooled rate of all adverse events from RFA with or without EMR was 8.8% (95% confidence interval [CI], 6.5%-11.9%); 5.6% of patients developed strictures (95% CI, 4.2%-7.4%), 1% had bleeding (95% CI, 0.8%-1.3%), and 0.6% developed a perforation (95% CI, 0.4%-0.9%). In studies that compared RFA with vs without EMR, the relative risk for adverse events was significantly higher for RFA with EMR (4.4) (Pxa0= .015). There was a trend toward higher proportions of adverse events in prospective studies compared with retrospective studies (11.3% vs 7.8%, Pxa0= .20). Other factors associated with adverse events included Barretts esophagus and length and baseline histology.nnnCONCLUSIONSnIn a systematic review and meta-analysis, we found the relative risk for adverse events from RFA to be about 4-fold higher with EMR than without; we identified factors associated with these events. Endoscopists should discuss these risks with patients before endoscopic eradication therapy.

Real-Time Characterization of Diminutive Colorectal Polyp Histology Using Narrow-Band Imaging: Implications for the Resect and Discard Strategy

BACKGROUND & AIMSnNarrow-band imaging (NBI) allows real-time histologic classification of colorectal polyps. We investigated whether endoscopists without prior training in NBI can achieve the following thresholds recommended by the American Society for Gastrointestinal Endoscopy: for diminutive colorectal polyps characterized with high confidence, a ≥90% negative predictive value for adenomas in the rectosigmoid and a ≥90% agreement in surveillance intervals.nnnMETHODSnTwenty-six endoscopists from 2 tertiary care centers underwent standardized training in NBI interpretation. Endoscopists made real-time predictions of diminutive colorectal polyp histology and surveillance interval predictions based on NBI. Their performance was evaluated by comparing predicted with actual findings from histologic analysis. Multilevel logistic regression was used to assess predictors of performance. Cumulative summation analysis was used to characterize learning curves.nnnRESULTSnThe endoscopists performed 1451 colonoscopies and made 3012 diminutive polyp predictions (74.3% high confidence) using NBI. They made 898 immediate post-procedure surveillance interval predictions. An additional 505 surveillance intervals were determined with histology input. The overall negative predictive value for high-confidence characterizations in the rectosigmoid was 94.7% (95% confidence interval: 92.6%-96.8%) and the surveillance interval agreement was 91.2% (95% confidence interval: 89.7%-92.7%). Overall, 97.0% of surveillance interval predictions would have brought patients back on time or early. High-confidence characterization was the strongest predictor of accuracy (odds ratioxa0= 3.42; 95% confidence interval: 2.72-4.29; P < .001). Performance improved over time, however, according to cumulative summation analysis, only 7xa0participants (26.9%) identified adenomas with sufficient sensitivity such that further auditing is not required.nnnCONCLUSIONSnWith standardized training, gastroenterologists without prior expertise in NBI were able to meet thexa0negative predictive value and surveillance interval thresholds set forth by the American Society for Gastrointestinal Endoscopy. The majority of disagreement in surveillance interval brought patients back early. Performance improves with time, but most endoscopists will require ongoing auditing of performance. ClinicalTrials.gov ID NCT02441998.

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

BACKGROUND & AIMSnLittle 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.nnnMETHODSnTwelve 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.nnnRESULTSnTrainees 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).nnnCONCLUSIONSnWe 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.

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

BACKGROUND AND AIMSnThere 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.nnnMETHODSnAETs 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.nnnRESULTSnFive 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.nnnCONCLUSIONnThis 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.

Diagnosis and Management of Low-Grade Dysplasia in Barrett’s Esophagus: Expert Review From the Clinical Practice Updates Committee of the American Gastroenterological Association

The purpose of this clinical practice update expert review is to define the key principles in the diagnosis and management of low-grade dysplasia (LGD) in Barretts esophagus patients. The best practices outlined in this review are based on relevant publications, including systematic reviews and expert opinion (when applicable). Practice Advice 1: The extent of Barretts esophagus should be defined using a standardized grading system documenting the circumferential and maximal extent of the columnar lined esophagus (Prague classification) with a clear description of landmarks and visible lesions (nodularity, ulceration) when present. Practice Advice 2: Given the significant interobserver variability among pathologists, the diagnosis of Barretts esophagus with LGD should be confirmed by an expert gastrointestinal pathologist (defined as a pathologist with a special interest in Barretts esophagus-related neoplasia who is recognized as an expert in this field by his/her peers). Practice Advice 3: Expert pathologists should report audits of their diagnosed cases of LGD, such as the frequency of LGD diagnosed among surveillance patients and/or the difference in incidence of neoplastic progression among patients diagnosed with LGD vs nondysplastic Barretts esophagus. Practice Advice 4: Patients in whom the diagnosis of LGD is downgraded to nondysplastic Barretts esophagus should be managed as nondysplastic Barretts esophagus. Practice Advice 5: In Barretts esophagus patients with confirmed LGD (based on expert gastrointestinal pathology review), repeat upper endoscopy using high-definition/high-resolution white-light endoscopy should be performed under maximal acid suppression (twice daily dosing of proton pump inhibitor therapy) in 8-12 weeks. Practice Advice 6: Under ideal circumstances, surveillance biopsies should not be performed in the presence of active inflammation (erosive esophagitis, Los Angeles grade C and D). Pathologists should be informed if biopsies are obtained in the setting of erosive esophagitis and if pathology findings suggest LGD, or if no biopsies are obtained, surveillance biopsies should be repeated after the anti-reflux regimen has been further intensified. Practice Advice 7: Surveillance biopsies should be performed in axa0four-quadrant fashion every 1-2 cm with target biopsiesxa0obtained from visible lesions taken first. Practice Advice 8: Patients with a confirmed histologic diagnosis of LGD should be referred to an endoscopist with expertise in managing Barretts esophagus-related neoplasia practicing at centers equipped with high-definition endoscopy and capable of performing endoscopic resection and ablation. Practice Advice 9: Endoscopic resection should be performed in Barretts esophagus patients with LGD with endoscopically visible abnormalities (no matter how subtle) in order to accurately assess the grade of dysplasia. Practice Advice 10: In patients with confirmed Barretts esophagus with LGD by expert GI pathology review that persists on a second endoscopy, despite intensification of acid-suppressive therapy, risks and benefits of management options of endoscopic eradication therapy (specifically adverse events associated with endoscopic resection and ablation), and ongoing surveillance should be discussed and documented. Practice Advice 11: Endoscopic eradication therapy should be considered in patients with confirmed and persistent LGD with the goal of achieving complete eradication of intestinal metaplasia. Practice Advice 12: Patients with LGD undergoing surveillance rather than endoscopic eradication therapy should undergo surveillance every 6 months times 2, then annually unless there is reversion to nondysplastic Barretts esophagus. Biopsies should be obtained in 4-quadrants every 1-2 cm and of any visible lesions. Practice Advice 13: In patients with Barretts esophagus-related LGD undergoing ablative therapy, radiofrequency ablation should be used. Practice Advice 14: Patients completing endoscopic eradication therapy should be enrolled in an endoscopic surveillance program. Patients who have achieved complete eradication of intestinal metaplasia should undergo surveillance every year for 2 years and then every 3 years thereafter to detect recurrent intestinal metaplasia and dysplasia. Patients who have not achieved complete eradication of intestinal metaplasia should undergo surveillance every 6 months for 1 year after the last endoscopy, then annually for 2 years, then every 3 years thereafter. Practice Advice 15: Following endoscopic eradication therapy, the biopsy protocol of obtaining biopsies in 4 quadrants every 2 cm throughout the length of the original Barretts esophagus segment and any visible columnar mucosa is suggested. Practice Advice 16: Endoscopists performing endoscopic eradication therapy should report audits of their rates of complete eradication of dysplasia and intestinal metaplasia and adverse events in clinical practice.

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

BACKGROUND AND AIMSnThe 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.nnnMETHODSnConsecutive 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.nnnRESULTSnA 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.nnnCONCLUSIONSnCyst 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.

Plastic biliary stent patency in patients with locally advanced pancreatic adenocarcinoma receiving downstaging chemotherapy

BACKGROUNDnPlastic stents in patients with biliary obstruction caused by pancreatic adenocarcinoma are typically exchanged at 3-month intervals. Plastic stents may have reduced durability in patients receiving chemotherapy.nnnOBJECTIVEnTo determine the duration of plastic biliary stent patency in patients undergoing chemotherapy for pancreatic adenocarcinoma.nnnDESIGNnRetrospective, multicenter cohort study.nnnSETTINGnThree tertiary academic referral centers.nnnPATIENTSnA total of 173 patients receiving downstaging chemotherapy for locally advanced or borderline resectable pancreatic adenocarcinoma from 1996 toxa02013.nnnINTERVENTIONSnPlacement of 10F or larger plastic biliary stents.nnnMAIN OUTCOME MEASUREMENTSnPrimary outcome was overall duration of stent patency. Secondary outcomes included the incidence of premature stent exchange (because of cholangitis or jaundice) and hospitalization rates.nnnRESULTSnA total of 233 plastic stents were placed, and the overall median duration of stent patency was 53 days (interquartile range [IQR] 25-99 days). Eighty-seven stents were removed at the time of surgical resection, andxa063xa0stents were exchanged routinely per protocol. The remaining 83 stent exchanges were performed forxa0worsening liver function test results, jaundice, or cholangitis, representing a 35.6% rate of premature stent exchange. The median stent patency duration in the premature stent exchange group was 49 days (IQR 25-91 days) with axa044.6% hospitalization rate. The overall rate of cholangitis was 15.0% of stent exchanges, occurring a median of 56 days after stent placement (IQR 26-89 days).nnnLIMITATIONSnRetrospective study.nnnCONCLUSIONSnPlastic biliary stents placed during chemotherapy/chemoradiation for pancreatic adenocarcinoma have a shorter-than-expected patency duration, and a substantial number of patients will require premature stent exchange. Consideration should be given to shortening the interval for plastic biliary stent exchange.

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.