A multicenter, retrospective study of a through-the-needle injection-capable electrosurgical knife for endoscopic submucosal dissection.

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) is a technically challenging resection technique for en-bloc removal of dysplastic and early cancerous gastrointestinal (GI) lesions. We conducted a single-arm retrospective study evaluating the safety and efficacy of a new through-the-needle injection-capable electrosurgical knife used in upper and lower ESD procedures performed at 6 US academic centers. METHODS: Data were retrospectively collected on consecutive cases in which the new ESD knife was used. The primary efficacy endpoint was successful ESD (en bloc resection with negative margins). Secondary efficacy endpoints included en-bloc resection rate, curative resection rate, median ESD time, and median dissection speed. The safety endpoint was device- or procedure-related serious adverse events (SAEs). RESULTS: ESD of 581 lesions in 579 patients were reviewed, including 187 (32.2%) upper GI and 394 (67.8%) lower GI lesions. Prior treatment was reported in 283 (48.9%) patients. Successful ESD was achieved in 477 (82.1% of 581) lesions ‒ lower for patients with versus without submucosal fibrosis (73.6% versus 87.0%, respectively, P < 0.001), but similar for those with versus without previous treatment (81.7% versus 82.3%, respectively, P = 0.848). Four hundred and forty-three (76.2% of 581) lesions met criteria for curative resection. Median ESD time was 1.0 (range 0.1-4.5) hour. Median dissection speed was 17.1 (IQR 5.3-29.8) cm2/hour. Related SAEs were reported in 15 (2.6%) patients, including delayed hemorrhage (1.9%), perforation (0.5%), or postpolypectomy syndrome (0.2%). CONCLUSION: A newly developed through-the-needle injection-capable ESD knife showed a good success rate and excellent safety at US centers. (ClinicalTrials.gov number, NCT04580940).

Impact of frailty on endoscopic retrograde cholangiopancreatography outcomes in nonagenarians: A United States national experience.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is an essential therapeutic tool for biliary and pancreatic diseases. Frail and elderly patients, especially those aged ≥ 90 years are generally considered a higher-risk population for ERCP-related complications. AIM: To investigate outcomes of ERCP in the Non-agenarian population (≥ 90 years) concerning Frailty. METHODS: This is a cohort study using the 2018-2020 National Readmission Database. Patients aged ≥ 90 were identified who underwent ERCP, using the international classification of diseases-10 code with clinical modification. Johns Hopkins's adjusted clinical groups frailty indicator was used to classify patients as frail and non-frail. The primary outcome was mortality, and the secondary outcomes were morbidity and the 30 d readmission rate related to ERCP. We used univariate and multivariate regression models for analysis. RESULTS: A total of 9448 patients were admitted for any indications of ERCP. Frail and non-frail patients were 3445 (36.46%) and 6003 (63.53%) respectively. Indications for ERCP were Choledocholithiasis (74.84%), Biliary pancreatitis (9.19%), Pancreatico-biliary cancer (7.6%), Biliary stricture (4.84%), and Cholangitis (1.51%). Mortality rates were higher in frail group [adjusted odds ratio (aOR) = 1.68, P = 0.02]. The Intra-procedural complications were insignificant between the two groups which included bleeding (aOR = 0.72, P = 0.67), accidental punctures/lacerations (aOR = 0.77, P = 0.5), and mechanical ventilation rates (aOR = 1.19, P = 0.6). Post-ERCP complication rate was similar for bleeding (aOR = 0.72, P = 0.41) and post-ERCP pancreatitis (aOR = 1.4, P = 0.44). Frail patients had a longer length of stay (6.7 d vs 5.5 d) and higher mean total charges of hospitalization ($78807 vs $71392) compared to controls (P < 0.001). The 30 d all-cause readmission rates between frail and non-frail patients were similar (P = 0.96). CONCLUSION: There was a significantly higher mortality risk and healthcare burden amongst nonagenarian frail patients undergoing ERCP compared to non-frail. Larger studies are warranted to investigate and mitigate modifiable risk factors.

Early and Late Readmissions of Radiation Proctitis in the United States: Are We Getting Better?

Background/Aims: Radiation proctitis (RP), a well-known complication of pelvic radiation therapy, may lead to recurrent hospitalizations. We aimed to assess readmissions of RP in the United States. Methods: We analyzed the Nationwide Readmission Database from 2016 to 2020 to identify all 30-, 60-, and 90-day readmissions of RP in the United States. Hospitalization characteristics, predictors, clinical outcomes, and healthcare burdens were assessed. Results: From 2016 to 2020, we noted a declining trend of 30-, 60-, and 90-day readmissions of RP in the US. However, the all-cause 30-, 60-, and 90-day readmission rates of RP were still high at 13.7%, 19.4%, and 23.16%, respectively. On readmission, RP was identified as the admitting diagnosis in only 20.61%, 17.87%, and 15.76% of 30-, 60-, and 90-day readmissions, respectively. The mean age for all readmissions was 70 years with a significant male dominance. Lower endoscopy at index admission reduced the risk of readmissions within 90 days, but this was not statistically significant. However, the Charlson Comorbidity Index (CCI) score was an independent predictor of all readmissions. Furthermore, the mean length of stay was 5.57 (95% CI 5.15-6), 5.50 (95% CI 5.12-5.89), and 5.47 (95% CI 5.07-5.87) days and the mean hospitalization charge was USD 60,451 (95% CI USD 54,728-66,174), USD 62,671 (95% CI USD 57,326-68,015), and USD 62,144 (95% CI USD 57,144-67,144) for 30-, 60-, and 90-day readmissions. The all-cause inpatient mortality for 30-, 60-, and 90-day readmissions was 3.58%, 3.89%, and 3.46%, respectively. Conclusions: RP readmissions are a significant healthcare burden. Further efforts must be directed toward improving management strategies to reduce readmission rates.

Endoscopic submucosal dissection with versus without traction for pathologically staged T1B esophageal cancer: a multicenter retrospective study.

BACKGROUND AND AIMS: Positive vertical margins (VMs) are common after endoscopic submucosal dissection (ESD) of T1b esophageal cancer (EC) and are associated with an increased risk of recurrence. Traction during ESD provides better exposure of the submucosa and may allow deeper dissection, potentially reducing the risk of positive VMs. We conducted a retrospective multicenter study to compare the proportion of resections with positive VMs in ESD performed with versus without traction in pathologically staged T1b EC. METHODS: Patients who underwent ESD revealing T1b EC (squamous or adenocarcinoma) at 10 academic tertiary referral centers in the United States (n = 9) and Brazil (n = 1) were included. Demographic and clinical data were abstracted. ESD using either traction techniques (tunneling, pocket) or traction devices (clip line, traction wire) were classified as ESD with traction (Tr-ESD) and those without were classified as conventional ESD without traction. The primary outcome was a negative VM. Multivariable logistic regression was used to assess associations with negative VMs. RESULTS: A total of 166 patients with pathologically staged T1b EC underwent Tr-ESD (n = 63; 38%) or conventional ESD without traction (n = 103; 62%). Baseline factors were comparable between both groups. On multivariable analysis, Tr-ESD was found to be independently associated with negative VMs (odds ratio, 2.25; 95% confidence interval, 1.06-4.91; P = .037) and R0 resection (odds ratio, 2.83; 95% confidence interval, 1.33-6.23; P = .008). CONCLUSION: Tr-ESD seems to be associated with higher odds of negative VMs than ESD without traction for pathologically staged T1b EC, and future well-conducted prospective studies are warranted to establish the findings of the current study.

Cold Versus Hot Endoscopic Mucosal Resection for Sessile Serrated Colorectal Polyps ≥10 mm: A Systematic Review and Meta-analysis.

INTRODUCTION: We performed a systematic review and meta-analysis studying the efficacy and safety of cold versus hot endoscopic mucosal resection (EMR) for resection of sessile serrated polyps (SSPs) ≥10 mm. METHODS: Multiple databases were searched until January 2023 for studies reporting outcomes of cold versus hot EMR for SSPs ≥10 mm. The primary outcome was the residual SSP rate. Secondary outcomes included technical success rate, R0 resection rate, and adverse events. We used standard meta-analysis methods using the random-effects model, and I2% was used to assess heterogeneity. RESULTS: Thirteen studies were included in the final analysis. In all, 1896 SSPs were included with a mean polyp size of 23.7 mm (range, 15.9 to 33). A total of 1452 SSPs were followed up for a median follow-up duration of 15.3 months (range, 6 to 37). The pooled residual SSP rate for cold EMR was 4.5% (95% CI: 1.0-17.4), and 5.1% (95% CI: 2.4-10.4) for hot EMR (P=0.9). The pooled rates of technical success, R0 resection, immediate bleeding, and perforation were comparable. Hot EMR was significantly associated with lower piecemeal resection (59.2% vs. 99.3%, P<0.001), higher en-bloc resection (41.4% vs. 1.4%, P<0.001), and delayed bleeding rate (4% vs. 0.7%, P=0.05) compared to cold EMR. CONCLUSIONS: Cold EMR has similar efficacy compared to hot EMR for resection of SSP ≥ 10 mm, despite limitations in piecemeal R0 resection rate reporting. Although hot EMR was associated with a higher rate of en-bloc resection, it also showed an increased risk of delayed bleeding compared to cold EMR.

Efficacy of scissor-type knife for endoscopic submucosal dissection: a systematic review and meta-analysis.

Background: Endoscopic submucosal dissection (ESD) is an effective resection technique for early cancers and large gastrointestinal luminal lesions. However, ESD is technically challenging, with the potential for severe adverse events. Scissor-type ESD (ST-ESD) knives with an inner cutting edge and an electrically insulated external coating could mitigate some of these risks. This study aimed to evaluate the performance of ST electrosurgical knives when used for ESDs. Methods: Electronic databases were queried for studies from January 2005 through December 2022 evaluating the performance of ST-ESD knives. Fixed- and random-effects models were used to calculate pooled proportions. Heterogeneity was assessed using the I2 test and by constructing funnel plots, while bias was calculated using Egger and Harbord bias indicators. Results: Final analysis included data from 17 studies comprising 1652 ESD procedures. The pooled en bloc resection rate and R0 resection rate were 97.94% (95% confidence interval [CI] 97.20-98.57) and 94.32% (95%CI 93.11-95.43), respectively. The main adverse events were perforation and delayed post-procedural bleeding, with pooled rates of 1.07% (95%CI 0.63-1.62) and 1.86% (95%CI 1.26-2.56), respectively. There was no heterogeneity, as indicated by an I2 score of 0% (95%CI 0-44.50%). The mean procedure time was 67.45 min (95%CI 58.01-76.89). Conclusions: Our analysis shows that ST-ESD knives deliver consistently good performance across various locations in the gastrointestinal lumen and lesion sizes, with a good safety profile. This could be particularly appealing to newer adopters of ESD.

Response of Locally Advanced Pancreatic Cancer to Intratumoral Injection of Large Surface Area Microparticle Paclitaxel: Initial Report of Safety and Clinical Outcome.

OBJECTIVES: Large surface area microparticle paclitaxel (LSAM-PTX) provides an intratumoral (IT) chemotherapeutic depot. Safety, tolerability, and tumor response to IT LSAM-PTX delivered by endoscopic ultrasound-fine needle injection were evaluated in subjects with unresectable locally advanced pancreatic cancer (LAPC). METHODS: Ten subjects treated in a dose escalation phase and 22 additional subjects receiving 2 injections, 4 weeks apart, of 15 mg/mL LSAM-PTX were followed for 12 months. Paclitaxel pharmacokinetics were evaluated, imaging at 3 and 6 months determined tumor response, and multiplex immunofluorescence was conducted to characterize local immune response. RESULTS: Most treatment-emergent adverse events were attributed to LAPC. Plasma paclitaxel levels were negligible. Eight subjects' tumors became resectable after IT LSAM-PTX, and 5 of 6 (83%) were resected with R0. Multiplex immunofluorescence of resected tumors demonstrated increased T cells, natural killer cells, and macrophages and decreased myeloid-derived suppressor cells. Six-month disease control rate was 94%, and median overall survival was 19.7 months in the 2-injection subjects. For nonresected and resected groups, overall survival times were 18.9 and 35.2 months, respectively. CONCLUSIONS: Neoadjuvant IT LSAM-PTX, in combination with SOC, was well tolerated and may provide benefits to LAPC patients, evidenced by enhanced immune response, improved disease control rate, restaging leading to surgery, and extended survival.

Flexible Endoscopy Versus Rigid Endoscopy or Surgery for the Management of Zenker's Diverticulum: A Systematic Review and Meta-Analysis.

Zenker's diverticulum treatment options range from endoscopic rigid or flexible procedures to surgery. There are limited studies available comparing these techniques. Frequently, the choice of treatment depends on the physician's preference or experience, as well as the institution's resources and capacity. Therefore, this study aims to define the best approach based on the highest efficacy and the lowest severe adverse events. In accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a comprehensive search was performed. Only comparative studies were included, analyzing flexible endoscopy versus rigid endoscopy or surgery. The outcomes analyzed were clinical and technical success, severe adverse events, length of stay, and duration of the procedure. Analysis was performed using Review Manager 5.4.1 (RevMan 5.4, The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark). Eight retrospective cohort studies met the inclusion criteria. A total of 1281 patients were identified, 492 underwent flexible endoscopy, 453 underwent rigid endoscopy, and 336 underwent surgery. There was no difference in clinical success [risk difference (RD), 0.07 (95% CI -0.05 to 0.19%); P = 0.26], technical success [RD, 0.07 (95% CI -0.03 to 0.16); P = 0.18], severe adverse events [RD, -0.03 (95% CI -0.13 to 0.07; P = 0.052), perforation [RD, 0.07 (95% CI -0.04 to 0.19); P = 0.22] or procedure time [mean difference (MD), - 10.03 (95% CI -26.93 to 6.88); P = 0.24). There was lower length of stay with flexible endoscopy compared to the other approaches [MD, -1.98 (95% CI -3.56 to -0.40); P = 0.001]. Based on the current evidence, the three main techniques are effective for the treatment of Zenker's diverticulum. Although there was no significant difference in the safety of each technique in this meta-analysis, this result should be interpreted cautiously due to the limited data and the risk of vies between the techniques, considering that the results tend to favor flexible endoscopy, mainly explained by the newer and safer devices. Length of stay is lower with flexible endoscopy versus the other techniques, which can be beneficial considering the geriatric populations where Zenker's diverticulum mainly occurs.

Role of Advanced Gastrointestinal Endoscopy in the Comprehensive Management of Neuroendocrine Neoplasms.

Neuroendocrine neoplasms (NENs), also called neuroendocrine tumors (NETs), are relatively uncommon, heterogenous tumors primarily originating in the gastrointestinal tract. With the improvement in technology and increasing use of cross-sectional imaging and endoscopy, they are being discovered with increasing frequency. Although traditionally considered indolent tumors with good prognoses, some NENs exhibit aggressive behavior. Timely diagnosis, risk stratification, and management can often be a challenge. In general, small NENs without local invasion or lymphovascular involvement can often be managed using minimally invasive advanced endoscopic techniques, while larger lesions and those with evidence of lymphovascular invasion require surgery, systemic therapy, or a combination thereof. Ideal management requires a comprehensive and accurate understanding of the stage and grade of the tumor. With the recent advancements, a therapeutic advanced endoscopist can play a pivotal role in diagnosing, staging, and managing this rare condition. High-definition white light imaging and digital image enhancing technologies like narrow band imaging (NBI) in the newer endoscopes have improved the diagnostic accuracy of traditional endoscopy. The refinement of endoscopic ultrasound (EUS) over the past decade has revolutionized the role of endoscopy in diagnosing and managing various pathologies, including NENs. In addition to EUS-directed diagnostic biopsies, it also offers the ability to precisely assess the depth of invasion and lymphovascular involvement and thus stage NENs accurately. EUS-directed locoregional ablative therapies are increasingly recognized as highly effective, minimally invasive treatment modalities for NENs, particularly pancreatic NENs. Advanced endoscopic resection techniques like endoscopic submucosal dissection (ESD), endoscopic submucosal resection (EMR), and endoscopic full-thickness resection (EFTR) have been increasingly used over the past decade with excellent results in achieving curative resection of various early-stage gastrointestinal luminal lesions including NENs. In this article, we aim to delineate NENs of the different segments of the gastrointestinal (GI) tract (esophagus, gastric, pancreatic, and small and large intestine) and their management with emphasis on the endoscopic management of these tumors.

Role of Therapeutic Endoscopic Ultrasound in Management of Pancreatic Cancer: An Endoscopic Oncologist Perspective.

Pancreatic cancer is a highly lethal disease with an aggressive clinical course. Patients with pancreatic cancer are usually asymptomatic until significant progression of their disease. Additionally, there are no effective screening guidelines for pancreatic cancer in the general population. This leads to a delay in diagnosis and treatment, resulting in poor clinical outcomes and low survival rates. Endoscopic Ultrasound (EUS) is an indispensable tool for the diagnosis and staging of pancreatic cancer. In the modern era, with exponential advancements in technology and device innovation, EUS is also being increasingly used in a variety of therapeutic interventions. In the context of pancreatic cancer where therapies are limited due to the advanced stage of the disease at diagnosis, EUS-guided interventions offer new and innovative options. Moreover, due to their minimally invasive nature and ability to provide real-time images for tumor localization and therapy, they are associated with fewer complication rates compared to conventional open and laparoscopic approaches. In this article, we detail the most current and important therapeutic applications of EUS for pancreatic cancer, namely EUS-guided Fine Needle Injections, EUS-guided Radiotherapy, and EUS-guided Ablations. Furthermore, we also discuss the feasibility and safety profile of each intervention in patients with pancreatic cancer to provide gastrointestinal medical oncologists, radiation and surgical oncologists, and therapeutic endoscopists with valuable information to facilitate patient discussions and aid in the complex decision-making process.

Diagnosis and Management of Pancreatic Cysts: A Comprehensive Review of the Literature.

The prevalence of pancreatic cysts has been rising due to the widespread use of cross-sectional imaging (CT scan and MRI) of the abdomen. While most pancreatic cysts are benign and do not require treatment or surveillance, a significant minority are premalignant and rarely malignant. The risk stratification of these lesions is not straightforward, and individual risk assessment, cyst size, distribution, and alarming morphologic features (when present) can guide the next steps in management. Neoplastic pancreatic cysts are mucinous or non-mucinous. Endoscopic ultrasound with fine-needle aspiration is often required to classify pancreatic cysts into mucinous and non-mucinous cysts and to assess the malignant potential. Advances in endoscopic techniques (confocal laser endomicroscopy, microforceps biopsy) can provide a definitive diagnosis of pancreatic cysts in some cases; however, the use of these techniques involves a higher risk of adverse events.

Endoscopic Ultrasound-guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis: A Prospective Multicenter Trial.

OBJECTIVE: To evaluate the safety and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS). BACKGROUND: For patients with acute cholecystitis who are poor surgical candidates, EUS-GBD using a LAMS is an important treatment alternative to percutaneous gallbladder drainage. METHODS: We conducted a regulatory-compliant, prospective multicenter trial at 7 tertiary referral centers in the United States of America and Belgium. Thirty consecutive patients with mild or moderate acute cholecystitis who were not candidates for cholecystectomy were enrolled between September 2019 and August 2021. Eligible patients had a LAMS placed transmurally with 30 to 60-day indwell if removal was clinically indicated, and 30-day follow-up post-LAMS removal. Endpoints included days until acute cholecystitis resolution, reintervention rate, acute cholecystitis recurrence rate, and procedure-related adverse events (AEs). RESULTS: Technical success was 93.3% (28/30) for LAMS placement and 100% for LAMS removal in 19 patients for whom removal was attempted. Five (16.7%) patients required reintervention. Mean time to acute cholecystitis resolution was 1.6±1.5 days. Acute cholecystitis symptoms recurred in 10.0% (3/30) after LAMS removal. Five (16.7%) patients died from unrelated causes. Procedure-related AEs were reported to the FDA in 30.0% (9/30) of patients, including one fatal event 21 days after LAMS removal; however, no AEs were causally related to the LAMS. CONCLUSIONS: For selected patients with acute cholecystitis who are at elevated surgical risk, EUS-GBD with LAMS is an alternative to percutaneous gallbladder drainage. It has high technical and clinical success, with low recurrence and an acceptable AE rate. Clinicaltrials.gov, Number: NCT03767881.

Does acute pancreatitis herald pancreatic ductal adenocarcinoma? A multicenter electronic health research network study.

BACKGROUND AND OBJECTIVES: High mortality in pancreas ductal adenocarcinoma (PDAC) is related to delayed diagnosis and lack of cost-effective early detection strategies. Retrospective studies have demonstrated an association between PDAC and acute pancreatitis (AP). Herein, we explore the incidence of PDAC in patients with non-biliary and non-alcoholic AP. METHODS: A population-based, retrospective cohort study was conducted utilizing TriNetX (Cambridge, MA). Patients ≥40 years with AP (ICD-10-CM code: K85) and without biliary AP (K85.1), alcohol-induced AP (K85.2) or chronic pancreatitis (K86.0, K86.1), were identified. The primary outcome was incidence of PDAC (C25) in patients at defined intervals following AP. We compared the rate of early-stage diagnosis (stage 1-2) and surgical resection among patients with and without preceding AP. RESULTS: The incidence of PDAC ranged from 2.16% (1 year) to 3.43% (5 years). Patients with PDAC and AP in preceding year were more likely to undergo surgical resection relative to those without AP (10.1% vs. 6.3%, risk ratio 1.62: 95% confidence interval, CI 1.47-1.79). Early-stage diagnosis of PDAC was more frequent in patients with preceding AP; however, difference was insignificant (p = 0.48; 95% CI 0.64-2.58). CONCLUSION: AP is infrequently associated with PDAC and can precede a diagnosis of PDAC in a minority of patients without another known etiology of pancreatitis. Patients with a recent AP are more likely to undergo surgical resection of PDAC and a trend toward diagnosis at an earlier stage compared to patients with PDAC and without AP. The impact of AP-related PDAC on survival is unknown.

Application of artificial intelligence in diagnosis of pancreatic malignancies by endoscopic ultrasound: a systemic review.

Background: Pancreatic cancer (PC) is a highly fatal malignancy with a global overall 5-year survival of under 10%. Screening of PC is not recommended outside of clinical trials. Endoscopic ultrasonography (EUS) is a very sensitive test to identify PC but lacks specificity and is operator-dependent, especially in the presence of chronic pancreatitis (CP). Artificial Intelligence (AI) is a growing field with a wide range of applications to augment the currently available modalities. This study was undertaken to study the effectiveness of AI with EUS in the diagnosis of PC. Methods: Studies from MEDLINE and EMBASE databases reporting the AI performance applied to EUS imaging for recognizing PC. Data were analyzed using descriptive statistics. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool was used to assess the quality of the included studies. Results: A total of 11 articles reported the role of EUS in the diagnosis of PC. The overall accuracy, sensitivity, and specificity of AI in recognizing PC were 80-97.5%, 83-100%, and 50-99%, respectively, with corresponding positive predictive value (PPV) and negative predictive value (NPV) of 75-99% and 57-100%, respectively. Types of AI studied were artificial neural networks (ANNs), convolutional neural networks (CNN), and support vector machine (SVM). Seven studies using other than basic ANN reported a sensitivity and specificity of 88-96% and 83-94% to differentiate PC from CP. Two studies using SVM reported a 94-96% sensitivity, 93%-99% specificity, and 94-98% accuracy to diagnose PC from CP. The reported sensitivity and specificity of detection of malignant from benign Intraductal Papillary Mucinous Neoplasms (IPMNs) was 96% and 92%, respectively. Conclusion: AI reported a high sensitivity with high specificity and accuracy to diagnose PC, differentiate PC from CP, and differentiate benign from malignant IPMN when used with EUS.

Outcomes for endoscopic submucosal dissection of pathologically staged T1b esophageal cancer: a multicenter study.

BACKGROUND AND AIMS: The outcomes of endoscopic submucosal dissection (ESD) for T1b esophageal cancer (EC) and its recurrence rates remain unclear in the West. Using a multicenter cohort, we evaluated technical outcomes and recurrence rates of ESD in the treatment of pathologically staged T1b EC. METHODS: We included patients who underwent ESD of T1b EC at 7 academic tertiary referral centers in the United States (n = 6) and Brazil (n = 1). We analyzed demographic, procedural, and histopathologic characteristics and follow-up data. Time-to-event analysis was performed to evaluate recurrence rates. RESULTS: Sixty-six patients with pathologically staged T1b EC after ESD were included in the study. A preprocedure staging EUS was available in 54 patients and was Tis/T1a in 27 patients (50%) and T1b in 27 patients (50%). En-bloc resection rate was 92.4% (61/66) and R0 resection rate was 54.5% (36/66). Forty-nine of 66 patients (74.2%) did not undergo surgery immediately after resection and went on to surveillance. Ten patients had ESD resection within the curative criteria, and no recurrences were seen in a 13-month (range, 3-18.5) follow-up period in these patients. Ten of 39 patients (25.6%) with noncurative resections had residual/recurrent disease. Of the 10 patients with noncurative resection, local recurrence alone was seen in 5 patients (12.8%) and metastatic recurrence in 5 patients (12.8%). On univariate analysis, R1 resection had a higher risk of recurrent disease (hazard ratio, 6.25; 95% confidence interval, 1.29-30.36; P = .023). CONCLUSIONS: EUS staging of T1b EC has poor accuracy, and a staging ESD should be considered in these patients. ESD R0 resection rates were low in T1b EC, and R1 resection was associated with recurrent disease. Patients with noncurative ESD resection of T1b EC who cannot undergo surgery should be surveyed closely, because recurrent disease was seen in 25% of these patients.

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.

Missed breast carcinoma: pitfalls and pearls.

Mammography is the standard of reference for the detection of breast carcinoma, yet 10%-30% of breast cancers may be missed at mammography. Possible causes for missed breast cancers include dense parenchyma obscuring a lesion, poor positioning or technique, perception error, incorrect interpretation of a suspect finding, subtle features of malignancy, and slow growth of a lesion. Recent studies have emphasized the use of alternative imaging modalities to detect and diagnose breast carcinoma, including ultrasonography (US), magnetic resonance imaging, and nuclear medicine studies. However, the radiologist can take a number of steps that will significantly enhance the accuracy of image interpretation at mammography and decrease the false-negative rate. These steps include performing diagnostic as well as screening mammography, reviewing clinical data and using US to help assess a palpable or mammographically detected mass, strictly adhering to positioning and technical requirements, being alert to subtle features of breast cancers, comparing recent images with earlier mammograms to look for subtle increases in lesion size, looking for additional lesions when one abnormality is seen, and judging a lesion by its most malignant features.