ABSTR AC TBackground and aims Rectal lesions traditionally represent the first lesions approached during endoscopic submucosal dissection (ESD) training in the West. We evaluated the safety and efficacy of rectal ESD in North America.Methods This is a multicenter retrospective analysis of rectal ESD between January 2010 and September 2018 in 15 centers. End points included: rates of en bloc resection, R0 resection, adverse events, comparison of pre-and post-ESD histology, and factors associated with failed resection. ResultsIn total, 171 patients (median age 63 years; 56 % men) underwent rectal ESD (median size 43 mm). En bloc resection was achieved in 141 cases (82.5 %; 95 %CI 76.8-88.2), including 24 of 27 (88.9 %) with prior failed endoscopic mucosal resection (EMR). R0 resection rate was 74.9 % (95 %CI 68.4-81.4). Post-ESD bleeding and perforation occurred in 4 (2.3 %) and 7 (4.1 %), respectively. Covert submucosal invasive cancer (SMIC) was identified in 8.6 % of post-ESD specimens. There was one case (1/120; 0.8 %) of recurrence at a median follow-up of 31 weeks; IQR: 19-76 weeks). Older age and higher body mass index (BMI) were predictors of failed R0 resection, whereas submucosal fi-R0 resection, n (%) 128 (74.9 %) R1 resection, n (%) 20 (11.7 %) Rx resection, n (%) 23 (13.5 %) Overall curative resection, n (%) 125 (73.1 %) Curative resection for superficial invasive adenocarcinoma (n = 11) , n (%) 9 (81.8 %) Adverse events, n (%) ▪ Bleeding 4 (2.3 %) ▪ Perforation 7 (4.1 %) ▪ Nausea/abdominal pain 3 (2.9 %) ▪ Postoperative urinary retention 3 (1.8 %)▪ Post-ESD anal stricture 1 (0.6 %) EMR, endoscopic mucosal resection; ESD, endoscopic submucosal dissection.

Background and Aims. Fecal elastase-1 (FE-1) as a screening test for exocrine pancreatic insufficiency (EPI) is gaining popularity in clinical practice. The role of imaging in patients with FE-1-related suspicion of EPI remains unclear. The aim of this study was to characterize endoscopic ultrasound (EUS) findings for patients with low FE-1. Methods. A retrospective cross-sectional study was performed in 40 patients who had low FE-1 and underwent EUS to evaluate the pancreas. We obtained data on demographic and lifestyle factors, EUS findings, and histopathology results. We compared these variables between patients with FE‐1<100 mcg/g vs. 100-200 mcg/g. Results. Most patients (82.5%) established one or more new diagnoses from EUS. Diagnoses included: definitive chronic pancreatitis (n=29, 72.5%), fatty pancreas (n=9, 22.5%), and pancreatic solid mass or cyst (n=9, 22.5%). Half (n=4) of the solid or cystic lesions were neoplastic. All patients with a solid pancreatic mass also had concurrent chronic pancreatitis. There were no significant differences in EUS findings or demographic or lifestyle factors between groups with FE‐1<100 mcg/g vs. 100-200 mcg/g. Conclusion. Chronic pancreatitis is the most common EUS finding in patients with low FE-1 levels. EUS appears helpful in determining the cause of EPI in most patients with low FE-1 and may detect unsuspected pancreatic neoplasia.

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INTRODUCTION: Pancreatic Mucinous cystic lesions (MCL) have significant potential for malignant transformation; delivery of SPP as a direct intratumoral injection confirmed SPP present at the delivery site for at least 100 days in a prior study; intracystic therapy with SPP may prevent progression to cancer without corresponding systemic toxicities. METHODS: Aim: To determine safety and preliminary efficacy of SPP for treatment of MCLs using endoscopic ultrasound Fine Needle Injection (EUS-FNI). Materials and Methods: Subjects with confirmed MCL, based on elevated intracystic CEA and cytology, receive intracystic SPP via EUS FNI at volumes equal to the aspirated cyst fluid volume in sequential cohorts at 6, 10, and 15 mg/mL in a standard “3+3” dose-escalation protocol. The highest dose with acceptable safety and tolerability profile, as determined by a DSMB, will proceed into the second phase of the study; 9 additional subjects will receive two injections of SPP (same dose) 12 weeks apart. Subjects are followed for 6 months for clinical endpoints including: safety and tolerability evaluations, physical examination findings and vital signs; pharmacokinetic analysis of systemic paclitaxel drug levels; and cyst volume response as reported by imaging at 3 and 6 months. RESULTS: Nine subjects have been enrolled to date; 5 have completed the study (1 injection). EUS, imaging, CEA and amylase concentration were consistent with branched duct IPMN cyst (BD-IPMN) or MCNs (Table 1). To date, no dose limiting toxicities, serious adverse events related to treatment, or clinically significant blood work (chemistry; hematology; coagulation) or urinalysis have been reported. Adverse events potentially related to SPP include mild, transient abdominal pain/discomfort in 4 subjects and nausea in 2 subjects. Systemic paclitaxel concentration did not exceed 1 ng/mL, and was undetectable at 2 weeks supporting retention of SPP at delivery site. Cyst volumes in 3 of 5 completed subjects reduced by month 6, 2 remained stable (Table 2). CONCLUSION: Intracystic SPP appears safe and tolerable when administered at 6, 10, and 15 mg/mL in a volume equal to that of aspirated cyst fluid. Minimal systemic study drug exposure is experienced. No patients developed pancreatitis. Intracystic SPP appears to prevent continued growth of the cysts and may reduce total cyst volume. Subject enrollment to the second phase (2 injections 12 weeks apart) is underway at 15 mg/mL.

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