Search

Background and Aims: Treatment of Zenker's diverticulum (ZD) has evolved from flexible endoscopic septotomy (FES) to peroral endoscopic myotomy (Z-POEM). In this study, we compare efficacy and safety of FES with a needle knife septotomy (FENKS) and Z-POEM for symptomatic ZD., Methods: Consecutive patients at a single institution who underwent endoscopic ZD treatment by FENKS or Z-POEM were identified. Demographics, clinical characteristics, procedure technique, technical and clinical success, and adverse events (AEs) within 30 days were reviewed and compared between the two groups. AEs were classified by the AGREE classification. Baseline and post-procedure Dakkak and Bennett's (DB) scores were reported at 6, 12 and 24 months. Clinical success (DB score ≤1) was assessed by per-protocol (PP) and intention-to-treat analyses (ITT)., Results: 60 patients (55% M, mean 72±12 yrs.) underwent FENKS (n=21) or Z-POEM (n=39) between 2016 and 2023. Baseline clinical characteristics were similar and overall technical success was 98.3%. Clinical success by PP and ITT analyses at 6, 12 and 24 months after intervention were similar between both groups. The FENKS group had a higher prevalence (29% vs. 5%, p=0.018) and severity (p=0.032) of AEs and were more likely to be hospitalized after treatment (71% vs. 33%, p=0.007). During a median follow up of 18 months, reintervention was required for 5 (10%) in the FENKS (n=2, 9%) and Z-POEM (n=3, 7.6%) groups (p=1.0) a mean 7.6 ± 4.4 months after initial therapy., Conclusion: Treatment of ZD with Z-POEM appears to be safer than FENKS with similar short- and mid-term clinical success., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Disclosure All authors disclosed no financial relationships.

Background and Aims: Video analysis has emerged as a potential strategy for performance assessment and improvement. We aimed to develop a video-based skill assessment tool for peroral endoscopic myotomy (POEM)., Methods: POEM was deconstructed into basic procedural components through video analysis by an expert panel. A modified Delphi approach and 2 validation exercises were conducted to refine the POEM assessment tool (POEMAT). Twelve assessors used the final POEMAT version to grade 10 videos. Fully crossed generalizability (G) studies investigated the contributions of assessors, endoscopists' performance, and technical elements to reliability. G coefficients below .5 were considered unreliable, between .5 and .7 as modestly reliable, and above .7 as indicative of satisfactory reliability., Results: After task deconstruction, discussions, and the modified Delphi process, the final POEMAT comprised 9 technical elements. G analysis showed low variance for endoscopist performance (.8%-24.9%) and high interrater variability (range, 63.2%-90.1%). The G score was moderately reliable (≥.60) for "submucosal tunneling" and "myotomy" and satisfactorily reliable (≥.70) for "active hemostasis" and "mucosal closure.", Conclusions: We developed and established initial content and response process validity evidence for the POEMAT. Future steps include appraisal of the tool using a wider range of POEM videos to establish and improve the discriminative validity of this tool., Competing Interests: Disclosure The following authors disclosed financial relationships: D. Yang: Consultant for Olympus, Fujifilm, Boston Scientific, Apollo Endosurgery, Medtronic, 3D-Matrix, Microtech, and Neptune Medical; and research grants from Microtech and 3D-Matrix. M.K. Hasan: Consultant for Boston Scientific and Olympus. P.V. Draganov: Consultant for Olympus, Boston Scientific, Fujifilm, Cook Medical, and Medtronic. S. Jawaid: Consultant for Lumendi, Creo Medical, and ConMed. M. Othman: Consultant for Olympus, Boston Scientific, Creo Medical, Apollo Endosurgery, Lumendi, AbbVie, and Nestle; and research support from Boston Scientific, ConMed, Lucid Diagnostic, AbbVie, and Nestle. N. Sharma: Consultant for Boston Scientific, Medtronic, Steris, and Olympus. A. Sethi: Consultant for Boston Scientific, Interscope, Medtronic, and Olympus; and research support from Boston Scientific and Fujifilm. M. Khashab: Consultant for Boston Scientific, Olympus, Medtronic, Apollo Endosurgery, Pentax, and Laborie; research support from Boston Scientific; and royalties from Elsevier and UpToDate. J. M. Dewitt: Consultant for Vyaire Medical Inc and Airel Diagnostics; and grant support from Vyaire Medical, Inc. H. Pohl: Consultant for InterVenn; and research grants from Steris and Cosmo. H. Aihara: Consultant for Olympus, Fujifilm, Boston Scientific, Medtronic, and 3D Matrix. R. Bechara: Consultant for Olympus, Medtronic, Pentax, and Pendopharm. N. Kumta: Consultant for Apollo Endosurgery, Boston Scientific, Olympus, and SafeHeal. A. A. Aadam: Consultant for Boston Scientific, Steris Endoscopy, and ERBE USA. R. Law: Consultant for Boston Scientific, ConMed, and Medtronic; and research support from Olympus. All other authors disclosed no financial relationships. This study was funded by a clinical research award grant from the American Society for Gastrointestinal Endoscopy., (Copyright © 2024. Published by Elsevier Inc.)

Background and Aims: The use of EUS for peristomal varices (PV) is limited to case reports., Methods: Patients who underwent EUS-guided treatment of PV with cyanoacrylate (CYA) and/or coils between April 2013 and December 2019 were identified. All patients had failed previous therapies or had comorbidities precluding other options. Endoscopic technique, adverse events (AEs), recurrent bleeding, and repeat interventions were assessed., Results: Twenty patients (12 men; median age, 62 years [interquartile range {IQR}, 54.8-69.5]) underwent initial EUS-guided PV injection of CYA for secondary (n = 19) or primary (n = 1) prophylaxis. Within 30 days, AEs occurred in 11 patients (55%), of which 8 were mild. During a median 2.5 months (IQR, 2-8.5) of follow-up, confirmed (n = 6) or suspected (n = 2) PV bleeding recurred; 5 of 8 recurrences were retreated with CYA and/or coils without AEs. After retreatment, PV bleeding recurred in 2 patients a median of 6 months (IQR, 6-30) later., Conclusions: EUS appears to be a safe and promising technique for treatment of PV., Competing Interests: Disclosure The following author disclosed financial relationships: M. A. Al-Haddad: Consultant for Interpace Diagnostics; research support from Amplified Sciences and Creatics. All other authors disclosed no financial relationships., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: We have endoscopically encountered a zone of transitional mucosa between the colonic and ileal mucosa located in a 3- to 10-mm-wide ring around the ileocecal valve (ICV) orifice. We aimed to describe the features of the ICV transitional zone mucosa., Methods: We used videos and photographs from normal ICVs and biopsy samples from normal colonic mucosa, transitional zone mucosa, and normal ileal mucosa to characterize the endoscopic and histologic features of the ICV transitional zone mucosa., Results: The ICV transitional zone is identifiable on every ICV without a circumferential adenoma or inflammation that obliterates the zone. The zone is characterized endoscopically by an absence of villi, which distinguishes it from the ileal mucosa, but the pits are more tubular and with more prominent blood vessels compared with normal colonic mucosa. Histologically, the villi of the transitional zone are blunted, and the amount of lymphoid tissue is intermediate between the colonic mucosa and ileal mucosa., Conclusions: This is the first description of the normal transitional zone of mucosa on the ICV. This zone has unique endoscopic features that should be recognized by colonoscopists and that can potentially create difficulty in identifying the margins of adenomas located on the ICV., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Chronic narcotic use may cause opioid-induced esophageal dysfunction and associated type III achalasia, hypercontractile esophagus (HE), diffuse esophageal spasm (DES), and esophagogastric junction outflow obstruction (EGJOO). The frequency of opioid use and its impact on peroral endoscopic myotomy (POEM) in these patients is unknown., Methods: Consecutive patients between April 2017 and September 2021 who underwent POEM for type III achalasia, EGJOO, DES, or HE with ≥6 months follow-up were identified. Baseline evaluation was done with EGD, esophageal high-resolution manometry (HRM), and functional lumen impedance planimetry (FLIP) of the esophagogastric junction (EGJ). Eckardt scores (ESs) were calculated at baseline and follow-up at 6 to 12 months after POEM for opioid users and nonusers. Clinical response was defined as ES ≤3, EGJ distensibility index >2.8 mm 2 /mm Hg, maximum EGJ diameter >14 mm, and integrated relaxation pressure (IRP) <15 mm Hg. Opioid use before baseline HRM was assessed., Results: One hundred twenty-six patients underwent POEM, and 89 had ≥6 months of follow-up. Daily opioid use was present in 18 of 89 patients (20%). Baseline demographics, FLIP metrics, IRP, distribution of motility disorders, and POEM characteristics were similar between both groups. At 6 to 12 months after POEM, clinical response and frequency of GERD, esophagitis, and proton pump inhibitor use were similar between opioid users and nonusers. Heartburn was more frequent in the opioid group (82.4% vs 38.6%, P = .002)., Conclusions: In this single-center study of 89 patients with type III achalasia, EGJOO, DES, or HE treated with POEM, daily opioid use was present in 20%. Response to POEM and post-POEM GERD were similar between opioid users and nonusers. (Clinical trial registration number: NCT02770859.)., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Performing a high-quality colonoscopy is critical for optimizing the adenoma detection rate (ADR). Colonoscopy withdrawal time (a surrogate measure) of ≥6 minutes is recommended; however, a threshold of a high-quality withdrawal and its impact on ADR are not known., Methods: We examined withdrawal time (excluding polyp resection and bowel cleaning time) of subjects undergoing screening and/or surveillance colonoscopy in a prospective, multicenter, randomized controlled trial. We examined the relationship of withdrawal time in 1-minute increments on ADR and reported odds ratio (OR) with 95% confidence intervals. Linear regression analysis was performed to assess the maximal inspection time threshold that impacts the ADR., Results: A total of 1142 subjects (age, 62.3 ± 8.9 years; 80.5% men) underwent screening (45.9%) or surveillance (53.6%) colonoscopy. The screening group had a median withdrawal time of 9.0 minutes (interquartile range [IQR], 3.3) with an ADR of 49.6%, whereas the surveillance group had a median withdrawal time of 9.3 minutes (IQR, 4.3) with an ADR of 63.9%. ADR correspondingly increased for a withdrawal time of 6 minutes to 13 minutes, beyond which ADR did not increase (50.4% vs 76.6%, P < .01). For every 1-minute increase in withdrawal time, there was 6% higher odds of detecting an additional subject with an adenoma (OR, 1.06; 95% confidence interval, 1.02-1.10; P = .004)., Conclusions: Results from this multicenter, randomized controlled trial underscore the importance of a high-quality examination and efforts required to achieve this with an incremental yield in ADR based on withdrawal time. (Clinical trial registration number: NCT03952611.)., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: ORISE (Boston Scientific, Marlborough, Mass, USA) is a viscous gel used for submucosal injection. We noted anecdotally that ORISE is associated with submucosal distortion of EMR scars at follow-up., Methods: We blindly reviewed photographs of 30 consecutive EMR scars at follow-up after resections using ORISE and 30 resections using other agents. Distortion was scored on a scale of 0 (no submucosal distortion) to 5 (overt submucosal distortion)., Results: The median submucosal distortion score at follow-up in ORISE cases was 3 (range, 0-5) versus 0 (range, 0-2) with other fluids (P < .001, Mann-Whitney U test) by 1 reviewer and 3 (range, 0-5) versus 2 (range, 0-5), respectively, by a second reviewer (P = .018). The kappa value for agreement in the submucosal distortion scores between the 2 experts was .148 for all photographs and .214 for the ORISE cases (overall minimal agreement)., Conclusions: ORISE can cause submucosal distortion in the region of EMR scars when they are viewed at follow-up. Such distortions must not be mistaken for submucosal tumor growth., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Outcomes after peroral endoscopic myotomy (POEM) are assessed clinically by the Eckardt score (ES) or objectively by high-resolution manometry (HRM) and functional lumen imaging probe (FLIP). This study compared HRM and FLIP to evaluate clinical response after POEM., Methods: This was a single tertiary center retrospective study of consecutive patients who underwent POEM for treatment-naive achalasia and with ≥6 months of follow-up. Baseline and follow-up testing in all patients included ES, HRM, and FLIP of the esophagogastric junction (EGJ). A normal post-POEM (or normalized) EGJ distensibility index (EGJ-DI) >2.8 mm 2 /mm Hg, maximum EGJ diameter (MxEGJD) ≥14 mm, and integrated relaxation pressure (IRP) <15 mm Hg were compared with a clinical response, defined as ES ≤3., Results: Eighty-seven patients (58% men, mean age 51 ± 17 years) were included. Overall clinical response by ES, IRP, MxEGJD, and EGJ-DI were 97.7%, 86.2%, 75.9%, and 92.0%, respectively. The sensitivity of a normal IRP (87.1% [95% confidence interval {CI}, 78.0-93.4]) was similar to the sensitivity of a normal MxEGJD (75.3% [95% CI, 64.7-84.0], P = .053) and normal EGJ-DI (91.8% [95% CI, 83.8%-96.6%], P = .39) after POEM to predict clinical response. However, the sensitivity of a normal post-POEM EGJ-DI was superior to a normal post-POEM MxEGJD (P = .001) to predict clinical response. There was no difference in the area under the curve of a normal MxEGJD or EGJ-DI to predict a normal IRP (P = .956) after POEM., Conclusions: Normal FLIP metrics ≥6 months after POEM for achalasia show good to excellent sensitivity but are equivalent to a normalized IRP by HRM to predict clinical response by ESs. FLIP may be used as an alternative to HRM to assess lower esophageal sphincter response to POEM in these patients. (Clinical trial registration number: NCT02770859.)., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: EUS and endoscopic pancreatic function tests (ePFTs) may be used to diagnose minimal-change chronic pancreatitis (MCCP). The impact of evaluation for exocrine pancreatic insufficiency (EPI) and real-time assessment of EUS changes after intravenous secretin on the clinical diagnosis of MCCP is unknown., Methods: Patients with suspected MCCP underwent baseline EUS assessment of the pancreatic parenchyma and measurement of the main pancreatic duct (B-MPD) in the head, body, and tail. Human secretin 0.2 μg/kg was given intravenously followed 4, 8, and 12 minutes later by repeat MPD (S-MPD) measurements. Duodenal samples at 15, 30, and 45 minutes were aspirated to assess bicarbonate concentration. Endoscopists rated the percentage clinical likelihood of chronic pancreatitis (1) before secretin; (2) after secretin but before aspiration; and (3) after bicarbonate results., Results: A total of 145 consecutive patients (mean age, 44±13 years; 98 females) were diagnosed with EPI (n = 32; 22%) or normal exocrine pancreatic function (n = 131, 78%). S-MPD/B-MPD ratios in the tail 4 and 8 minutes after secretin were higher in the group with normal exocrine function. Ratios at other times, locations, and duodenal fluid volumes were similar between the 2 groups. A statistically significant change in the median percentage likelihood of chronic pancreatitis was noted after secretin in all groups. The sensitivity and specificity of EPI for the EUS diagnosis of chronic pancreatitis (≥5 criteria) were 23.4% (95% confidence interval, 12.3-38.0) and 78.6% (95% confidence interval, 69.1-86.2), respectively., Conclusion: Real-time EUS findings and ePFTs have a significant impact on the clinical assessment of MCCP. The diagnosis of EPI shows poor correlation with the EUS diagnosis of MCCP. (Clinical trial registration number: NCT01997476.)., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Previous studies have validated EUS-guided needle-based confocal laser endomicroscopy (nCLE) diagnosis of intraductal papillary mucinous neoplasms (IPMNs). We sought to derive EUS-guided nCLE criteria for differentiating IPMNs with high-grade dysplasia/adenocarcinoma (HGD-Ca) from those with low/intermediate-grade dysplasia (LGD)., Methods: We performed a post hoc analysis of consecutive IPMNs with a definitive diagnosis from a prospective study evaluating EUS-guided nCLE in the diagnosis of pancreatic cysts. Three internal endosonographers reviewed all nCLE videos for the patients and identified potential discriminatory EUS-guided nCLE variables to differentiate HGD-Ca from LGD IPMNs (phase 1). Next, an interobserver agreement (IOA) analysis of variables from phase 1 was performed among 6 blinded external nCLE experts (phase 2). Last, 7 blinded nCLE-naïve observers underwent training and quantified variables with the highest IOA from phase 2 using dedicated software (phase 3)., Results: Among 26 IPMNs (HGD-Ca in 16), the reference standard was surgical histopathology in 24 and cytology confirmation of metastatic liver lesions in 2 patients. EUS-guided nCLE characteristics of increased papillary epithelial "width" and "darkness" were the most sensitive variables (90%; 95% confidence interval [CI], 84%-94% and 91%; 95% CI, 85%-95%, respectively) and accurate (85%; 95% CI, 78%-90% and 84%; 95% CI, 77%-89%, respectively) with substantial (κ = 0.61; 95% CI, 0.51-0.71) and moderate (κ = 0.55; 95% CI, 0.45-0.65) IOAs for detecting HGD-Ca, respectively (phase 2). Logistic regression models were fit for the outcome of HGD-Ca as predictor variables (phase 3). For papillary width (cut-off ≥50 μm), the sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for detection of HGD-Ca were 87.5% (95% CI, 62%-99%), 100% (95% CI, 69%-100%), and 0.95, respectively. For papillary darkness (cut-off ≤90 pixel intensity), the sensitivity, specificity, and AUC for detection of HGD-Ca were 87.5% (95% CI, 62%-99%), 100% (95% CI, 69%-100%), and 0.90, respectively., Conclusions: In this derivation study, quantification of papillary epithelial width and darkness identified HGD-Ca in IPMNs with high accuracy. These quantifiable variables can be used in multicenter studies for risk stratification of IPMNs. (Clinical trial registration number: NCT02516488.)., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Devices for flattening colon folds can improve polyp detection at colonoscopy. However, there are few data on the endoscopic ring-fitted cap (EndoRings; EndoAid, Caesarea, Israel). We sought to compare adenoma detection with EndoRings with that of standard high-definition colonoscopy., Methods: This was a single-center, randomized controlled trial of 562 patients (284 randomized to EndoRings and 278 to standard colonoscopy) at 2 outpatient endoscopy units in the Indiana University Hospital system. Adenoma detection was the primary outcome measured as adenoma detection rate (ADR) and adenomas per colonoscopy (APC). We also compared sessile serrated polyp detection rate, insertion times, withdrawal times, and ease of passage through the sigmoid colon., Results: EndoRings was superior to standard colonoscopy in terms of APC (1.46 vs 1.06, P = .025), but there were no statistically significant differences in ADR or sessile serrated polyp detection rate. Mean withdrawal time (in patients with no polyps) was shorter and insertion time (all patients) was longer in the EndoRings arm by 1.8 minutes and 0.75 minutes, respectively. One provider had significantly higher detection with Endo-Rings and contributed substantially to the overall results., Conclusions: EndoRings can increase adenoma detection without a significant increase in procedure time, but the effect varies between operators. The use of EndoRings slows colonoscope insertion. (Clinical trial registration number: NCT03418662.)., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Colonoscopy is the most commonly performed endoscopic procedure and overall is considered a low-risk procedure. However, adverse events (AEs) related to this routinely performed procedure for screening, diagnostic, or therapeutic purposes are an important clinical consideration. The purpose of this document from the American Society for Gastrointestinal Endoscopy's Standards of Practice Committee is to provide an update on estimates of AEs related to colonoscopy in an evidence-based fashion. A systematic review and meta-analysis of population-based studies was conducted for the 3 most common and important serious AEs (bleeding, perforation, and mortality). In addition, this document includes an updated systematic review and meta-analysis of serious AEs (bleeding and perforation) related to EMR and endoscopic submucosal dissection for large colon polyps. Finally, a narrative review of other colonoscopy-related serious AEs and those related to specific colonic interventions is included., (Copyright © 2019. Published by Elsevier Inc.)

Background and Aims: Endocuff (Arc Medical Design, Leeds, UK) and Endocuff Vision (Arc Medical Design, Leeds, UK) are effective mucosal exposure devices for improving polyp detection during colonoscopy. AmplifEYE (Medivators Inc, Minneapolis, Minn, USA) is a device that appears similar to the Endocuff devices but has received minimal clinical testing., Methods: We performed a randomized controlled clinical trial using a noninferiority design to compare Endocuff Vision with AmplifEYE., Results: The primary endpoint of adenomas per colonoscopy was similar in AmplifEYE at 1.63 (standard deviation 2.83) versus 1.51 (2.29) with Endocuff Vision (P = .535). The 95% lower confidence limit was 0.88 for ratio of means, establishing noninferiority of AmplifEYE (P = .008). There was no difference between the arms for mean insertion time, and mean inspection time (withdrawal time minus polypectomy time and time for washing and suctioning) was shorter with AmplifEYE (6.8 minutes vs 6.9 minutes, P = .042)., Conclusions: AmplifEYE is noninferior to Endocuff Vision for adenoma detection. The decision on which device to use can be based on cost. Additional comparisons of AmplifEYE with Endocuff by other investigators are warranted. (Clinical trial registration number: NCT03560128.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration. A SEMS with a tricuspid antireflux valve (SEMS-V) was designed to address this issue. The aim of this study was to evaluate the efficacy and safety of this stent., Methods: A phase III, multicenter, prospective, noninferiority, randomized controlled trial was conducted on patients with malignant dysphagia requiring SEMSs to be placed across the GEJ. Patients were randomized to receive SEMSs with no valve (SEMS-NV) or SEMS-V. Postdeployment dysphagia score at 2 weeks and Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire score at 4 weeks were measured. Patients were followed for 24 weeks., Results: Sixty patients were randomized (SEMS-NV: 30 patients, mean age 67 ± 13 years; SEMS-V: 30 patients, mean age 65 ± 12 years). Baseline dysphagia scores (SEMS-NV, 2.5 ± .8; SEMS-V, 2.5 ± .8) and GERD-HRQL scores (SEMS-NV, 11.1 ± 8.2; SEMS-V, 12.8 ± 8.3) were similar. All SEMSs were successfully deployed. A similar proportion of patients in both arms improved from advanced dysphagia to moderate to no dysphagia (SEMS-NV, 71%; SEMS-V, 74%; 95% confidence interval, 1.93 [-17.8 to 21.7]). The dysphagia scores were also similar across all follow-up time points. Mean GERD-HRQL scores improved by 7.4 ± 10.2 points in the SEMS-V arm and by 5.2 ± 8.3 in the SEMS-NV group (P = .96). The GERD-HRQL scores were similar across all follow-up time points. Aspiration pneumonia occurred in 3.3% in the SEMS-NV arm and 6.9% in the SEMS-V arm (P = .61). Migration rates were similar (SEMS-NV, 33%; SEMS-V, 48%; P = .29). Two SEMS-V spontaneously fractured. There was no perforation, food impaction, or stent-related death in either group., Conclusions: The SEMS-V was equally effective in relieving dysphagia as compared with the SEMS-NV. Presence of the valve did not increase the risks of adverse events. GERD symptom scores were similar between the 2 stents, implying either that the valve was not effective or that all patients on proton pump inhibitors could have masked the symptoms of GERD. Studies with objective evaluations such as fluoroscopy and/or pH/impedance are recommended. (Clinical trial registration number: NCT02159898.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Locally advanced pancreatic cancer (LAPC) has a poor prognosis. There are limited data describing the use of photodynamic therapy (PDT) for pancreatic cancer in humans. We hypothesized that EUS-guided PDT for LAPC is safe, technically feasible, and produces a dose- and time-dependent increasing degree of image-defined tumor necrosis., Methods: In a single-center, prospective, dose-escalation phase 1 study, patients with treatment-naïve LAPC received intravenous porfimer sodium (Concordia Laboratories Inc, St Michael, Barbados) followed 2 days later by EUS-PDT. EUS-PDT was performed by puncture with a 19-gauge needle and insertion of a 1.0-cm light diffuser (Pioneer Optics, Bloomfield, Conn) and illumination with a 630-nm light (Diomed Inc, Andover, Mass). A CT scan 18 days after PDT was done to assess for change in pancreatic necrosis. Nab-paclitaxel (125 mg/ m 2 intravenously) and gemcitabine (1000 mg /m 2 intravenously) were initiated 7 days after CT and given weekly for 3 of 4 weeks (1 cycle) until disease progression or unacceptable toxicity., Results: Twelve patients (mean age, 67 ± 6 years; 8 male) with tumors (mean diameter, 45.2 ± 12.9 mm) in the head and/or neck (8) or body and/or tail (4) underwent EUS-PDT. Compared with baseline imaging, increased volume and percentage of tumor necrosis were observed in 6 of 12 patients (50%) after EUS-PDT. The mean overall increases in volume and percentage necrosis were 10 ± 26 cm 3 (P = .20) and 18% ± 22% (P = .016), respectively. After a median follow-up of 10.5 months (range, 1.0-37.4 months), median progression-free (PFS) and overall survival (OS) were 2.6 months (95% confidence interval, 0.7, not estimable) and 11.5 months (95% confidence interval, 1.1, 16.9), respectively. Surgical resection was attempted in 2 patients, and pathology showed a complete response (n = 1) and residual 2-mm tumor (n = 1). There were 8 serious adverse events and none related to EUS or EUS-PDT., Conclusion: EUS-PDT for LAPC appears to be safe and produces measurable imaged-defined tumor necrosis. Phase 2 studies are warranted. (Clinical trial registration number: NCT01770132.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Endoscopic suturing of fully covered self-expanding metal stents (FC-SEMSs) may prevent migration. The aim of this study was to compare rates of migration between sutured FC-SEMSs (S-FCSEMSs), unsecured FC-SEMSs, and partially covered SEMSs (PC-SEMSs) placed for benign esophageal leaks and strictures., Methods: In a retrospective, single-center, cohort study, rates of migration for S-FCSEMSs, FC-SEMSs, and PC-SEMSs were assessed in patients with at least 1 month of follow-up or experiencing clinically significant stent migration (CSSM) any time after placement. CSSM was defined as proximal or distal displacement of the stent by ≥2 cm or passage into the stomach plus the recurrence of pre-SEMS symptoms or signs. A multivariable analysis was done to identify additional risk factors for stent migration., Results: A total of 184 SEMSs were placed in 101 patients, including 32 S-FCSEMSs in 25 patients, 114 FC-SEMSs in 59 patients, and 38 PC-SEMSs in 30 patients. CSSM occurred with 56 of 184 stents (30.4%) in 36 of 101 patients (35.6%), including 3 of 32 (9.4%) S-FCSEMSs, 45 of 114 (39.5%) FC-SEMSs, and 8 of 38 (21.1%) PC-SEMSs (P = .005). Migration was less likely for S-FCSEMSs than for FC-SEMSs (9.4% vs 39.5%; P = .01) but not between S-FCSEMSs and PC-SEMSs (9.4% vs 21.1%; P = .07) or between FC-SEMSs and PC-SEMSs (39.5% vs 21.1%; P = .38). Previous stent migration (odds ratio [OR], 3.93; 95% confidence interval [CI], 1.88-8.19; P = .01) and previous esophageal surgery (OR, 0.33; 95% CI, 0.16-0.67; P = .002) were associated with increased and decreased risk of CSSM, respectively., Conclusions: Endoscopic suturing of FC-SEMSs for benign esophageal disease reduces CSSM compared with unsecured FC-SEMSs but not PC-SEMSs. Patients with previous stent migration may benefit from prophylactic suturing of FC-SEMSs., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. All rights reserved.)

Background and Aims: EUS-guided needle-based confocal laser endomicroscopy (nCLE) characteristics of common types of pancreatic cystic lesions (PCLs) have been identified; however, surgical histopathology was available in a minority of cases. We sought to assess the performance characteristics of EUS nCLE for differentiating mucinous from non-mucinous PCLs in a larger series of patients with a definitive diagnosis., Methods: Six endosonographers (nCLE experience >30 cases each) blinded to all clinical data, reviewed nCLE images of PCLs from 29 patients with surgical (n = 23) or clinical (n = 6) correlation. After 2 weeks, the assessors reviewed the same images in a different sequence. A tutorial on available and novel nCLE image patterns was provided before each review. The performance characteristics of nCLE and the κ statistic for interobserver agreement (IOA, 95% confidence interval [CI]), and intraobserver reliability (IOR, mean ± standard deviation [SD]) for identification of nCLE image patterns were calculated. Landis and Koch interpretation of κ values was used., Results: A total of 29 (16 mucinous PCLs, 13 non-mucinous PCLs) nCLE patient videos were reviewed. The overall sensitivity, specificity, and accuracy for the diagnosis of mucinous PCLs were 95%, 94%, and 95%, respectively. The IOA and IOR (mean ± SD) were κ = 0.81 (almost perfect); 95% CI, 0.71-0.90; and κ = 0.86 ± 0.11 (almost perfect), respectively. The overall specificity, sensitivity, and accuracy for the diagnosis of serous cystadenomas (SCAs) were 99%, 98%, and 98%, respectively. The IOA and IOR (mean ± SD) for recognizing the characteristic image pattern of SCA were κ = 0.83 (almost perfect); 95% CI, 0.73-0.92; and κ = 0.85 ± 0.11 (almost perfect), respectively., Conclusions: EUS-guided nCLE can provide virtual histology of PCLs with a high degree of accuracy and inter- and intraobserver agreement in differentiating mucinous versus non-mucinous PCLs. These preliminary results support larger multicenter studies to evaluate EUS nCLE. (Clinical trial registration number: NCT02516488.)., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: OncoGel (Protherics Salt Lake City, Inc, Salt Lake City, UT) is paclitaxel (PTX) formulated in a thermosensitive, biodegradable copolymer for focused cytotoxicity and radiosensitization. A phase 2a study suggested that EUS-guided PTX injection into esophageal tumors subsequently receiving radiotherapy was safe., Methods: In an international multicenter, prospective, randomized phase 2b study, patients with local or locoregional adenocarcinoma or squamous cell carcinoma (SCC) of the esophagus/gastroesophageal junction and eligible for neoadjuvant chemoradiotherapy (CRT) before surgery were randomized to standard of care (SOC) plus EUS-guided PTX injection or SOC alone. PTX was injected in 0.5 to 1.0 mL aliquots throughout the tumor. Planned CRT as SOC was intravenous 5-fluorouracil for the first 4 days (weeks 1 and 5), intravenous cisplatin on the first day of each 5-fluorouracil course, and radiotherapy over 5.5 weeks. Patients were evaluated weekly during CRT and re-evaluated at 12 weeks for surgical eligibility and CT for change in overall tumor volume., Results: The analysis included 137 patients (97 males; mean age, 58 ± 9.1 years) randomized to PTX + SOC (n = 72) and SOC (n = 65) by using a modified intention-to-treat approach. Overall response by tumor volume between the PTX (12.5%) and the SOC group (20.0%; P = .24; odds ratio, 0.57; 95% confidence interval, 0.23-1.44) was similar. Pathologic complete response was higher in the SOC group (26.2% vs 12.5%; P = .046); however, 12-month survival (P = .412) and the overall frequency of 1 or more adverse events (P = .17) were similar between the 2 groups., Conclusions: SOC + PTX is safe but does not improve overall survival or overall tumor response at the primary tumor site for patients with local or locoregional cancer of the esophagus/gastroesophageal junction. (Clinical trial registration number: NCT00573131.)., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Management of branch-duct intraductal papillary mucinous neoplasms (BD-IPMNs) remains challenging. We determined factors associated with malignancy in BD-IPMNs and long-term outcomes., Methods: This retrospective cohort study included all patients with established BD-IPMNs by the International Consensus Guidelines (ICG) 2012 and/or pathologically confirmed BD-IPMNs in a tertiary care referral center between 2001 and 2013. Main outcome measures were the association between high-risk stigmata (HRS)/worrisome features (WFs) of the ICG 2012 and malignant BD-IPMNs, performance characteristics of EUS-FNA for the diagnosis of malignant BD-IPMNs, and recurrence and long-term outcomes of BD-IPMN patients undergoing surgery or imaging surveillance., Results: Of 364 BD-IPMN patients, 229 underwent imaging surveillance and 135 underwent surgery. Among the 135 resected BD-IPMNs, HRS/WFs on CT/magnetic resonance imaging (MRI) were similar between the benign and malignant groups, but main pancreatic duct (MPD) dilation (5-9 mm) was more frequently identified in malignant lesions. On EUS-FNA, mural nodules, MPD features suspicious for involvement, and suspicious/positive malignant cytology were more frequently detected in the malignant group with a sensitivity, specificity, and accuracy of 33%, 94%, and 86%; 42%, 91%, and 83%; and 33% 91%, and 82%, respectively. Mural nodules identified by EUS were missed by CT/MRI in 28% in the malignant group. Patients with malignant lesions had a higher risk of any IPMN recurrence during a mean follow-up period of 131 months (P = .01)., Conclusions: Among HRS and WFs of the ICG 2012, an MPD size of 5 to 9 mm on CT/MRI was associated with malignant BD-IPMNs. EUS features including mural nodules, MPD features suspicious for involvement, and suspicious/malignant cytology were accurate and highly specific for malignant BD-IPMNs. Our study highlights the incremental value of EUS-FNA over imaging in identifying malignant BD-IPMNs, particularly in patients without WFs and those with smaller cysts. Benign IPMN recurrence was observed in some patients up to 8 years after resection., (Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: EUS-guided biopsy of the liver has a variable diagnostic accuracy and specimen adequacy. A new core biopsy needle has been developed that may improve performance. The objective of this study was to compare the diagnostic yield of a new core biopsy needle with the previous standard needle., Methods: In this cross-sectional study, consecutive patients who underwent EUS-guided core liver biopsy over a 7-year period for suspected parenchymal disease were prospectively evaluated. Between 2007 and 2011, all biopsies were performed with a 19-gauge Tru-cut biopsy needle (Quick-core [QC]), whereas a novel reverse bevel needle (PC) was used exclusively from 2011 to 2014. All specimens were examined by 1 of 3 experienced, blinded pathologists for the following: presence of visible core, aggregate specimen length, number of complete portal tracts, and specimen adequacy., Results: A total of 75 patients (mean age 51 years, 51 female) underwent liver biopsy by using the QC (n = 45) or PC (n = 30) needle. The QC and PC groups had similar demographics, indications for EUS, indications for liver biopsy, and liver findings on EUS. Compared with those of the QC, biopsies with the PC required fewer passes (median 2 vs 3; P < .0001) but produced longer aggregate length (median 20 mm vs 9 mm; P < .0001) with more complete portal tracts (median 5 vs 2; P = .0003) and adequate specimens (P < .01). Two patients had abdominal pain after liver biopsy with the QC needle., Conclusions: Compared with the QC needle, EUS-guided core liver biopsy with the PC needle produced longer aggregate length, more complete portal tracts, and more adequate specimens despite fewer passes (Clinical trial registration number: NCT00586313.)., (Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Detection of hepatic metastases during EUS is an important component of tumor staging., Objective: To describe our experience with EUS-guided FNA (EUS-FNA) of solid hepatic masses and derive and validate criteria to help distinguish between benign and malignant hepatic masses., Design: Retrospective study, survey., Setting: Single, tertiary-care referral center., Patients: Medical records were reviewed for all patients undergoing EUS-FNA of solid hepatic masses over a 12-year period., Interventions: EUS-FNA of solid hepatic masses., Main Outcome Measurements: Masses were deemed benign or malignant according to predetermined criteria. EUS images from 200 patients were used to create derivation and validation cohorts of 100 cases each, matched by cytopathologic diagnosis. Ten expert endosonographers blindly rated 15 initial endosonographic features of each of the 100 images in the derivation cohort. These data were used to derive an EUS scoring system that was then validated by using the validation cohort by the expert endosonographer with the highest diagnostic accuracy., Results: A total of 332 patients underwent EUS-FNA of a hepatic mass. Interobserver agreement regarding the initial endosonographic features among the expert endosonographers was fair to moderate, with a mean diagnostic accuracy of 73% (standard deviation 5.6). A scoring system incorporating 7 EUS features was developed to distinguish benign from malignant hepatic masses by using the derivation cohort with an area under the receiver operating curve (AUC) of 0.92; when applied to the validation cohort, performance was similar (AUC 0.86). The combined positive predictive value of both cohorts was 88%., Limitations: Single center, retrospective, only one expert endosonographer deriving and validating the EUS criteria., Conclusion: An EUS scoring system was developed that helps distinguish benign from malignant hepatic masses. Further study is required to determine the impact of these EUS criteria among endosonographers of all experience., (Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: The accuracy of EUS in the locoregional assessment of ampullary lesions is unclear., Objectives: To compare EUS with ERCP and surgical pathology for the evaluation of intraductal extension and local staging of ampullary lesions., Design: Retrospective cohort study., Setting: Tertiary-care referral center., Patients: All patients who underwent EUS primarily for the evaluation of an ampullary lesion between 1998 and 2012., Intervention: EUS., Main Outcome Measurements: Comparison of EUS sensitivity/specificity for intraductal and local extension with ERCP and surgical pathology by using the area under the receiver-operating characteristic (AUROC) curves and outcomes of the subgroup referred for endoscopic papillectomy., Results: We identified 119 patients who underwent EUS for an ampullary lesion, of whom 99 (83%) had an adenoma or adenocarcinoma. Compared with ERCP (n = 90), the sensitivity/specificity of EUS for any intraductal extension was 56%/97% (AUROC = 0.77; 95% confidence interval [CI], 0.64-0.89). However, when using surgical pathology as the reference (n = 102), the sensitivity/specificity of EUS (80%/93%; AUROC = 0.87; 95% CI, 0.76-0.97) and ERCP (83%/93%; AUROC = 0.88; 95% CI, 0.77-0.99) were comparable. The overall accuracy of EUS for local staging was 90%. Of 58 patients referred for endoscopic papillectomy, complete resection was achieved in 53 (91%); in those having intraductal extension by EUS or ERCP, complete resection was achieved in 4 of 5 (80%) and 4 of 7 (57%), respectively., Limitation: Retrospective design., Conclusions: EUS and ERCP perform similarly in evaluating intraductal extension of ampullary adenomas. Additionally, EUS is accurate in T-staging ampullary adenocarcinomas. Future prospective studies should evaluate whether EUS can identify characteristics of ampullary lesions that appropriately direct patients to endoscopic or surgical resection., (Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

We recommend that uncomplicated GERD be diagnosed on the basis of typical symptoms without the use of diagnostic testing, including EGD. We recommend EGD for patients who have symptoms suggesting complicated GERD or alarm symptoms. We recommend that EGD not be routinely performed solely for the assessment of extraesophageal GERD symptoms. We recommend that endoscopic findings of reflux esophagitis be classified according to an accepted grading scale or described in detail. We suggest that repeat EGD be performed in patients with severe erosive esophagitis after at least an 8-week course of PPI therapy to exclude underlying BE or dysplasia. 44BB We recommend against obtaining tissue samples from endoscopically normal tissue to diagnose GERD or exclude BE in adults. We suggest that endoscopy be considered in patients with multiple risk factors for Barrett’s esophagus. We recommend that tissue samples be obtained to confirm endoscopically suspected Barrett’s esophagus. We suggest that endoscopic antireflux therapy be considered for selected patients with uncomplicated GERD after careful discussion with the patient regarding potential adverse effects, benefits, and other available therapeutic options.

OAE is commonly used. The majority of patients referred for OAE are considered appropriate for endoscopy according to ASGE guidelines. Most patients undergoing OAE procedures are knowledgeable about the study and are satisfied with the experience. Several potential problems have been identified, including inappropriate referrals, communication errors, and inadequately prepared or informed patients. OAE can be safely used if preprocedure assessment, informed consent, information transfer, patient safety, and satisfaction are addressed in all cases.