Performance and Predictors of Migration of Partially and Fully Covered Esophageal Self-Expanding Metal Stents for Malignant Dysphagia.

BACKGROUND & AIMS: Self-expanding metal stents (SEMS) are routinely used to palliate malignant dysphagia. However esophageal SEMS can migrate or obstruct due to epithelial hyperplasia. The aim of this study was to evaluate the rates and factors predicting migration and obstruction, and the nutritional outcomes in partially covered (pc) vs. fully covered (fc) SEMS vs. fcSEMS with antimigration fins (AF) placed for malignant dysphagia. METHODS: A retrospective review of consecutive patients undergoing SEMS placement for malignant dysphagia at three academic medical centers. RESULTS: Among 357 patients, there were 55 (15.4%) stent migrations, 45 (12.6%) obstructions from epithelial hyperplasia, and 20 (5.6%) food impactions. Median overall survival was 79 days (IQR 41,199). The percent weight change/change in albumin at 30 and 60 days after SEMS placement were -2.24%/-0.544 g/dL and -2.98%/-0.55 g/dL, respectively. Stent migration occurred significantly more often with fcSEMS than pcSEMS (25.3% vs 10.9%; P < .003), but there was no difference when either group was compared to fcSEMS-AF (19.3%). The overall rate of epithelial hyperplasia resulting in stent obstruction was low (12.6%) and not different between stent types. Factors associated with increased risk of SEMS migration on multivariable logistic regression included stricture traversability with a diagnostic endoscope (OR, 2.37; 95% CI, 1.29-4.35) and use of fcSEMS (OR, 2.56; 1.31-5.00) or fcSEMS-AF (OR, 2.30, 1.03-5.14). CONCLUSIONS: Traversability of a malignant esophageal stenosis predicts SEMS migration. In these patients with a limited overall survival, pcSEMS are associated with lower rates of stent migration and similar rates of obstruction compared to fcSEMS.

Tacrolimus and Indomethacin Are Safe and Effective at Reducing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography in Patients Who Have Undergone Liver Transplantation.

BACKGROUND & AIMS: Biliary complications occur in up to 25% of patient following liver transplantation and are often managed by endoscopic retrograde cholangiopancreatography (ERCP). Pancreatitis is the most common adverse event after ERCP (PEP). Tacrolimus and rectal indomethacin have each been reported to reduce risk of PEP. We investigated the incidence of PEP in patients who have undergone ERCP after liver transplantation and the effectiveness of tacrolimus and/or indomethacin in reducing risk of PEP. METHODS: We performed a retrospective study of 337 patients who underwent ERCP (n = 937 procedures) for biliary complications after liver transplantation from June 1, 2007 through December 1, 2015. After June 1, 2012, rectal indomethacin (100 mg) was routinely administered at the conclusion of the ERCP unless patients had contraindications. Indomethacin was given after 286 ERCP procedures. After excluding patients with acute/chronic rejection, 323 patients were maintained on a stable dose of tacrolimus prior to ERCP (901 procedures). We collected data on demographic and clinical variables, pre-procedural tacrolimus trough levels, and development of PEP. We calculated adjusted odds ratios (ORs) for the association between tacrolimus and indomethacin use and risk of PEP using mixed-effects multivariable logistic regression. The primary outcome was development of PEP; secondary outcomes included the development moderate-to-severe PEP, cholangitis and bleeding. RESULTS: PEP occurred after 2.2% of ERCP procedures. A trough level of tacrolimus above 2.5 ng/mL was associated with 79% lower odds of PEP (OR, 0.21; 95% CI, 0.06-0.72; P = .01). Indomethacin was associated with a 91% reduction in risk of PEP (OR, 0.09; 95% CI, 0.01-0.85; P = .03). Indomethacin use did not affect rates of bleeding or cholangitis or decrease in glomerular filtration rate. In patients with trough levels of tacrolimus above 2.5 ng/mL, addition of indomethacin reduced the odds of PEP by 93% compared with patients who were unexposed to indomethacin. (OR, 0.07; 95% CI, 0.01-0.90; P = .04). CONCLUSIONS: In a retrospective study of patients who underwent ERCP for biliary complications after liver transplantation, we found trough levels of tacrolimus above 2.5 ng/mL to significantly reduce risk for PEP. Rectal administration of indomethacin after ERCP significantly decreased rates of pancreatitis, and reduced risk further in patients given tacrolimus. Administration of both drugs prevented patients from developing moderate or severe pancreatitis. Indomethacin did not worsen renal function in patients with chronic kidney disease.

Incidence and risk factors of advanced neoplasia after endoscopic mucosal resection of colonic laterally spreading lesions.

PURPOSE: To investigate advanced neoplasia (AN) after endoscopic mucosal resection (EMR) of colonic laterally spreading lesions (LSLs). METHODS: A retrospective study of patients who underwent injection-assisted EMR of colonic LSLs ≥ 10 mm was performed. Primary outcome was overall rate of AN at initial surveillance colonoscopy. Secondary outcomes were the rates of residual AN (rAN) at the EMR site and metachronous AN (mAN), and analysis of risk factors for AN, including effect of surveillance guidance. RESULTS: Three hundred seventy-four patients underwent successful EMR for 388 LSLs. AN occurred in 66/374 (17.6%) patients on initial surveillance colonoscopy at median follow-up of 364.5 days. Two patients had both rAN and mAN, for a total of 68 instances of AN, including 30/374 (8.0%) cases of rAN and 38/374 (10.2%) cases of mAN. On multivariate analysis, use of piecemeal resection was associated with increased likelihood of residual AN (P = 0.003, OR 9.2, 95% CI 2.1-33.3). Twenty-nine out of thirty cases (96.7%) of rAN were successfully endoscopically managed at surveillance colonoscopy. CONCLUSIONS: AN occurred in 17.6% of all patients at initial surveillance colonoscopy at a median of 1 year after EMR. Roughly half of the instances of AN were metachronous lesions. Our data support a 1-year surveillance interval after EMR of LSLs ≥ 10 mm with careful inspection of the entire colon, not just the prior resection site.

En bloc endoscopic mucosal resection is equally effective for sessile serrated polyps and conventional adenomas.

BACKGROUND: Sessile serrated polyps (SSPs) are associated with higher rates of incomplete resection compared to conventional adenomas after traditional snare polypectomy. Outcomes after endoscopic mucosal resection (EMR) are less established. The aim of this study was to evaluate the rate of residual neoplasia at surveillance colonoscopy for SSPs compared to conventional adenomas ≥ 10 mm after en bloc EMR. METHODS: Retrospective cohort study of consecutive patients referred for EMR of a colonic lesion ≥ 10 mm from 2005 to 2013. Data on procedures, histopathology, and surveillance colonoscopies were recorded. The primary outcome was rate of macroscopically evident residual neoplasia at surveillance colonoscopy for SSPs compared to adenomas. Secondary outcomes included rate of neoplasia at the resection margin. RESULTS: 283 consecutive patients with 293 polyps underwent en bloc EMR including 101 SSPs and 192 adenomas. Pathology commented on the lateral resection margins of the specimen in 235 cases (80%). Of these, neoplasia was noted at the resection margin in 29/64 SSPs (45.3%) compared to 65/171 adenomas (38.0%; P = .37). Surveillance data were available for 153 index lesions with a median interval of 13 months (interquartile range, 10.75-23.25 months). Ten resection sites (6.5%) were found to have residual neoplasia, including 2/52 SSPs (3.8%) and 8/101 adenomas (7.9%; P = .50). Of the cases with surveillance data 128/153 (84%) commented on the lateral margin of the resection specimen. Residual neoplasia was noted in 3/68 lesions (4.4%) with negative margins compared to 5/60 lesions (8.3%) with positive margins (P = .47). CONCLUSIONS: En bloc EMR for colonic lesions ≥ 10 mm is associated with a 6.5% rate of macroscopic residual neoplasia. Although 45% of SSPs had neoplasia extending to the resection margin, rates of residual neoplasia at surveillance colonoscopy were low. These results suggest that when feasible en bloc EMR is a reasonable option to resect SSPs ≥ 10 mm.

Therapeutic Endoscopy for the Control of Nonvariceal Upper Gastrointestinal Bleeding in Children: A Case Series.

OBJECTIVES: Gastrointestinal bleeding is one of the most common indications for urgent endoscopy in the pediatric setting. The majority of these procedures are performed for control of variceal bleeding, with few performed for nonvariceal upper gastrointestinal (NVUGI) bleeding. The data on therapeutic endoscopy for NVUGI are sparse. The aims of our study were to review our experience with NVUGI bleeding, describe technical aspects and outcomes of therapeutic endoscopy, and determine gastroenterology fellows' training opportunities according to the national training guidelines. METHODS: We performed a retrospective review of endoscopy database (Endoworks, Olympus Inc, Center Valley, PA) from January 2009 to December 2014. The search used the following keywords: bleeding, hematemesis, melena, injection, epinephrine, cautery, clip, and argon plasma coagulation. The collected data included demographics, description of bleeding lesion and medical/endoscopic therapy, rate of rebleeding, relevant laboratories, physical examination, and need for transfusion and surgery. The study was approved by the institutional review board. RESULTS: During the study period 12,737 upper endoscopies (esophagogastroduodenoscopies) were performed. A total of 15 patients underwent 17 esophagogastroduodenoscopies that required therapeutic intervention to control bleeding (1:750 procedures). The mean ±â€Šstandard deviation (median) age of patients who required endoscopic intervention was 11.6 ±â€Š6.0 years (14.0 years). Seven out of 17 patients received dual therapy to control the bleeding lesions. All but 3 patients received medical therapy with intravenous proton pump inhibitor, and 3 received octreotide infusions. Six of the patients experienced rebleeding (40%), with 4 out of 6 initially only receiving single modality therapy. Two of these patients eventually required surgical intervention to control bleeding and both patients presented with bleeding duodenal ulcers. There were no cases of aspiration, perforation, or deaths. There were a total of 24 fellows trained in our program during the study period. Less than 1 therapeutic endoscopy per fellow for NVUGI bleeding was performed. CONCLUSIONS: NVUGI bleeding requiring therapeutic endoscopic intervention is rare in pediatrics. A high rate (40%) of rebleeding was noted with a large proportion (66%) of patients receiving single modality therapy. Two patients required surgical intervention to control bleeding and both presented with bleeding duodenal ulcers. An insufficient number of therapeutic procedures is available for adequate fellow training requiring supplemental simulator and hands-on animal model, or adult endoscopy unit training.

Endoscopic Therapy is Effective for Recurrent Anastomotic Biliary Strictures after Orthotopic Liver Transplantation.

INTRODUCTION: Orthotopic liver transplantation anastomotic biliary strictures (OLT ABS) are managed with endoscopic biliary stent therapy but the recurrence rate is substantial. Our aims were to retrospectively determine the recurrence rates of OLT ABS after initial successful stent therapy, characterize the management of recurrences and identify associated variables. MATERIALS AND METHODS: Clinical data from 943 patients receiving non-living donor OLT at our institution from 2005-2012 were reviewed, and 123 OLT ABS patients receiving stent therapy were identified. Features of their endoscopic stent therapy and other pertinent clinical information were evaluated. RESULTS: ABS recurred in 25.5% of patients (24/94) after an initial successful course of stent therapy. Recurrences were received a second course of endoscopic stent therapy and 67% of patients (16/24) achieved long-term remediation of ABS. Six patients underwent a third course of endoscopic stent therapy with 4 patients achieving remediation. Overall remediation rate among ABS recurrences was 83.3% (20/24). A bivariate comparison demonstrated HCV infection, age, median months of maximal stenting and a lower maximum cumulative stent diameter were risk factors for ABS recurrence. Using a Cox regression model, only HCV status proved to be a risk factor for recurrence. DISCUSSION: In conclusion repeat stent therapy achieved high stricture remediation rates. Recurrence after the first or even second course of stenting should not imply failure of endoscopic therapy. A positive HCV status may be associated with higher stricture recurrence rates and this association should be further investigated.

Chronic immunosuppression does not potentiate the malignant progression of mucinous pancreatic cystic lesions.

BACKGROUND: Premalignant mucinous pancreatic cystic lesions (mPCLs) are increasingly identified. AIMS: In this study, we aim to assess the effect of selected immunosuppressive therapies on the progression of mPCLs, including side-branch intraductal papillary mucinous neoplasms and mucinous cystic neoplasms. METHODS: We performed a retrospective cohort study of patients with mPCLs diagnosed over a 24-year period who received chronic immunosuppression. Controls were matched on age at cyst diagnosis (±11 yrs) and cyst size (±8 mm). Measured outcomes included increase in cyst size, development of "worrisome features" as defined by consensus guidelines, progression to malignancy, and rate of surgical resection. RESULTS: 39 patients (mean age 60 yrs) with mPCLs were on immunosuppression. Leading indications for immunosuppression were solid organ transplant (n = 14), inflammatory bowel disease (n = 6), and rheumatoid arthritis (n = 5). 33% were on biologics, 77% on antimetabolites and 79% on multiple medications. Mean cyst size increased from 12.6 mm to 17.8 mm over a median of 16.5 months. 6 patients elected for surgical resection, and none ultimately developed malignancy. 26 cases with follow-up were matched to control subjects, with no significant differences among cases and controls in initial cyst size (12.8 mm vs 11.9 mm, P = 0.69), mean size increase (6.9 mm vs 5 mm, P = 0.47), follow-up interval (24.3 months vs 21.5 months, P = 0.44). No significant differences in the rate of worrisome features, malignancy, or surgical resection. CONCLUSIONS: Patients with mPCLs exposed to immunosuppressive medications did not have higher rates of malignancy or development worrisome features in the short term. This suggests that patients with mPCLs can be initiated or maintained on these agents without changes to surveillance practices.

Impact and outcomes of research sponsored by the American Society for Gastrointestinal Endoscopy.

BACKGROUND AND AIMS: Since 1985, the American Society for Gastrointestinal Endoscopy (ASGE) has awarded grants for endoscopic-related research. The goals of this study were to examine trends in ASGE grant funding and to assess productivity of previous recipients of the ASGE grant awards. METHODS: This was a retrospective cohort analysis of all research grants awarded by the ASGE through 2009. Measures of academic productivity and self-assessment of the ASGE awards' impact on the recipients' careers were defined by using publicly available resources (eg, National Library of Medicine-PubMed) and administration of an electronic survey to award recipients. RESULTS: The ASGE awarded 304 grants totaling $12.5 million to 214 unique awardees. Funding increased 7.5-fold between 1985 and 1989 (mean $102,000/year) and between 2005 and 2009 (mean $771,000/year). The majority of awardees were men (83%), were at or below the level of assistant professor (82%), with a median of 3 years of postfellowship experience at the time of the award, and derived from a broad spectrum of institutions as measured by National Institutes of Health funding rank (median 26, interquartile range [IQR] 12-64). Nineteen percent had a master's degree in a research-related field. Awardees' median publications per year increased from 3.5 (IQR 1.2-9.0) before funding to 5.7 (IQR 1.8-9.5) since funding; P = .04, and median h-index scores increased from 3 (IQR 1-8) to 17 (IQR 8-26); P < .001. Multivariate analysis found that the presence of a second advanced degree (eg, masters or doctorate) was independently predictive of high productivity (odds ratio [OR] 2.92; 95% confidence interval [CI], 1.09-7.81). Among 212 unique grant recipients, 82 (40%) completed the online survey. Of the respondents, median peer-reviewed publications per year increased from 3.4 (IQR 1.9-5.5) to 4.5 (IQR 2.0-9.5); P = .17. Ninety-one percent reported that the ASGE grant had a positive or very positive impact on their careers, and 85% of respondents are currently practicing in an academic environment. Most of the grants resulted in at least 1 peer-reviewed publication (67% per Internet-based search and 81% per survey). CONCLUSIONS: The ASGE research program has grown considerably since 1985, with the majority of grants resulting in at least 1 grant-related publication. Overall academic productivity increased after the award, and the majority of awardees report a positive or very positive impact of the award on their careers. Medical professional societies are an important sponsor of clinical research.

Sendai and Fukuoka Consensus Guidelines Identify Advanced Neoplasia in Patients With Suspected Mucinous Cystic Neoplasms of the Pancreas.

BACKGROUND & AIMS: Little is known about whether the 2006 Sendai guidelines or 2012 Fukuoka guidelines are being used to determine the level of risk posed by suspected pancreatic mucinous cystic neoplasms (PCNs). We evaluated whether the guidelines accurately predicted which patients with suspected PCNs, which was based on cross-sectional imaging findings, would be found to have advanced neoplasia in surgery. METHODS: We performed a retrospective study of data collected from 194 patients with cystic lesions of the pancreas, which were assessed by cross-sectional imaging analyses, who underwent surgery for suspected PCNs at the Hospital at the University of Pennsylvania from 2000 through 2008. Imaging data were used to classify patients according to the Sendai guidelines as high risk or low risk and according to the Fukuoka guidelines as high risk, worrisome, or low risk. Pathology analyses of samples collected during surgery were used as the reference. A logistic regression model was created to identify factors associated with advanced neoplasia. The Sendai and Fukuoka guideline criteria were analyzed by univariate and multivariable logistic regression analyses. RESULTS: Advanced neoplasias were found in 36 patients (18.5%; 22 invasive cancers and 14 high-grade dysplasias). The median size of cysts was 33 mm. All patients found to have invasive cancers were accurately assigned to the Sendai guidelines high risk or Fukuoka guidelines high risk groups. However, 3 patients in the Sendai guidelines low risk and 2 patients in the Fukuoka guidelines low risk groups were found to have high-grade dysplasia. The Sendai guidelines identified patients with advanced neoplasia with 91.7% sensitivity, 21.5% specificity, 21% positive predictive value, and 91.9% negative predictive value. A designation of Fukuoka guidelines high risk identified patients with advanced neoplasia with 55.6% sensitivity, 73% specificity, 32% positive predictive value, and 87.9% negative predictive value. Overall, there was no statistically significant difference between the guidelines in predicting which patients had advanced neoplasia. On multivariate analysis, the presence of a mural nodule (odds ratio [OR], 2.88; 95% confidence interval [CI], 1.33-6.27; P = .008), dilated main pancreatic duct >10 mm (OR, 7.44; 95% CI, 2.36-23.52; P = .001), or enhancing solid component (OR, 2.92; 95% CI, 1.16-7.64; P = .02) were associated with detection of advanced neoplasia in pancreatic cysts. CONCLUSION: On the basis of a retrospective analysis, the Sendai and Fukuoka guidelines accurately determine which patients with pancreatic cysts have advanced neoplasia. The guidelines accurately recommended surgical resection for all patients found to have invasive cancer, although some patients with high-grade dysplasia were missed. The updated Fukuoka guidelines are not superior to the Sendai guidelines in identifying neoplasias. Cyst size was not associated with advanced neoplasia.

Prevalence of H. pylori and Gastric Intestinal Metaplasia in BRCA1 and BRCA2 Carriers.

BRCA1 and BRCA2 carriers may be at increased risk for gastric cancer; however, the mechanisms of gastric carcinogenesis remain poorly understood. We sought to determine the prevalence of gastric cancer risk factors Helicobacter pylori (H. pylori) infection and gastric intestinal metaplasia (GIM) among BRCA1/2 carriers to gain insight into the pathogenesis of gastric cancer in this population. A total of 100 unselected BRCA1/2 carriers who underwent endoscopic ultrasound from March 2022 to March 2023 underwent concomitant upper endoscopy with nontargeted gastric antrum and body biopsies. The study population (70% women; mean age 60.1 years) included 66% BRCA2 carriers. H. pylori was detected in one (1%) individual, 7 (7%) had GIM, 2 (2%) had autoimmune atrophic gastritis, and no gastric cancers were diagnosed. Among BRCA1/2 carriers, H. pylori prevalence was low and GIM prevalence was similar to that in the general population; however, identification of H. pylori or GIM may help inform future gastric cancer risk management strategies in BRCA1/2 carriers. Prevention Relevance: Evaluating the burden of H. pylori infection and GIM among BRCA1/2 carriers is warranted to better understand the mechanisms of gastric carcinogenesis and to help inform risk management strategies for gastric cancer among this at-risk population.

Outcomes of the IMMray PanCan-d Test in High-Risk Individuals Undergoing Pancreatic Surveillance: Pragmatic Data and Lessons Learned.

PURPOSE: An effective blood-based test for pancreatic cancer (PC) screening has remained elusive. The IMMray PanCan-d is the first commercially available blood-based test specifically designed for early detection of PC; however, outcomes from its use in clinical practice have not been reported. METHODS: We performed a blinded spike-in study of 100 individuals who had an IMMray PanCan-d test, including 94 high-risk individuals (HRIs) undergoing PC surveillance and six individuals with known PC. Specimens were processed blindly following the commercial laboratory's standardized operating procedure. Positive predictive value (PPV) and negative predictive value (NPV) were calculated. RESULTS: Cohort characteristics included a median age of 63 (IQR, 55-70) years, 57% female, 96% non-Hispanic White, 57% with a pathogenic variant in a PC risk gene (BRCA2 most commonly-18%), and 83% with a family history of PC. Among IMMray PanCan-d results from 94 HRIs undergoing PC surveillance, there was one positive (1%), seven borderlines (7%), 73 negatives (78%), and 13 tests not performed because of low CA19-9 expression (14%). No PC was diagnosed among these HRIs; however, there were two sub-cm pancreatic neuroendocrine tumors, seven clinically diagnosed side branch intraductal papillary mucinous neoplasms ≥1 cm, and a sub-cm solid mass with indeterminate cytology requiring close follow-up; all these individuals had negative IMMray PanCan-d tests. Of the six spiked-in PCs, four (67%) yielded a positive and two (33%) yielded a negative. With an estimated disease prevalence of 2%, the PPV and NPV are 52% and 99%, respectively, if borderline results are considered negative and 12% and 99%, respectively, if borderline tests are considered positive. CONCLUSION: In clinical practice, IMMray PanCan-d has a robust NPV; however, PPV is dramatically influenced by whether borderline results are characterized as a positive or negative result.

Assessment of the Psychosocial Impact of Pancreatic Cancer Surveillance in High-Risk Individuals.

OBJECTIVES: Pancreatic cancer (PC) surveillance of high-risk individuals (HRIs) downstages PC and improves survival. However, it remains less clear whether PC surveillance has a positive psychosocial impact on HRIs. Herein, we aimed to define the attitudes and beliefs of HRIs undergoing PC surveillance, and the immediate and sustained psychosocial impact of PC surveillance in HRIs. METHODS: 100 HRIs undergoing PC surveillance by endoscopic ultrasound (EUS) completed three surveys addressing different components of the psychosocial impact of PC surveillance. Logistic regression analyses were performed to identify predictive factors relating to these components. RESULTS: Most HRIs reported increased perceived benefits of PC surveillance, self-efficacy, and perceived severity of PC. HRIs reported few negative emotions prior to surveillance and frequent positive emotions after surveillance. Compared to prior to surveillance, there was a 53.5% decrease in the level of distress reported by HRIs after surveillance, which was sustained for 4-6 weeks post-surveillance. Family history of PC and lower self-reported mental health were identified as predictors for increased perceived susceptibility to PC (p < 0.01) and greater change in distress pre- to post-surveillance (p < 0.01), respectively. CONCLUSIONS: Our findings suggest that PC surveillance can lead to sustained psychosocial benefits in HRIs.

Poor discriminatory function for endoscopic skills on a computer-based simulator.

BACKGROUND: Computer-based endoscopy simulators may enable trainees to learn and develop technical skills before performing on patients. Simulators require validation as adequate models of live endoscopy before being used for training or assessment purposes. OBJECTIVE: To evaluate content and criterion validity of the CAE EndoscopyVR Simulator colonoscopy and EGD modules as predictors of clinical endoscopic skills. DESIGN: Prospective, observational, non-randomized, parallel cohort study. SETTING: Single academic center with accredited gastroenterology training program. PARTICIPANTS: Five novice first-year gastroenterology fellows and 6 expert gastroenterology attending physicians. INTERVENTION: Participants performed 18 simulated colonoscopies and 6 simulated EGDs. The simulator recorded objective performance parameters. Participants then completed feedback surveys. MAIN OUTCOME MEASUREMENTS: The 57 objective performance parameters measured by the endoscopy simulator were compared between the two study groups. Novice and expert survey responses were analyzed. RESULTS: Significant differences between novice and expert performance were detected in only 19 of 57 (33%) performance metrics. Eight of these 19 (42%) were time-related metrics, such as total procedure time, time to anatomic landmarks, and time spent in contact with GI mucosa. Of 49 non-time related measures, the few additional statistically significant differences between novices and experts involved air insufflation, sedation management, endoscope force, and patient comfort. These findings are of uncertain clinical significance. Survey data found multiple aspects of the simulation to be unrealistic compared with human endoscopy. LIMITATIONS: Small sample size. CONCLUSION: The CAE EndoscopyVR Simulator displays poor content and criterion validity and is thereby incapable of predicting skill during in vivo endoscopy.

Use of antimicrobials for EUS-guided FNA of pancreatic cysts: a retrospective, comparative analysis.

BACKGROUND: Pancreatic cystic lesions present a challenge for patients and physicians alike. Morphology alone is inaccurate in discriminating lesion pathology, and use of EUS-guided FNA (EUS-FNA) improves accuracy. Current American Society for Gastrointestinal Endoscopy guidelines recommend prophylactic antibiotics during FNA of cystic lesions to minimize infection risk. However, evidence pertaining to infection risk has been conflicting. The use of prophylactic antibiotics might not be free of other adverse events and might not prevent infection. OBJECTIVE: To assess the impact of antimicrobial therapy for prophylaxis during EUS-FNA of pancreatic cysts. DESIGN: Retrospective cohort study. PATIENTS: This study involved all patients who underwent EUS-FNA of pancreatic cysts at one institution from May 2007 to April 2010. INTERVENTION: Antibiotic prophylaxis for EUS-FNA. MAIN OUTCOME MEASUREMENTS: Infection of a pancreatic cyst, fever, or bacteremia after EUS-FNA. Secondary variables included other complications of the procedure related to the use of prophylaxis (ie, allergic reactions, secondary infections). RESULTS: EUS-FNA was performed on 253 patients in 266 procedures. Antibiotics were used in 88 endoscopy cases (ATB group), whereas no antibiotics were used in 178 cases (NATB group). There were no differences in patient or cyst characteristics between groups. There were 4 major complications in the NATB group (localized bleeding, 2; pancreatitis, 1; bile leakage, 1) and 2 in the ATB group (possible cyst infection, 1; bile leakage, 1) (P = 1.0). Eight mild adverse events were observed in the NATB group and 6 in the ATB group (P = .56). Infections and antibiotic-related complications occurred in 1 (0.6%) (transient fever) in the NATB group and 4 (4.5%) in the ATB group (local allergic reaction, 2; possible cyst infection, 1; Clostridium difficile diarrhea, 1) (P = .04). LIMITATIONS: Retrospective analysis. CONCLUSION: The incidence of infectious complications after EUS-FNA of pancreatic cystic lesions, with or without antibiotic prophylaxis, appears very low. We have not observed a protective effect from periprocedural prophylactic antibiotic administration.

A Multimodal Interdisciplinary QI Intervention Is Associated with Reduction in After Hours Inpatient Endoscopy Cases.

BACKGROUND AND AIMS: Increasing demand for inpatient endoscopic services results in performing more non-emergent endoscopic cases after-hours, which poses risks to patient safety and negatively impacts patient and provider satisfaction. This study sought to quantify the existing state using quality improvement (QI) methodology, design targeted interventions, and determine their effectiveness. METHODS: We conducted an existing state evaluation through a process map, time-series study, and caseload analysis from 7/2017-12/2018. Using end-of-workday (EOW) as a proxy for patient/provider dissatisfaction and risk for patient safety events, we performed a prospective evaluation of a staged interdisciplinary multimodal intervention aimed to decrease the proportion of days with EOW after 7PM, decrease the proportion of cases begun after 5PM, and decrease EOW variability. The post-intervention period was 6/2019-2/2020. RESULTS: Based on existing state analyses, we implemented a series of targeted interventions: (1) provider workflow tips, (2) expedited transport for select patients, (3) pathway to reschedule appropriate cases to outpatient endoscopy, and (4) increased staffing for high caseload days through resource pooling. The proportion of days with EOW after 7PM decreased from 42.4% to 29.3% (caseload-adjusted odds ratio of 0.39, p< 0.001). Despite increased caseload, cases begun after 5PM decreased from 17.5% to 14.2% (OR 0.75, p = 0.009). EOW SD decreased from 2:20 hours to 1:36 hours. CONCLUSIONS: The multimodal intervention reduced days with EOW after 7PM and the proportion of cases begun after 5PM, despite increased caseload. This study shows how applying research methods to implement QI interventions successfully decreases late inpatient endoscopic cases.

EUS-based Pancreatic Cancer Surveillance in BRCA1/BRCA2/PALB2/ATM Carriers Without a Family History of Pancreatic Cancer.

Carriers of a pathogenic/likely pathogenic (P/LP) BRCA1/BRCA2/ATM/PALB2 variant are at increased risk of pancreatic ductal adenocarcinoma (PDAC), yet current guidelines recommend surveillance only for those with a family history of PDAC. We aimed to investigate outcomes of endoscopic ultrasound (EUS)-based PDAC surveillance in BRCA1/BRCA2/ATM/PALB2 carriers without a family history of PDAC. We performed a retrospective analysis of all P/LP BRCA1/BRCA2/ATM/PALB2 carriers who underwent EUS at a tertiary care center. Of 194 P/LP BRCA1/BRCA2/ATM/PALB2 carriers who underwent EUS, 64 (33%) had no family history of PDAC and had at least 1 EUS for PDAC surveillance. These individuals underwent 143 total EUSs, were predominantly female (72%), and BRCA2 carriers (73%), with the majority having a personal history of cancer other than PDAC (67%). The median age at time of first EUS was 62 years [interquartile range (IQR), 53-67 years] and a median of 2 EUSs (IQR 1-3) were performed per patient, with a median of 3 years (IQR 2-4.5 years) between the first and last EUS for those with more than 1 EUS. Pancreatic abnormalities were detected in 44%, including cysts in 27%, and incidental luminal abnormalities in 41%. Eight percent developed a new pancreatic mass or cyst during surveillance, 2 individuals developed PDAC, and no serious complications resulted from surveillance. After discussion of the risks, limitations, and potential benefits, PDAC surveillance can be considered in BRCA1/BRCA2/ATM/PALB2 carriers without a family history of PDAC; however, the effectiveness of PDAC surveillance in this population requires further study. PREVENTION RELEVANCE: BRCA1/BRCA2/ATM/PALB2 carriers have increased pancreatic ductal adenocarcinoma (PDAC) risk, yet are typically not eligible for PDAC surveillance in the absence of PDAC family history. Herein we describe outcomes of PDAC surveillance in BRCA1/BRCA2/ATM/PALB2 carriers without a family history of PDAC, showing that PDAC surveillance can be considered in this high-risk group.

Clinical outcomes after self-expanding plastic stent placement for refractory benign esophageal strictures.

BACKGROUND: Refractory benign esophageal strictures (RBES) are defined as those that persist structurally and symptomatically after repeated dilation sessions. Small series have reported favorable outcomes after placement and subsequent removal of Polyflex self-expanding plastic stents (SEPS). AIMS: To characterize the outcomes after Polyflex stent placement in patients with RBES. METHODS: Outcomes of consecutive patients who underwent Polyflex stent placement for RBES between April 15, 2005 and November 20, 2006 were analyzed retrospectively. The etiology of the stricture, number of dilations prior to initial SEPS placement, size of stent placed, stricture resolution after SEPS removal, cases of stent migration, duration of SEPS placement, time to repeat dilation and/or SEPS replacement after stent removal, and complications were assessed. RESULTS: Twenty-three Polyflex stents were placed in 13 patients suitable for analysis. The majority of stenoses (11/13) were attributable to anastomotic strictures after curative esophagogastrectomy for esophageal neoplasms. All 11 patients in this group had satisfactory relief of dysphagia to solids determined clinically with indwelling SEPS placement. SEPS migration occurred in seven instances (30% of SEPS placed). Dysphagia remediation after subsequent SEPS removal was observed in only three patients (23%). Placement of a partially covered metal stent within a Polyflex stent was necessary in one case due to epithelial hyperplasia. The mean time for repeat dilation and/or SEPS reinsertion due to recurrent dysphagia after stent removal was 37 days (range 6-120 days). CONCLUSIONS: Polyflex stents provided satisfactory palliation of dysphagia for RBES while in place. However, unplanned SEPS migration and dysphagia recurrence after stent removal were common.