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Duodenoscope-associated transmission of infections has raised questions about efficacy of endoscope reprocessing using high-level disinfection (HLD). Although ethylene oxide (ETO) gas sterilization is effective in eradicating microbes, the impact of ETO on endoscopic ultrasound (EUS) imaging equipment remains unknown. In this study, we aimed to compare the changes in EUS image quality associated with HLD vs HLD followed by ETO sterilization. Four new EUS instruments were assigned to 2 groups: Group 1 (HLD) and Group 2 (HLD + ETO). The echoendoscopes were assessed at baseline, monthly for 6 months, and once every 3 to 4 months thereafter, for a total of 12 time points. At each time point, review of EUS video and still image quality was performed by an expert panel of reviewers along with phantom-based objective testing. Linear mixed effects models were used to assess whether the modality of reprocessing impacted image and video quality. For clinical testing, mixed linear models showed minimal quantitative differences in linear analog score (P =.04; estimated change, 3.12; scale, 0–100) and overall image quality value (P =.007; estimated change, −0.12; scale, 1–5) favoring ETO but not for rank value (P =.06). On phantom testing, maximum depth of penetration was lower for ETO endoscopes (P <.001; change in depth, 0.49 cm). In this prospective study, expert review and phantom-based testing demonstrated minimal differences in image quality between echoendoscopes reprocessed using HLD vs ETO + HLD over 2 years of clinical use. Further studies are warranted to assess the long-term clinical impact of these findings. In the interim, these results support use of ETO sterilization of EUS instruments if deemed clinically necessary. [ABSTRACT FROM AUTHOR]

A significant proportion of individuals with pancreatic fluid collections (PFCs) require step-up therapy after endoscopic drainage with lumen-apposing metal stents. The aim of this study is to identify factors associated with PFCs that require step-up therapy. A retrospective cohort study of patients undergoing endoscopic ultrasound–guided drainage of PFCs with lumen-apposing metal stents from April 2014 to October 2019 at a single center was performed. Step-up therapy included direct endoscopic necrosectomy, additional drainage site (endoscopic or percutaneous), or surgical intervention after the initial drainage procedure. Multivariable logistic regression was performed using a backward stepwise approach with a P ≤.2 threshold for variable retention to identify factors predictive for the need for step-up therapy. One hundred thirty-six patients were included in the final study cohort, of whom 69 (50.7%) required step-up therapy. Independent predictors of step-up therapy included: collection size measuring ≥10 cm (odds ratio [OR], 8.91; 95% confidence interval [CI], 3.36–23.61), paracolic extension of the PFC (OR, 4.04; 95% CI, 1.60–10.23), and ≥30% solid necrosis (OR, 4.24; 95% CI, 1.48–12.16). In a sensitivity analysis of 81 patients with walled-off necrosis, 51 (63.0%) required step-up therapy. Similarly, factors predictive of the need for step-up therapy for walled-off necrosis included: collection size measuring ≥10 cm (OR, 6.94; 95% CI, 1.76–27.45), paracolic extension of the PFC (OR, 3.79; 95% CI, 1.18–12.14), and ≥30% solid necrosis (OR, 7.10; 95% CI, 1.16–43.48). Half of all patients with PFCs drained with lumen-apposing metal stents required step-up therapy, most commonly direct endoscopic necrosectomy. Individuals with PFCs ≥10 cm in size, paracolic extension, or ≥30% solid necrosis are more likely to require step-up therapy and should be considered for early endoscopic reintervention. [ABSTRACT FROM AUTHOR]

Background & Aims Acute cholecystitis in patients who are not candidates for surgery is often managed with percutaneous transhepatic gallbladder drainage (PT-GBD). Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with a lumen-apposing metal stent (LAMS) is an effective alternative to PT-GBD. We compared the technical success of EUS-GBD versus PT-GBD, and patient outcomes, numbers of adverse events (AEs), length of hospital stay, pain scores, and repeat interventions. Methods We performed a retrospective study to compare EUS-GBD versus PT-GBD at 7 centers (5 in the United States, 1 in Europe, and 1 in Asia), from 2013 through 2015, in management of acute cholecystitis in patients who are not candidates for surgery. A total of 90 patients (56 men) with acute cholecystitis (61 calculous, 29 acalculous) underwent EUS-GBD (n = 45) or PT-GBD (n = 45). Data were collected on technical success, clinical success (resolution of symptoms or laboratory and/or radiologic abnormalities within 3 days of intervention), and need for repeat intervention. Characteristics were compared using Student t tests for continuous variables and the chi-square test, or the Fisher exact test, when appropriate, for categorical variables. Adverse events were graded according to American Society for Gastrointestinal Endoscopy definitions and compared using the Fisher exact test. Postprocedure pain scores were compared using the Mann-Whitney U test. Results Baseline characteristics, type, and clinical severity of cholecystitis were comparable between groups. In the EUS-GBD group, noncautery LAMS were used in 30 patients and cautery-enhanced LAMS were used in 15. Technical success was achieved for 98% of patients in the EUS-GBD and 100% of the patients in the PT-GBD group ( P = .88). Clinical success was achieved by 96% of patients in the EUS-GBD group and 91% in the PT-GBD group ( P = .20). There was a nonsignificant trend toward fewer AEs in the EUS-GBD group (5 patients; 11%) than in the PT-GBD group (14 patients; 32%) ( P = .065). There were no significant differences in the severity of the AEs: mild, 2 in the EUS-GBD group versus 5 in the PT-GBD group ( P = .27); moderate, 4 versus 3 ( P = .98); severe, 1 versus 3 ( P = .62); or deaths, 1 versus 3 ( P = .61). The mean postprocedure pain score was lower in the EUS-GBD group than in the PT-GBD group (2.5 vs 6.5; P < .05). The EUS-GBD group had a shorter average length of stay in the hospital (3 days) than the PT-GBD group (9 days) ( P < .05) and fewer repeat interventions (11 vs 112) ( P < .05). The average number of repeat interventions per patients was 0.2 ± 0.4 EUS-GBD group versus 2.5 ± 2.8 in the PT-GBD group ( P < .05). Median follow-up after drainage was comparable in EUS-GBD group (215 days; range, 1–621 days) versus the PT-GBD group (265 days; range, 1–1638 days). Conclusions EUS-GBD has similar technical and clinical success compared with PT-GBD and should be considered an alternative for patients who are not candidates for surgery. Patients who undergo EUS-GBD seem to have shorter hospital stays, lower pain scores, and fewer repeated interventions, with a trend toward fewer AEs. A prospective, comparative study is needed to confirm these results. [ABSTRACT FROM AUTHOR]

Patients with infected or symptomatic walled-off necrosis (WON) have high morbidity and health care utilization. Despite the recent adoption of nonsurgical treatment approaches, WON management remains nonalgorithmic. We investigated the impact of a protocolized early necrosectomy approach compared with a nonprotocolized, clinician-driven approach on important clinical outcomes. Records were reviewed for consecutive patients with WON who underwent a protocolized endoscopic drainage with a lumen-apposing metal stent (cases), and for patients with WON treated with a lumen-apposing metal stent at the same tertiary referral center who were not managed according to the protocol (control subjects). The protocol required repeat cross-sectional imaging within 14 days after lumen-apposing metal stent placement, with regularly scheduled endoscopic necrosectomy if WON diameter reduction was <50%. Control patients were treated according to their clinician's preference without an a priori strategy. Inverse probability of treatment weighting–adjusted analysis was used to evaluate the influence of being in the protocolized group on time to resolution. A total of 24 cases and 47 control subjects were included. There were no significant differences in baseline characteristics. Although numbers of endoscopies and necrosectomies were similar, cases had lower adverse event rates, shorter intensive care unit stay, and required nutritional support for fewer days. On matched multivariate Cox regression, cases had earlier WON resolution (hazard ratio, 5.73; 95% confidence interval, 2.62–12.5). This was confirmed in the inverse probability of treatment weighting–adjusted analysis (hazard ratio, 3.4; 95% confidence interval, 1.92–6.01). A protocolized strategy resulted in faster WON resolution compared with a discretionary approach without the need for additional therapeutic interventions, and with a better safety profile and decreased health care utilization. [ABSTRACT FROM AUTHOR]

The Primary Obesity Surgery Endoluminal (POSE) 2.0 procedure involves a novel pattern of full-thickness gastric body plications to shorten and narrow the stomach using durable suture anchor pairs. Our prospective, multicenter trial examined the safety, efficacy, durability, and physiologic effects of POSE 2.0 in adults with obesity. Adults with obesity underwent POSE 2.0 at 3 centers. Primary outcomes were percent total body weight loss (%TBWL) and proportion of patients achieving >5% TBWL at 12 months. Secondary outcomes included change in obesity comorbidities, satiety, quality of life at 6 months, and durability of plications at 12 and 24 months. Subjects were followed for adverse events throughout the study duration. 44 patients (61% female; mean age, 45 ± 9.7 years; mean body mass index, 37 ± 2.1 kg/m2) were enrolled. This procedure used an average of 19 suture anchor pairs, with a mean duration of 37 ± 11 minutes, and was technically successful in all subjects. Mean %TBWL at 12 months was 15.7% ± 6.8%. At 12 months, %TBWL >5%, >10%, and >15% was achieved in 98%, 86%, and 58% of patients, respectively. Improvements in lipid profile, liver biochemistries, and hepatic steatosis were seen at 6 months. Improvements in hepatic steatosis persisted for 24 months in a subgroup of patients (P <.01). POSE 2.0 reduced maximum tolerated meal volume (P =.03) and was associated with increased fullness (P <.01) and improved eating behavior (P <.01) at 6 months. Impact of weight on quality-of-life questionnaire improved at 6 months (2.23 vs 1.23; P <.01). Repeat assessment at 24 months (n = 26) showed fully intact plications. No serious adverse events occurred. POSE 2.0 is an effective and durable endoscopic bariatric therapy which may influence physiologic pathways impacting satiety. Larger comparative studies are needed to further elucidate these initial findings. ClinicalTrials.gov Identifier: NCT03721731 [ABSTRACT FROM AUTHOR]

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. A retrospective review of consecutive patients undergoing SEMS placement for malignant dysphagia at three academic medical centers. 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). 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. [ABSTRACT FROM AUTHOR]

Obese patients with nonalcoholic steatohepatitis (NASH) are at risk for cirrhosis if significant weight loss is not achieved. The single fluid-filled intragastric balloon (IGB) induces meaningful weight loss and might be used in NASH treatment. We performed an open-label prospective study to evaluate the effects of IGB placement on metabolic and histologic features of NASH. Twenty-one patients with early hepatic fibrosis (81% female; mean age, 54 years; average body mass index, 44 kg/m2) underwent magnetic resonance elastography (MRE) and endoscopic ultrasound with core liver biopsy collection at time IGB placement and removal at a single center from October 2016 through March 2018. The primary outcome measure was the changes in liver histology parameters after IGB, including change in nonalcoholic fatty liver disease activity score (NAS) and fibrosis score. We also evaluated changes in weight, body mass index, waist to hip ratio, aminotransaminases, fasting levels of lipids, fasting glucose, glycosylated hemoglobin, and MRE-detected liver stiffness. Six months after IGB, patients' mean total body weight loss was 11.7% ± 7.7%, with significant reductions in HbA1c (1.3% ± 0.5%) (P =.02). Waist circumference decreased by 14.4 ± 2.2 cm (P =.001). NAS improved in 18 of 20 patients (90%), with a median decrease of 3 points (range, 1–4 points); 16 of 20 patients (80%) had improvements of 2 points or more. Fibrosis improved by 1.17 stages in 15% of patients, and MRE-detected fibrosis improved by 1.5 stages in 10 of 20 patients (50%). Half of patients reached endpoints approved by the Food and Drug Administration of for NASH resolution and fibrosis improvement. Percent total body weight loss did not correlate with reductions in NAS or fibrosis. Other than post-procedural pain (in 5% of patients), no serious adverse events were reported. In a prospective study, IGB facilitated significant metabolic and histologic improvements in NASH. IGB appears to be safe and effective for NASH management when combined with a prescribed diet and exercise program. ClinicalTrials.gov no: NCT02880189 [ABSTRACT FROM AUTHOR]

Bariatric surgery is the most successful treatment for obesity. However, many patients avoid surgery due to its perceived invasive nature and fear of complications. Endoscopic sleeve gastroplasty (ESG) is a seemingly less invasive option for patients with obesity. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of ESG in adults. We searched MEDLINE, Embase, Web of Science, and Cochrane Library through July 2019. Investigated outcomes included the percent total body weight loss (TBWL), body mass index reduction, percent excess weight loss (EWL), and adverse events. We extracted data from 8 original studies, published from 2016 through 2019, which included a total of 1772 patients. At 6 months, mean TBWL was 15.1% (95% CI, 14.3–16.0), mean decrease in body mass index was 5.65 kg/m2 (95% CI, 5.07–6.22), and mean excess weight loss was 57.7% (95% CI, 52.0–63.4). Weight loss was sustained at 12 months and 18–24 months with a TBWL of 16.5% (95% CI, 15.2–17.8) and 17.2% (95% CI, 14.6–19.7), respectively. The pooled post-ESG rate of severe adverse events was 2.2% (95% CI, 1.6%–3.1%), including pain or nausea requiring hospitalization (n = 18, 1.08%), upper gastrointestinal bleeding (n=9, 0.56%), and peri-gastric leak or fluid collection (n = 8, 0.48%). In a systematic review and meta-analysis, we found ESG to produce clinically significant weight loss that was reproducible among independent centers and to have a low rate of severe adverse events. ESG appears to be an effective intervention for patients with obesity, although comparative studies and randomized controlled trials are necessary. PROSPERO Identifier: CRD42019121921 [ABSTRACT FROM AUTHOR]

Gastric emptying (GE) is involved in the regulation of appetite. We compared times of GE after different bariatric endoscopic and surgical interventions and associations with weight loss. We performed a comprehensive search of publication databases, through September 14, 2018, for randomized and nonrandomized studies reporting outcomes of weight-loss surgeries. Two independent reviewers selected and appraised studies. The outcome of interest was GE T 1/2 (min), measured before and after the procedure. A random-effects model was used to pool the mean change in T 1/2 (min) after the intervention. We performed a meta-regression analysis to find associations between GE and weight loss. Heterogeneity was calculated using the I2 statistic. Methodologic quality was assessed. From 762 citations, the following studies were included in our analysis: 9 sleeve gastrectomies, 5 intragastric balloons, and 5 antral botulinum toxins. After sleeve gastrectomy, the pooled mean reduction in GE T 1/2 at 3 months was 29.2 minutes (95% CI, 40.9–17.5 min; I2 = 91%). Fluid-filled balloons increased GE T 1/2 by 116 minutes (95% CI, 29.4–203.4 min; I2 = 58.6%). Air-filled balloons did not produce a statistically significant difference in GE T 1/2. Antral botulinum injections increased GE T 1/2 by 9.6 minutes (95% CI, 2.8–16.4 min; I2 = 13.3%). Placebo interventions reduced GE T 1/2 by 6.3 minutes (95% CI, 10-2.6 min). Changes in GE were associated with weight loss after sleeve gastrectomy and intragastric balloons, but not botulinum toxin injections. In a systematic review and meta-analysis, we found that sleeve gastrectomy reduced GE T 1/2 whereas fluid-filled balloons significantly increased GE T 1/2. Air-filled balloons do not significantly change the time of GE, which could account for their low efficacy. Antral botulinum toxin injections produced small temporary increases in GE time, which were not associated with weight loss. Changes in GE time after surgical and endoscopic bariatric interventions correlated with weight loss and might be used to select interventions, based on patients' physiology. [ABSTRACT FROM AUTHOR]

Tumor cells can migrate via diminutive perivascular cuffing to distant sites along blood vessels to form extravascular migratory metastases (EVMM). These metastases usually are identified during surgery or autopsies. We aimed to evaluate the feasibility and safety of endoscopic ultrasound fine-needle aspiration (EUS-FNA) of perivascular soft-tissue cuffs to detect EVMM. We compared findings from EUS with those from noninvasive cross-sectional imaging (reference standard) of patients who underwent EUS-FNA to assess suspected EVMM and studied the effects on pancreatic tumor staging and determination of resectability. We performed a retrospective analysis of 253 patients (mean age, 62 ± 12 y) who underwent EUS-FNA of 267 vessels for evaluation of suspected EVMM, from April 2001 through May 2018. EUS findings were compared with those from computed tomography (CT) and magnetic resonance imaging (MRI) as the reference standard. Lesions were considered to be malignant based on cytology analysis of FNA samples, histology analyses of surgical or biopsy specimens, or vascular abnormalities detected by CT or MRI that clearly indicate EVMM. Thirty patients were found to have benign lesions. The remaining 223 patients who had malignancies (166 with pancreatic ductal adenocarcinomas [PDACs]), underwent further analyses. A median of 4 FNAs (range, 1–20 FNAs) were obtained from 4-mm perivascular soft-tissue cuffs (range, 2–20 mm). FNA and cytology analysis showed malignant cells in 163 vessels (69.4%) from 157 patients (70.4%). CT or MRI did not detect EVMM in 44 patients (28%) with malignancies, including 24 patients (24%) with newly diagnosed PDAC. Detection of EVMM by EUS-FNA resulted in upstaging of 15 patients and conversion of 14 patients with PDAC from resectable (based on CT or MRI) to unresectable. No adverse events were reported during a follow-up period of 3.9 months (range, 0–117 mo). EUS-FNA and cytologic analysis of perivascular soft-tissue cuffs can detect EVMM that were not found in 28% of patients by CT or MRI. Detection of EVMM affects tumor staging and determination of tumor resectability. [ABSTRACT FROM AUTHOR]

Background & Aims Pancreatic cancer produces debilitating pain that opioids often ineffectively manage. The suboptimal efficacy of celiac plexus neurolysis (CPN) might result from brief contact of the injectate with celiac ganglia. We compared the effects of endoscopic ultrasound-guided celiac ganglia neurolysis (CGN) vs the effects of CPN on pain, quality of life (QOL), and survival. Methods We performed a randomized, double-blind trial of patients with unresectable pancreatic ductal adenocarcinoma and abdominal pain; 60 patients (age 66.4±11.6 years; male 66%) received CPN and 50 patients (age 66.8±10.0 years; male 56%) received CGN. Primary outcomes included pain control and QOL at week 12 and survival (overall median and 12 months). Secondary outcomes included morphine response, performance status, secondary neurolytic effects, and adverse events. Results Rates of pain response at 12 weeks were 46.2% for CGN and 40.4% for CPN (P =.84). There was no significant difference in improvement of QOL between the techniques. The median survival time was significantly shorter for patients receiving CGN (5.59 months) compared to (10.46 months) (hazard ratio for CGN, 1.49; 95% CI, 1.02–2.19; P =.042), particularly for patients with non-metastatic disease (hazard ratio for CGN, 2.95; 95% CI, 1.61–5.45; P <.001). Rates of survival at 12 months were 42% for patients who underwent CPN vs 26% for patients who underwent CGN. The number of adverse events did not differ between techniques. Conclusion In a prospective study of patients with unresectable pancreatic ductal adenocarcinoma and abdominal pain, we found CGN to reduce median survival time without improving pain, QOL, or adverse events, compared to CPN. The role of CGN must be therefore be reassessed. Clinicaltrials.gov no: NCT01615653. [ABSTRACT FROM AUTHOR]

Background & Aims Endoscopic ultrasound (EUS) allows visualization of celiac lymph nodes (CLNs) and celiac ganglia (CG). Reliably distinguishing these structures is important for tumor staging and CG ablative therapies. We aimed to evaluate the accuracy of EUS in distinguishing CLNs from CG using a strict cytopathology reference standard. We also determined the rate of detection of CLN and CG by conventional cross-sectional imaging. Methods From EUS and cytopathology databases, we identified all patients who underwent EUS-FNA of a presumed CLN or CG from October 1, 2004, through March 1, 2017, and compared the findings with those from cytology (reference standard). Indeterminate cytology results were re-reviewed. EUS imaging (ie, index test) results were compared with those from the reference standard. An expert radiologist re-reviewed computed tomography and magnetic resonance images from 100 lesions, from 94 randomly selected patients with a reference standard, to determine the rates of CLN and CG detection. Results A total of 504 patients (mean age, 63.4 ± 13.2 years; 292 men) underwent a median of 7 EUS-FNA passes (range, 1–13) for a total of 566 lesions perceived to be either a CLN or CG; the cytology reference standard was available for 521 lesions (92.1%). When we excluded indeterminate cytology results, the EUS accurately identified 281/286 CLNs (98.3%) and 166/186 CGs (89.2%), for an overall accuracy of 447/472 (94.7%). EUS-FNA distinguished CG from CLNs with a 93.3% sensitivity, 93.7% specificity, a positive predictive value of 96.2%, and a negative predictive value of 89.2%. Of 100 lesions in 94 patients randomly selected for a second expert radiology review, computed tomography and magnetic resonance imaging detected 59/67 CLNs (88.1%) and 13/33 CG (39.4%). Conclusion EUS accurately distinguishes CLNs from CG. EUS might therefore be used to increase the accuracy of tumor staging, to select tumor stage-appropriate therapy, and to guide CG-ablative therapies. [ABSTRACT FROM AUTHOR]

A subset of patients with nonvariceal gastrointestinal bleeding fail, or are unsuitable candidates for, endoscopic, radiologic, and surgical interventions. Endoscopic ultrasound (EUS)-guided intervention might be effective in these patients. We performed EUS-guided hemostatic interventions for 17 patients with nonvariceal gastrointestinal bleeding from June 2003 through May 2014 who failed, or were unsuitable candidates for, additional therapies. Indications for treatment included gastrointestinal stromal tumors, colorectal vascular malformations, duodenal masses or polyps, Dieulafoy lesions, duodenal ulcers, rectally invasive prostate cancer, pancreatic pseudoaneurysms, ulcerated esophageal cancer, and ulceration after Roux-en-Y gastric bypass. After the procedure, 88% of patients have had no further bleeding related to the treated lesion, over a median follow-up period of 12 months. EUS-guided hemostatic therapy therefore is feasible and useful for select patients with clinically severe, refractory, or recurrent nonvariceal gastrointestinal bleeding. [ABSTRACT FROM AUTHOR]