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Lumen-apposing metal stents (LAMSs) have revolutionized the treatment of various gastroenterologic conditions that previously required surgery. The use of LAMSs for the management of small-bowel obstruction (SBO) involves EUS-guided coloenterostomy (EUS-CE) between the colon and a dilated loop of the small intestine proximal to the point of obstruction. This procedure is potentially beneficial for patients with malignant SBO who are poor surgical candidates. A retrospective cohort study was conducted at 2 tertiary care hospitals. Patients who underwent EUS-CE for SBO were identified, and data regarding patient demographics, indication for the procedure, location of the obstruction, procedural details, and adverse events were collected. The primary outcome was technical success of the procedure. Secondary outcomes were clinical success, resolution of symptoms, ability to tolerate enteral nutrition, and adverse events. Twenty-six patients who underwent the EUS-CE procedure were included. Technical success was achieved in all 26 patients, clinical success (resolution of obstructive symptoms) was achieved in 92.3% of patients (24/26), and the ability to resume enteral nutrition in 84.6% (22/26). Adverse events occurred in 4 patients (15.4%) and included bleeding (1/26), diarrhea (2/26), and postprocedure sepsis (1/26). Patients were followed for a mean of 54.8 days (range, 2-190). This study highlights that EUS-CE with LAMSs can be performed with high technical and clinical success for the management of SBO, particularly in patients with malignant obstructions who are not suitable candidates for surgical interventions. Further research with larger sample sizes will be essential to substantiate its efficacy and safety. [Display omitted] [ABSTRACT FROM AUTHOR]

Direct endoscopic necrosectomy (DEN) of walled-off pancreatic necrosis (WOPN) lacks dedicated instruments and requires repetitive and cumbersome procedures. This study evaluated the safety and efficacy of a new powered endoscopic debridement (PED) system designed to simultaneously resect and remove solid debris within WOPN. This was a single-arm, prospective, multicenter, international device trial conducted from November 2018 to August 2019 at 10 sites. Patients with WOPN ≥6 cm and ≤22 cm and with >30% solid debris were enrolled. The primary endpoint was safety through 21 days after the last DEN procedure. Efficacy outcomes included clearance of necrosis, procedural time, adequacy of debridement, number of procedures until resolution, hospital stay duration, and quality of life. Thirty patients (mean age, 55 years; 60% men) underwent DEN with no device-related adverse events. Of 30 patients, 15 (50%) achieved complete debridement in 1 session and 20 (67%) achieved complete debridement within 2 or fewer sessions. A median of 1.5 interventions (range, 1-7) were required. Median hospital stay was 10 days (interquartile range, 22). There was an overall reduction of 91% in percent necrosis within WOPN from baseline to follow-up and 85% in collection volume. Baseline WOPN volume was positively correlated with the total number of interventions (ρ =.363, P =.049). The new PED system seems to be a safe and effective treatment tool for WOPN, resulting in fewer interventions and lower hospital duration when compared with published data on using conventional instruments. Randomized controlled trials comparing the PED system with conventional DEN are needed. (Clinical trial registration number: NCT03694210.) [Display omitted] [ABSTRACT FROM AUTHOR]

Digital single-operator cholangioscopy (DSOC) allows direct visualization of the biliary tree for evaluation of biliary strictures. Our objective was to assess the interobserver agreement (IOA) of DSOC interpretation for indeterminate biliary strictures using newly refined criteria. Fourteen endoscopists were asked to review an atlas of reference clips and images of 5 criteria derived from expert consensus. They then proceeded to score 50 deidentified DSOC video clips based on the visualization of tortuous and dilated vessels, irregular nodulations, raised intraductal lesions, irregular surface with or without ulcerations, and friability. The endoscopists then diagnosed the clips as neoplastic or non-neoplastic. Intraclass correlation (ICC) analysis was done to evaluate inter-rater agreement for both criteria sets and final diagnosis. Clips of 41 malignant lesions and 9 benign lesions were scored. Three of 5 revised criteria had almost perfect agreement. ICC was almost perfect for presence of tortuous and dilated vessels (.86), raised intraductal lesions (.90), and presence of friability (.83); substantial agreement for presence of irregular nodulations (.71); and moderate agreement for presence of irregular surface with or without ulcerations (.44). The diagnostic ICC was almost perfect for neoplastic (.90) and non-neoplastic (.90) diagnoses. The overall diagnostic accuracy using the revised criteria was 77%, ranging from 64% to 88%. The IOA and accuracy rate of DSOC using the new Mendoza criteria shows a significant increase of 16% and 20% compared with previous criteria. The reference atlas helps with formal training and may improve diagnostic accuracy. (Clinical trial registration number: NCT02166099.) [ABSTRACT FROM AUTHOR]

EUS-directed transgastric ERCP (the EDGE procedure) is a simplified method of performing ERCP in Roux-en-Y gastric bypass patients. The EDGE procedure involves placement of a lumen-apposing metal stent (LAMS) into the excluded stomach to serve as a conduit for passage of the duodenoscope for pancreatobiliary intervention. Originally a multistep process, urgent indications for ERCP have led to the development of single-session EDGE (SS-EDGE) with LAMS placement and ERCP performed in the same session. The goal of this study was to identify predictive factors of intraprocedural LAMS migration in SS-EDGE. We conducted a multicenter retrospective review that included 9 tertiary medical centers across the United States. Data were collected and analyzed from 128 SS-EDGE procedures. The primary outcome was intraprocedural LAMS migration. Secondary outcomes were other procedural adverse events such as bleeding and perforation. Eleven LAMS migrations were observed in 128 procedures (8.6%). Univariate analysis of clinically relevant variables was performed, as was a binary logistic regression analysis of stent diameter and stent dilation. This revealed that use of a smaller (15 mm) diameter LAMS was an independent predictor of intraprocedural stent migration (odds ratio, 5.36; 95% confidence interval, 1.29-22.24; P =.021). Adverse events included 3 patients who required surgery and 2 who experienced intraprocedural bleeding. Use of a larger-diameter LAMS is a predictive factor for a nonmigrated stent and improved procedural success in SS-EDGE. Although larger patient cohorts are needed to adequately assess these findings, performance of LAMS dilation and fixation may also decrease risk of intraprocedural LAMS migration and improve procedural success. [Display omitted] [ABSTRACT FROM AUTHOR]

Lumen apposing metal stents (LAMS) have been used increasingly for drainage of pancreatic fluid collections (PFC). We present an international, multicenter study evaluating the safety and efficacy of LAMS in PFCs. Consecutive patients undergoing LAMS placement for PFC at 12 international centers were included (ClinicalTrials.gov NCT01522573). Demographics, clinical history, and procedural details were recorded. Technical success was defined as successful LAMS deployment. Clinical success was defined as PFC resolution at three-month follow-up. 192 patients were included (140 males (72.9%), mean-age 53.8 years), with mean follow-up of 4.2 months ± 3.8. Mean PFC size was 11.9 cm (range 2–25). The median number of endoscopic interventions was 2 (range 1–14). Etiologies for PFC were gallstone (n = 82, 42.7%), alcohol (n = 50, 26%), idiopathic (n = 26, 13.5%), and other (n = 34, 17.7%). Technical success was achieved in 189 patients (98.4%). Clinical success was observed in 125 of 135 patients (92.6%). Adverse events included bleeding (n = 11, 5.7), infection (n = 2, 1%), and perforation (n = 2, 1%). Three or more endoscopy sessions were a positive predictor for PFC resolution and the only significant predictor for AEs. LAMS has a high technical and clinical success rate with a low rate of AEs. PFC drainage via LAMS provides a minimally invasive, safe, and efficacious procedure for PFC resolution. [ABSTRACT FROM AUTHOR]

Abstract Introduction Evaluation of indeterminate biliary strictures remains a diagnostic challenge. Optical coherence tomography (OCT) provides in-vivo, wide-field, cross-sectional imaging at the microstructure level. We present the first preliminary data using a second-generation OCT system using volumetric laser endomicroscopy (VLE) in biliary and pancreatic duct strictures. Methods 10 consecutive patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) and OCT for indeterminate biliary or pancreatic stricture evaluation were captured in a registry. Following ductal cannulation and guidewire placement, an imaging probe was advanced into the duct and images were interpreted in-vivo. Tissue sampling with cytology brushing was performed in all cases. Demographics, procedural information, imaging data, and histologic findings were collected. Results 8 had biliary strictures and 2 had pancreatic duct strictures. VLE was successfully performed in all patients (100%). Histology revealed malignancy in 3 patients (cholangiocarcinoma) and benign disease in the remaining 7 patients, including 1 with primary sclerosing cholangitis (PSC). All 3 cholangiocarcinoma patients demonstrated epithelial thickening with projections, a hyper-reflective surface with shadowing, and layering effacement (loss of visualization and haziness of inner mucosal layers). A PSC patient showed onion skin layering and hyper-reflective sub-surface structures but with preserved wall layering. Benign biliary strictures showed clearly delineated epithelial layer and clear layering in the inner mucosal layers as well as the presence of dilated hypo-reflective structures. Conclusion There may be characteristic VLE findings for malignant, inflammatory, and benign biliary strictures. [ABSTRACT FROM AUTHOR]

Background and Aims Per-oral endoscopic myotomy (POEM) has become an accepted treatment for patients with achalasia. Despite its excellent efficacy rate of greater than 80%, a small percentage of patients remain symptomatic after the procedure. Limited data exist as to the best management for recurrence of symptoms after POEM. We present the first international, multicenter experience on the efficacy and safety of a repeat POEM in the management of achalasia. Methods Patients who underwent a redo POEM from 15 centers in 9 countries were included in a dedicated registry. Technical success was defined as successful completion of a second myotomy. Clinical success was defined as an Eckardt score of less than or equal to 3 after the second myotomy. Adverse events including anesthesia-related, operative, and postoperative adverse events were recorded. Results Forty-six patients were included in the study. The average age was 49.3 ± 16.78 years. Twenty (45%) patients were male. The mean pre-redo-POEM Eckardt score was 4.3 ± 2.48. Technical success was achieved in 46 (100%) patients. Clinical success was achieved in 41 patients (85%). The average post-POEM Eckardt score was 1.64 ± 1.67, with a significant difference of 2.58 ( P < .00001). Eight patients (17%) had adverse events consisting of procedural bleeding, all managed endoscopically. There were no deaths. No POEMs were aborted or required surgical conversion or assistance. Discussion For patients with persistent symptoms after POEM, repeat POEM appears to be an efficacious and safe technique. Further randomized trials comparing redo POEM versus Heller should be considered. (Clinical trial registration number: NCT02162589 .) [ABSTRACT FROM AUTHOR]

Background and Aims EUS-guided biliary drainage (EUS-BD) is increasingly used as an alternate therapeutic modality to percutaneous transhepatic biliary drainage (PTBD) for biliary obstruction in patients who fail ERCP. We conducted a systematic review and meta-analysis to compare the efficacy and safety of these 2 procedures. Methods We searched several databases from inception to September 4, 2016 to identify comparative studies evaluating the efficacy and safety of EUS-BD and PTBD. Primary outcomes of interest were the differences in technical success and postprocedure adverse events. Secondary outcomes of interest included clinical success, rate of reintervention, length of hospital stay, and cost comparison for these 2 procedures. Odds ratios (ORs) and standard mean difference were calculated for categorical and continuous variables, respectively. These were analyzed using random effects model of meta-analysis. Results Nine studies with 483 patients were included in the final analysis. There was no difference in technical success between 2 procedures (OR, 1.78; 95% CI, .69-4.59; I 2 = 22%) but EUS-BD was associated with better clinical success (OR, .45; 95% CI, .23-.89; I 2 = 0%), fewer postprocedure adverse events (OR, .23; 95% CI, .12-.47; I 2 = 57%), and lower rate of reintervention (OR, .13; 95% CI, .07-.24; I 2 = 0%). There was no difference in length of hospital stay after the procedures, with a pooled standard mean difference of –.48 (95% CI, –1.13 to .16), but EUS-BD was more cost-effective, with a pooled standard mean difference of –.63 (95% CI, –1.06 to –.20). However, the latter 2 analyses were limited by considerable heterogeneity. Conclusions When ERCP fails to achieve biliary drainage, EUS-guided interventions may be preferred over PTBD if adequate advanced endoscopy expertise and logistics are available. EUS-BD is associated with significantly better clinical success, lower rate of postprocedure adverse events, and fewer reinterventions. [ABSTRACT FROM AUTHOR]

Background & Aims Endoscopic sleeve gastroplasty (ESG) is an incisionless, minimally invasive bariatric procedure that reduces the length and width of the gastric cavity to facilitate weight loss. We performed a prospective study to evaluate the effects of ESG on total body weight loss and obesity-related comorbidities. Methods We collected data from 91 consecutive patients (mean age, 43.86 ± 11.26 years; 68% female) undergoing ESG from August 2013 through March 2016. All patients had a body mass index (BMI) greater than 30 kg/m 2 and had failed noninvasive weight-loss measures or had a BMI greater than 40 kg/m 2 and were not considered as surgical candidates or refused surgery. All procedures were performed with a cap-based flexible endoscopic suturing system to facilitate a triangular pattern of sutures to imbricate the greater curvature of the stomach. Patients were evaluated after 6 months (n = 73), 12 months (n = 53), and 24 months (n = 12) for anthropometric features (BMI, weight, waist circumference, blood pressure) and underwent serologic (hemoglobin A1c), lipid panel, serum triglycerides, and liver function tests. The primary outcomes were total body weight loss at 6, 12, and 24 months. Secondary outcomes were the effects of ESG on metabolic factors (blood pressure, diabetes, hyperlipidemia, steatohepatitis) and safety. Results The patients’ mean BMI before the procedure was 40.7 ± 7.0 kg/m 2 . Patients had lost 14.4% of their total body weight at 6 months (80% follow-up rate), 17.6% at 12 months (76% follow-up rate), and 20.9% at 24 months (66% follow-up rate) after ESG. At 12 months after ESG, patients had statistically significant reductions in levels of hemoglobin A1c ( P = .01), systolic blood pressure ( P = .02), waist circumference ( P < .001), alanine aminotransferase ( P < .001), and serum triglycerides ( P = .02). However, there was no significant change in low-density lipoprotein after vs before ESG ( P = .79). There was one serious adverse event (1.1%) (perigastric leak) that occurred that was managed non-operatively. Conclusions ESG is a minimally invasive and effective endoscopic weight loss intervention. In addition to sustained total body weight loss up to 24 months, ESG reduced markers of hypertension, diabetes, and hypertriglyceridemia. [ABSTRACT FROM AUTHOR]

Background and Aims Endoscopic retrograde pancreatography (ERP) is considered first-line therapy for management of symptomatic pancreatic duct obstruction. Technical failure with ERP occurs when the main pancreatic duct cannot be cannulated. EUS-guided drainage of the pancreatic duct is a minimally invasive alternative to surgery for failed conventional ERP. We present an international, multicenter study on the safety and efficacy of EUS-guided pancreatic drainage (EUS-PD) for patients who fail conventional endoscopic therapy. Methods Between January 2006 and December 2015, 80 patients underwent EUS-PD at 4 academic centers in 3 countries. Patient demographics, medical history, procedure data, and follow-up clinical data were collected. Technical success was defined as successful pancreatic duct drainage with stent placement. Clinical success was defined as resolution or improvement of symptoms or improvement on postprocedure imaging. Results Eighty patients (62.5% men; mean age, 58.2 ± 15.5 years) were included. All patients had attempted ERP and/or extracorporeal lithotripsy if needed before EUS-PD. Technical success was achieved in 89% of patients (n = 71). Clinical success was achieved in 81% of patients overall (65/80) and in 92% of patients who achieved technical success (65/71). Immediate adverse events occurred in 20% of patients (n = 16) and delayed adverse events occurred in 11% of patients (n = 9). Conclusions With appropriate endoscopic expertise, EUS-PD offers a minimally invasive, more effective, and safer alternative to some surgical PD procedures. Prospective studies are needed to evaluate long-term outcomes. (Clinical trial registration number: NCT01522573 .) [ABSTRACT FROM AUTHOR]

Background and Aims EUS-guided biliary drainage (EUS-BD) has been offered for more than a decade as an alternative to percutaneous biliary drainage. Multiple approaches have been described. We propose an algorithm for biliary drainage based on patient anatomy. We aim to assess its validity and safety to guide EUS-BD drainage. Methods All patients with biliary obstruction who underwent EUS-BD after failed ERCP from July 2011 through November 2015 underwent the drainage procedure according to the novel algorithm and were enrolled in a dedicated prospective registry. Patients with a dilated intrahepatic biliary tree (IHBT) on cross-sectional imaging received an intrahepatic (IH) approach with anterograde biliary stent placement or hepaticogastrostomy stent placement if anterograde placement was not feasible. Patients with a nondilated IHBT on cross-sectional imaging underwent an extrahepatic (EH) approach with a rendezvous (RDV) technique or a transenteric stent placement if the RDV technique was not feasible. If IH drainage was attempted but unsuccessful, conversion to an EH approach was performed. Results Fifty-two patients (mean age, 68 ± 12 years; 52% men) were included in the registry. Technical success was achieved in 50 patients (96%). Twenty-seven of 52 patients (52%) underwent IH anterograde stent placement, 8 of 52 (15%) underwent hepaticogastrostomy, 11 of 52 (21%) underwent EH drainage with the RDV technique, and 6 of 52 (12%) underwent EH drainage with transenteric stent placement. Adverse events were observed in 5 patients (10%) and included a liver abscess requiring percutaneous drainage (n = 1) and bleeding (n = 4) with 1 postprocedural death secondary to bleeding. Conclusions EUS-BD obstruction after failed conventional ERCP is successful and safe when this novel algorithm is used. (Clinical trial registration number: NCT01438385 .) [ABSTRACT FROM AUTHOR]

Background & Aims Endoscopic ultrasound–guided transmural drainage and necrosectomy have become the standard treatment for patients with pancreatic walled-off necrosis (WON). Lumen-apposing metal stents (LAMS) have shown success in the management of pancreatic fluid collections. However, there are few data on their specific roles in management of WON. We investigated the efficacy and safety of LAMS in treatment of WON. Methods We performed a retrospective multicenter case series of 124 patients with WON who underwent endoscopic transmural drainage by using LAMS at 17 tertiary care centers from January 2014 through May 2015. Patients underwent endoscopic ultrasound–guided cystogastrostomy or cystoenterostomy with placement of an LAMS into the WON collection. At the discretion of the endoscopist, we performed direct endoscopic necrosectomy, irrigation with hydrogen peroxide, and/or nasocystic drain placement. We performed endoscopic retrograde cholangiopancreatography with pancreatic duct stent placement when indicated. Concomitant therapies included direct endoscopic debridement (n = 78), pancreatic duct stent placement for leak (n = 19), hydrogen peroxide–assisted necrosectomy (n = 38), and nasocystic irrigation (n = 22). We collected data for a median time of 4 months (range, 1–34 months) after the LAMS placement. The primary outcomes were rates of technical success (successful placement of the LAMS), clinical success (resolution of WON, on the basis of image analysis, without need for further intervention via surgery or interventional radiology), and adverse events. Results The median size of the WON was 9.5 cm (range, 4–30 cm). Eight patients had 2 LAMS placed for multiport access, all with technical success (100%). Clinical success was achieved in 107 patients (86.3%) after 3 months of follow-up. Thirteen patients required a percutaneous drain, and 3 required a surgical intervention to manage their WON. The stents remained patent in 94% of patients (117 of 124) and migrated in 5.6% of patients (7 of 124). The median number of endoscopic interventions was 2 (range, 1–9 interventions). Conclusions On the basis of a retrospective analysis of 124 patients, endoscopic therapy of WON by using LAMS is safe and effective. Creation of a large and sustained cystogastrostomy or cystoenterostomy tract is effective in the drainage and treatment of WON. [ABSTRACT FROM AUTHOR]

Background ERCP is challenging in patients with Roux-en-Y gastric bypass. Using EUS to gain access to the excluded stomach and subsequently performing transcutaneous ERCP was described recently. Objective We describe our initial experience with an internal EUS-directed transgastric ERCP (EDGE) procedure by using a lumen-apposing metal stent (LAMS). Design Single-center case series. Setting Tertiary center with expertise in EUS-guided procedures. Patients Five patients with Roux-en-Y gastric bypass underwent EDGE via a LAMS. Interventions A linear echoendoscope was used to access the excluded stomach. A LAMS was deployed over a wire to create a gastrogastric or jejunogastric fistula. A duodenoscope was then passed through the LAMS and conventional ERCP was performed. Main Outcome Measurements Technical and clinical success rates as well as adverse events. Results EUS-guided creation of a gastrogastric or jejunogastric fistula via placement of a LAMS was successful in all cases (100%). The ability to perform ERCP through the fashioned fistula during the index procedure was successful in 3 of 5 cases (60%). Two LAMS dislodgments requiring restenting were observed. No major adverse events were observed. No weight regain occurred. The median procedure time was 68.0 minutes. Limitations Small sample, single-institution experience. Conclusion The internal EDGE procedure may offer a cost-effective, minimally invasive option for a common problem in a growing patient demographic. Further refinement of the technique is required to minimize adverse events. (Clinical trial registration number: NCT01522573 .) [ABSTRACT FROM AUTHOR]