Digital Single-operator Cholangioscopy (DSOC) Improves Interobserver Agreement (IOA) and Accuracy for Evaluation of Indeterminate Biliary Strictures: The Monaco Classification.

BACKGROUND: Visual characteristics seen during digital single-operator cholangioscopy (DSOC) have not been validated. The aim of this 2-phase study was to define terminology by consensus for the visual diagnosis of biliary lesions to develop a model for optimization of the diagnostic performance of DSOC. MATERIALS AND METHODS: In phase 1 (criteria identification), video-cholangioscopy clips were reviewed by 12 expert biliary endoscopists, who were blinded to the final diagnosis. Visual criteria were consolidated into the following categories: (1) stricture, (2) lesion, (3) mucosal features, (4) papillary projections, (5) ulceration, (6) abnormal vessels, (7) scarring, (8) pronounced pit pattern.During the second phase (validation), 14 expert endoscopists reviewed DSOC (SpyGlass DS, Boston Scientific) clips using the 8 criteria to assess interobserver agreement (IOA) rate. RESULTS: In phase 1, consensus for visual findings were categorized into 8 criteria titled the "Monaco Classification." The frequency of criteria were: (1) presence of stricture-75%, (2) presence of lesion type-55%, (3) mucosal features-55%, (4) papillary projections-45%, (5) ulceration-42.5%, (6) abnormal vessels-10%, (7) scarring-40%, and (8) pronounced pit pattern-10%. The accuracy on final diagnosis based on visual impression alone was 70%.In phase 2, the IOA rate using Monaco Classification criteria ranged from slight to fair. The presumptive diagnosis IOA was fair (κ=0.31, SE=0.02), and overall diagnostic accuracy was 70%. CONCLUSIONS: The Monaco classification identifies 8 visual criteria for biliary lesions on single-operator digital cholangioscopy. Using the criteria, the IOA and diagnostic accuracy rate of DSOC is improved compared with prior studies.

EUS-guided drainage of pancreatic fluid collections using lumen apposing metal stents: An international, multicenter experience.

INTRODUCTION: 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. METHODS: 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. RESULTS: 192 patients were included (140 males (72.9%), mean-age 53.8 years), with mean follow-up of 4.2 months ±â€¯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. CONCLUSION: 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.

Peroral endoscopic myotomy as salvation technique post-Heller: International experience.

BACKGROUND: Treatment for achalasia has traditionally been Heller myotomy (HM). Despite its excellent efficacy rate, a number of patients remain symptomatic post-procedure. Limited data exist as to the best management for recurrence of symptoms post-HM. We present an international, multicenter experience evaluating the efficacy and safety of post-HM peroral endoscopic myotomy (POEM). METHODS: Patients who underwent POEM post-HM from 13 centers from January 2012 to January 2017 were included as part of a prospective registry. Technical success was defined as successful completion of the myotomy. Clinical success was defined as an Eckardt score of ≤3 on 12-month follow up. Adverse events (AE) including anesthesia-related, operative, and postoperative complications were recorded. RESULTS: Fifty-one patients were included in the study (mean age 54.2, 47% male). Technical success was achieved in 100% of patients. Clinical success on long-term follow up was achieved in 48 patients (94%), with a mean change in Eckardt score of 6.25. Seven patients (13%) had AE: six experienced periprocedural mucosal defect treated endoscopically and two patients developed mediastinitis treated conservatively. CONCLUSION: For patients with persistent symptoms after HM, POEM is a safe salvation technique with good short-term efficacy. As a result of the challenge associated with repeat HM, POEM might become the preferred technique in this patient population. Further studies with longer follow up are needed.

EUS-guided Versus Percutaneous Gallbladder Drainage: Isn't It Time to Convert?

BACKGROUND AND AIMS: Endoscopic ultrasound-guided drainage (EUS-GLB) is a minimally invasive option for patients with cholecystitis who are poor surgical candidates. Compared with percutaneous drainage (PC-GLB), earlier studies have demonstrated similar efficacy with improved quality of life. We present a multicenter, international experience comparing PC-GLB and EUS-GLB in nonsurgical patients with cholecystitis. METHODS: All patients who underwent either PC-GLB drainage or EUS-GLB drainage from 7 centers between January 2010 and December 2015 were included. Technical success was defined as successful placement of a catheter or stent into the gallbladder. Clinical success was defined as resolution of clinical symptoms after intervention. Adverse events, length of stay, and the need for repeat interventions and/or hospitalizations were recorded for all patients. RESULTS: A total of 155 patients were included (mean age 74±14.24 y; range, 31 to 96; 56% male). Forty-two patients underwent EUS-GLB and 113 patients underwent PC-GLB. Technical success was achieved in 40 patients (95%) in the EUS-GLB group and 112 patients (99%) in the PC-GLB group (P=0.179). Clinical success was achieved in 40 patients (95%) in the EUS-GLB group and 97 patients (86%) in the PC-GLB group (P=0.157). There was no difference in hospital readmission rates between the 2 groups (14% vs. 24%; P=0.194). However, there was significantly higher number of patients requiring repeat interventions in the PC-GLB group (n=28, 24%) compared with the EUS-GLB group (n=4, 10%) (P=0.037). There was no difference in adverse events between the 2 groups. CONCLUSIONS: EUS-GLB is safe and efficacious, with comparable technical and clinical success rates and no difference in adverse events. In addition, EUS-GLB offers a potential cost-saving benefit and morbidity benefit by demonstrating a decreased number of repeat interventions.

GeNET: a web application to explore and share Gene Co-expression Network Analysis data.

Gene Co-expression Network Analysis (GCNA) is a popular approach to analyze a collection of gene expression profiles. GCNA yields an assignment of genes to gene co-expression modules, a list of gene sets statistically over-represented in these modules, and a gene-to-gene network. There are several computer programs for gene-to-gene network visualization, but these programs have limitations in terms of integrating all the data generated by a GCNA and making these data available online. To facilitate sharing and study of GCNA data, we developed GeNET. For researchers interested in sharing their GCNA data, GeNET provides a convenient interface to upload their data and automatically make it accessible to the public through an online server. For researchers interested in exploring GCNA data published by others, GeNET provides an intuitive online tool to interactively explore GCNA data by genes, gene sets or modules. In addition, GeNET allows users to download all or part of the published data for further computational analysis. To demonstrate the applicability of GeNET, we imported three published GCNA datasets, the largest of which consists of roughly 17,000 genes and 200 conditions. GeNET is available at bengi.cs.mun.ca/genet.

EUS-guided Gastrojejunostomy Versus Laparoscopic Gastrojejunostomy: An International Collaborative Study.

INTRODUCTION: Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) with placement of a lumen-apposing metal stent is a minimally invasive and efficacious procedure for gastric outlet obstruction (GOO) patients not amenable to surgery. Laparoscopic gastrojejunostomy (Lap-GJ) has traditionally been the standard of care. No direct comparison between EUS-GJ and Lap-GJ has been described. Our aim was to compare the clinical outcomes, success rate, and adverse events (AE) of EUS-GJ with Lap-GJ. METHODS: Patients with GOO from 4 academic centers in 3 countries were included. Technical success was defined as successful creation of a gastrojejunostomy. Clinical success was defined as the ability to tolerate a diet postprocedure. RESULTS: Data were collected on 54 patients. A total of 25 patients underwent EUS-GJ (male n=11, mean age 63.9 y) and 29 patients underwent Lap-GJ (male n=22, mean age 75.8 y). Technical success was achieved in 29 (100%) Lap-GJ group patients and 23 (88%) in the EUS-GJ group (P=0.11). AEs occurred in 41% (n=12) of patients in the Lap-GJ group and 12% (n=3) in the EUS-GJ group (P=0.0386). According to the Clavien-Dindo Classification, the Lap-GJ group AEs were grade I (n=4), grade II (n=5), grade III (n=2), and grade V (n=1); the EUS-GJ AEs were grade II (n=2) and grade V (n=1). CONCLUSIONS: Although the EUS-GJ group contained more complex patients, efficacy was similar between the groups. AEs were significantly lower in the EUS-GJ group. EUS-GJ is a safe and efficacious, minimally invasive option for patients with GOO.

Endoscopic Sleeve Gastroplasty Significantly Reduces Body Mass Index and Metabolic Complications in Obese Patients.

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/m2 and had failed noninvasive weight-loss measures or had a BMI greater than 40 kg/m2 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/m2. 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.

A multicenter international registry of redo per-oral endoscopic myotomy (POEM) after failed POEM.

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.).

Endoscopic Therapy With Lumen-apposing Metal Stents Is Safe and Effective for Patients With Pancreatic Walled-off Necrosis.

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.

EUS-guided biliary drainage after failed ERCP: a novel algorithm individualized based on patient anatomy.

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.).

Endoscopic ultrasound-guided biliary drainage versus percutaneous transhepatic biliary drainage: predictors of successful outcome in patients who fail endoscopic retrograde cholangiopancreatography.

BACKGROUND: Patients with failed endoscopic retrograde cholangiopancreatography (ERCP) are conventionally offered percutaneous transhepatic biliary drainage (PTBD). While PTBD is effective, it is associated with catheter-related complications, pain, and poor quality of life. Endoscopic ultrasound-guided biliary drainage (EUS-BD) is a minimally invasive endoscopic option increasingly offered as an alternative to PTBD. We compare outcomes of EUS-BD and PTBD in patients with biliary obstruction at a single tertiary care center. METHODS: A retrospective review was performed in patients with biliary obstruction who underwent EUS-BD or PTBD after failed ERCP from June 2010 through December 2014 at a single tertiary care center. Patient demographics, procedural data, and clinical outcomes were documented for each group. The aim was to compare efficacy and safety of EUS-BD and PTBD and evaluate predictors of success. RESULTS: A total of 60 patients were included (mean age 67.5 years, 65 % male). Forty-seven underwent EUS-BD, and thirteen underwent PTBD. Technical success rates of PTBD and EUS-BD were similar (91.6 vs. 93.3 %, p = 1.0). PTBD patients underwent significantly more re-interventions than EUS-BD patients (mean 4.9 versus 1.3, p < 0.0001), had more late (>24-h) adverse events (53.8 % vs. 6.6 %, p = 0.001) and experienced more pain (4.1 vs. 1.9, p = 0.016) post-procedure. In univariate analysis, clinical success was lower in the PTBD group (25 vs. 62.2 %, p = 0.03). In multivariable logistic regression analysis, EUS-BD was the sole predictor of clinical success and long-term resolution (OR 21.8, p = 0.009). CONCLUSION: Despite similar technical success rates compared to PTBD, EUS-BD results in a lower need for re-intervention, decreased rate of late adverse events, and lower pain scores, and is the sole predictor for clinical success and long-term resolution. EUS-BD should be the treatment of choice after a failed ERCP.

Optical coherence tomography (OCT) prior to peroral endoscopic myotomy (POEM) reduces procedural time and bleeding: a multicenter international collaborative study.

BACKGROUND: Per-oral endoscopic myotomy (POEM) has emerged as an endoscopic treatment of achalasia. There are no pre-procedural imaging modalities to predict the safest and the most efficacious approach. AIM: To evaluate the use of optimal coherence tomography (OCT) in providing a pre-procedural esophageal assessment. METHODS: Patients undergoing POEM from July 2013 to November 2015 were captured in a multicenter, international registry. Patients who underwent OCT pre-POEM ("OCT arm") were compared to patients without pre-POEM OCT ("control arm"). OCT images were assessed for the degree of vascularity and the thickness of the circular muscular layer, and an approach was determined. RESULTS: A total of 84 patients were captured in the registry. Fifty-one patients underwent pre-POEM OCT. Using OCT as a guide, 24 (47 %) of patients underwent anterior POEM while 27 (53 %) underwent posterior POEM. Technical success was achieved in 96 % of patients. Significantly less bleeding occurred in the OCT arm when compared to the control group [4 (8 %) vs. 14 (43 %), p = 0.0001]. As a result, procedural time was significantly lower in the OCT group as compared to the control group (85.8 vs. 121.7 min, p = 0.000097). CONCLUSION: Pre-POEM OCT results in a reduction in procedural bleeding which contributes to a reduction in overall procedural time. CLINICAL TRIAL REGISTRATION: NCT01438385.

Gaps in recognition and evaluation of incidentally identified hepatic steatosis.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD), the most common cause of liver disease, is frequently diagnosed incidentally on imaging. The goal of the present study was to characterize rates of documentation and evaluation of incidentally identified steatosis. METHODS: Adults who underwent abdominal computed tomography with incidentally reported steatosis from January 2008 to October 2011 and with ≥1 primary care appointment within 14 months following imaging were included. RESULTS: One hundred twenty-seven individuals with newly identified steatosis on imaging were included. Medical record documentation of newly identified steatosis occurred in only 29 individuals (22.8 %). Mention of steatosis within the "impression" section of radiology reports in addition to the report body was associated with significantly higher likelihood of primary care documentation (p = 0.007). Primary care documentation of steatosis was associated higher rates of evaluation for the etiology of steatosis include testing of aminotransferase levels (96.5 vs. 77.5 %, p = 0.025), alcohol use screening (89.6 vs. 66.3 %, p = 0.02), and hepatitis C screening (20.6 vs. 2.0 %, p = 0.002). No patient had documentation of the NAFLD fibrosis score and none were referred for specialist evaluation or for liver biopsy. However, when calculated, the NAFLD fibrosis score identified 14 patients (11 %) as high risk for advanced hepatic fibrosis. CONCLUSION: Documentation of incidentally identified steatosis is infrequent but was improved when steatosis was mentioned in the "impression" of radiographic reports. Documentation of steatosis was associated with increased rates of aminotransferase testing and alcohol use and hepatitis C screening. An important proportion of individuals with incidentally identified steatosis are at high risk of fibrosis and may benefit from additional evaluation.