Endoscopy Ultrasound-Guided Biliary Drainage Using Lumen Apposing Metal Stent in Malignant Biliary Obstruction.

This narrative review provides an overview of the application of endoscopic ultrasound-guided biliary drainage (EUS-BD), including EUS-guided gallbladder drainage (EUS-GBD), for the treatment of malignant biliary obstruction. EUS-BD has demonstrated excellent technical and clinical success rates, with lower rates of adverse events when compared with percutaneous trans-hepatic biliary drainage (PTBD). EUS-BD is currently the preferred alternative technique for biliary drainage (BD) in patients with distal malignant biliary obstruction (DMBO) after failed endoscopic retrograde cholangiopancreatography (ERCP). Particularly, this review will focus on EUS-BD performed with the use of lumen apposing metal stent (LAMS). The introduction of these innovative devices, followed by the advent of electrocautery-enhanced LAMS (EC-LAMS), gave the procedure a great technical implementation and a widespread application.

Noninvasive Assessment of Postoperative Disease Recurrence in Crohn's Disease: A Multicenter, Prospective Cohort Study on Behalf of the Italian Group for Inflammatory Bowel Disease.

BACKGROUND & AIMS: Colonoscopy (CS) is the gold standard to assess postoperative recurrence (POR) in Crohn's disease (CD). However, CS is invasive and may be poorly tolerated by patients. The aim of this study was to prospectively assess the diagnostic accuracy of a noninvasive approach in detecting POR, using the endoscopic Rutgeerts' score (RS) as the reference standard. METHODS: Consecutive patients with CD who underwent ileo-cecal resection were prospectively enrolled in 3 referral Italian centers. Patients underwent CS and bowel ultrasound within 1 year of surgery. Uni- and multivariable analyses were used to assess the correlation between noninvasive parameters and endoscopic recurrence, defined by a RS ≥2. RESULTS: Ninety-one patients were enrolled. Sixty patients (66%) experienced endoscopic POR. The multivariable analysis identified bowel wall thickness (BWT) per 1-mm increase (odds ratio [OR], 2.43; 95% confidence interval [CI], 1.21-4.89; P = .012), the presence of mesenteric lymph nodes (OR, 15.63; 95% CI, 1.48-164.54; P = .022), and fecal calprotectin (FC) values ≥50 mcg/g (OR, 8.58; 95% CI, 2.45-29.99; P < .001) as independent predictors for endoscopic recurrence. The presence of lymph nodes or the combination of BWT ≥3 mm and FC values ≥50 mcg/g correctly classified 56% and 75% of patients, with less than 5% of patients falsely classified as having endoscopic recurrence. Conversely, the combination of BWT <3 mm and FC <50 mcg/g correctly classified 74% of patients with only 4.5% of patients falsely classified as not having endoscopic recurrence. CONCLUSIONS: A noninvasive approach combining bowel ultrasound and FC can be used with confidence for detecting POR in patients with CD without the requirement for CS.

Tumor-associated macrophages and risk of recurrence in stage III colorectal cancer.

Tumor-associated macrophages (TAMs) have a unique favorable effect on the prognosis of colorectal cancer (CRC), although their association with stage-specific outcomes remains unclear. We assessed the densities of CD68+ and CD163+ TAMs at the invasive front of resected CRC stage III CRC from 236 patients, 165 of whom received post-surgical FOLFOX treatment, and their relationship with disease-free survival (DFS). Associations between macrophage mRNAs and clinical outcome were investigated in silico in 59 stage III CRC and FOLFOX-treated patients from The Cancer Genome Atlas (TCGA). Biological interactions of SW480 and HT29 cells and macrophages with FOLFOX were tested in co-culture models. Low TAM densities were associated with shorter DFS among patients receiving FOLFOX (CD68+ , p = 0.0001; CD163+ , p = 0.0008) but not among those who were untreated. By multivariate Cox analysis, only low TAM (CD68+ , p = 0.001; CD163+ , p = 0.002) and nodal status (CD68+ , p = 0.009; CD163+ , p = 0.007) maintained an independent predictive value. In the TCGA cohort, high CD68 mRNA levels were associated with better outcome (p = 0.02). Macrophages enhanced FOLFOX cytotoxicity on CRC cells (p < 0.01), and drugs oriented macrophage polarization from M2- to M1-phenotype. Low TAM densities identify stage III CRC patients at higher risk of recurrence after adjuvant therapy, and macrophages can augment the chemo-sensitivity of micro-metastases.

Predictive value of Milan ultrasound criteria in ulcerative colitis: A prospective observational cohort study.

BACKGROUND: Endoscopic healing is an established treatment target for ulcerative colitis (UC). We have recently validated the Milan ultrasound criteria (MUC) to assess endoscopic activity in UC; a MUC score > 6.2 is a valid cut-off to discriminate endoscopic activity (Mayo endoscopic subscore > 1). OBJECTIVE: The aim of this study was to assess the predictive value of MUC on disease course in a prospective cohort of UC patients. METHODS: UC patients regardless of disease activity and current therapy, underwent colonoscopy and bowel ultrasound (US) at baseline in a blinded fashion. Correlations between baseline MUC and Mayo endoscopic subscore were assessed using Spearman's rank correlation. UC-related negative course (defined as the need for corticosteroids, or treatment escalation, or hospitalization, or need for colectomy: a composite outcome) over a median 20 months follow-up, was investigated using the Kaplan-Meier method and Cox regression analysis. RESULTS: 98 UC patients were followed up for a median time of 1.6 years (IQR 0.9¬2.7). Milan ultrasound criteria and Mayo endoscopic subscore significantly correlated at baseline (ρ = 0.653; p < 0.001). 70 patients (71%) had negative disease course during the follow-up period. Milan ultrasound criteria > 6.2 at baseline was statistically significantly associated with negative disease course (HR: 3.87, 95% CI: 2.25-6.64, p < 0.001). Kaplan-Meier analyses drawed a statistically significantly lower cumulative probability of treatment escalation, need of corticosteroids, hospitalization and colectomy, among patients who had MUC ≤ 6.2 at baseline as compared to patients with MUC > 6.2 (p < 0.05 for all outcomes). CONCLUSION: we have demonstrated for the first time the value of bowel US and an US score in predicting disease course in UC. Milan ultrasound criteria, a validated US-based score, predicts disease course in UC. Milan ultrasound criteria ≤ 6.2 may be the new treatment target to achieve to reduce the risk of worse outcomes.

Cross-Sectional Imaging Instead of Colonoscopy in Inflammatory Bowel Diseases: Lights and Shadows.

International guidelines recommend a treat-to-target strategy with a close monitoring of disease activity and therapeutic response in inflammatory bowel diseases (IBD). Colonoscopy (CS) represents the current first-line procedure for evaluating disease activity in IBD. However, as it is expensive, invasive and poorly accepted by patients, CS is not appropriate for frequent and repetitive reassessments of disease activity. Recently, cross-sectional imaging techniques have been increasingly shown as reliable tools for assessing IBD activity. While computed tomography (CT) is hampered by radiation risks, routine implementation of magnetic resonance enterography (MRE) for close monitoring is limited by its costs, low availability and long examination time. Novel magnetic resonance imaging (MRI)-based techniques, such as diffusion-weighted imaging (DWI), can overcome some of these weaknesses and have been shown as valuable options for IBD monitoring. Bowel ultrasound (BUS) is a noninvasive, highly available, cheap, and well accepted procedure that has been demonstrated to be as accurate as CS and MRE for assessing and monitoring disease activity in IBD. Furthermore, as BUS can be quickly performed at the point-of-care, it allows for real-time clinical decision making. This review summarizes the current evidence on the use of cross-sectional imaging techniques as cost-effective, noninvasive and reliable alternatives to CS for monitoring patients with IBD.

Sporadic non-ampullary duodenal adenomas: efficacy and outcomes of endoscopic resection.

BACKGROUND AND AIMS: Sporadic non-ampullary duodenal adenomas (SNDAs) are often referred to tertiary centers because of the challenges in endoscopic resection. There is a paucity of data on both technical and clinical outcomes. The aim of our study was to evaluate the efficacy and safety of endoscopic resection for the treatment of SNDA in two western centers. METHODS: This is a retrospective study reporting data of a cohort of patients referred for resection of SNDA between 2013 and 2017. Patients with familial adenomatous polyposis or ampullary lesions were excluded from present analysis. Outcomes considered for this study were technical success, adverse events, recurrence and need for surgery. RESULTS: 120 patients (mean age 66 ± 11.9 years, 64male) were enrolled in the study. Mean size of the lesions was 23.3 mm (range 5-80). Fifty-six en-bloc endoscopic mucosal resection (EMR) (46.6%), 41 piecemeal EMR (pEMR) and 23 endoscopic submucosal dissection were performed. Intra-procedural perforation was observed in 4 patients (3.3%). Fourteen post-procedural (11.6%) adverse events were recorded. All post-procedural perforations occurred in lesions > 30 mm. Recurrence was observed in 11 patients (9.5%) during a mean follow-up of 29 months. All recurrences were successfully managed endoscopically. 119 patients were still alive at last follow-up. CONCLUSION: Endoscopic resection can be successfully carried out in majority of patients. Size > 30 mm seems to be the predictor of high adverse events risk.

Predictive Value of Bowel Ultrasound in Crohn's Disease: A 12-Month Prospective Study.

BACKGROUND & AIMS: Mucosal healing is associated with better outcomes in Crohn's disease (CD). Colonoscopy is invasive and poorly tolerated. Bowel ultrasound (US) is a noninvasive tool that increasingly is being used for CD assessment. We assessed the predictive role of baseline bowel US findings on disease course in a large prospective cohort of CD patients for 12 months. METHODS: Ileocolonic CD consecutive patients were followed up for 12 months after performing bowel US. The negative course of CD, defined as the need for steroids and/or change of therapy and/or hospitalization and/or the need for surgery, was assessed. We evaluated this composite end point and subsequently considered each individual end point separately. Predictors of negative disease course were analyzed by logistic regression analysis. RESULTS: There were 225 ileal and/or colonic CD consecutive patients included in the study. We analyzed the association between baseline bowel US parameters and endoscopic activity (defined as a Simplified Endoscopic Activity score for CD > 2) to set up a noninvasive quantitative ultrasound-based score (bowel ultrasound score). The multivariable analysis identified the following independent predictors of a worse outcome throughout the 12-month period as follows: bowel ultrasound score greater than 3.52 (odds ratio [OR], 6.97; 95% CI, 2.87-16.93; P < .001), presence of at least 1 disease complication (stricture, fistula, abscess) at baseline bowel US (OR, 3.90; 95% CI, 1.21-12.53; P = .021), fecal calprotectin value of 250 µg/g or greater at baseline (OR, 5.43; 95% CI, 2.25-13.11; P < .001), and male sex (OR, 2.60; 95% CI, 1.12-6.02; P = .025). CONCLUSIONS: Bowel US predicts the 12-month course in CD.

Bowel ultrasound score is accurate in assessing response to therapy in patients with Crohn's disease.

BACKGROUND: We developed a non-invasive bowel ultrasound score (BUSS) to assess disease activity in Crohn's disease (CD). BUSS >3.52 is an indicator of endoscopic activity (SES-CD>2). AIM: To assess whether BUSS, in addition to detecting inflammatory lesions, also detects relevant changes of these lesions over time. METHODS: This was a prospective observational study of 49 patients with active CD. All patients underwent bowel ultrasound and colonoscopy at baseline and at re-assessment after treatment with biologics and/or immunosuppressants. The primary objective was to assess the sensitivity to change of BUSS in patients treated for active CD, using the SES-CD as reference standard. RESULTS: BUSS changed significantly from baseline to re-assessment in patients achieving endoscopic response (a reduction of SES-CD of at least 50% vs baseline: 4.87 [3.78-6.0] vs 2.47 [2.25-3.36], P < 0.001) and endoscopic remission (SES-CD ≤ 2: 4.65 [3.58-6.03] vs 2.25 [2.25-3.46], P = 0.003). A change of -1.2 in BUSS over time predicted endoscopic response (AUC 0.786, 95% CI 0.645-0.890; sensitivity 74%, specificity 83%). BUSS determined endoscopic response with 80% accuracy, and endoscopic remission with 78% accuracy. BUSS accurately detected changes in lesion severity (Guyatt score: 1.41 and standardized effect score: 1.74). BUSS did not change significantly in patients who did not achieve endoscopic response (5.62 [5.26-6.15] vs 5.70 [4.97-6.19], P = 0.53) or endoscopic remission (5.62 [5.18-6.14] vs 5.10 [4.58-6.05]; P = 0.10). CONCLUSION: BUSS is sensitive to change in CD.

Viral infections in inflammatory bowel disease: Tips and tricks for correct management.

Over the past decades, the treatment of inflammatory bowel diseases (IBD) has become more targeted, anticipating the use of immune-modifying therapies at an earlier stage. This top-down approach has been correlated with favorable short and long-term outcomes, but it has also brought with it concerns regarding potential infectious complications. This large IBD population treated with immune-modifying therapies, especially if combined, has an increased risk of severe infections, including opportunistic infections that are sustained by viral, bacterial, parasitic, and fungal agents. Viral infections have emerged as a focal safety concern in patients with IBD, representing a challenge for the clinician: they are often difficult to diagnose and are associated with significant morbidity and mortality. The first step is to improve effective preventive strategies, such as applying vaccination protocols, adopt adequate prophylaxis and educate patients about potential risk factors. Since viral infections in immunosuppressed patients may present atypical signs and symptoms, the challenges for the gastroenterologist are to suspect, recognize and diagnose such complications. Appropriate treatment of common viral infections allows us to minimize their impact on disease outcomes and patients' lives. This practical review supports this standard of care to improve knowledge in this subject area.

Risk Stratification of Cholangiocarcinoma Patients Presenting with Jaundice: A Retrospective Analysis from a Tertiary Referral Center.

Cholangiocarcinomas (CCAs) are a heterogeneous group of tumors that arise from the biliary tract. Jaundice is a common clinical presentation; however, the prognostic impact of this symptom is poorly understood, and current management recommendations lack solid evidence. We aim to assess the clinical outcomes and predictive factors of CCA patients presenting with jaundice in the Emergency Room (ER). We retrospectively analyzed all consecutive ER cases presenting with jaundice between January 2010 and December 2017. During the study period, 403,766 patients were admitted to the ER, 1217 (0.3%) presented with jaundice, and in 200 (0.049%), the diagnosis was CCA. CCA cases increased during the study period (p for trend 0.026). Most of them presented with advance disease (stage III 46.5%, stage IV 43.5%) and median survival was 4.5 months (95% CI 3.4-6.0). Factors associated with better survival were age, stage of disease, presence of jaundice at the moment of diagnosis, and lack of concomitant viral hepatitis. A nomogram was constructed that significantly predicts 1-month, 6-month, and 1-year survival after patients' admission. In conclusion, the majority of CCA patients presenting with jaundice to the ER have advanced disease and poor prognosis. Risk stratification of these patients can allow tailored management.

Risk of Covert Submucosal Cancer in Patients With Granular Mixed Laterally Spreading Tumors.

BACKGROUND AND AIMS: Granular mixed laterally spreading tumors (GM-LSTs) have an intermediate level of risk for submucosal invasive cancer (SMICs) without clear signs of invasion (covert); the optimal resection method is uncertain. We aimed to determine the risk of covert SMIC in GM-LSTs based on clinical and endoscopic factors. METHODS: We collected data from 693 patients (50.6% male; median age, 69 years) with colorectal GM-LSTs, without signs of invasion, who underwent endoscopic resection (74.2%) or endoscopic submucosal dissection (25.2%) at 7 centers in Italy from 2016 through 2019. We performed multivariate and univariate analyses to identify demographic and endoscopic factors associated with risk of SMIC. We developed a multivariate model to calculate the number needed to treat (NNT) to detect 1 SMIC. RESULTS: Based on pathology analysis, 66 patients (9.5%) had covert SMIC. In multivariate analyses, increased risk of covert SMIC were independently associated with increasing lesion size (odds ratio per mm increase, 1.02, 95% CI, 1.01-1.03; P = .003) and rectal location (odds ratio, 3.08; 95% CI, 1.62-5.83; P = .004). A logistic regression model based on lesion size (with a cutoff of 40 mm) and rectal location identified patients with covert SMIC with 47.0% sensitivity, 82.6% specificity, and an area under the curve of 0.69. The NNT to identify 1 patient with a nonrectal SMIC smaller than 4 cm was 20; the NNT to identify 1 patient with a rectal SMIC of 4 cm or more was 5. CONCLUSIONS: In an analysis of data from 693 patients, we found the risk of covert SMIC in patients with GM-LSTs to be approximately 10%. GM-LSTs of 4 cm or more and a rectal location are high risk and should be treated by en-bloc resection. ClinicalTrials.gov, Number: NCT03836131.

Application of Ultrasound Elastography for Assessing Intestinal Fibrosis in Inflammatory Bowel Disease: Fiction or Reality?

BACKGROUND: Intestinal fibrosis and subsequent strictures represent an important burden in inflammatory bowel disease (IBD). Both the detection and evaluation of the degree of fibrosis in stricturing Crohn's disease (CD) are important when deciding the best therapeutic strategy (medical anti-inflammatory therapy, endoscopic dilation, surgery). Ultrasound elastography (USE) is a non-invasive technique that has been proposed in the field of IBD for evaluating intestinal stiffness as a biomarker of intestinal fibrosis. OBJECTIVE: The aim of this review is to discuss the ability and current role of ultrasound elastography in the assessment of intestinal fibrosis. RESULTS AND CONCLUSION: Data on USE in IBD are provided by pilot and proof-of-concept studies with small sample size. The first type of USE investigated was strain elastography, while shear wave elastography has been introduced recently. Despite the heterogeneity of the methods of the studies, USE has been proven to be able to assess intestinal fibrosis in patients with stricturing CD. However, before introducing this technique in current practice, further studies with larger sample sizes are needed. In addition, the use of homogeneous parameters, the assessment of reproducibility, and the identification of validated cut-off values are essential.

Computer-aided detection-assisted colonoscopy: classification and relevance of false positives.

BACKGROUND AND AIMS: False positive (FP) results by computer-aided detection (CADe) hamper the efficiency of colonoscopy by extending examination time. Our aim was to develop a classification of the causes and clinical relevance of CADe FPs, and to assess the relative distribution of FPs in a real-life setting. METHODS: In a post-hoc analysis of a randomized trial comparing colonoscopy with and without CADe (NCT: 04079478), we extracted 40 CADe colonoscopy videos. Using a modified Delphi process, 4 expert endoscopists identified the main domains for the reasons and clinical relevance of FPs. Then, 2 expert endoscopists manually examined each FP and classified it according to the proposed domains. The analysis was limited to the withdrawal phase. RESULTS: The 2 main domains for the causes of CADe FPs were identified as artifacts due to either the mucosal wall or bowel content, and clinical relevance was defined as the time spent on FPs and the FP rate per minute. The mean number of FPs per colonoscopy was 27.3 ± 13.1, of which 24 ± 12 (88%) and 3.2 ± 2.6 (12%) were due to artifacts in the bowel wall and bowel content, respectively. Of the 27.3 FPs per colonoscopy, 1.6 (5.7%) required additional exploration time of 4.8 ± 6.2 seconds per FP (ie, 0.7% of the mean withdrawal time). In detail, 15 (24.2%), 33 (53.2%), and 14 (22.6%) FPs were classified as being of mild, moderate, or severe clinical relevance. The rate of FPs per minute of withdrawal time was 2.4 ± 1.2, and was higher for FPs due to artifacts from the bowel wall than for those from bowel content (2.4 ± 0.6 vs 0.3 ± 0.2, P < .001). CONCLUSIONS: FPs by CADe are primarily due to artifacts from the bowel wall. Despite a high frequency, FPs result in a negligible 1% increase in the total withdrawal time because most of them are immediately discarded by the endoscopist.

Targeting the gut layers in Crohn's disease: mucosal or transmural healing?

INTRODUCTION: Although the landmark of Crohn's Disease (CD) is the transmural inflammation, mucosal healing (MH), which is assessed by colonoscopy, is currently the gold standard of CD management. Transmural healing (TH) is a new concept evaluated by cross-sectional imaging (CSI) techniques, such as bowel ultrasound (US), computed tomography enterography (CTE), and magnetic resonance enterography (MRE). Little is known about the clinical significance of persisting mural disease and the predictive value of complete TH. AREAS COVERED: The authors reviewed the available literature on TH and its meaning as predictor of long-term outcomes in CD, to explore if TH may be a better target compared to MH in CD patients, in terms of disease outcome, such as medication changes, hospitalization, or surgery. EXPERT OPINION: Some evidence suggests that achieving TH has a predictive value in CD management and correlates with better disease outcome than MH, although existing studies are few and with limitations. A definitive definition of TH is not yet established and the frequency or the preferred modality of TH evaluation remains unclear. Implementing TH in treat-to-target approach may enable stricter disease monitoring with noninvasive methods and finally change the disease course, preventing irreversible bowel damage.

Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial.

BACKGROUND & AIMS: One-fourth of colorectal neoplasias are missed during screening colonoscopies; these can develop into colorectal cancer (CRC). Deep learning systems allow for real-time computer-aided detection (CADe) of polyps with high accuracy. We performed a multicenter, randomized trial to assess the safety and efficacy of a CADe system in detection of colorectal neoplasias during real-time colonoscopy. METHODS: We analyzed data from 685 subjects (61.32 ± 10.2 years old; 337 men) undergoing screening colonoscopies for CRC, post-polypectomy surveillance, or workup due to positive results from a fecal immunochemical test or signs or symptoms of CRC, at 3 centers in Italy from September through November 2019. Patients were randomly assigned (1:1) to groups who underwent high-definition colonoscopies with the CADe system or without (controls). The CADe system included an artificial intelligence-based medical device (GI-Genius, Medtronic) trained to process colonoscopy images and superimpose them, in real time, on the endoscopy display a green box over suspected lesions. A minimum withdrawal time of 6 minutes was required. Lesions were collected and histopathology findings were used as the reference standard. The primary outcome was adenoma detection rate (ADR, the percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy, non-neoplastic resection rate, and withdrawal time. RESULTS: The ADR was significantly higher in the CADe group (54.8%) than in the control group (40.4%) (relative risk [RR], 1.30; 95% confidence interval [CI], 1.14-1.45). Adenomas detected per colonoscopy were significantly higher in the CADe group (mean, 1.07 ±1.54) than in the control group (mean 0.71 ± 1.20) (incidence rate ratio, 1.46; 95% CI, 1.15-1.86). Adenomas 5 mm or smaller were detected in a significantly higher proportion of subjects in the CADe group (33.7%) than in the control group (26.5%; RR, 1.26; 95% CI, 1.01-1.52), as were adenomas of 6 to 9 mm (detected in 10.6% of subjects in the CADe group vs 5.8% in the control group; RR, 1.78; 95% CI, 1.09-2.86), regardless of morphology or location. There was no significant difference between groups in withdrawal time (417 ± 101 seconds for the CADe group vs 435 ± 149 for controls; P = .1) or proportion of subjects with resection of non-neoplastic lesions (26.0% in the CADe group vs 28.7% of controls; RR, 1.00; 95% CI, 0.90-1.12). CONCLUSIONS: In a multicenter, randomized trial, we found that including CADe in real-time colonoscopy significantly increases ADR and adenomas detected per colonoscopy without increasing withdrawal time. ClinicalTrials.gov no: 04079478.

Evaluation of Human Esophageal Epithelium Permeability in Presence of Different Formulations Containing Hyaluronic Acid and Chondroitin Sulphate.

PURPOSE: New medical devices that contain hyaluronic acid (HA) and chondroitin sulphate (CS), with or without antacid components, have been developed for the treatment of gastroesophageal reflux disease (GERD) with the aim of improving oesophageal mucosal defences by creating a film on the oesophageal mucosa and acting as a mechanical barrier against the noxious components of refluxate, both acidic and basic. METHODS: The film-forming and protective efficacy of medical device A based on HA and CS plus aluminium hydroxide, device B combining HA and CS with magnesium trisilicate and device C with only the combination of HA and CS was tested on a reconstructed human oesophageal epithelium (HO2E/S/5) as a biological model in 2 different pH environments, neutral and acidic, to mimic realistic conditions. Caffeine penetration kinetics and Lucifer yellow (LY) permeability modifications induced by these products were compared to those induced by a negative control series (saline solution, code NC) and positive control series (white Vaseline, code V) under neutral and acidic pH conditions. RESULTS: Under neutral and acidic pH conditions, compared to the negative control, all the products tested reduced (>80% and 85-90%, respectively) the caffeine passage, and no significant difference was observed among the products tested. Under neutral and acidic conditions, the LY permeabilities registered with device A and device C were not different from that registered with the negative control, while an LY flux% increase was calculated after 2 hrs of treatment (21.1%) with device B under acidic conditions. CONCLUSION: These results confirm the ability of the products tested to interact with the oesophageal epithelium in order to adhere and create a stable protective film for at least 2 hours after their homogeneous distribution on the epithelium surface. Further clinical studies are needed to test these devices in the topical treatment of gastroesophageal reflux symptoms.

Risk factors and clinical outcomes of endoscopic dilation in benign esophageal strictures: a long-term follow-up study.

BACKGROUND AND AIMS: Endoscopic dilation (ED) is still the mainstay of therapeutic management of benign esophageal strictures (BESs). This study aimed to establish risk factors for refractory BESs and assess long-term clinical outcomes of ED. METHODS: We performed a retrospective study in 891 patients who underwent ED from 2003 to 2018 for BESs. We searched electronic medical records in 6 tertiary care centers in the Netherlands for data on clinical outcome of ED. Median follow-up was 39 months. The primary endpoint was risk factors for refractory BESs, defined as factors associated with an increased number of ED sessions during follow-up. Secondary endpoints were time from first to last ED session and adverse events. RESULTS: Dilation up to 13 to 15 mm was associated with a higher number of ED sessions than dilation up to 16 to 18 mm (5.0 vs 4.1; hazard ratio [HR], 1.4; P = .001). Compared with peptic strictures, anastomotic (4.9 vs 3.6; HR, 2.1; P < .001), radiation (5.0 vs 3.6; HR, 3.0; P < .001), caustic (7.2 vs 3.6; HR, 2.7; P < .001), and postendotherapy (3.9 vs 3.6; HR, 1.8; P = .005) strictures were associated with a higher number of ED sessions. After 1 year of follow-up, the proportions of patients who remained free of ED was 75% in anastomotic, 71% in radiation, 70% in peptic, 83% in postendotherapy, and 62% in caustic strictures. Esophageal perforation occurred in 23 ED sessions (.4%) in 22 patients (2.4%). CONCLUSIONS: More than 60% of patients with BESs remain free of ED after 1 year of follow-up. Because dilation up to 16 to 18 mm diameter was associated with fewer ED sessions during follow-up, we suggest that clinicians should consider dilation up to at least 16 mm to reduce the number of ED sessions in these patients.

Multi-band mucosectomy for neoplasia in patients with Barrett's esophagus: in vivo comparison between two different devices.

BACKGROUND: Multi-band mucosectomy (MBM) is effective and safe for Barrett's neoplasia. No studies have yet compared the efficacy and safety of the MBM devices commercially available: Duette™ (CookMedical) and Captivator™ (BostonScientific). Our aim is to compare the two devices. METHODS: This is a dual-center retrospective case-control study (Rozzano, Portsmouth) comparing efficacy, safety, and histology of resected specimens between Duette™ (DUE) and Captivator™ (CAPT). Efficacy was assessed by R0 and local recurrence (LR) rate. Bleedings, perforations, and strictures were recorded as safety outcomes. Moreover, the specimens were re-examined by two pathologists, blinded about the study group, to assess the maximum thickness of both the whole specimens and the resected submucosal layer. RESULTS: Seventy-six patients (38 per group) were included. The two groups did not differ in terms of baseline characteristics. R0 resection was achieved in 96.7% versus 96.3% (p = ns) and LR were recorded in 4/38 (10.5%) versus 3/38 (7.9%) in DUE and CAPT group, respectively (p = ns). Considering Duette™ versus Captivator™, 2 versus 3 patients developed a symptomatic stricture. Only one post-procedural bleeding occurred (Captivator™). Maximum medium thicknesses of specimens and of resected submucosa did not differ between the groups. CONCLUSIONS: MBM is safe and effective for resecting visible lesions using either of the two available devices.