Assessment of Endoscopy-Based Scoring Systems for Prognostication in Ulcerative Colitis: A Comparative Analysis.

BACKGROUND AND OBJECTIVE: Endoscopy-based scoring systems, including Mayo Endoscopic Score (MES), Modified Mayo Endoscopic Score (MMES), and Degree of Ulcerative Colitis Burden of Luminal Inflammation (DUBLIN) Score, have been introduced to evaluate UC prognosis. This study aims to compare their predictive capacity for clinical outcomes in UC patients. METHODS: Consecutive UC patients from a tertiary hospital were included. The primary outcome was acute severe ulcerative colitis (ASUC), and secondary outcomes were UC-related admission, medication treatment escalation, disease extension and surgery. Predictive performance was assessed using receiver operating characteristic (ROC) curves. RESULTS: Among 300 patients, 15.3% developed ASUC. Robust correlations were observed among the three scoring systems and were with elevated serum inflammatory markers. The DUBLIN score exhibited superior predictive ability for UC-related admission (AUC 0.751; 95%CI 0.698-0.799) and medication treatment escalation (AUC 0.735; 95% CI 0.681-0.784). No statistical differences were found among three scoring systems for predicting ASUC, disease extension, and surgery. Employing respective cut-offs of 2, 11.25, and 3, higher MES (HR = 3.859, 95% CI 1.636-9.107, p = 0.002), MMES (HR = 3.352, 95% CI 1.879-5.980, p < 0.001), and DUBLIN score (HR = 5.619, 95% CI 2.378-13.277, p < 0.001) were associated with an increased risk of developing ASUC. CONCLUSION: The DUBLIN score, assessing the overall inflammatory burden of the intestinal tract, outperforms the MMES in predicting admission and medication treatment escalation related to UC. Its integration into clinical practice has the potential to enhance risk stratification for patients with UC.

Second branchial cleft fistula/sinus tract endoscopy: a novel intraoperative technique assisting complete surgical resection.

PURPOSE: Second branchial cleft (BC) sinus/fistula anomalies usually present in children. Their definitive management requires complete tract surgical excision, which necessities accurate extension assessment. Our aim is to propose and describe a novel intraoperative endoscopic technique that can help in evaluating the exact BC anomaly tract extension and overcome disadvantages of currently used methods including imaging and intraoperative methylene blue tract injection. METHODS: The innovative intraoperative endoscopic technique involves performing BC sinus/fistula tract intraluminal endoscopy utilizing miniature 1.3 or 1.6 mm all-in-one semi-rigid endoscopes as well as other accessory equipment currently available and used for sialendoscopy for delineation of exact tract extension followed by a complete standard surgical excision tailored to and assisted by the endoscopic procedure. RESULTS: This novel endoscopic technique was used successfully in five children (age range 8-16 years) presenting with unilateral or bilateral congenital second BC discharging fistula/sinus tracts in the neck. Intraoperative endoscopic assessment took 10-15 min and confirmed the exact tract extension and nature in all patients without complications. Five fistulas and two sinuses were identified and completely surgically resected. No recurrence has been observed after a median follow-up of 29 (range 13-45) months. CONCLUSION: Intraoperative second BC fistula/sinus tract endoscopy could help in accurately assessing anomaly extension, thereby assisting in complete surgical excision. This innovative novel endoscopic technique could avoid disadvantages of currently used methods, especially regarding radiation exposure required for imaging children in whom this anomaly usually presents.

Correlation between indocyanine green visualization time in the gastric tube and postoperative endoscopic assessment of the anastomosis after esophageal surgery.

PURPOSE: To evaluate the correlation between blood supply speed in the gastric tube (GT), assessed by the intraoperative indocyanine green (ICG) fluorescence method, and postoperative endoscopic assessment (PEA) of the anastomosis or anastomotic leakage (AL). METHODS: The subjects of this retrospective analysis were 66 consecutive patients who underwent GT reconstruction using ICG fluorescence during esophageal surgery. We measured the ICG visualization time, from ICG injection to visualization at the top of the GT. We performed PEA on 54 patients and classified ulcer formation as involving less than or more than half of the circumference. RESULTS: PEA revealed that nine patients (16.7%) had an anastomotic ulcer involving more than half of the circumference and ten (15.4%) had AL. The ICG visualization time in these patients was significantly delayed compared with that in those with less than half of the circumference involved by ulcer formation (37 s vs. 27 s; P = 0.015) and without AL (36 s vs. 28 s; P = 0.045). Multivariate analysis revealed that delay in the ICG visualization time (> 36 s) of the pulled-up GT (odds ratio, 6.098; 95% confidence interval, 1.125-33.024; P = 0.036) was an independent risk factor associated with AL. CONCLUSION: Delay in the ICG visualization time of pulled-up GT was associated with ulcer formation on the anastomosis and AL after esophageal surgery.

Variation in Endoscopic Activity Assessment and Endoscopy Score Validation in Adults With Eosinophilic Esophagitis.

BACKGROUND & AIMS: Eosinophilic esophagitis (EoE) is assessed endoscopically (endoscopic activity), based on grades of edema, rings, exudates, furrows, and strictures (EREFS). We examined variations in endoscopic assessments of severity, developed and validated 3 EREFS-based scoring systems, and assessed responsiveness of these systems using data from a randomized placebo-controlled trial of patients with EoE. METHODS: For the development set, 5 gastroenterologists reviewed EREFS findings from 266 adults with EoE and provided endoscopist global assessment scores (EndoGA, scale of 0 to 10); variation (ΔEndoGA) was assessed using linear regression. We evaluated simple scores (features given arbitrary values from 0 to 3) and developed 2 scoring systems (adjusted score range, 0-100). We then fitted our linear regression model with mean EndoGA to data from 146 adults recruited in centers in Switzerland and the United States between April 2011 and December 2012. For the validation set, we collected data from 120 separate adults (recruited in centers in Switzerland and the United States between May 2013 and July 2014), assessing regression coefficient-based scores using Bland-Altman method. We assessed the responsiveness of our scoring systems using data from a randomized trial of patients with EoE given fluticasone (n=16) or placebo (n=8). RESULTS: The distribution of EndoGA values differed among endoscopists (mean ΔEndoGA, 2.6±1.8; range 0-6.6). We developed 2 regression-based scoring systems to assess overall and proximal and distal esophageal findings; variation in endoscopic features accounted for more than 90% of the mean EndoGA variation. In the validation group, differences between mean EndoGA and regression-based scores were small (ranging from -4.70 to 2.03), indicating good agreement. In analyses of data from the randomized trial, the baseline to end of study change in patients given fluticasone was a reduction of 24.3 in simple score (reduction of 4.6 in patients given placebo, P=.052); a reduction of 23.5 in regression-based overall score (reduction of 6.56 in patients given placebo, P=.12), and a reduction of 23.8 (reduction of 8.44 in patients given placebo, P=.11). CONCLUSION: Assessments of endoscopic activity in patients with EoE vary among endoscopists. In an analysis of data from a randomized controlled trial, we found that newly developed scoring systems are no better than simple scoring system in detecting changes in endoscopic activity. These results support the use of a simple scoring system in evaluation of endoscopic activity in patients with EoE. clinicaltrials.gov no: NCT00939263 and NCT01386112.

Assessment of the blood supply using the indocyanine green fluorescence method and postoperative endoscopic evaluation of anastomosis of the gastric tube during esophagectomy.

BACKGROUND: Postoperative anastomotic leakage is a severe complication after gastric tube reconstruction during esophagectomy. The aim of this study was to evaluate the usefulness of postoperative endoscopic assessment of anastomosis and its correlation with intraoperative indocyanine green (ICG) fluorescence assessment of the gastric tube. METHODS: We retrospectively reviewed 72 consecutive patients who underwent gastric tube reconstruction using the ICG fluorescence method during esophagectomy. Forty-six patients underwent the ICG line-marking method (LMM group; ICG before gastric tube creation). The other 26 underwent the conventional procedure and comprised the control group (ICG after gastric tube creation). Postoperative endoscopic assessment (PEA) of anastomosis was performed 7 days after surgery and results were classified as follows: grade 1 (normal or partial white coat), grade 2 (ulcer comprising less than half the circumference), and grade 3 (ulcer comprising more than half the circumference). RESULTS: Anastomotic leakage occurred in 7 of 72 patients (9.7%). The incidence of anastomotic leakage in the LMM group was tended to be lower than those in the control group (6.5% vs. 15.4%; P = 0.244). Of the 40 patients who underwent PEA, 3 (7.5%) had leakage. PEA grading was significantly associated with anastomotic leakage (P < 0.001). Better intraoperative ICG assessment was significantly associated with better endoscopic assessment grade (P = 0.041). CONCLUSION: Intraoperative ICG assessment of the gastric tube was associated with PEA grading on anastomosis during esophagectomy.

Upper Airway Anomalies in Congenital Tracheoesophageal Fistula and Esophageal Atresia Patients.

OBJECTIVE: To examine the prevalence of upper airway anomalies in patients diagnosed with congenital tracheoesophageal fistula and esophageal atresia (TEF/EA). METHODS: A retrospective review was conducted of all TEF/EA patients seen at a tertiary pediatric hospital between January 2008 and December 2013. Inclusion criteria included evaluation by the otolaryngology service. Exclusion criteria included age>18 years, acquired TEF/EA, subsequent rule out of TEF/EA, and otolaryngology evaluation for reasons not pertaining to the airway. Data collected and analyzed included demographics, comorbidities, presenting symptoms, surgical interventions, laryngoscopic and bronchoscopic examinations, and subsequent medical and surgical management. RESULTS: Four hundred and thirty patients were diagnosed with TEF/EA at our institution. In all, 32.3%, or 139 children, were included in the analysis; 56.1% (n=78) male, 43.9% (n=61) female. Of the analyzed patients, 4.3% (n=6) were diagnosed with laryngomalacia. Eighteen patients (12.9%) were diagnosed with subglottic stenosis. Thirty (21.6%) had vocal fold paresis or immobility. Laryngeal cleft was diagnosed in 25.9% (n=36). Tracheomalacia was the most common airway finding, diagnosed in 37.4% (n=52) patients. CONCLUSION: Patients diagnosed with congenital TEF/EA have a high rate of secondary upper airway anomalies. Consideration should be given to perform a complete airway evaluation in all of these patients.

Voice outcomes after endoscopic treatment of laryngotracheal stenosis.

OBJECTIVE: This study aimed to assess vocal disability in patients with laryngotracheal stenosis who are managed with endoscopic surgery, comparing patients with posterior glottic stenosis (PGS) to those with subglottic or tracheal stenosis (SGS/TS). METHODS: Patients who underwent endoscopic treatment for laryngotracheal stenosis with voice outcomes data from 2005 to 2013 were studied. The mean Voice Handicap Index-10 (VHI-10) was compared over the study period. Of those with SGS/TS, the distance from the vocal folds to the proximal portion of the stenosis was obtained and compared to VHI-10. RESULTS: Forty-four patients met inclusion criteria. The mean VHI-10 for all patients was 14.6. Fifty percent were dysphonic (VHI-10>11). The mean VHI-10 for PGS patients was 22.4, and for SGS/TS patients, 10.9 (P=.004). Of those with PGS, 78.6% were dysphonic compared to only 36.7% of those with SGS/TS. Voice Handicap Index-10 improved from 14.1 for those with proximal stenosis to 4 for those with stenosis more than 2 cm distal to the vocal folds. CONCLUSION: Following endoscopic management of stenosis, those with PGS have poorer voice outcomes compared to those with SGS/TS. The majority of those with SGS/TS are not dysphonic. Vocal outcomes are greatest for those with stenosis beginning at least 2 cm distal to the vocal folds.

Esophageal wishbone extraction: not for the chicken-hearted.

OBJECTIVE: Ingestion of foreign bodies in the pediatric population is common and in the majority of cases involves spontaneous passage through the esophagus; however, they can become lodged in spaces of anatomical narrowing. Sharp foreign bodies are of particular concern due to a higher chance of perforation and other complications. The goal of this case report is to describe the safe removal of a chicken wishbone and 3 alternate options in the event that the initial choice was unsuccessful. METHODS: We report the case of a 2-year-old boy who presented to our pediatric tertiary center after unsuccessful endoscopic removal of a chicken wishbone from the esophagus. RESULTS: Radiologically, the wishbone was oriented with the tines pointing up. Endoscopic examination revealed the tips of both tines to be embedded deeply into the lateral walls of the esophageal mucosa. Esophagoscopy and protecting the sharp points of the wishbone were used to successfully extract the intact wishbone. CONCLUSION: Previous techniques have involved cutting the bone; however, in this case, tension was so high that it was felt that cutting the bone would result in perforation. Proper management of such cases requires planning and often multiple strategies.

EndoTrainer: a novel hybrid training platform for endoscopic surgery.

PURPOSE: Endoscopy implies high demanding procedures, and their practice requires structured formation curricula supported by adequate training platforms. Physical platforms are the most standardised solution for surgical training, but over the last few years, virtual platforms have been progressively introduced. This research work presents a new hybrid, physic-virtual, endoscopic training platform that exploits the benefits of the two kind of platforms combining realistic tools and phantoms together with the capacity of measuring all relevant parameters along the execution of the exercises and of providing an objective assessment performance. METHODS: The developed platform, EndoTrainer, has been designed to train and assess surgical skills in hysteroscopy and cystoscopy following a structured curricula. The initial development and validation is focused on hysteroscopic exercises proposed in the Gynaecological Endoscopic Surgical Education and Assessment (GESEA) Certification Programme from The Academy and European Society for Gynaecological Endoscopy (ESGE) and analyses the obtained results of an extensive study with 80 gynaecologists executing 30 trials of the standard 30 degree endoscope navigation exercise. RESULTS: The experiments demonstrate the benefits of the presented hybrid platform. Multi-variable statistical analysis points out that all subjects have obtained statistically significant improvement in all relevant parameters: shorter and safer trajectories, improved 30-degree endoscope navigation, accurate positioning over the targets and reduction of the execution time. CONCLUSION: This paper presents a new hybrid approach for training, and evaluating whether it provides an objectivable improvement of camera navigation endoscopic basic skills. The obtained results demonstrate the initial hypothesis: all subjects have improved their camera handling and navigation skills.

Pre-Endoscopic Scores Predicting Low-Risk Patients with Upper Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis.

BACKGROUND: Several risk scores have attempted to risk stratify patients with acute upper gastrointestinal bleeding (UGIB) who are at a lower risk of requiring hospital-based interventions or negative outcomes including death. This systematic review and meta-analysis aimed to compare predictive abilities of pre-endoscopic scores in prognosticating the absence of adverse events in patients with UGIB. METHODS: We searched MEDLINE, EMBASE, Central, and ISI Web of knowledge from inception to February 2023. All fully published studies assessing a pre-endoscopic score in patients with UGIB were included. The primary outcome was a composite score for the need of a hospital-based intervention (endoscopic therapy, surgery, angiography, or blood transfusion). Secondary outcomes included: mortality, rebleeding, or the individual endpoints of the composite outcome. Both proportional and comparative analyses were performed. RESULTS: Thirty-eight studies were included from 2153 citations, (n = 36,215 patients). Few patients with a low Glasgow-Blatchford score (GBS) cutoff (0, ≤1 and ≤2) required hospital-based interventions (0.02 (0.01, 0.05), 0.04 (0.02, 0.09) and 0.03 (0.02, 0.07), respectively). The proportions of patients with clinical Rockall (CRS = 0) and ABC (≤3) scores requiring hospital-based intervention were 0.19 (0.15, 0.24) and 0.69 (0.62, 0.75), respectively. GBS (cutoffs 0, ≤1 and ≤2), CRS (cutoffs 0, ≤1 and ≤2), AIMS65 (cutoffs 0 and ≤1) and ABC (cutoffs ≤1 and ≤3) scores all were associated with few patients (0.01-0.04) dying. The proportion of patients suffering other secondary outcomes varied between scoring systems but, in general, was lowest for the GBS. GBS (using cutoffs 0, ≤1 and ≤2) showed excellent discriminative ability in predicting the need for hospital-based interventions (OR 0.02, (0.00, 0.16), 0.00 (0.00, 0.02) and 0.01 (0.00, 0.01), respectively). A CRS cutoff of 0 was less discriminative. For the other secondary outcomes, discriminative abilities varied between scores but, in general, the GBS (using cutoffs up to 2) was clinically useful for most outcomes. CONCLUSIONS: A GBS cut-off of one or less prognosticated low-risk patients the best. Expanding the GBS cut-off to 2 maintains prognostic accuracy while allowing more patients to be managed safely as outpatients. The evidence is limited by the number, homogeneity, quality, and generalizability of available data and subjectivity of deciding on clinical impact. Additional, comparative and, ideally, interventional studies are needed.

Increased modified DUBLIN scores are associated with serious ulcerative colitis and treatment failure.

Background: Grading of endoscopic lesions is important for determining the severity of ulcerative colitis and developing treatment strategies, but the commonly used methods are not sufficient. Objectives: This study aimed to investigate whether new endoscopic scoring systems incorporating lesions and disease extent are associated with clinical disease severity and maintainable remission. Design: This was a retrospective study. In all, 110 patients with ulcerative colitis were included and 87 completed 12-month follow-up. Methods: Colonoscopy was performed within 1 week before blood samples were taken. Degree of ulcerative colitis burden of luminal inflammation (DUBLIN) scores were calculated as the product of Mayo endoscopic score (MES) by disease extent and ulcerative colitis endoscopic index of severity was used to replace MES when calculating modified DUBLIN scores. Results: DUBLIN and modified DUBLIN scores were increased in the moderate and severe groups significantly (p < 0.05). Both of increased scores contributed to the detection of serious diseases, and the clinical cutoff values of DUBLIN and modified DUBLIN were 3[area under the curve (AUC) = 0.809, p = 0.001) and 7(AUC = 0.815, p = 0.001), respectively. They were with high sensitivity, but the specificity of DUBLIN was lower. Both scores were correlated to partial Mayo scores, C-reactive protein and erythrocyte sedimentation rate positively, and they were correlated to the albumin negatively (p < 0.05). Higher modified DUBLIN scores (>7) were associated with an increased risk of treatment failure (hazard ratio = 4.96, 95% confidence interval: 1.17-21.00, p = 0.03), but there were no association between DUBLIN scores and long-term remission (p > 0.05). Conclusion: Increased DUBLIN and modified DUBLIN scores were conducive to screening serious disease, but only modified DUBLIN scores had the potential to assist in making an upgraded therapeutic schedule.

Correlations of Radiographic and Endoscopic Observations in Subglottic Stenosis.

OBJECTIVE(S): Subglottic stenosis (SGS) represents a constellation of diverse pathologic processes that ultimately lead to narrowing of the subglottic region and can produce significant morbidity. Existing endoscopic and radiographic assessments may not be consistent in practice. METHODS: Severity of stenosis was evaluated and reported using the Cotton-Myer classification system from 33 endoscopic procedures from 32 unique subjects. Radiographic imaging within the preceding 3 month period was subsequently reviewed and narrowing was measured by a blinded radiologist. Degree of stenosis was reported as a percentage in 30 out of 33 endoscopic evaluations and subsequently compared to radiographically determined percentage of stenosis. Statistical analyzes were conducted to evaluate concordance between endoscopic and radiographic assessments. RESULTS: About 45.5% (15/33) of the evaluations were in agreement using Cotton-Myer scoring, while 27.3% (9/33) were discrepant by 1 grade and 27.3% (9/33) by 2 grades. Correlation of degree of stenosis as a percentage using Spearman (coefficient: 0.233, P-value: .214) and Pearson (coefficient: 0.138, P-value: .466) methods demonstrated very weak relationships. Radiographic scoring did not predict endoscopic classification to a significant degree using mixed effects regression. CONCLUSIONS: Radiographic and endoscopic grading of subglottic stenosis may not be reliably concordant in practice.

Predicting Gag, Discomfort, and Laryngeal Visualization in Patients Undergoing Flexible Laryngoscopy with Stroboscopy.

OBJECTIVE: To investigate potential associations between the Predictive Gagging Survey (PGS) with patient experience of gag and discomfort as well as provider perception of patient gag and level of laryngeal visualization during flexible laryngoscopy with stroboscopy (FL-S). METHODS: A total of 53 adult patients undergoing FL-S were recruited for this prospective non-controlled study. PGS was completed before FL-S. Patients rated perceived level of gag and discomfort on a 10-point severity scale after FL-S. Additionally, providers completed a Gagging Severity Index (GSI) reflecting their impression of patient gag and level of laryngeal visualization following FL-S. Spearman rank correlation coefficients were used to assess associations. RESULTS: There was a positive association with PGS score and patient perception of gagging (0.34; P = .013) and patient perception of discomfort (0.38; P = .005). No significant association was found between PGS score and provider GSI (-0.12; P = .39) or level of laryngeal visualization (0.15; P = .29). A negative association was found between level of laryngeal visualization and patient perception of gagging (-0.34; P = .012) and discomfort (-0.44; P = .001). No significant differences were found between current and former smokers compared to never smokers for GSI or patient-perceived gag or discomfort. CONCLUSIONS: While not predictive of GSI or level of laryngeal visualization, the PGS was found to be a useful tool in predicting patient experience of gagging and discomfort during FL-S, further reinforcing the subjective experience of this procedure. Use of the PGS may be helpful in identifying specific candidates who may struggle with subjective discomfort or gagging during FL-S for future studies considering interventions to manage and meaningfully decrease discomfort. Having such an instrument is important given the low number of individuals who struggle with discomfort during the exam.

Accuracy of contrast swallow study in assessment of caustic esophageal stricture length in children: Agreement study.

BACKGROUND: Caustic esophageal stricture length assessment is essential for planning endoscopic management and predicting its prognosis. We aimed to assess the accuracy of contrast swallow study (CSS) in measuring stricture length in comparison to endoscopy (definitive investigation for actual length measurement). METHOD: Medical records of caustic esophageal strictures between 2010 and 2020 were retrospectively reviewed. Reliability study was done to compare between radiological and endoscopic measurement of stricture length. RESULT: 124 CSSs for 91 patients were analyzed. Six studies showed no stricture, single stricture was reported in 101 studies, double strictures were reported in 16 studies, triple strictures were reported in one study (136 radiological stricture). Endoscopy revealed 133 true strictures. Number of the strictures was consistent between CSS and endoscopy in 112 studies (90.3%) and different in 12 studies (9.7%). Eight endoscopies revealed strictures not reported in CSS (5.5% false negative strictures), while 10 CSSs reported 11 strictures that were not detected during the endoscopy (7.6% false positive strictures). Reliability analysis revealed interclass correlation coefficient = 0.6 (95% CI 0.5 to 0.7) indicating moderate reliability. CONCLUSION: CSS is not accurate in assessing caustic esophageal stricture length. Combination of CSS and endoscopic investigation is better for proper evaluation of these patients. Level III of evidence.

Infectious Esophagitis in Romanian Children: From Etiology and Risk Factors to Clinical Characteristics and Endoscopic Features.

OBJECTIVES: The aim of this study is to provide information about prevalence, etiology, risk factors, clinical characteristics and endoscopic features of various types of infectious esophagitis in children. METHODS: We performed a total of 520 upper gastrointestinal tract endoscopies in Pediatric Clinic II, Emergency Hospital for Children, Cluj-Napoca. Indications for endoscopy in our cohort were gastrointestinal tract symptoms such as dysphagia, heartburn, or appetite loss. RESULTS: The prevalence of infectious esophagitis in the study population was 2.11% (11 patients). Candida albicans (C. albicans) was the most frequent cause. Our data illustrates that herpes simplex virus (HSV)-induced esophagitis is common in immunocompromised patients and should be systematically suspected in cases of severe dysphagia, heartburn, or hematemesis. In the present study, all cytomegalovirus (CMV) esophagitis patients were immunocompromised. Immunodeficiency (81.8%) and prolonged antibiotic therapy with broad-spectrum antibiotics were by far the most important risk factors involved in the pathogenicity of the disease. Dysphagia, appetite loss, heartburn, epigastralgia, and hematemesis were the main clinical manifestations. Infectious esophagitis was associated with significant mortality. In four patients, endoscopy during life showed signs of infectious esophagitis; however, the precise etiology was only established post-mortem, in the pathological anatomy laboratory department. A risk factor involved in pathogenesis of post-mortem diagnosed infectious esophagitis is the DiGeorge syndrome for CMV and HSV patients. CONCLUSIONS: The study illustrates that infectious esophagitis should be considered in immunocompromised infants with prolonged antibiotic therapy with broad-spectrum antibiotics.

Evaluation of Performance and Tolerability of Nebulized Hyaluronic Acid Nasal Hypertonic Solution in the Treatment of Chronic Rhinosinusitis.

BACKGROUND: Nasal solutions are part of the recommended therapy of chronic rhinosinusitis (CRS). Formulations containing hyaluronic acid (HA) may represent a promising topical treatment in CRS patients in light of the anti-inflammatory and protective effect of HA on the sinonasal mucosa. OBJECTIVE: Primary aim was to evaluate the performance of a new nebulized HA nasal hypertonic solution in the relief of symptoms of CRS. Secondarily, evaluation of symptoms improvement, endoscopic nasal findings, and safety profile were assessed. METHODS: A monocenter, single arm, not controlled, premarket clinical trial on a new nasal solution containing HA was performed. All the included patients had a history of previously diagnosed or recurrent CRS or they had received a clinical diagnosis of CRS defined, according to the European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Each patient was evaluated on 3 visits. Endoscopic nasal examination and Nasal Obstruction Symptom Evaluation Instrument questionnaire filling were performed during each visit. Patients' adherence to treatment and overall satisfaction, patients' and investigator's global evaluation of performance, and safety parameters were also assessed. RESULTS: Eighty patients were enrolled. The use of the investigated HA nasal solution revealed to be significantly effective in the relief of symptoms of CRS. According to daily patients' diaries, several signs and symptoms significantly improved after therapy. The comparison between endoscopic assessments before and after treatment confirmed improvement of the condition in at least 75% of patients. Seventy-four percent of the patients were quite or very satisfied with the treatment and 80% reported an improvement. The investigator's global assessment of performance was in agreement with this view, as more than 80% of the patients were considered clinically improved. CONCLUSIONS: The use of the investigated new nebulized HA nasal hypertonic solution is an effective and safe the treatment of CRS.

DUBLIN [Degree of Ulcerative colitis Burden of Luminal Inflammation] Score, a Simple Method to Quantify Inflammatory Burden in Ulcerative Colitis.

BACKGROUND AND AIMS: Endoscopic scores of local severity do not reflect disease extent, or disease burden. The DUBLIN score is a simple bedside clinical score that estimates inflammatory burden using both disease severity and extent. As the need to personalize therapy for ulcerative colitis [UC] patients increases, a score accurately assessing disease burden will be of great relevance. The aim of this study was to assess the clinical utility of the DUBLIN score by comparing its performance with objective biomarkers. METHODS: The DUBLIN score was calculated as a product of the Mayo Endoscopic Score [0-3] and disease extent [E1-E3]. Correlation with objective biomarkers was performed in a retrospective 'discovery cohort'. A 'validation cohort was recruited from a single centre, where clinical outcomes, colectomy rate, and biochemical data were collected prospectively. RESULTS: The discovery cohort included 70 patients with UC. The DUBLIN score correlated significantly with faecal calprotectin [FCP] levels [r = 0.394; p < 0.01]. Receiver operating characteristic [ROC] analysis using FCP>50µg/g showed a higher area under the ROC curve [AUC] with the DUBLIN score [AUC = 0.76] than with the Mayo Score [AUC = 0.73]. The validation cohort included 41 patients. Patients with a high inflammatory burden [DUBLIN >3] had higher C-reactive protein and FCP, and lower albumin than patients with a low inflammatory burden. A high DUBLIN score was associated with an increased risk of treatment failure. [hazard ratio 2.98 95%, confidence interval 1.002-8.87; p = 0.049]. CONCLUSION: The DUBLIN score is a simple measure of inflammatory burden, which correlates with objective inflammatory markers and is associated with clinical outcomes, such as treatment failure. The DUBLIN score has the potential to assist in personalizing therapy for patients with UC.

Safety and feasibility of above cuff vocalisation for ventilator-dependant patients with tracheostomies.

INTRODUCTION: Temporary tracheostomy is commonly used in patients admitted to intensive care units. Cuffed tubes prevent laryngeal airflow, preventing vocalisation. Sub-glottic suction tubes such as the 'Blue Line Ultra Suctionaid™' are used primarily to remove sub-glottic secretions, but retrograde gas flows via the suction port can facilitate above cuff vocalisation. The aims were to assess whether patients could achieve an audible voice using above cuff vocalisation, to demonstrate the safe use of the Blue Line Ultra Suctionaid™ tracheostomy tube for above cuff vocalisation, and to assess potential benefits of above cuff vocalisation for communication, secretion management and swallowing. METHODS: Our study (Reference 15/NW/0464, IRAS 178997) recruited adult intensive care unit patients who were alert, able to participate in an above cuff vocalisation trial and dependent on an inflated Blue Line Ultra Suctionaid™ cuff for ventilatory support. Consenting participants underwent fibreoptic endoscopic assessment of swallow by experienced Speech & Language Therapy staff with and without above cuff vocalisation. Clinical and fibreoptic endoscopic assessment of swallow, assessment of voice quality, swallowing and secretion management were recorded and scored. Median differences between paired observations and scores were analysed with and without above cuff vocalisation. Adverse events were identified by follow up fibreoptic endoscopic assessment of swallow and patient accounts. RESULTS: Ten patients completed the study. Above cuff vocalisation was used for a median of 15 min, during a median of nine episodes, over a median of three days. Above cuff vocalisation resulted in an audible voice in eight of the 10 patients, during 66 out of 91 above cuff vocalisation attempts. There improvements in unstimulated dry cough and swallow frequency and aspiration ratings measured by fibreoptic endoscopic assessment of swallow. No complications were reported or observed in 66 attempts with only one episode terminated prematurely. CONCLUSIONS: Above cuff vocalisation can achieve effective, safe, well-tolerated vocalisation in ventilator-dependant intensive care unit patients. Above cuff vocalisation has the potential to aid earlier, more effective communication and may improve laryngeal function and rehabilitation.