Publications by authors named "Nicola Bortoli"

115 Publications

Diagnostic delay and misdiagnosis in eosinophilic oesophagitis.

Dig Liver Dis 2021 Jun 8. Epub 2021 Jun 8.

Department of Internal Medicine, IRCCS San Matteo Hospital Foundation, University of Pavia, Pavia, Italy. Electronic address:

Background: Eosinophilic oesophagitis (EoE) may lead to severe complications if not promptly recognised.

Aims: To assess the diagnostic delay in patients with EoE and to explore its risk factors.

Methods: EoE patients followed-up at eight clinics were included via retrospective chart review. Diagnostic delay was estimated as the time lapse occurring between the appearance of the first likely symptoms indicative of EoE and the final diagnosis. Patient-dependent and physician-dependent diagnostic delays were assessed. Multivariable regression models were computed.

Results: 261 patients with EoE (mean age 34±14 years; M:F ratio=3:1) were included. The median overall diagnostic delay was 36 months (IQR 12-88), while patient- and physician-dependent diagnostic delays were 18 months (IQR 5-49) and 6 months (IQR 1-24). Patient-dependent delay was greater compared to physician-dependent delay (95% CI 5.1-19.3, p<0.001). A previous misdiagnosis was formulated in 109 cases (41.8%; gastro-oesophageal reflux disease in 67 patients, 25.7%). The variables significantly associated with greater overall diagnostic delay were being a non-smoker, >1 episode of food impaction, previous endoscopy with no biopsies, regurgitation, and ≥2 assessing physicians. Being single was significantly associated with lower overall and patient-dependent diagnostic delay.

Conclusion: EoE is burdened by substantial diagnostic delay, depending on both patient-related and physician-related factors.
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http://dx.doi.org/10.1016/j.dld.2021.05.017DOI Listing
June 2021

Raising Children on a Vegan Diet: Parents' Opinion on Problems in Everyday Life.

Nutrients 2021 May 25;13(6). Epub 2021 May 25.

Gastrointestinal Unit, Department of Translational Sciences and New Technology in Medicine and Surgery, University of Pisa, 56124 Pisa, Italy.

A growing number of Italian families are adopting a vegan diet (VD) for their offspring from infancy for various reasons, with health benefits and ethics being the most common reasons. Barriers to effective communication with primary care pediatricians (PCPs) are perceived by many parents and, depending on the actors involved and the environment, a VD may affect social interactions in everyday life. A national cross-sectional survey was conducted between July and September 2020. Parents of children following a VD completed an online questionnaire. Data from 176 Italian parents were collected. About 72% (71.8%) of the children included in this study had been on a VD since weaning. Parents did not inform their primary care pediatricians (PCP) about the VD in 36.2% of the cases. In 70.8% of the cases, PCPs were perceived as skeptical or against a VD. About 70% (71.2%) of the parents relied on medical dietitians, and 28.2% on nutritionists/dietitians for dietary counseling. Parents administered an individual B12 supplement in 87.2% of the cases. To the best of our knowledge, this survey is the first which explores the relationship between vegan parents and their PCPs, the parental management of their children's diet and problems regarding the implementation of a VD in everyday life.
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http://dx.doi.org/10.3390/nu13061796DOI Listing
May 2021

Dietary Management of Eosinophilic Esophagitis: Tailoring the Approach.

Nutrients 2021 May 12;13(5). Epub 2021 May 12.

Division of Gastroenterology, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, 56124 Pisa, Italy.

Eosinophilic esophagitis (EoE) is a unique form of non-immunoglobulin E-mediated food allergy, restricted to the esophagus, characterized by esophageal eosinophil-predominant inflammation and dysfunction. The diagnosis requires an esophago-gastroduodenoscopy with esophageal biopsies demonstrating active eosinophilic inflammation with 15 or more eosinophils/high-power field, following the exclusion of alternative causes of eosinophilia. Food allergens trigger the disease, withdairy/milk, wheat/gluten, egg, soy/legumes, and seafood the most common. Therapeutic strategies comprise dietary restrictions, proton pump inhibitors, topical corticosteroids, biologic agents, and esophageal dilation when strictures are present. However, avoidance of trigger foods remains the only option targeting the cause, and not the effect, of the disease. Because EoE relapses when treatment is withdrawn, dietary therapy offers a long-term, drug-free alternative to patients who wish to remain off drugs and still be in remission. There are currently multiple dietary management strategies to choose from, each having its specific efficacy, advantages, and disadvantages that both clinicians and patients should acknowledge. In addition, dietary regimens should be tailored around each individual patient to increase the chance of tolerability and long-term adherence. In general, liquid elemental diets devoid of antigens and elimination diets restricting causative foods are valuable options. Designing diets on the basis of food allergy skin tests results is not reliable and should be avoided. This review summarizes the most recent knowledge regarding the clinical use of dietary measures in EoE. We discussed endpoints, rationale, advantages and disadvantages, and tailoring of diets, as well as currently available dietary regimens for EoE.
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http://dx.doi.org/10.3390/nu13051630DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8151361PMC
May 2021

Reflux characteristics triggering post-reflux swallow-induced peristaltic wave (PSPW) in patients with GERD symptoms.

Neurogastroenterol Motil 2021 May 29:e14183. Epub 2021 May 29.

Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padova, Italy.

Background: Esophageal chemical clearance has been evaluated with the post-reflux swallow-induced peristaltic wave (PSPW) index. The factors triggering PSPW in Gastro-esophageal reflux disease (GERD) have not yet been investigated. This multicenter study was aimed at evaluating the characteristics of reflux episodes associated with PSPW occurrence in patients with typical GERD symptoms.

Methods: Impedance-pH tracings from patients with typical reflux symptoms were analyzed. Sixteen healthy subjects were included for comparison. Multivariate analysis was performed to determine predictors of PSPW events.

Key Results: Impedance-pH tracings from 60 patients and 16 healthy subjects were evaluated. A total of 3454 refluxes were recorded. In patients, comparing reflux episodes followed with those not followed by a PSPW, significantly higher proportions of acid (79% vs. 74%, p: 0.02), mixed (47% vs. 32%, p: 0.0001) and proximal refluxes (34% vs. 20%, p: 0.0001) were observed. A multivariate analysis, acid (OR: 1.3, 95% CI: 1.05-1.6), mixed (OR: 2, 95% CI: 1.6-2.3), and proximal (OR: 2.1, 95% CI: 1.7-2.5) refluxes were independently associated with PSPWs. Reflux episodes followed by a PSPW were characterized by a significantly higher bolus clearing time [(mean ± SD) 41 s ± 6 s vs. 30 s ± 5 s, p < 0.05] whereas nadir pH value of reflux events preceding PSPWs was tangentially but not significantly lower [(mean ± SD) 2.61 ± 1.22 vs. 2.74 ± 1.26, p: 0.057].

Conclusions And Inferences: Acid, mixed and proximal refluxes, and their duration are key factors in eliciting PSPWs. PSPW represents a response to reflux directly related to the potential harmfulness of reflux contents.
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http://dx.doi.org/10.1111/nmo.14183DOI Listing
May 2021

Pharmacological Management of Gastro-Esophageal Reflux Disease: An Update of the State-of-the-Art.

Drug Des Devel Ther 2021 19;15:1609-1621. Epub 2021 Apr 19.

Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.

Gastro-esophageal reflux disease (GERD) is a highly prevalent, chronic disorder, whose knowledge remains limited and the management of these patients changes continuously. This review provides a summary of the most recent advancements in the pathogenesis of this disease and the new drugs introduced into the market to overcome some of the unmet needs of traditional therapies. Nowadays, the most fruitful diagnostic examinations are 24-hour impedance-pH monitoring, which allows us to separate true NERD from esophageal functional disorders and high-resolution manometry, which helps to exclude the existence of motility disorders sharing the same symptoms of GERD. Proton pump inhibitors (PPIs) remain the first-choice therapy in the treatment of GERD, but a consistent proportion of these patients continue to experience symptoms despite their intake. These cases pertain mainly to the subpopulation with non-erosive reflux disease (NERD) and represent very challenging clinical situations, because it is mandatory to understand the reasons for PPI failure. The management of these difficult patients requires necessarily to test them and avoid the use of empiric treatments that are often unsuccessful, costly and potentially dangerous. Recently, several new drugs have been used to increase the defensive properties of this mucosa with promising results in randomized clinical trials.
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http://dx.doi.org/10.2147/DDDT.S306371DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8064680PMC
April 2021

Ig Glycosylation in Ulcerative Colitis: It's Time for New Biomarkers.

Front Pharmacol 2021 9;12:654319. Epub 2021 Apr 9.

Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.

Ulcerative colitis (UC) is a chronic relapsing disease, which needs a continue monitoring, especially during biological therapies. An increasing number of patients is treated with anti-Tumor Necrosis factor (TNF) drugs, and current research is focalized to identify biomarkers able to monitor the disease and to predict therapeutic outcome. We enrolled consecutive UC patients treated with anti-TNF, naïve to biologic drugs. Therapeutic outcome was evaluated after 54 weeks of treatment in terms of clinical remission (Partial Mayo Score -PMS- <2) and mucosal healing (Mayo Endoscopic Score <2). On serum samples collected at baseline and after 54 weeks of treatment, a Lectin-based ELISA assay was performed, and specific glycosylation patterns were evaluated by biotin-labelled lectins. We have also collected 21 healthy controls (NHS) samples, age and sex-matched. Out of 44 UC patients enrolled, 22 achieved clinical remission and mucosal healing after 54 weeks. At baseline, when Protein A was used as coating, UC patients non-responders showed a reduced reactivity to Jacalin (JAC) in comparison with NHS ( = 0.04). After one year of treatment, a decrease in JAC binding was seen only in responders, in comparison with baseline ( = 0.04). When JAC binding was tested selecting IgG by means of Fab anti-IgG Fab, UC patients displayed an increased reactivity after anti-TNF therapy ( < 0,0001 vs controls). At baseline, PMS inversely correlates with JAC binding when Fab anti-IgG Fab was used in solid phase ( = 0,2211; = 0,0033). Patients with higher PMS at baseline (PMS ≥5) presented lower binding capacity for JAC in comparison with NHS and with lower PMS patients ( = 0,0135 and = 0,0089, respectively). Ig glycosylation was correlated with clinical and endoscopic activity in patients with UC. JAC protein A-selected Ig showed a possible role in predicting therapeutic effectiveness. If these data would be confirmed, Ig glycosylation could be used as biomarker in UC.
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http://dx.doi.org/10.3389/fphar.2021.654319DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8062917PMC
April 2021

Response of eosinophilic oesophagitis to proton pump inhibitors is associated with impedance-pH parameters implying anti-reflux mechanism of action.

Aliment Pharmacol Ther 2021 06 15;53(11):1183-1189. Epub 2021 Apr 15.

Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padova, Padua, Italy.

Background: Proton pump inhibitors (PPIs) are effective therapies for eosinophilic oesophagitis (EoE), but the mechanism of action is uncertain. At on-PPI impedance-pH monitoring, improvement in oesophageal chemical clearance assessed with post-reflux swallow-induced peristaltic wave (PSPW) index characterises PPI-responsive EoE and reflux disease. Off-PPI, higher efficacy of the oesophago-salivary reflex as measured with PSPW-associated pH increments characterises PPI-responsive reflux disease and could typify PPI-responsive EoE as well.

Aim: To establish whether PPI responsiveness in EoE is associated with higher efficacy of the oesophago-salivary reflex.

Methods: Prospective multicentre study in EoE patients investigated with impedance-pH monitoring before starting PPI. Impedance-pH parameters in PPI-responsive and PPI-refractory cases were compared. PPI response was defined histologically.

Results: Considerable PSPW-associated pH increments (median 1.4 units) were found in 80 EoE patients, with significantly higher values in 48 PPI-responsive than in 32 PPI-refractory cases (1.8 vs 1.0, P = 0.02). Mucosal integrity, as measured with mean nocturnal baseline impedance was more severely impaired in the distal oesophagus in PPI-responsive cases, the gradient between mid and distal oesophagus being significantly higher (546 vs 137 Ω, P = 0.0002). PSPW-associated pH increments and the baseline impedance gradient between mid and distal oesophagus were independently associated with histological response at multivariable logistic regression; at receiver operating characteristic analysis, the area under the curve of PPI response calculated by combined assessment was 0.88.

Conclusion: Higher efficacy of oesophago-salivary reflex and more severe mucosal damage in the distal oesophagus are associated with EoE response to PPIs, implying an anti-reflux mechanism of action as most likely.
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http://dx.doi.org/10.1111/apt.16371DOI Listing
June 2021

Chicago Classification Update (v4.0): Technical review on diagnostic criteria for hypercontractile esophagus.

Neurogastroenterol Motil 2021 Jun 17;33(6):e14115. Epub 2021 Mar 17.

Department of Gastroenterology & Hepatology, Flinders University, Adelaide, SA, Australia.

Hypercontractile esophagus (HE), defined by the Chicago Classification version 3.0 (CCv3.0) as 20% or more hypercontractile peristalsis (Distal Contractile Integral >8000 mmHg·s·cm) on high-resolution manometry (HRM), is a heterogeneous disorder with variable clinical presentations and natural course, leading to management challenges. An update on the diagnostic criteria for clinically relevant HE was needed. Literature on HE was extensively reviewed by the HE subgroup of the Chicago Classification version 4.0 (CCv4.0) Working Group and statements relating to the diagnosis of HE were ranked according to the RAND UCLA Appropriateness methodology by the Working Group, and the quality of evidence was rated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. An overall emphasis of the CCv4.0 is on clinically relevant esophageal dysmotility, and thus it is recommended that an HE diagnosis requires both conclusive manometric diagnosis and clinically relevant symptoms of dysphagia and non-cardiac chest pain. The Working Group also recognized the subtypes of HE, including single-peaked, multi-peaked contractions (Jackhammer esophagus), and hypercontractile lower esophageal sphincter. However, there are no compelling data currently for formally subdividing HE to these subgroups in clinical practice.
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http://dx.doi.org/10.1111/nmo.14115DOI Listing
June 2021

Oral Sucrosomial Iron Is as Effective as Intravenous Ferric Carboxy-Maltose in Treating Anemia in Patients with Ulcerative Colitis.

Nutrients 2021 Feb 12;13(2). Epub 2021 Feb 12.

Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, 56100 Pisa, Italy.

Anemia is a frequent complication of ulcerative colitis, and is frequently caused by iron deficiency. Oral iron supplementation displays high rates of gastrointestinal adverse effects. However, the formulation of sucrosomial iron (SI) has shown higher tolerability. We performed a prospective study to compare the effectiveness and tolerability of oral SI and intravenous ferric carboxy-maltose (FCM) in patients with ulcerative colitis in remission and mild-to-moderate anemia. Patients were randomized 1:1 to receive 60 mg/day for 8 weeks and then 30 mg/day for 4 weeks of oral SI or intravenous 1000 mg of FCM at baseline. Hemoglobin and serum levels of iron and ferritin were assessed after 4, 8, and 12 weeks from baseline. Hemoglobin and serum iron increased in both groups after 4 weeks of therapy, and remained stable during follow up, without significant treatment or treatment-by-time interactions ( = 0.25 and = 0.46 for hemoglobin, respectively; = 0.25 and = 0.26 for iron, respectively). Serum ferritin did not increase over time during SI supplementation, while it increased in patients treated with FCM (treatment effect, = 0.0004; treatment-by-time interaction effect, = 0.0002). Overall, this study showed that SI and FCM displayed similar effectiveness and tolerability for treatment of mild-to-moderate anemia in patients with ulcerative colitis under remission.
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http://dx.doi.org/10.3390/nu13020608DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7917674PMC
February 2021

Eosinophilic esophagitis: clinical, endoscopic, histologic and therapeutic differences and similarities between children and adults.

Therap Adv Gastroenterol 2021 31;14:1756284820980860. Epub 2021 Jan 31.

Gastroenterology Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Via Roma 67, Pisa (PI), 56124, Italy.

In the absence of secondary causes, eosinophilic esophagitis (EoE) is a chronic, local, progressive, T-helper type 2 immune-mediated disorder characterized by symptoms of esophageal dysfunction and eosinophil-predominant inflammation. In the last 20 years, the incidence and prevalence of EoE have risen sharply, and the chances of encountering affected patients in clinics and endoscopy rooms have increased. Nevertheless, it is estimated that the mean diagnostic delay of EoE is 4-6 years in both children and adults. Unfortunately, the longer the disease stays unrecognized, the likelier it is for the patient to have persistent or increased esophageal eosinophilic inflammation, to complain of non-resolving symptoms, and to develop fibrotic complications. Early detection depends on the recognition of initial clinical manifestations that vary from childhood to adulthood and even among patients of the same age. The disease phenotype also influences therapeutic approaches that include drugs, dietary interventions, and esophageal dilation. We have herein reviewed epidemiologic, clinical, endoscopic, and histologic features and therapeutic options of EoE focusing on differences and similarities between children and adults that may certainly serve in daily clinical practice.
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http://dx.doi.org/10.1177/1756284820980860DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7871287PMC
January 2021

Low Levels of Gastrin 17 are Related with Endoscopic Findings of Esophagitis and Typical Symptoms of GERD.

J Gastrointestin Liver Dis 2021 Feb 12;30(1):25-29. Epub 2021 Feb 12.

Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.

Background And Aims: In clinical practice, most patients with symptoms suggestive of gastroesophageal reflux disease (GERD) undergo esophago-gastro-duodenoscopy (EGD), despite its low sensitivity in detecting reflux stigmata. Gastrin 17 (G-17) has been proposed to be related with GERD, due to the negative feedback between acid secretion and this hormone. We assessed the clinical usefulness of fasting G-17 serum determination for a non-invasive diagnosis of GERD in patients with typical symptoms.

Methods: We consecutively enrolled patients complaining of typical GERD symptoms in two different settings: a single referral center and a primary care setting. Control groups consisted of dyspeptic patients. All subjects underwent assessment of serum levels of G-17 and EGD.

Results: At the academic hospital, 100 GERD patients (n=89 with erosive esophagitis and 11 with Barrett's esophagus) had statistically significant low levels of G-17 as compared with 184 dyspeptic patients (1.7±1.2 pg/L vs 8.9±5.7 pg/L p<0.0001). Similarly, in the primary care setting, 163 GERD patients had statistically significant low levels of G-17 as compared with 132 dyspeptic patients (0.5±0.2 pg/L vs. 4.0±2.6 pg/L, p<0.0001). Moreover, in the primary care setting, no statistically significant differences were found for G-17 levels between patients with erosive and non-erosive reflux pattern (0.4±0.2 vs 0.7±0.3; p=0.08). In primary care, the accuracy of G-17 less than 1 pg/L to diagnose non-invasively GERD was 94.3%.

Conclusions: Low levels of G-17 were detected in patients with erosive esophagitis and Barrett's esophagus in a referral center and in patients with typical GERD symptoms in a sample of patients from a primary care setting.
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http://dx.doi.org/10.15403/jgld-2952DOI Listing
February 2021

Esophageal pH increments associated with post-reflux swallow-induced peristaltic waves show the occurrence and relevance of esophago-salivary reflex in clinical setting.

Neurogastroenterol Motil 2021 Jan 20:e14085. Epub 2021 Jan 20.

Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padova, Italy.

Background: Following acid perfusion, esophageal pH is restored by swallowed bicarbonate-containing saliva secreted in response to a vagal esophago-salivary reflex. At impedance-pH monitoring, the post-reflux swallow-induced peristaltic wave (PSPW) index puts into relationship timely post-reflux swallows with the number of reflux events: Low values typify reflux-related heartburn (RRH) and lack of on-therapy improvement characterizes proton pump inhibitor (PPI) failure. Considerable esophageal pH increments associated with PSPWs could demonstrate the occurrence of esophago-salivary reflex in clinical setting, while its relevance could be shown by lower esophageal pH increments in PPI-refractory RRH.

Methods: Prospective multicenter study in patients with PPI-refractory or PPI-responsive RRH evaluated with off-PPI impedance-pH monitoring. Increments in pH associated with PSPWs were measured and the mean calculated to obtain the PSPW-associated ∆pH.

Key Results: The mean PSPW-associated ∆pH in 294 RRH patients was 1.2 ± 0.7 and was lower in 137 PPI-refractory (1.0 ± 0.6) than in 157 PPI-responsive (1.5 ± 0.6) cases (p < 0.0001). Lower PSPW-associated ∆pH was independently related to PPI failure at multivariable logistic regression analysis (OR 0.16, 95% CI 0.09-0.26). At ROC analysis, comparing PPI-refractory to PPI-responsive cases the AUC for PSPW-associated ∆pH was 0.76 (95% CI 0.71-0.82), the best cutoff value being 1.2.

Conclusions And Inferences: Considerable PSPW-associated pH increments demonstrate the occurrence of esophago-salivary reflex in clinical setting. Lower increments in PPI-refractory RRH cases show the clinical relevance of esophago-salivary reflex, confirming that PSPW represents a defense mechanism against reflux. PSPW-associated ∆pH can efficiently predict PPI response in patients undergoing off-therapy impedance-pH monitoring.
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http://dx.doi.org/10.1111/nmo.14085DOI Listing
January 2021

Eosinophilic esophagitis: novel concepts regarding pathogenesis and clinical manifestations.

Minerva Gastroenterol Dietol 2021 Jan 13. Epub 2021 Jan 13.

Division of Gastroenterology, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy -

Eosinophilic esophagitis is a chronic disease whose incidence and prevalence are increasing, based on a genetic-driven interaction between environment and immune system. Several gene loci involved in the development of the disease have been identified. A two-step mechanism has been hypothesized: a TSLP-induced allergic sensitization followed by upregulation of CAPNA14-related esophageal-specific pathways. Environment seems to have a larger effect than genetic variants. Factors that could play a role are allergens, drugs, colonizing bacteria and possibly Helicobacter Pylori infection. Acting on these modifiable risk factors may be a tool to prevent the disease. EoE is characterized by a typical eosinophilic infiltrate limited to the esophageal epithelium, supported by a Th2-mediated immune response, found in other atopic conditions. The key of the pathogenesis is the disfunction of the epithelial barrier which allow the interaction between allergens and inflammatory cells. Eosinophilic-predominant inflammation leads to the typical wall remodeling, histologically characterized by epithelial and smooth muscle hyperplasia, lamina propria fibrosis and neo-angiogenesis. These alterations find their clinical expression in the pattern of symptoms: dysphagia, food impaction, chest pain, heartburn.
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http://dx.doi.org/10.23736/S1121-421X.20.02807-XDOI Listing
January 2021

Life-Saving Procedures Performed While Wearing CBRNe Personal Protective Equipment: A Mannequin Randomized Trial.

Simul Healthc 2021 Jan 8;Publish Ahead of Print. Epub 2021 Jan 8.

From the Department of Medicine (DIMED) (G.M., M.P., C.A., S.S., F.F.), University of Padova, Padova; Venice Emergency Medical Service Operations Center (N.B., D.P.), Venezia; and Istituto di Anestesia e Rianimazione-Azienda Ospedaliera Universitaria di Padova (A.G., P.N.), Padova, Italy.

Introduction: Chemical-biological-radiological-nuclear-explosive (CBRNe) are complex events. Decontamination is mandatory to avoid harm and contain hazardous materials, but can delay care. Therefore, the stabilization of patients in the warm zone seems reasonable, but research is limited. Moreover, subjects involved in biological events are considered infectious even after decontamination and need to be managed while wearing personal protective equipment (PPE), as seen with Ebola and COVID-19 pandemic. With this simulation mannequin trial, we assessed the impact of CBRNe PPE on cardiopulmonary resuscitation and combat casualty care procedures.

Methods: We compared procedures performed by emergency medicine and anesthesiology senior residents, randomized in 2 groups (CBRNe PPE vs. no PPE). Chest compression (CC) depth was defined as the primary outcome. Time to completion was calculated for the following: tourniquet application; tension pneumothorax needle decompression; peripheral venous access (PVA) and intraosseous access positioning; and drug preparation and administration. A questionnaire was delivered to evaluate participants' perception.

Results: Thirty-six residents participated. No significant difference between the groups in CC depth (mean difference = 0.26 cm [95% confidence interval = -0.26 to 0.77 cm, P = 0.318]), as well as for CC rate, CC complete release, and time for drugs preparation and administration was detected. The PPE contributed to significantly higher times for tourniquet application, tension pneumothorax decompression, peripheral venous access, and intraosseous access positioning. The residents found simulation relevant to the residencies' core curriculum.

Conclusions: This study suggests that cardiopulmonary resuscitation can be performed while wearing PPE without impacting quality, whereas other tasks requiring higher dexterity can be significantly impaired by PPE.Trial Registration Number: NCT04367454, April 29, 2020 (retrospectively registered).
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http://dx.doi.org/10.1097/SIH.0000000000000540DOI Listing
January 2021

Esophageal motility disorders on high-resolution manometry: Chicago classification version 4.0.

Neurogastroenterol Motil 2021 01;33(1):e14058

Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.

Chicago Classification v4.0 (CCv4.0) is the updated classification scheme for esophageal motility disorders using metrics from high-resolution manometry (HRM). Fifty-two diverse international experts separated into seven working subgroups utilized formal validated methodologies over two-years to develop CCv4.0. Key updates in CCv.4.0 consist of a more rigorous and expansive HRM protocol that incorporates supine and upright test positions as well as provocative testing, a refined definition of esophagogastric junction (EGJ) outflow obstruction (EGJOO), more stringent diagnostic criteria for ineffective esophageal motility and description of baseline EGJ metrics. Further, the CCv4.0 sought to define motility disorder diagnoses as conclusive and inconclusive based on associated symptoms, and findings on provocative testing as well as supportive testing with barium esophagram with tablet and/or functional lumen imaging probe. These changes attempt to minimize ambiguity in prior iterations of Chicago Classification and provide more standardized and rigorous criteria for patterns of disorders of peristalsis and obstruction at the EGJ.
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http://dx.doi.org/10.1111/nmo.14058DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8034247PMC
January 2021

Is Gluten the Only Culprit for Non-Celiac Gluten/Wheat Sensitivity?

Nutrients 2020 Dec 10;12(12). Epub 2020 Dec 10.

Gastrointestinal Unit, Department of Translational Sciences and New Technologies in Medicine and Surgery, University of Pisa, 56124 Pisa, Italy.

The gluten-free diet (GFD) has gained increasing popularity in recent years, supported by marketing campaigns, media messages and social networks. Nevertheless, real knowledge of gluten and GF-related implications for health is still poor among the general population. The GFD has also been suggested for non-celiac gluten/wheat sensitivity (NCG/WS), a clinical entity characterized by intestinal and extraintestinal symptoms induced by gluten ingestion in the absence of celiac disease (CD) or wheat allergy (WA). NCG/WS should be regarded as an "umbrella term" including a variety of different conditions where gluten is likely not the only factor responsible for triggering symptoms. Other compounds aside from gluten may be involved in the pathogenesis of NCG/WS. These include fructans, which are part of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs), amylase trypsin inhibitors (ATIs), wheat germ agglutinin (WGA) and glyphosate. The GFD might be an appropriate dietary approach for patients with self-reported gluten/wheat-dependent symptoms. A low-FODMAP diet (LFD) should be the first dietary option for patients referring symptoms more related to FODMAPs than gluten/wheat and the second-line treatment for those with self-reported gluten/wheat-related symptoms not responding to the GFD. A personalized approach, regular follow-up and the help of a skilled dietician are mandatory.
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http://dx.doi.org/10.3390/nu12123785DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7762999PMC
December 2020

Hypercontractile Esophagus From Pathophysiology to Management: Proceedings of the Pisa Symposium.

Am J Gastroenterol 2021 02;116(2):263-273

Division of Gastroenterology, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Padua, Italy.

Hypercontractile esophagus (HE) is a heterogeneous major motility disorder diagnosed when ≥20% hypercontractile peristaltic sequences (distal contractile integral >8,000 mm Hg*s*cm) are present within the context of normal lower esophageal sphincter (LES) relaxation (integrated relaxation pressure < upper limit of normal) on esophageal high-resolution manometry (HRM). HE can manifest with dysphagia and chest pain, with unclear mechanisms of symptom generation. The pathophysiology of HE may entail an excessive cholinergic drive with temporal asynchrony of circular and longitudinal muscle contractions; provocative testing during HRM has also demonstrated abnormal inhibition. Hypercontractility can be limited to the esophageal body or can include the LES; rarely, the process is limited to the LES. Hypercontractility can sometimes be associated with esophagogastric junction (EGJ) outflow obstruction and increased muscle thickness. Provocative tests during HRM can increase detection of HE, reproduce symptoms, and predict delayed esophageal emptying. Regarding therapy, an empiric trial of a proton pump inhibitor, should be first considered, given the overlap with gastroesophageal reflux disease. Calcium channel blockers, nitrates, and phosphodiesterase inhibitors have been used to reduce contraction vigor but with suboptimal symptomatic response. Endoscopic treatment with botulinum toxin injection or pneumatic dilation is associated with variable response. Per-oral endoscopic myotomy may be superior to laparoscopic Heller myotomy in relieving dysphagia, but available data are scant. The presence of EGJ outflow obstruction in HE discriminates a subset of patients who may benefit from endoscopic treatment targeting the EGJ.
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http://dx.doi.org/10.14309/ajg.0000000000001061DOI Listing
February 2021

Postreflux swallow-induced peristaltic wave index from pH-impedance monitoring associates with esophageal body motility and esophageal acid burden.

Neurogastroenterol Motil 2021 02 16;33(2):e13973. Epub 2020 Aug 16.

Division of Gastroenterology, Washington University School of Medicine, St Louis, MO, USA.

Background: Postreflux swallow-induced peristaltic wave (PSPW) on pH-impedance monitoring and contraction vigor on high-resolution manometry (HRM) both assess esophageal peristaltic response. We aimed to evaluate relationships between PSPW and esophageal peristalsis on HRM in the context of reflux disease in this multicenter cohort study.

Methods: pH-impedance and HRM studies performed on patients with persisting reflux symptoms were reviewed from 6 centers (5 in Europe and 1 in US). Total, upright and supine acid exposure time (AET) were evaluated from pH-impedance studies; PSPW index (PSPWI) and mean nocturnal baseline impedance (MNBI) were calculated using standard methodology. Esophageal body contraction vigor was analyzed using distal contractile integral (DCI), and DCI ratio > 1 between single swallows and multiple rapid swallows (MRS) defined presence of contraction reserve. Student's t test, ANOVA, and linear regression were utilized to investigate relationships between PSPW, contraction vigor, and contraction reserve.

Key Results: Of 296 patients (52.8 ± 0.8 yr, 63% F), median PSPWI was 0.475. Only 24.0% had intact DCI; the remainder had varying degrees of hypomotility. As hypomotility increased, PSPWI and MNBI decreased significantly, while total AET and reflux episodes had an inverse response (P ≤ .002 for each). MRS data were available in 167 (56.4%), 72.5% had contraction reserve. MRS cohorts with normal PSPWI had significantly lower reflux burden compared to low PSPWI, regardless of presence or absence of contraction reserve (P ≤ .001).

Conclusions And Inferences: PSPWI correlates with esophageal hypomotility and reflux burden, and complements clinical reflux evaluation. Intact PSPW is more relevant to esophageal reflux clearance than contraction reserve.
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http://dx.doi.org/10.1111/nmo.13973DOI Listing
February 2021

Refractoriness to Treatment Suggests That Clinical Evaluation Should Go Beyond the Diagnosis of Reflux Disease.

Clin Gastroenterol Hepatol 2021 May 26;19(5):1077-1078. Epub 2020 Nov 26.

Gastroenterology Unit, Department of Internal Medicine, IRCCS Ospedale Policlinico San Martino, University of Genoa, Genoa, Italy.

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http://dx.doi.org/10.1016/j.cgh.2020.06.057DOI Listing
May 2021

Eosinophilic esophagitis a rising disease.

Minerva Gastroenterol Dietol 2020 Nov 19. Epub 2020 Nov 19.

Division of Gastroenterology, Department of Oncology, Surgery and Gastroenterology, University of Padua, Padua, Itay.

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http://dx.doi.org/10.23736/S1121-421X.20.02806-8DOI Listing
November 2020

Low Fermentable Oligo- Di- and Mono-Saccharides and Polyols (FODMAPs) or Gluten Free Diet: What Is Best for Irritable Bowel Syndrome?

Nutrients 2020 Nov 1;12(11). Epub 2020 Nov 1.

Clinical and Experimental Medicine-Rheumatology Unit, University of Pisa, 56100 Pisa, Italy.

Irritable Bowel Syndrome (IBS) is a very common functional gastrointestinal disease. Its pathogenesis is multifactorial and not yet clearly defined, and hence, its therapy mainly relies on symptomatic treatments. Changes in lifestyle and dietary behavior are usually the first step, but unfortunately, there is little high-quality scientific evidence regarding a dietary approach. This is due to the difficulty in setting up randomized double-blind controlled trials which objectively evaluate efficacy without the risk of a placebo effect. However, a Low Fermentable Oligo-, Di- and Mono-saccharides And Polyols (FODMAP) Diet (LFD) and Gluten Free Diet (GFD) are among the most frequently suggested diets. This paper aims to evaluate their possible role in IBS management. A GFD is less restrictive and easier to implement in everyday life and can be suggested for patients who clearly recognize gluten as a trigger of their symptoms. An LFD, being more restrictive and less easy to learn and to follow, needs the close supervision of a skilled nutritionist and should be reserved for patients who recognize that the trigger of their symptoms is not, or not only, gluten. Even if the evidence is of very low-quality for both diets, the LFD is the most effective among the dietary interventions suggested for treating IBS, and it is included in the most updated guidelines.
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http://dx.doi.org/10.3390/nu12113368DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7692077PMC
November 2020

Esophageal reflux hypersensitivity: Non-GERD or still GERD?

Dig Liver Dis 2020 12 21;52(12):1413-1420. Epub 2020 Oct 21.

Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy. Electronic address:

The most recent iteration of the classifications for functional esophageal disorders, Rome IV, proposed relevant modifications of the previous definitions for Rome III. They specifically considered increased esophageal acid exposure as the marker of gastroesophageal reflux disease (GERD), including the remaining part of non-erosive reflux disease patients with normal acid in the group with functional alterations, considering both reflux hypersensitivity and functional heartburn. However, recent pathophysiological and therapeutic data suggest the need for a return to including reflux hypersensitivity in the GERD spectrum. Indeed, physiologic alterations in esophageal mucosal integrity and chemical clearance, the presence of microscopic esophagitis, and strict symptom-reflux association support the concept that reflux hypersensitivity pertains to GERD. Surgical anti-reflux therapy has resulted in positive outcomes, even in the long term, in patients with reflux hypersensitivity and not in those with functional heartburn. Moreover, clinical trials using neuromodulators have been scarce and provided conflicting results. As a result, the real progress of the Rome IV classifications is in dispute. This article aims to summarize the most recent knowledge of non-erosive reflux disease and reflux hypersensitivity to discuss the utility of Rome IV criteria in the identification and management of functional esophageal disorders.
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http://dx.doi.org/10.1016/j.dld.2020.10.003DOI Listing
December 2020

Normal values and regional differences in oesophageal impedance-pH metrics: a consensus analysis of impedance-pH studies from around the world.

Gut 2020 Oct 9. Epub 2020 Oct 9.

Division of Gastroenterology, Washington University School of Medicine, St. Louis, Missouri, USA.

Objective: Limitations of existing impedance-pH thresholds include small sample size of normative studies, inclusion of artefactual pH drops and incorrect identification of impedance reflux events. We aimed to obtain new impedance-pH thresholds from expert consensus analysis of tracings from a large number of healthy subjects.

Design: Of 541 studies performed worldwide using two different systems (Diversatek, USA, and Laborie, Netherlands), 150 tracings with oesophageal diagnoses, behavioural disorders and study-related artefacts were excluded. The remainder studies were subject to two reviewer consensus analysis, in-person or through video conference, consisting of editing meals and pH drops, identification of impedance reflux and postreflux swallow-induced peristaltic wave (PSPW) using strict pre-established criteria and measurement of distal mean nocturnal baseline impedance (MNBI).

Results: Consensus analysis was performed in 391 tracings (age 32.7 years, range 18-71, 54.2% female). Normative thresholds were significantly different between Diversatek and Laborie (total acid exposure time: 2.8% and 5%; reflux episodes: 55 and 78; MNBI at 3 cm: 1400 and 1500 ohms, at 5 cm: 1400 and 1800 ohms). Males had higher acid exposure, more reflux episodes and lower MNBI. Significant regional differences were identified, including higher PSPW scores in Western countries, and higher MNBI in Asia using Diversatek, and higher acid exposure in the Netherlands, higher MNBI in Asia and South Africa, and lower MNBI in Turkey using Laborie.

Conclusion: Normal impedance-pH monitoring thresholds have regional and system-related differences. Clinical interpretation needs to use normal thresholds valid for the system used and world region, following careful editing of the tracings.
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http://dx.doi.org/10.1136/gutjnl-2020-322627DOI Listing
October 2020

A Low-FODMAP Diet for Irritable Bowel Syndrome: Some Answers to the Doubts from a Long-Term Follow-Up.

Nutrients 2020 Aug 7;12(8). Epub 2020 Aug 7.

Clinical and Experimental Medicine-Rheumatology Unit, University of Pisa, 56100 Pisa, Italy.

A low-FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet (LFD) is a possible therapy for irritable bowel syndrome (IBS). This study investigates the short- and long-term efficacy and nutritional adequacy of an LFD and the patients' long-term acceptability. Patients' adherence and ability to perceive the "trigger" foods were also evaluated. Seventy-three IBS patients were given an LFD (T0) and after 2 months (T1), 68 started the reintroduction phase. At the end of this period (T2), 59 were advised to go on an Adapted Low-FODMAP Diet (AdLFD) and 41 were evaluated again after a 6-24 month follow-up (T3). At each time, questionnaires and Biolectrical Impedance Vector Analysis (BIVA) were performed. The LFD was effective in controlling digestive symptoms both in the short- and long-term, and in improving quality of life, anxiety and depression, even if some problems regarding acceptability were reported and adherence decreased in the long term. The LFD improved the food-related quality of life without affecting nutritional adequacy. When data collected at T0 were compared with those collected at T2, the perception of trigger foods was quite different. Even if some problems of acceptability and adherence are reported, an LFD is nutritionally adequate and effective in improving IBS symptoms also in the long term.
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http://dx.doi.org/10.3390/nu12082360DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7468924PMC
August 2020

Achalasia and Obstructive Motor Disorders Are Not Uncommon in Patients With Eosinophilic Esophagitis.

Clin Gastroenterol Hepatol 2020 Aug 4. Epub 2020 Aug 4.

Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy. Electronic address:

Background: An association has been reported between achalasia and eosinophilic esophagitis (EoE). We performed a retrospective study of high-resolution manometry (HRM) patterns in a large cohort of patients with EoE.

Material And Methods: We collected data from consecutive patients with a new diagnosis of EoE from 2012 through 2019 undergoing HRM during the initial assessment at different centers in Italy. Demographic, clinical, endoscopic and histological characteristics were recorded at baseline and during management. Diagnoses of EoE and esophageal motility disorders were made according to established criteria. Treatments offered included proton pump inhibitors and topical steroids for EoE, and pneumatic dilation and myotomy for achalasia. Response to therapy was defined as less than 15 eosinophils per high power field in esophageal biopsies.

Results: Of 109 consecutive patients (mean age 37 years, 82 male), 68 (62%) had normal findings from HRM. Among 41 patients with motor disorders, 24 (59%) had minor motor disorders and 17 (41%) presented with major motor disorders, including 8 with achalasia (1 with type 1, 4 with type 2, and 3 with type 3). Achalasia and nonachalasia obstructive motor disorders had 14.7% prevalence among patients with EoE. Achalasia was more frequent in women, with longer diagnostic delay and abnormal esophagogram (P < .05) compared with EoE without achalasia or obstructive motor disorders. Clinical features and endoscopic findings did not differ significantly between patients with EoE with vs without achalasia and obstructive motor disorders. A higher proportion of patients without achalasia and obstructive motor disorders responded to topical steroids than patients with these features (P < .005). Invasive achalasia management was required for symptom relief in 50% of patients with achalasia and obstructive motor disorders.

Conclusion: Achalasia and obstructive motor disorders are found in almost 15% of patients with EoE-esophageal eosinophilia might cause these disorders. Patients with EoE who does not respond to standard treatments might require targeted muscle disruption.
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http://dx.doi.org/10.1016/j.cgh.2020.07.056DOI Listing
August 2020

Fecal Calprotectin Predicts Mucosal Healing in Patients With Ulcerative Colitis Treated With Biological Therapies: A Prospective Study.

Clin Transl Gastroenterol 2020 05;11(5):e00174

IBD Unit, Department of General Surgery and Gastroenterology, Pisa University Hospital, Pisa, Italy.

Introduction: Biological therapies are widely used for the treatment of ulcerative colitis. However, only a low proportion of patients achieve clinical remission and even less mucosal healing. There is currently scarce knowledge about the early markers of therapeutic response, with particular regard to mucosal healing. The aim of this prospective study was to evaluate the role of fecal calprotectin (FC) as early predictor of mucosal healing.

Methods: A prospective observational study was conducted on patients with ulcerative colitis, who started biological therapy with infliximab, adalimumab, golimumab, or vedolizumab at our center. All patients underwent colonoscopy, performed by 2 blinded operators, at baseline and week 54 or in case of therapy discontinuation because of loss of response. FC was assessed at baseline and week 8 and evaluated as putative predictor of mucosal healing at week 54.

Results: We enrolled 109 patients, and 97 were included in the analysis. Twenty-six patients (27%) experienced loss of response. Over 71 patients (73%) with clinical response at week 54, clinical remission was obtained in 60 patients (61.9%) and mucosal healing in 45 patients (46.4%). After 8 weeks of treatment, FC predicted mucosal healing at week 54 (P < 0.0001). Sensitivity, specificity, positive predictive value, and negative predictive value were estimated to be 75%, 88.9%, 86.6%, and 75.5%, respectively, based on a cutoff of 157.5 mg/kg.

Discussion: The present study suggests that FC assessment after 8 weeks of treatment with all the biological drugs could represent a promising early marker of response to therapy in terms of mucosal healing.
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http://dx.doi.org/10.14309/ctg.0000000000000174DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7263645PMC
May 2020

Bile reflux in patients with nerd is associated with more severe heartburn and lower values of mean nocturnal baseline impedance and chemical clearance.

Neurogastroenterol Motil 2020 12 22;32(12):e13919. Epub 2020 Jun 22.

Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.

Background: Mean nocturnal baseline impedance (MNBI) and postreflux swallow-induced peristaltic wave (PSPW) index are novel impedance-based markers of reflux, but the effect of bile reflux on these metrics is unknown. The aim of this study was to evaluate bile reflux, MNBI, and PSPW index in patients with endoscopy-negative GERD partially responsive to PPI therapy.

Methods: All patients underwent off-PPI endoscopy, esophageal manometry, multichannel intraluminal impedance pH (MII-pH), and bile reflux monitoring. Abnormal esophageal acid exposure time (AET) was required for inclusion. Symptom intensity (using 10-cm visual analog scales), and conventional and novel MII-pH metrics were compared between patients with and without abnormal bile reflux.

Key Results: We evaluated 42 NERD patients (29 males, mean age: 53.4 ± 13. years), mean AET 6.1 ± 2%, of which 21 had abnormal bile reflux (Group A, 10.2 ± 4.9%), and 21 had normal bile reflux (Group B, 0.4 ± 0.1%, P < .05 compared with Group A). Heartburn reporting on PPI was higher in Group A (7.2 ± 2.1 vs 5.8 ± 0.9; P = .002), but AET, number of reflux events (acidic and weakly acidic), did not differ between the two groups. However, both PSPW index and MNBI were lower in Group A (P < .001). A strong inverse linear correlation was found between bile reflux and both MNBI (Pearson's test; R = -0.714; P < .001) and PSPW index (R = -0.722; P < .001).

Conclusions And Inferences: Compared to acid reflux alone, the presence of bile in an acidic esophageal environment is associated with more severe heartburn, lesser relief from PPI therapy, higher impairment of esophageal mucosal integrity and less effective chemical clearance.
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http://dx.doi.org/10.1111/nmo.13919DOI Listing
December 2020

A SIGE-SINGEM-AIGO technical review on the clinical use of esophageal reflux monitoring.

Dig Liver Dis 2020 09 6;52(9):966-980. Epub 2020 Jun 6.

Gastrointestinal Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy.

Patients with esophageal symptoms potentially associated with gastroesophageal reflux disease such as heartburn, regurgitation, chest pain, or cough represent one of the most frequent reasons for referral to gastroenterological evaluation. The utility of esophageal reflux monitoring in clinical practice is: (1) to accurately define reflux burden, (2) to segregate patients according to reflux monitoring results as true GERD, reflux hypersensitivity and functional heartburn, and (3) to establish a treatment plan. With this in mind, in the last decade, investigations and technical advances, with the introduction of impedance-pH monitoring and wireless pH capsule, have enhanced our understanding and management of GERD. The following recommendations were discussed and approved after a comprehensive review of the medical literature pertaining to reflux testing techniques and their recent application. This review created under the auspices of the Società Italiana di Gastroenterologia ed Endoscopia Digestiva (SIGE), Società Italiana di Neuro-Gastro-Enterologia e Motilità (SINGEM) and Associazione Italiana Gastroenterologi ed Endoscopisti Digestivi Ospedalieri (AIGO) is intended to help clinicians in applying reflux studies in the most fruitful manner within the context of their patients with esophageal symptoms.
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http://dx.doi.org/10.1016/j.dld.2020.04.031DOI Listing
September 2020

Serum oncostatin M at baseline predicts mucosal healing in Crohn's disease patients treated with infliximab.

Aliment Pharmacol Ther 2020 07 7;52(2):284-291. Epub 2020 Jun 7.

Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Background: Oncostatin M is upregulated in Crohn's disease inflamed intestinal mucosa, and has been suggested as a promising biomarker to predict responsiveness to anti-TNF therapy in patients with inflammatory bowel diseases.

Aim: To evaluate the suitability of serum oncostatin M as a predictive marker of response to infliximab in Crohn's disease.

Methods: We included patients treated with infliximab monotherapy. All patients underwent colonoscopy at week 54 to evaluate mucosal healing. Serum oncostatin M and faecal calprotectin were measured at baseline and after 14 weeks of treatment. Mann-Whitney test was used to evaluate correlation of oncostatin M and faecal calprotectin at baseline and week 14 with mucosal healing at week 54. Their accuracy in predicting mucosal healing was assessed by area under the curve (AUC).

Results: In a cohort of 45 included patients, 27 displayed mucosal healing. At both baseline and week 14, oncostatin M levels were significantly lower in patients with mucosal healing than in patients not achieving this endpoint (P < 0.001). Faecal calprotectin levels at week 14 were lower also in responders than nonresponders (P < 0.001). Oncostatin M values at baseline and week 14 were significantly associated (Spearman correlation = 0.92, P < 0.001). The diagnostic accuracy of oncostatin M at baseline in predicting mucosal healing (AUC = 0.91) was greater than faecal calprotectin (AUC = 0.51, P < 0.001).

Conclusion: These results suggest that oncostatin M can predict the outcome of infliximab treatment. Compared with faecal calprotectin, the predictive capability of oncostatin M was appreciable at baseline, thus indicating oncostatin M as a promising biomarker for driving therapeutic choices in Crohn's disease.
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http://dx.doi.org/10.1111/apt.15870DOI Listing
July 2020

Assessment and Diagnostic Accuracy Evaluation of the Reflux Symptom Index (RSI) Scale: Psychometric Properties using Optimal Scaling Techniques.

Ann Otol Rhinol Laryngol 2020 Oct 29;129(10):1020-1029. Epub 2020 May 29.

ENT Audiology Phoniatric Unit, University of Pisa, Pisa, Italy.

Objectives: To investigate the psychometric properties of the reflux symptom index (RSI) as short screening approach for the diagnostic of laryngopharyngeal reflux (LPR) in patients with confirmed diagnosed regarding the 24-hour multichannel intraluminal impedance-pH monitoring (MII-pH).

Methods: From January 2017 to December 2018, 56 patients with LPR symptoms and 71 healthy individuals (control group) were prospectively enrolled. The LPR diagnosis was confirmed through MII-pH results. All subjects (n = 127) fulfilled RSI and the Reflux Finding Score (RFS) was performed through flexible fiberoptic endoscopy. The sensitivity and the specificity of RSI was assessed by ROC (Receiver Operating Characteristic) analysis.

Results: A total of 15 LPR patients (26.8%) of the clinical group met MII-pH diagnostic criteria. Among subjects classified as positive for MII- pH diagnoses, RSI and RFS mean scores were respectively 20 (SD ± 10.5) and 7.1 (SD ± 2.5), values not significantly different compared to the negative MII-pH group. The metric analysis of the items led to the realization of a binary recoding of the score. Both versions had similar psychometric properties, α was 0.840 for RSI original version and 0.836 for RSI binary version. High and comparable area under curve (AUC) values indicate a good ability of both scales to discriminate between individuals with and without LPR pathology diagnosis. Based on balanced sensitivity and specificity, the optimal cut-off scores for LPR pathology were ≥ 5 for RSI binary version and ≥ 15 for RSI original version. Both version overestimated LPR prevalence. The original version had more sensitivity and the RSI Binary version had more specificity.

Conclusions: It would be necessary to think about modifying the original RSI in order to improve its sensitivity and specificity (RSI binary version, adding or changing some items), or to introduce new scores in order to better frame the probably affected of LPR patient.
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http://dx.doi.org/10.1177/0003489420930034DOI Listing
October 2020