Poliprotect vs Omeprazole in the Relief of Heartburn, Epigastric Pain, and Burning in Patients Without Erosive Esophagitis and Gastroduodenal Lesions: A Randomized, Controlled Trial.

INTRODUCTION: In the treatment of upper GI endoscopy-negative patients with heartburn and epigastric pain or burning, antacids, antireflux agents, and mucosal protective agents are widely used, alone or as add-on treatment, to increase response to proton-pump inhibitors, which are not indicated in infancy and pregnancy and account for significant cost expenditure. METHODS: In this randomized, controlled, double-blind, double-dummy, multicenter trial assessing the efficacy and safety of mucosal protective agent Poliprotect (neoBianacid, Sansepolcro, Italy) vs omeprazole in the relief of heartburn and epigastric pain/burning, 275 endoscopy-negative outpatients were given a 4-week treatment with omeprazole (20 mg q.d.) or Poliprotect (5 times a day for the initial 2 weeks and on demand thereafter), followed by an open-label 4-week treatment period with Poliprotect on-demand. Gut microbiota change was assessed. RESULTS: A 2-week treatment with Poliprotect proved noninferior to omeprazole for symptom relief (between-group difference in the change in visual analog scale symptom score: [mean, 95% confidence interval] -5.4, -9.9 to -0.1; -6.2, -10.8 to -1.6; intention-to-treat and per-protocol populations, respectively). Poliprotect's benefit remained unaltered after shifting to on-demand intake, with no gut microbiota variation. The initial benefit of omeprazole was maintained against significantly higher use of rescue medicine sachets (mean, 95% confidence interval: Poliprotect 3.9, 2.8-5.0; omeprazole 8.2, 4.8-11.6) and associated with an increased abundance of oral cavity genera in the intestinal microbiota. No relevant adverse events were reported in either treatment arm. DISCUSSION: Poliprotect proved noninferior to standard-dose omeprazole in symptomatic patients with heartburn/epigastric burning without erosive esophagitis and gastroduodenal lesions. Gut microbiota was not affected by Poliprotect treatment. The study is registered in Clinicaltrial.gov (NCT03238534) and the EudraCT database (2015-005216-15).

Transoral incisionless fundoplication with Medigus ultrasonic surgical endostapler (MUSE) for the treatment of gastro-esophageal reflux disease: outcomes up to 3 years.

BACKGROUND: Transoral incisionless fundoplication (TIF) with Medigus Ultrasonic Surgical Endostapler (MUSE) is a new intervention for treatment of gastro-esophageal reflux disease (GERD). We aimed at assessing the clinical, functional, and endoscopic effects of TIF by MUSE. METHODS: Forty-six patients underwent TIF. Proton pump inhibitor (PPI) consumption, GERD-health-related quality of life (HRQL) and reflux symptom index (RSI) questionnaires, upper gastrointestinal (GI) endoscopy, esophageal 24-h pH-impedance recording, and high-resolution manometry (HRM) were done before TIF and scheduled 6 and 12 months later (HRM only at 6-month). PPI consumption and symptoms were then assessed yearly. Data up to 3 years are reported in this study (PP- and ITT-analysis). RESULTS: TIF was successfully performed in 45/46 patients; in one patient esophageal intubation was impossible. Perforation occurred in two cases. One patient required surgery within 6 months. Clinical follow-up was available for 42 patients at 6 months and 1 year, 35 patients at 2 years, and 31 patients at 3 years. At 1, 2, and 3 years, PPI consumption was stopped, respectively, in 64.3%, 62.9%, and 74.2% of cases (ITT-analysis: 58.7%, 56.4%, and 65.7%). GERD-HRQL and RSI scores decreased at least 50%, respectively, in 71.5% and 76.2%, 71.4% and 68.6%, and 67.7% of cases (ITT-analysis: 65.2% and 69.6%, 64.1% and 61.5%, and 60%). A significant improvement of both scores was observed up to 3 years. 6-month and 1-year functional follow-up were possible in 31 and 20 patients. HRM showed significant increase of the median lower esophageal sphincter length and rate of peristaltic waves. Esophageal pH-impedance recording found significantly fewer acid, proximal and total refluxes, and percentage of esophageal pH < 4 total time at 6 months, but not at 1 year. CONCLUSION: TIF by MUSE significantly improved symptoms and PPIs consumption up to 3 years. However, esophagitis still persisted in one-third of cases at 1 year and functional improvement at 6 months was not confirmed at 1 year. Severe complications requiring surgery occurred in two cases. CLINICALTRIALS: GOV: ID: NCT03669874.

Does Sleeve Gastrectomy Worsen Gastroesophageal Reflux Disease in Obese Patients? A Prospective Study.

BACKGROUND: To evaluate the impact of laparoscopic sleeve gastrectomy (LSG) and gastric bypass (LGB) on gastroesophageal reflux disease (GERD). METHODS: GERD was evaluated by the Modified Italian Gastroesophageal reflux disease-Health-Related Quality of Life (MI-GERD-HRQL) questionnaire, pH-manometry, endoscopy, and Rx-esophagogram, before and 12 months after surgery. Based on these exams, patients without GERD underwent LSG, and patients with GERD underwent LGB. RESULTS: Thirteen and six patients underwent LSG and LGB, respectively. After LSG, the only statistically significant difference observed at pH-manometry was the median DeMeester score, from 5.7 to 22.7 (P = .0026). De novo GERD occurred in 6 patients (46.2%), with erosive esophagitis in one. The median MI-GERD-HRQL score improved from 3 to 0. Overall, nine patients underwent LGB, but three were lost to follow-up. Preoperative pH-manometry changed the surgical indication from LSG to LGB in 7 out of 9 patients (77.8%). Six patients who underwent LGB completed the study, and at pH-manometry, statistically significant differences were observed in the percentage of total acid exposure time, with the number of reflux episodes lasting >5 minutes and DeMeester score (P = .009). The median MI-GERD-HRQL score improved from 6.5 to 0. Statistically significant differences were not observed at endoscopy and Rx-esophagogram findings in both groups. CONCLUSIONS: LSG has a negative impact on GERD, even in patients without preoperative GERD. LGB confirmed to be the intervention of choice in patients with GERD. Preoperative pH-manometry may identify patients with silent GERD, to candidate them to LGB rather than LSG. pH-manometry should be used more liberally to establish the correct surgical indication on objective grounds.

Manometric and pH-monitoring changes after laparoscopic sleeve gastrectomy: a systematic review.

PURPOSE: Aim of this systematic review is to assess the changes in esophageal motility and acid exposure of the esophagus through esophageal manometry and 24-hours pH-monitoring before and after laparoscopic sleeve gastrectomy (LSG). METHODS: Articles in which all patients included underwent manometry and/or 24-hours pH-metry or both, before and after LSG, were included. The search was carried out in the PubMed, Embase, Cochrane, and Web of Science databases, revealing overall 13,769 articles. Of these, 9702 were eliminated because they have been found more than once between the searches. Of the remaining 4067 articles, further 4030 were excluded after screening the title and abstract because they did not meet the inclusion criteria. Thirty-seven articles were fully analyzed, and of these, 21 further articles were excluded, finally including 16 articles. RESULTS: Fourteen and twelve studies reported manometric and pH-metric data from 402 and 547 patients, respectively. At manometry, a decrease of the lower esophageal sphincter resting pressure after surgery was observed in six articles. At 24-hours pH-metry, a worsening of the DeMeester score and/or of the acid exposure time was observed in nine articles and the de novo gastroesophageal reflux disease (GERD) rate that ranged between 17.8 and 69%. A meta-analysis was not performed due to the heterogeneity of data. CONCLUSIONS: After LSG a worsening of GERD evaluated by instrumental exams was observed such as high prevalence of de novo GERD. However, to understand the clinical impact of LSG and the burden of GERD over time further long-term studies are necessary.

Intrahepatic cholangiocarcinoma: Evolving strategies in management and treatment.

Intrahepatic cholangiocarcinoma is the second most frequent primary liver cancer after hepatocellular carcinoma. According to International Classification of Diseases-11 (ICD-11), intrahepatic cholangiocarcinoma is identified by a specific diagnostic code, different with respect to perihilar-CCA or distal-CCA. Intrahepatic cholangiocarcinoma originates from intrahepatic small or large bile ducts including the second-order bile ducts and has a silent presentation that combined with the highly aggressive nature and refractoriness to chemotherapy contributes to the alarming increasing incidence and mortality. Indeed, at the moment of the diagnosis, less than 40% of intrahepatic cholangiocarcinoma are suitable of curative surgical therapy, that is so far the only effective treatment. The main goals of clinicians and researchers are to make an early diagnosis, and to carry out molecular characterization to provide the patient with personalized treatment. Unfortunately, these goals are not easily achievable because of the heterogeneity of this tumor from anatomical, molecular, biological, and clinical perspectives. However, recent progress has been made in molecular characterization, surgical treatment, and management of intrahepatic cholangiocarcinoma and, this article deals with these advances.

Gastroesophageal Reflux Disease - Health-Related Quality of Life Questionnaire: prospective development and validation in Italian.

OBJECTIVE: To date, two questionnaires investigating the symptoms of gastroesophageal reflux disease (GERD) (Quality of Life Reflux and Dyspepsia and Reflux Disease Questionnaire) are validated in Italian, but neither of the two questionnaires was correlated with an instrumental examination. The aim of the present study is to improve the GERD-Health Related Quality of Life (HRQL) questionnaire, to evaluate the reliability and validity of its Italian translation, and its sensitivity and specificity. METHODS: A modified Italian GERD-HRQL (MI-GERD-HRQL) questionnaire was developed adding six questions investigating on regurgitation, for a total of 15 questions. The forward-backward translation process was employed to obtain a definitive from-English-to-Italian version. Data obtained from the questionnaire were compared to upper gastrointestinal endoscopy findings. RESULTS: The questionnaire was administered twice to 130 Italian-speaking patients by two different and independent raters. Cronbach's α of the first and second questionnaire was 0.944 and 0.942, respectively. Spearman correlation and inter-rater reliability were 0.923 and 0.929, respectively. Sensitivity and specificity were 73.3 and 64%, and 69.5 and 64%, respectively, for the first and second questionnaire. CONCLUSION: The MI-GERD-HRQL questionnaire proved good consistency, reliability, sensitivity and specificity in the evaluation of typical GERD symptoms.

Role of Fibre in Nutritional Management of Pancreatic Diseases.

The role of fibre intake in the management of patients with pancreatic disease is still controversial. In acute pancreatitis, a prebiotic enriched diet is associated with low rates of pancreatic necrosis infection, hospital stay, systemic inflammatory response syndrome and multiorgan failure. This protective effect seems to be connected with the ability of fibre to stabilise the disturbed intestinal barrier homeostasis and to reduce the infection rate. On the other hand, in patients with exocrine pancreatic insufficiency, a high content fibre diet is associated with an increased wet fecal weight and fecal fat excretion because of the fibre inhibition of pancreatic enzymes. The mechanism by which dietary fibre reduces the pancreatic enzyme activity is still not clear. It seems likely that pancreatic enzymes are absorbed on the fibre surface or entrapped in pectin, a gel-like substance, and are likely inactivated by anti-nutrient compounds present in some foods. The aim of the present review is to highlight the current knowledge on the role of fibre in the nutritional management of patients with pancreatic disorders.