BACKGROUND:Anastomotic leakages are one of the most frequent complications of gastroesophageal surgery with a high mortality. OBJECTIVE:This study aimed to assess the efficacy and safety of endoscopic therapy using fully covered self-expanding metal stents (FC-SEMS) for the management of anastomotic leaks. METHODS:In this cohort study, all patients with leak after oncological gastroesophageal surgery treated with FC-SEMS were included. Procedures were performed by one expert endoscopist in three Italian endoscopic units. The primary outcome was clinical success defined as complete resolution of clinical and laboratory manifestations of sepsis with radiological evidence of leak closure. Secondary outcomes were technical success, stent-related adverse events (AEs), and mortality. RESULTS:28 patients (21.4% female, mean age 64.3 years) were included in the study, of whom 17 (60.7%) had undergone total gastrectomy, 9 (32.1%) Ivor-Lewis procedure, and 2 (7.1%) extended gastrectomy (transhiatal-abdominal approach). The leaks were located in esophagogastric anastomosis in 5 patients (17.9%), esophagojejunal anastomosis in 19 (67.9%), and esophagus in 4 (14.3%). A total of 34 stents were placed (mean of 1.2 per patient). Technical success of stent placement was achieved in all cases (100%). Clinical success was observed in 78.6% of patients. Stent-related early AEs occurred in 9 patients (32.1%, all were migration). Late AEs occurred in 21.4%, which all were treated endoscopically. CONCLUSION:Stenting therapy using FC-SEMS is a safe and effective modality for the management of anastomotic leaks.

INTRODUCTION:Impairment of the gastrointestinal barrier leads to microbial translocation and peripheral immune activation, which are linked to disease progression. Data in the setting of primary HIV/SIV infection suggest that gut barrier damage is one of the first events of the pathogenic cascade, preceding mucosal immune dysfunction and microbial translocation. We assessed gut structure and immunity as well as microbial translocation in acutely and chronically-infected, combination antiretroviral therapy (cART)-naive individuals. METHODS:Fifteen people with primary HIV infection (P-HIV) and 13 with chronic HIV infection (C-HIV) c-ART-naive participants were cross-sectionally studied. Gut biopsies were analysed in terms of gut reservoirs (total, integrated and unintegrated HIV DNA); tight junction proteins (E-cadherin, Zonula Occludens-1), CD4 + expression, neutrophil myeloperoxidase (histochemical staining); collagen deposition (Masson staining). Flow cytometry was used to assess γδ T-cell frequency (CD3 + panγδ+Vδ1+/Vδ2+). In plasma, we measured microbial translocation (LPS, sCD14, EndoCAb) and gut barrier function (I-FABP) markers (ELISA). RESULTS:P-HIV displayed significantly higher tissue HIV DNA, yet neutrophil infiltration and collagen deposition in the gut were similar in the two groups. In contrast, microbial translocation markers were significantly lower in P-HIV compared with C-HIV. A trend to higher mucosal E-cadherin, and gut γδ T-cells was also observed in P-HIV. CONCLUSION:Early HIV infection features higher HIV DNA in the gut, yet comparable mucosal alterations to those observed in chronic infection. In contrast, microbial translocation is contained in primary HIV infection, likely because of a partial preservation of E-cadherin and mucosal immune subsets, namely γδ T-cells.

Background First-line over-the-scope (OTS) clip treatment has shown higher efficacy than standard endoscopic therapy in acute nonvariceal upper gastrointestinal bleeding (NVUGIB) from different causes. We compared OTS clips with through-the-scope (TTS) clips as first-line mechanical treatment in the specific setting of peptic ulcer bleeding. Methods We conducted an international, multicenter randomized controlled trial on consecutive patients with suspected NVUGIB. Patients with Forrest Ia-IIb gastroduodenal peptic ulcer were randomized 1:1 to OTS clip or TTS clip treatment. The primary outcome was the rate of 30-day rebleeding after successful initial hemostasis. Secondary outcomes included the rates of successful initial hemostasis and overall clinical success, defined as the composite of successful initial hemostasis and no evidence of 30-day rebleeding. Results 251 patients were screened and 112 patients were randomized to OTS (n = 61) or TTS (n = 51) clip treatment. The 30-day rebleeding rates were 1.6% (1/61) and 3.9% (2/51) in patients treated with OTS clips and TTS clips, respectively (Kaplan-Meier log-rank, P = 0.46). Successful initial hemostasis rates were 98.4% (60/61) in the OTS clip group and 78.4% (40/51) in the TTS clip group ( P = 0.001). Overall clinical success rates were 96.7% (59/61) with OTS clips and 74.5% (38/51) with TTS clips ( P = 0.001). Conclusions Low rates of 30-day rebleeding were observed after first-line endoscopic treatment of acute peptic ulcer bleeding with either OTS or TTS clips. However, OTS clips showed higher efficacy than TTS clips in achieving successful initial hemostasis and overall clinical success.

Aims First-line over-the-scope clip (OTS-clip) treatment has shown higher efficacy than standard endoscopic therapy in acute non-variceal upper GI bleeding from several different causes [1] [2]. However, no randomized controlled trial (RCT) comparing first-line mechanical treatment with OTS-clip vs through-the-scope clips (TTSCs) in the specific setting of peptic ulcer (PU) bleeding has been performed to date. This was our study aim (▶Table [1]).

Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) are rare tumors derived from the neuroendocrine cell system, which that have increased in incidence and prevalence in recent years. Despite improvements in radiological and metabolic imaging, endoscopy still plays a pivotal role in the number of GEP-NENs. Tumor detection, characterization, and staging are essential in management and treatment planning. Upper and lower gastrointestinal (GI) endoscopy is essential for correct localization of the primary tumor site of GI NENs. Endoscopic ultrasonography (EUS) has an important role in the imaging and tissue acquisition of pancreatic NENs and locoregional staging of GI neuroendocrine tumors. Correct staging and histological diagnosis have important prognostic implications. Endoscopic operating techniques allow the removal of small GI NENs in the early stage of mucosal or submucosal invasion of the intestinal wall. Preoperative EUS-guided techniques may help the surgeon locate small and deep tumors, thus avoiding formal pancreatic resections in favor of parenchymal-sparing surgery. Finally, locoregional ablative treatments have been proposed in recent studies with promising results in selected patients.

BACKGROUND:Leaks are the major complication associated with laparoscopic sleeve gastrectomy.OBJECTIVE:The study aimed to assess the efficacy and safety of specifically designed large covered metal stents for the management of post-laparoscopic sleeve gastrectomy leaks.METHODS:Prospectively collected databases from three Italian Endoscopy Units were reviewed. The primary outcome of the study was to evaluate the clinical success of stents placement, defined as complete resolution of clinical and laboratory signs of sepsis with radiological evidence of leak closure. Secondary outcomes were stent-related adverse events and mortality.RESULTS:Twenty-one patients (67% females, mean age 45 years) were included in the study and a total of 26 stents were placed. Technical success of stent placement was achieved in all cases (100%). Clinical success was observed in 85.5% of patients. Stent-related adverse events occurred in 9 patients (43%), with stent migration as the most frequent complication (33%). Adverse events were more frequently observed in patients who had undergone bariatric surgery prior to laparoscopic sleeve gastrectomy compared to patients without previous surgery (83% et al. 27%, p=0.018).CONCLUSION:The placement of specifically designed covered metal stents appears to be an effective and safe therapeutic approach for post-laparoscopic sleeve gastrectomy leaks. Stent migration can be a frequent complication.

BACKGROUND. COVID-19 pandemic has impacted the Italian national health care system at many different levels, causing a complete reorganization of surgical wards. In this context, in this study we retrospectively analyzed our management strategy for patients with acute cholecystitis. METHODS We analyzed all patients admitted to our Emergency Department for acute cholecystitis from February 27 th to April 30 th , 2020. We graded each case according to the 2018 Tokyo Guidelines. All patients were tested for positivity to SARS-CoV-2 and received an initial conservative treatment. RESULTS Thirty-seven patients were admitted for acute cholecystitis (13 grade I, 16 grade II and 8 grade III). According to Tokyo Guidelines 2018, patients were successfully treated with antibiotic only, bedside percutaneous transhepatic gallbladder drainage and laparoscopic cholecystectomy in 29.7%, 21.6 % and 48.7% of cases respectively. Therapeutic strategy of three out of 8 cases, otherwise fit for surgery, submitted to percutaneous transhepatic gallbladder drainage (37.5%), were directly modified by COVID-19 pandemic: one due to the SARS-CoV-2 positivity, while two others due to unavailability of operating room and intensive care unit for post-operative monitoring respectively. Overall success rate of percutaneous drainage was of 87.5%, the mean post-procedural hospitalization length was 9 days, and no related adverse event were observed. CONCLUSIONS. Bedside cholecystostomy has shown to be an effective and safe treatment, which acquired an increased relevance in the present acute phase of the pandemic. This strategy will potentially be taken into consideration in future phases, when the coexistence with the virus will require us to respond in an even more virtuous fashion.

The diagnosis of coeliac disease (CD) in adult patients requires the simultaneous assessment of clinical presentation, serology, and typical histological picture of villous atrophy. However, several years ago, the European Society of Pediatric Gastroenterology, Hepatology, and Nutrition guidelines approved new criteria for the diagnosis in children: Biopsy could be avoided when anti-transglutaminase antibody (TGA) values exceed the cut-off of × 10 upper limit of normal (ULN) and anti-endomysium antibodies are positive, independently from value. This "no biopsy" approach is a decisive need for pediatric population, allowing to avoid stressful endoscopic procedures in children, if unnecessary. This approach relies on the correlation existing in children between TGA levels and assessment of mucosal atrophy according to Marsh's classification. Several lines of evidence have shown that patients with villous atrophy have markedly elevated TGA levels. Therefore, we aim to perform a narrative review on the topic in adults. Despite that some studies confirmed that the × 10 ULN threshold value has a very good diagnostic performance, several lines of evidence in adults suggest that TGA cut off should be different from that of pediatric population for reaching a good correlation with histological picture. In conclusion, the heterogeneity of study reports as well as some conditions, which may hamper the serological diagnosis of CD (such as seronegative CD and non-celiac villous atrophy) and are much more common in adults than in children, could represent a limitation for the "no biopsy" approach to CD diagnosis in patients outside the pediatric age.

Background and Objective: Pediatric guidelines on celiac disease (CD) state that children with anti-transglutaminase antibodies (TGAs) >×10 upper limit of normal (ULN) may avoid endoscopy and biopsy. We aimed to evaluate whether these criteria may be suitable for villous atrophy diagnosis in CD adults. Materials and Methods: We retrospectively enrolled patients with CD aged >18 years. TGAs were expressed as xULN. Duodenal lesions were classified as atrophic or non-atrophic according to Marsh-Oberhuber. Fisher’s exact and t-test were used for variables comparison. Receiver operating characteristics (ROC) curve analysis was performed with estimation of area under the curve (AUC), sensitivity, specificity, and positive and negative predictive value (PPV/NPV). Results: One hundred and twenty-one patients were recruited. Sixty patients (49.6%) had TGA >×10 ULN, and 93 (76.8%) had villous atrophy. The cut-off of >×10 ULN had sensitivity = 53.7%, specificity = 64.3%, PPV = 83.3%, and NPV = 29.5% to predict atrophy. Therefore, considering pediatric criteria, in 50 (41.3%) patients, biopsy could have been avoided. Patient subgroup with atrophy had higher TGA levels despite being not significant (37.2 ± 15.3 vs. 8.0 ± 1.3 ULN, p = 0.06). In adults, a slightly better diagnostic performance was obtained using a cut-off of TGA >×6.2 ULN (sensitivity = 57.1%, specificity = 65.6%, and AUC = 0.62). Conclusions: Despite our confirmation that villous atrophy is linked to high TGA levels, CD and atrophy diagnosis based only on serology is not reliable in adults.

GOALS:The present survey from the Italian Society of Digestive Endoscopy (SIED-Società Italiana di Endoscopia Digestiva) was aimed at reporting infection control practice and outcomes at Digestive Endoscopy Units in a high-incidence area.BACKGROUND:Lombardy was the Italian region with the highest coronavirus disease-2019 (COVID-19) prevalence, at the end of March 2020 accounting for 20% of all worldwide deaths. Joint Gastro-Intestinal societies released recommendations for Endoscopy Units to reduce the risk of the contagion. However, there are few data from high-prevalence areas on adherence to these recommendations and on their efficacy.METHODS:A survey was designed by the Lombardy section of SIED to analyze (a) changes in activity and organization, (b) adherence to recommendations, (c) rate of health care professionals' (HCP) infection during the COVID-19 outbreak.RESULTS:In total, 35/61 invited centers (57.4%) participated; most modified activities were according to recommendations and had filtering face piece 2/filtering face piece 3 and water-repellent gowns available, but few had negative-pressure rooms or provided telephonic follow-up; 15% of HCPs called in sick and 6% had confirmed COVID-19. There was a trend (P=0.07) toward different confirmed COVID-19 rates among endoscopists (7.9%), nurses (6.6%), intermediate-care technicians (3.4%), and administrative personnel (2.2%). There was no correlation between the rate of sick HCPs and COVID-19 incidence in the provinces and personal protective equipment availability and use, whereas an inverse correlation with hospital volume was found.CONCLUSIONS:Adherence to recommendations was rather good, though a minority were able to follow all recommendations. Confirmed COVID-19 seemed higher among endoscopists and nurses, suggesting that activities in the endoscopy rooms are at considerable viral spread risk.

OBJECTIVE:Proton Pump Inhibitors (PPIs) and traditional antacids are the common standard set of therapy for the management of gastroesophageal reflux disease (GERD) symptoms. The aim of the current study was to evaluate efficacy and safety of a novel galactomannan-based liquid formulation in reducing typical GERD symptoms in patients not taking PPIs.PATIENTS AND METHODS:This was a single-center, randomized, double-blind, placebo-controlled study. Sixty patients met the eligibility criteria and were treated either with the investigational product (RefluG™) or placebo, one sachet three times per day for 14 consecutive days. Symptom intensity/frequency and quality of life were assessed over the course of the study by Reflux Disease Questionnaire (RDQ) and GERD-Health related Quality of life (HRQL) Questionnaire, respectively. The primary endpoint was to determine the number of subjects with at least 30% symptoms reduction from baseline to day 14 compared to placebo.RESULTS:RefluG™ was statistically superior to placebo (p <0.001) as 100% of subjects experienced at least 30% symptoms reduction at the end of the study while none achieved a 30% reduction in the placebo group. For all domains both after 7 and 14 days of treatment, significant improvement in HRQL was seen in the active group in comparison to placebo. Tolerability and safety were good and comparable between groups.CONCLUSIONS:The investigational product was safe and effective as mono-therapy in providing early resolution of troublesome GERD symptoms as well as for improving quality of life.

Abstract Background The Endocuff Vision device (Arc Medical Design Ltd., Leeds, UK) has been shown to increase mucosal exposure, and consequently adenoma detection rate (ADR), during colonoscopy. This nationwide multicenter study assessed possible benefits and harms of using Endocuff Vision in a fecal immunochemical test (FIT)-based screening program. Methods Patients undergoing colonoscopy after a FIT-positive test were randomized 1:1 to undergo Endocuff-assisted colonoscopy or standard colonoscopy, stratified by sex, age, and screening history. Primary outcome was ADR. Secondary outcomes were ADR stratified by endoscopists’ ADR, advanced ADR (AADR), adenomas per colonoscopy (APC), withdrawal time, and adverse events. Results 1866 patients were enrolled across 13 centers. After exclusions, 1813 (mean age 60.1 years; male 53.8 %) were randomized (908 Endocuff Vision, 905 standard colonoscopy). ADR was significantly higher in the Endocuff Vision arm (47.8 % vs. 40.8 %; relative risk [RR] 1.17, 95 % confidence interval [CI] 1.06–1.30), with no differences between arms regarding size or morphology. When stratifying for endoscopists’ ADR, only low detectors (ADR < 33.3 %) showed a statistically significant ADR increase (Endocuff Vision 41.1 % [95 %CI 35.7–46.7] vs. standard colonoscopy 26.0 % [95 %CI 21.3–31.4]). AADR (24.8 % vs. 20.5 %, RR 1.21, 95 %CI 1.02–1.43) and APC (0.94 vs. 0.77; P  = 0.001) were higher in the Endocuff Vision arm. Withdrawal time and adverse events were similar between arms. Conclusion Endocuff Vision increased ADR in a FIT-based screening program by improvingexamination of the whole colonic mucosa. Utility was highest among endoscopists with a low ADR.

The incidence of colorectal cancer (CRC) is characterized by rapid declines in the wake of widespread screening. Colonoscopy is the gold standard for CRC screening, but its accuracy is related to high quality of bowel preparation (BP). In this review, we aimed to summarized the current strategy to increase bowel cleansing before colonoscopy. Newly bowel cleansing agents were developed with the same efficacy of previous agent but requiring less amount of liquid to improve patients’ acceptability. The role of the diet before colonoscopy was also changed, as well the contribution of educational intervention and the use of adjunctive drugs to improve patients’ tolerance and/or quality of BP. The review also described BP in special situations, as lower gastrointestinal bleeding, elderly people, patients with chronic kidney disease, patients with inflammatory bowel disease, patients with congestive heart failure, inpatient, patient with previous bowel resection, pregnant/lactating patients. The review underlined the quality of BP should be described using a validate scale in colonoscopy report and it explored the available scales. Finally, the review explored the possible contribution of bowel cleansing in post-colonoscopy syndrome that can be related by a transient alteration of gut microbiota. Moreover, the study underlined several points needed to further investigations.

Background and Aims: Liver cirrhosis (LC) of any origin has always been a source of several emergencies for physicians working at the Emergency Department (ER). LC patients can present with several complications that are sometimes difficult to recognize and treat. Thus, we reviewed the literature evidence for the diagnosis and management of several LC related emergencies. Methods: We conducted a search on the main medical databases for papers, reviews, metanalyses, case series, and RCTs using the following keywords and their associations: liver cirrhosis, variceal hemorrhage, ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, hepato-renal syndrome, emergency. Results: Main LC emergencies are upper gastrointestinal hemorrhage, decompensated ascites and spontaneous bacterial peritonitis, hepatic encephalopathy, hepato-renal syndrome. Their management is partly medical and interventional. Very often, the final cure of some complications, such as hepato-renal syndrome, is represented by liver transplantation. Conclusions: Although LC prevalence is going to fall in the following years, due to HBV and HCV optimized treatments, its complications represent a significant admission percentage at the ER and challenge for physicians’ skills.

The original version of this article unfortunately contained a mistake. All the authors first name and second name has been inadvertently interchanged. Now the authors name are corrected.

OBJECTIVE. The purpose of this study was to evaluate the accuracy of CT colonography (CTC) in the diagnosis of synchronous colonic lesions in a cohort of patients with an occlusive colorectal cancer (CRC) causing incomplete colonoscopy. SUBJECTS AND METHODS. Among 109 patients with CRC causing incomplete colonoscopy who underwent CTC with IV contrast enhancement after cathartic purgation, fecal tagging, and colon distention, 70 (mean age, 70 years) for whom reference standards (surgical reports, first surveillance colonoscopy) were available were evaluated. Per-patient and per-lesion sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) of CTC in the diagnosis of synchronous colonic lesions measuring 6 mm or larger were assessed. RESULTS. Twenty-seven of the 70 patients (39%) had at least one 6-mm or larger synchronous lesion, and four patients (6%) had a total of five synchronous CRCs. Per-patient sensitivity in diagnosing synchronous CRC was 1.00 (4/4). There were 59 lesions: 20 with a diameter of 10 mm or greater; 30, 6-9 mm; and nine, 5 mm or less. The overall per-patient CTC sensitivity in detecting synchronous lesions 6 mm or larger was 0.93 (25/27); specificity, 0.98 (42/43); PPV, 0.96; and NPV, 0.95. Per-patient sensitivity for the diagnosis of synchronous advanced neoplasia (advanced adenoma and colorectal cancers) was 0.94 (15/16). Per-lesion CTC sensitivity for detecting synchronous lesions 6 mm or larger was 0.88 (37/42); all adenomatous lesions, 0.89 (55/62); and advanced neoplasia, 0.92 (22/24). CONCLUSION. CTC is a highly accurate test for detecting synchronous colonic lesions in patients with occlusive CRC. The prevalence of advanced neoplasia is high (23%).

INTRODUCTION: The wide use of hemoclips during laparoscopic surgery has led to a variety of unusual complications. among these, there is the migration of Hem-o-Lok clip into the duodenum. We performed a literature review of all cases of Hem-o-Lok clip migration into the duodenum after laparoscopic digestive surgery reported in literature. EVIDENCE ACQUISITION: All relevant articles were extracted up to June 2019 based on the results of searches in MEDLINE, PubMed, Scopus, Web of Science and Google Scholar. EVIDENCE SYNTHESIS: At the time of this review, a total of seven cases have been described. The mean age was 49 years and the majority of these patients were women (57%). Previous laparoscopic surgery was performed for cholecystectomy (four patients). cholecystectomy with common bile duct exploration (one patient), right hemicolectomy (one patient) and distal gastrectomy (one patient). Symptoms occurred from 3 months to 2 years after laparoscopic surgery. The majority of patients developed symptoms of bowel occlusion and abdominal pain. Three patients remained asymptomatic. In many cases the Hem-o-Lok wedged into the wall of the first or second portion of the duodenum. In all cases, esophageal gastroduodenoscopy was the primary modality to make the diagnosis. Initial treatment was conservative with watch-and-wait strategy or proton pump inhibitors followed by endoscopic removal, while surgical treatment was required in two cases. CONCLUSIONS: The application of Hem-o-Lok clip during laparoscopic surgery is safe and effective. Postoperative Hem-o-Lok migration into the duodenum is rare. The treatment could be conservative in the majority of cases.