Rifaximin in diverticulosis and diverticular disease: a national survey among Italian gastroenterologists and general practitioners.

The management of patients with diverticular disease remains challenging. The aim of this national survey was to assess how gastroenterologists and general practitioners use rifaximin to manage diverticulosis and diverticular disease. Members of the Italian Association of Hospital Gastroenterologists and Endoscopists (AIGO) and the Italian Federation of General Practitioners (FIMMG) were invited to complete a 39-item online survey concerning the use of rifaximin in five clinical settings: (1) diverticulosis; (2) reducing symptoms in symptomatic uncomplicated diverticular disease; (3) reducing the occurrence of diverticulitis in patients with symptomatic uncomplicated diverticular disease (primary prevention); (4) reducing the recurrence of diverticulitis in patients with previous attacks of diverticulitis (secondary prevention); (5) treatment of uncomplicated acute diverticulitis. A total of 1094 physicians completed the survey. Overall, 25.1%, 83.5%, 68%, 74.2%, and 63% of physicians prescribed rifaximin for the clinical settings 1, 2, 3, 4, and 5, respectively. In each clinical setting, the dosage of rifaximin most frequently used was 800 mg/day, the most common duration of therapy was 7 days, and the cyclic administration of treatment (expressed in months) most frequently used was > 24 months. These results highlight that a reappraisal of the use of rifaximin in patients with diverticulosis and diverticular disease is required to reduce the gap between the evidence available and the daily clinical practice, optimizing also the use of healthcare resources.

A New Step-Up Dual Endoscopic Approach for Large-Size Infected Pancreatic Necrosis: Percutaneous Endoscopic Necrosectomy Followed by Transluminal Endoscopic Drainage/Necrosectomy.

BACKGROUND: Acute pancreatitis in 10% to 20% of cases can be associated with necrosis of the pancreatic gland, peripancreatic tissue, or both. We report a case series of a new endoscopic approach to treat infected pancreatic necrosis (IPN). PATIENTS AND METHODS: Consecutive patients with IPN, extending from the perigastric area up to the paracolic gutters or into the pelvis, were prospectively studied from January 2017 to June 2022. The treatment protocol was radiologic percutaneous drainage as the first step, followed by fully covered metal stent placement (FC-SEMS) in the track of the catheter. Percutaneous endoscopic necrosectomy (PEN) was performed 2 to 4 days later using a flexible endoscope through the percutaneous tract. About 2 to 4 weeks later, when a matured sac was visible, EUS-guided endoscopic transluminal drainage (ETD) with lumen-apposing metal stents (LAMS) was performed. Control of sepsis with resolution of collection(s) was the primary outcome measure. RESULTS: We included 18 patients, males in 50% of cases with age 60±12 years old. Most frequent cause of pancreatitis was biliary (7 cases) followed by alcoholic in 6 cases; in 3 cases pancreatitis was caused by hyperlipemia and in 2 cases was idiopathic. Mean size of WON was 18±2 cm. For PEN, SEMSs used were esophageal FC-SEMS. LAMS used for ETD were Hot Axios, Hot Spaxus and Nagistent. Mean time of endoscopic intervention for PEN and ETD was 18±3 and 37±4 days, respectively. In 5 cases adverse events occurred: 3 cases of overinflations resolved with introduction of Verres needles in abdomen. In 2 cases postprocedural GI bleeding required endoscopic intervention. In all cases control of sepsis was reached together with resolution of collections. No cases of deaths were observed. CONCLUSIONS: Step-up percutaneous and transluminal endoscopic necrosectomy therapy is an effective strategy for large-size IPN with combined central and peripheral necrosis.

Over-the-scope Technique for Partially Covered Self-expandable Metal Stent Placement to Treat Duodenal Perforation during EUS.

BACKGROUND AND AIMS: Although endoscopic ultrasound (EUS) is generally safe, duodenal perforation may occur during the procedure. When the iatrogenic break is wide, endoscopic positioning of a covered self- expandable metal stent is indicated to avoid a more invasive surgical approach. We evaluated the efficacy of the 'over-the-scope stenting' (OTSS) technique to treat iatrogenic duodenal perforations occurred during EUS. METHODS: Data of patients with large iatrogenic duodenal perforations treated with OTSS procedure were collected in 5 centers. Technical success was defined as a correct stent placement on the perforation site, and clinical success as complete healing of the duodenal leak at stent removal 3 weeks later. RESULTS: A total of 15 (7 males; median age: 78 years, range 47-91) patients were included in this series. A correct stent positioning was achieved in all cases (technical success: 100%), and the perforation was healed in all, apart from one patient at stent removal (clinical success: 93%). This patient was successfully treated with a novel stent placement. No immediate post-procedural adverse events occurred, and no need for emergency surgery was recorded. In one (6.7%) patient, stent migration occurred 10 days after positioning, and it was spontaneously expulsed with stool movement without complications two days later. CONCLUSIONS: Our data showed that the OTTS technique for partially covered self-expandable metal stent placement is feasible, safe and effective to tread large iatrogenic duodenal perforation occuring during EUS.

Endoscopic Submucosal Dissection for Subepithelial Tumor Treatment in the Upper Digestive Tract: A Western, Multicenter Study.

Background/Aims: Endoscopic submucosal dissection (ESD) has been proposed for removal of gastrointestinal subepithelial tumors (GI-SETs), but data are still scanty. This study aimed to report a case series from a western country. Patients and Methods: Data of patients with upper GI-SETs suitable for ESD removal observed in 4 centers were retrospectively reviewed. Before endoscopic procedure, the lesion was characterized by endosonographic evaluation, histology, and CT scan. The en bloc resection and the R0 resection rates were calculated, as well as incidence of complications, and the 1-year follow-up was reported. Results: Data of 84 patients with esophageal (N = 13), gastric (N = 61), and duodenal (N = 10) GI-SETs were collected. The mean diameter of lesions was 26 mm (range: 12-110 mm). There were 17 gastrointestinal stromal tumors, 12 neuroendocrine tumors, 35 leiomyomas, 18 lipomas, and 2 hamartomas. En bloc and R0 resection were achieved in 83 (98.8%) and in 80 (95.2%) patients, respectively. Overall, a complication occurred in 11 (13.1%) patients, including bleeding (N = 7) and perforation (N = 4). Endoscopic approach was successful in all bleedings, but 1 patient who required radiological embolization, and in 2 perforations, while surgery was performed in the other patients. Overall, a surgical approach was eventually needed in 5 (5.9%), including 3 in whom R0 resection failed and 2 with perforation. Conclusions: Our study found that ESD may be an effective and safe alternative to surgical intervention for both benign and localized malignant GI-SETs.

Introdução/objetivos: A dissecção endoscópica da submucosa (ESD) tem sido proposta para a exérese de tumores subepiteliais gastrointestinais (GI-SETs), embora a literatura seja escassa. Este estudo teve como objetivo reportar uma série de casos de um país ocidental. Métodos: Coorte retrospectiva incluindo doentes com SETs do tubo digestivo superior submetidos a ESD em 4 centros (1 ano de follow-up). Antes do procedimento, a lesão foi caracterizada por ecoendoscopia, histologia e tomografia computadorizada. Foram avaliadas as taxas de ressecção em bloco e R0, bem como a incidência de complicações. Resultados: Incluídos 84 doentes com GI-SETs esofágicos (N = 13), gástricos (N = 61) e duodenais (N = 10). O diâmetro médio das lesões foi de 26 mm (intervalo 12­110 mm) ­ 17 tumores do estroma gastrointestinal, 12 tumores neuroendócrinos, 35 leiomiomas, 18 lipomas e 2 hamartomas. A resseção foi em bloco e R0 em 83 (98.8%) e em 80 (95.2%) doentes, respectivamente. Globalmente, ocorreram complicações em 11 (13.1%) doentes, incluindo hemorragia (N = 7) e perfuração (N = 4). A terapêutica endoscópica foi eficaz em todas as hemorragias exceto em 1 doente que necessitou de embolização radiológica e em 2 perfurações (submetidas a cirurgia). No geral, a abordagem cirúrgica foi necessária em 5 (5.9%) ­ 3 doentes com resseção R1 e 2 com perfuração. Conclusões: A ESD pode ser uma alternativa eficaz e segura à intervenção cirúrgica para GI-SETs benignos e malignos localizados.

Newly designed OTS Clip for preventing fully-covered self-expandable metal stent migration in the gastrointestinal tract.

Background and study aims Fully-covered self-expandable metal stents (FCSEMS) are frequently used for endoscopic management of gastrointestinal lesions. However, stent migration occurs in up to one-third of patients. Different tools are used to anchor stents to prevent migration. A specifically designed over-the-scope device (Stentfix OTS Clip system) was recently introduced to prevent fully covered SEMS migration in the gastrointestinal tract. The study aimed to evaluate technical success and stent migration rates with the Stentfix device. Patients and methods Data were collected from consecutive patients at four participating centers who were at high risk of FCSEMS migration and in whom the anchoring system was used to prevent migration. Results A total of 31 patients were enrolled. Technically successful clip placement was achieved in all cases. At follow-up, the distal part of the device dislocated from the duodenum into the antrum at 3 days in one patient, accounting for a 3.2 % (95 % CI = 0-9.4) rate of stent migration. The underlying lesion being treated healed in all patients, but 10 patients died before stent removal due to neoplastic progression. Conclusions A dedicated over-the-scope stent fixation device appears to be safe and effective in preventing fully-covered SEMS migration through the gastrointestinal tract.

Acute cholecystitis: Which flow-chart for the most appropriate management?

Acute cholecystitis (AC) is a very common disease in clinical practice. Laparoscopic cholecystectomy remains the gold standard treatment for AC, however due to aging population, the increased prevalence of multiple comorbidities and the extensive use of anticoagulants, surgical procedures may be too risky when dealing with patients in emergency settings. In these subsets of patients, a mini-invasive management may be an effective option, both as a definitive treatment or as bridge-to-surgery. In this paper, several non-operative treatments are described and their benefits and drawbacks are highlighted. Percutaneous gallbladder drainage (PT-GBD) is one of the most common and widespread techniques. It is easy to perform and has a good cost/benefit ratio. Endoscopic transpapillary gallbladder drainage (ETGBD) is a challenging procedure that is usually performed in high volume centers by expert endoscopists, and it has a specific indication for selected cases. EUS-guided drainage (EUS-GBD) is still not widely available, but it is an effective procedure that could have several advantages, especially in rate of reinterventions. All these treatment options should be considered together in a stepwise approach and addressed to patients after an accurate case-by-case evaluation in a multidisciplinary discussion. In this review, we provide a possible flowchart in order to optimize treatments, resource and provide to patients a tailored approach.

An atypical gastric duplication cyst as a rare cause of gastric dilatation: the key role of the endoscopy ultrasound.

We have written a "letter to Editor" about a case of gastric dilatation caused by a symptomatic gastric duplication cyst with ectopic pancreas ingrowth, in a 13 years old boy. The Endoscopy Ultra Sound characterized the lesion and permitted the aspiration of the internal liquid. The patient underwent to laparoscopic excision of the mass and the histology revealed a gastric duplication cyst with ectopic pancreas ingrowth.

Endoscopic ultrasonography-guided biliary drainage for malignant jaundice by using electrocautery-enhanced lumen-apposing metal stents (Hot-SPAXUS stent).

Background: Biliary drainage with endoscopic retrograde cholangiopancreatography (ERCP) for tumoral jaundice fails in a certain percentage of patients. In these patients, endoscopic ultrasonography-guided lumen-apposing metal stents (LAMS) with electrocautery-enhanced (ECE) technology allows a single-step, radiation-free palliative treatment. Methods: We reviewed the data of patients who underwent choledochoduodenostomy with placement of ECE-LAMS (Hot-SPAXUS stent) after ERCP failure in a single tertiary center. Technical and clinical success rates were calculated and adverse events recorded. Results: Data of 15 patients (8 male, median age 72 years) were collected. The procedure was technically successful in all patients, whilst clinical success was achieved in 14 (93.3%) patients. One (6.7%) patient presented delayed bleeding treated endoscopically. At follow up, stent occlusion with recurrence of jaundice occurred in 2 (13.3%) patients, due to food impaction (n=1), or neoplastic ingrowth (n=1). Conclusion: Our results suggest that the Hot-SPAXUS procedure is effective and safe for palliative treatment in patients with distal biliary malignant obstruction after failure of ERCP.

Transabdominal self-expandable metal stent placement as a rescue therapy for drainage of walled-off necrosis.

Video 1CT scan of a walled-off necrosis in the right pararenal space extended to the iliac area.

Real-time gastric juice analysis with EndoFaster for H. pylori diagnosis: a large, multicentre study.

BACKGROUND: Helicobacter pylori infection is the main cause of the most frequent gastroduodenal diseases. Because its prevalence is decreasing in developed countries, gastric biopsies are negative in several patients. By measuring ammonium in the gastric juice, EndoFaster allows to exclude H. pylori infection during endoscopy. This study aimed to assess the accuracy of device versions working with either 6 ml or 3 ml of gastric juice. STUDY DESIGN: This prospective study involved 12 endoscopic units. During endoscopy, EndoFaster testing was performed and standard five gastric biopsies were taken. The accuracy was calculated by considering histological assessment as the gold standard for H. pylori diagnosis. RESULTS: Gastric juice analysis was attempted in 1279 patients, but it failed in 131 (15.5%) and in 10 (2.3%), with the 6 ml and the 3 ml device, respectively (P < 0.001). Overall, EndoFaster detected H. pylori infection with an 86.3% sensitivity, 83.3% specificity, 52.7% positive predictive value, 96.6% negative predictive value and 83.8% accuracy. The performance was not affected either by ongoing proton pump inhibitor therapy or a previous H. pylori eradication. No significant difference in accuracy emerged between the two versions of the device. CONCLUSION: The novel version of the EndoFaster device operating with 3 ml gastric juice may be performed in virtually all patients, and it allows excluding H. pylori infection with a very high accuracy. Gastric biopsies can be avoided in a definite portion of cases without endoscopic lesions or other clinical indications.

Efficacy of Helicobater pylori eradication in patients with diffuse large B-cell lymphoma of the stomach: A systematic review.

OBJECTIVES: The role of Helicobater pylori eradication in the treatment of high-grade diffuse large B-cell lymphoma (DLBCL) of the stomach is unclear. METHODS: We performed a systematic review and meta-analysis of currently available data. DLBCL-remission rate after eradication therapy, post-remission maintenance, and response rate in the case of additional oncological therapy were extracted. RESULTS: By considering data of seven studies, the DLBCL remission was achieved in 81 (53.3%; 95% CI = 45.3-61.2) out of 152 H. pylori eradicated patients. The regression rate did not differ between pure DLCBL and DLCBL with MALT component, between stage I and stage II disease, and between Caucasians and Asians. Disease regression was maintained in all patients after at a median of 63 months (range: 46-29) follow-up. In those non-responders, DLBLC remission after additional chemo-immunotherapy was achieved in 63 (98.4%; 95% CI = 95.4-100) out of 64 patients. CONCLUSIONS: Data this systematic review suggest considering H. pylori eradication as first-line therapy to treat infected patients with early-stage, high-grade gastric lymphoma.

Real-time determination of gastric juice pH with EndoFaster® for atrophic gastritis assessment.

BACKGROUND: In patients with atrophic gastritis involving gastric body mucosa the pH value of gastric juice is distinctly increased, so that pH assessment would allow predict this precancerous lesion. We tested whether EndoFaster® - a device allowing real-time pH measure and H. pylori diagnosis - may optimize the need of taking gastric biopsies. METHODS: In this prospective, multicentre study, the accuracy of EndoFaster® for ruling out gastric atrophy involving corporal mucosa was assessed. Real-time pH and ammonium determination was performed by aspirating 3-6 ml gastric juice during endoscopy. Histology performed on 5 standard gastric biopsies was used as gold standard. RESULTS: A total of 1008 consecutive patients were observed in 12 centres. At histology, gastric body mucosa atrophy/metaplasia was detected in 65 (6.4%) cases, and a pH value >4.5 in the gastric juice was observed in 150 patients. The values of EndoFaster® performance in predicting the presence of atrophic gastritis were as follow: 51% sensitivity, 84% specificity, 18% PPV, 96% NPV, and 82% accuracy. The NPV value was not distinctly affected by neither ongoing proton pump inhibitor therapy nor H. pylori infection. By considering also data of ammonium concentrations, the values of EndoFaster® in detecting extensive atrophy on gastric mucosa were 74% sensitivity, 84% specificity, 24% PPV, 98% NPV, and 83% accuracy. CONCLUSION: The very high NPV of EndoFaster® might allow to safely rule out presence of atrophic gastritis, reducing the need of taking gastric biopsies in unselected patients managed in clinical practice.

Cap-assisted EMR versus standard inject and cut EMR for treatment of large colonic laterally spreading tumors: a randomized multicenter study (with videos).

BACKGROUND AND AIMS: Piecemeal EMR of colorectal laterally spreading tumors (LSTs) >20 mm is effective. Experience is limited in the use of cap-assisted EMR (EMR-C) for resection of colonic lesions. We compared the efficacy and the safety of EMR-C for the removal of colonic LSTs ≥30 mm with "inject-and-cut" standard EMR (EMR-S). METHODS: In this randomized trial from 4 Italian centers, 138 patients were treated with EMR-C and 102 with EMR-S. The rates of residual lesions, percentage of recurrence after 12 months, and adverse events were evaluated. RESULTS: One hundred forty-three lesions were resected with EMR-C and 102 with EMR-S. Argon plasma coagulation (APC) was used as adjunctive treatment in 2.9% of EMR-Cs and in 22.5% of EMR-Ss (P < .001). The median time required was 20 minutes for EMR-C and 30 minutes for EMR-S (P < .001). Adverse events (AEs) occurred in 14 EMR-Cs (10.1%; 2 perforations, 11 bleeding events, and 1 stenosis) and in 22 EMR-Ss (21.6%; 1 perforation and 21 bleeding events) (P = .017). Intraprocedural AEs occurred in 3.6% of EMR-Cs and 16.7% of EMR-Ss (P = .001). Overall, residual lesions within 12 months were found to be significantly higher with EMR-S (32 patients, 31.4%) than with EMR-C (8 patients, 5.8%) (P < .001). Recurrence at follow-up colonoscopy in 12 months occurred in 7 EMR-Cs (5.1%) and 17 EMR-Ss (16.7%; P < .001). CONCLUSIONS: The study demonstrated the feasibility and safety of EMR-C for removing large colorectal LSTs, with higher eradication rates, shorter resection time, and less use of APC when compared with EMR-S. (Clinical trial registration number: NCT03498664.).

Endoscopic clipping in non-variceal upper gastrointestinal bleeding treatment.

Since the earliest reports, advanced clipping systems have been developed, and it is possible to choose among many models with different structural and technical features. The main drawback of through-the-scope clips is their small size, which allows the compression of limited amounts of tissue needed for large-size vessel treatment. Therefore, the over-the-scope clip system was realized, allowing a larger and stronger mechanical compression of large tissue areas, with excellent results in achieving a definitive hemostasis in difficult cases. Many studies have analyzed the indications and efficacy of two-pronged endoclips and have shown good results for initial and permanent hemostasis. The aim of this review was to provide updated information on indications, positioning techniques, and results of clip application for endoscopic treatment of upper gastrointestinal non-variceal bleeding lesions.

Culture-based antibiotic susceptibility testing for Helicobacter pylori infection: a systematic review.

Background: Primary antibiotic resistance in Helicobacter pylori (H. pylori) strains is increasing worldwide, affecting therapy success. The use of therapies tailored on susceptibility pre-testing at culture has been proposed, but data are still conflicting. Method: We performed a systematic review to evaluate the role of a culture-based therapeutic approach for H. pylori treatment, taking into account the sensitivity of culture and the success rates achieved with tailored therapies in different therapeutic steps. Results: We analyzed data from 51 studies. Overall, H. pylori strains were isolated in 80.7% of 7889 patients, the success rates being 78.1%, 77.5%, 86.3% and 86.6%, before first-, second-, third-line or more therapies, respectively. In comparative studies, the infection was cured in 89.9% of 2052 patients treated with tailored therapies, and in 77.6% of 2516 patients receiving empiric therapy (P<0.001). However, in the subanalysis, the tailored approach achieved optimal eradication rates (>90%) only when it was applied before first- and second-line therapies, but not before third-line or more attempts (<80%). Moreover, no significant difference emerged between the 2 approaches when data from only the most recent (last 5 years) studies were considered, as well as in those performed in Western populations. Conclusions: The attempt to achieve antibiotic susceptibility testing before treatment failed in 20% of infected patients managed in dedicated laboratories. Culture-tailored therapies administered after 2 or more therapies achieved suboptimal eradication rates. The role of bacterial culture in patients whose therapeutic management failed to eradicate H. pylori probably needs to be corroborated by further data.

A new designed self-expandable metal stent for the management of benign radiotherapy-induced hypopharyngeal or cervical esophageal strictures.

BACKGROUND AND AIMS: The management of patients with hypopharyngeal or cervical esophageal refractory benign strictures (RBS) after surgery and radiotherapy ± chemotherapy for laryngeal cancer is challenging. We aimed to assess the long-term efficacy and safety of a new designed fully covered SEMS in these patients. METHODS: We reviewed the results of a prospectively collected database of 40 consecutive patients with dysphagia due to RBS of the cervical esophagus or hypopharynx after surgery and radiotherapy with or without chemotherapy for laryngeal cancer, unfit for surgery, referred in two tertiary-care endoscopic centers from June 2005 to December 2018. All of them were treated with placement of a Niti-S Conio cervical stent. RESULTS: After placement of the first stent, dysphagia improved in all patients. The total number of adverse events was 35 out of a total of 299 procedures (11.7%): 25 (8.4%) stent migrations, 6 (2%) tumor overgrowth, 3 severe pain and 1 pharyngo-cutaneous fistula. Stents were periodically changed. In only one patient with a cervical esophageal stricture the stent was definitively removed after 7 sessions of stent placement because of stricture resolution. Patients were followed-up for a median of 11.6 months and a significant improvement in dysphagia was reported in all patients (p < 0.001). CONCLUSIONS: The use of this conformable, small caliber new designed Niti-S stent, exchanged periodically, appeared safe and permitted durable oral intake in patients with difficult-to-treat hypopharyngeal or cervical esophagus strictures, avoiding the need for periodic dilations.

Rescue Therapies for H. pylori Infection in Italy.

Background/Aims: Curing Helicobacter pylori infection remains challenging for clinicians, as no proposed first-line therapy achieves bacterial eradication in all treated patients so that several patients need two or more consecutive treatments. Bacterial culture with antibiotics susceptibility testing is largely unachievable in Italy, and empiric second-line and rescue therapies are generally used. This study aimed to identify what eradication regimens perform better in Italy, following first-line therapy failure. Methods: We performed a literature search on PubMed for studies on standard therapy regimens used as second-line or rescue treatments performed in adult patients. Studies including modified drug combinations were not considered. Both intention-to-treat and per- protocol analyses were computed for each therapy subgroup. Results: Data from 35 studies with a total of 4830 patients were eventually considered. As a second-line therapy, Pylera® (90.6%) and a sequential regimen (89.8%) achieved eradication rates significantly higher than other therapies. For third-line therapy, a levofloxacin-based regimen and Pylera® achieved comparable eradication rates (88.2% vs. 84.7%; p = 0.2). Among therapies used as fourth (or more) attempts, Pylera® and a rifabutin-based therapy achieved 77.4% and 66.4% cure rates, respectively (p = 0.013). A therapy sequence based on the type of first-line therapy used was proposed. Conclusions: Data obtained through our review indicate that standard therapies for H. pylori eradication can be used when following an appropriate sequence, allowing clinicians to improve the cure rate without resorting to bacterial culture.

Palliation of malignant esophageal obstruction using an anti-migration self-expandable metal stent: Results of a prospective multicenter study.

BACKGROUND: Self-expanding metal stents (SEMS) placement is primarily indicated to palliate dysphagia for patients with expected short-term survival. We aimed to assess the migration rate and other stent-related adverse events (AEs) of a fully covered SEMS with an anti-migration system (FCSEMS-AMS) for palliation of malignant dysphagia. METHODS: This is a prospective study including patients with inoperable esophageal cancer that received a FCSEMS-AMS (Taewoong, Niti-S Beta™), in five tertiary-care endoscopic centers from January 2014 to February 2016. RESULTS: Fifty-three consecutive patients were enrolled. Tumor location was proximal, mid and distal esophagus±esophago-gastric junction (EGJ) in 6, 14, and 33 cases, respectively. Overall, non-severe AEs were reported in 18 patients (34.0%), 13 of them required an additional endoscopic procedure. Migration occurred in 7 patients (13.2%): 3 from the upper and 4 from the lower esophagus and EGJ. Stent retrieval was necessary in one patient due to intolerable pain. Food bolus impaction and tumor overgrowth occurred in 2 patients (3.8%) and 4 (7.5%) patients respectively. Four patients complained of gastroesophageal reflux as late AEs. Median follow-up was 19.3 months. Dysphagia significantly improved until 3 and 6 months from stent insertion (median score before FCSEMS-AMS: 3, vs median score: 1). Median dysphagia-free time was 10 months. CONCLUSIONS: Placement of the Taewoong, Niti-S Beta™ stent appeared to be a safe and effective treatment of malignant dysphagia. The anti-migration system reduced the overall migration rate, although it remained high in strictures located in the upper esophagus and when the stent was placed across the EGJ.