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Since it was first described in 2001, endoscopic ultrasonography-guided biliary drainage (EUS-BD) has emerged as an alternative procedure for achieving an endoscopic internal drainage in case of endoscopic retrograde cholangiopancreatography (ERCP) failure. Biliary drainage can be achieved by either a transduodenal extrahepatic approach through EUS-guided choledochoduodenostomy (EUS-CDS), or a transgastric intrahepatic approach, namely EUS-guided hepaticogastrostomy (EUS-HGS) which already holds a remarkable place in the treatment of patients with malignant biliary obstruction.For this review we did a comprehensive search of PubMed/MEDLINE from inception to May 31, 2021 for papers with a significant sample size (at least 20 patients enrolled) dealing with EUS-HGS. Data on technical success, clinical success and rate of adverse events were collected.A total of 22 studies with different design, comprising 874 patients, were included. Technical success was achieved in about 96% of cases (ranging from 65% to 100%). Clinical success was obtained in almost 91% of cases (ranging from 76% to 100%). Overall rate of adverse events was 19% (ranging from 0% to 35%). Abdominal pain, self-limiting pneumoperitoneum, bile leak, cholangitis, bleeding, perforation and intraperitoneal migration of the stent were the most common.Despite both safety and efficacy profile, at the moment HGS still remains a challenging procedure at every single step and must therefore be conducted by a very experienced endoscopist in interventional EUS and ERCP procedures, who is able to deal with the possible severe adverse events of this procedure. A rapid introduction in clinical practice of dedicated devices is desiderable.

Nutritional support is essential in patients who have a limited capability to maintain their body weight. Therefore, oral feeding is the main approach for such patients. When physiological nutrition is not possible, positioning of a nasogastric, nasojejunal tube, or other percutaneous devices may be feasible alternatives. Creating a percutaneous endoscopic gastrostomy (PEG) is a suitable option to be evaluated for patients that need nutritional support for more than 4 wk. Many diseases require nutritional support by PEG, with neurological, oncological, and catabolic diseases being the most common. PEG can be performed endoscopically by various techniques, radiologically or surgically, with different outcomes and related adverse events (AEs). Moreover, some patients that need a PEG placement are fragile and are unable to express their will or sign a written informed consent. These conditions highlight many ethical problems that become difficult to manage as treatment progresses. The aim of this manuscript is to review all current endoscopic techniques for percutaneous access, their indications, postprocedural follow-up, and AEs.

Sporadic non-ampullary duodenal adenomas (SNDAs) are often referred to tertiary centers because of the challenges in endoscopic resection. There is a paucity of data on both technical and clinical outcomes. The aim of our study was to evaluate the efficacy and safety of endoscopic resection for the treatment of SNDA in two western centers.This is a retrospective study reporting data of a cohort of patients referred for resection of SNDA between 2013 and 2017. Patients with familial adenomatous polyposis or ampullary lesions were excluded from present analysis. Outcomes considered for this study were technical success, adverse events, recurrence and need for surgery.120 patients (mean age 66 ± 11.9 years, 64male) were enrolled in the study. Mean size of the lesions was 23.3 mm (range 5-80). Fifty-six en-bloc endoscopic mucosal resection (EMR) (46.6%), 41 piecemeal EMR (pEMR) and 23 endoscopic submucosal dissection were performed. Intra-procedural perforation was observed in 4 patients (3.3%). Fourteen post-procedural (11.6%) adverse events were recorded. All post-procedural perforations occurred in lesions 30 mm. Recurrence was observed in 11 patients (9.5%) during a mean follow-up of 29 months. All recurrences were successfully managed endoscopically. 119 patients were still alive at last follow-up.Endoscopic resection can be successfully carried out in majority of patients. Size 30 mm seems to be the predictor of high adverse events risk.

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Background: Treatment of chronic Hepatitis C with directly acting antivirals (DAAs) can bring to sustained virologic response (SVR) in approximately 95% of patients. Efficacy and safety of DAAs in ...

Several studies have shown a significant adenoma miss rate up to 35% during screening colonoscopy, especially in patients with diminutive adenomas. The use of artificial intelligence (AI) in colonoscopy has been gaining popularity by helping endoscopists in polyp detection, with the aim to increase their adenoma detection rate (ADR) and polyp detection rate (PDR) in order to reduce the incidence of interval cancers. The efficacy of deep convolutional neural network (DCNN)-based AI system for polyp detection has been trained and tested in ex vivo settings such as colonoscopy still images or videos. Recent trials have evaluated the real-time efficacy of DCNN-based systems showing promising results in term of improved ADR and PDR. In this review we reported data from the preliminary ex vivo experiences and summarized the results of the initial randomized controlled trials.

Enteral stents are endoscopic medical devices used to treat gastrointestinal strictures. Since the first primitive stent, improvements in enteral stent s design and composition have been made. Currently, different kinds of stents with different shapes, sizes, calibers, and materials have been introduced. Gastrointestinal stents can be manufactured from plastic, metal, or biodegradable material. The new different composition of the stents are crucial for the correct function of the devices and guarantee physical properties able to improve clinical outcomes. The principal indication for stent placement remains the management of gastrointestinal strictures in order to resolve, temporarily or definitively, enteral obstruction. The improvements in enteral stent allow to increase their use in clinical practice. Nowadays for example, it is possible to seal leaks and GI fistulae or they can make a therapeutic link between 2 hollow organs. Moreover, the development of biodegradable stents avoids the need of repeated endoscopy for stent removal.

EUS-guided biliary drainage (BD) through hepaticogastrostomy (HGS) is an option in case of ERCP failure. Available data suggest that this procedure may be challenging with possible severe adverse events (AEs) mainly due to stent migration. The aim of our pilot study was to prospectively assess the technical and clinical outcomes of EUS-HGS using a new dedicated partially covered self-expandable metal stent with anti-migratory systems.This is a single-center prospective study enrolling patients with malignant biliary obstruction undergoing EUS-HGS after failed ERCP, between June 2020 and March 2021. The primary endpoint was the technical success rate. Evaluation of specific stent-related technical features as compared with commonly used self-expandable metal stent, clinical success rate, and procedure-related AEs was also assessed.Twenty-two patients (15%-68.2%, female; mean age, 66.0 ± 10.0) were enrolled in the study analysis. Different causes of ERCP failure were infiltration of papilla by neoplastic tissue (4, 18.2%), unreachable papilla for duodenal stricture (9, 40.9%), surgically altered anatomy with Roux-en-Y reconstruction (4, 18.2%), and incomplete BD after transpapillary stent placement (5, 22.7%). Technical success was achieved in all patients, in a mean procedural time of 43.3 ± 26.8 min. Technical features were graded as high or medium in all cases. The clinical success rate was 91% (20/22, mean follow-up: 10.8 ± 3.1 months). There were no cases of stent misplacement or stent migration. Three (13.6%) cases of a hepatic abscess requiring percutaneous drainage and systemic antibiotics were reported, with no impact on clinical success and following oncologic treatments. No deaths occurred.EUS-HGS with a new dedicated stent with anti-migratory systems is feasible and effective, preventing stent migration, and misplacement. Although the persistent procedural challenges, dedicated devices may contribute to outcomes improvement and procedure diffusion.

Background and aimsArtificial intelligence has been shown to increase adenoma detection rate (ADR) as the main surrogate outcome parameter of colonoscopy quality. To which extent this effect may be related to physician experience is not known. We performed a randomised trial with colonoscopists in their qualification period (AID-2) and compared these data with a previously published randomised trial in expert endoscopists (AID-1).MethodsIn this prospective, randomised controlled non-inferiority trial (AID-2), 10 non-expert endoscopists (ResultsIn 660 patients (62.3±10 years; men/women: 330/330) with equal distribution of study parameters, overall ADR was higher in the CADe than in the control group (53.3% vs 44.5%; relative risk (RR): 1.22; 95% CI: 1.04 to 1.40; pConclusionsIn less experienced examiners, CADe assistance during colonoscopy increased ADR and a number of related polyp parameters as compared with the control group. Experience appears to play a minor role as determining factor for ADR.Trial registration numberNCT:04260321.

Background and aims: Adequate bowel cleansing is critical to ensure quality and safety of a colonoscopy. A novel 1-L polyethylene glycol plus ascorbate (1L-PEG+ASC) regimen was previously validated against low-volume regimens but was never compared with high-volume regimens. Methods: In a phase IV study, patients undergoing colonoscopy were randomized 1:1 to receive split-dose 1L PEG+ASC or a split-dose 4-L PEG-based regimen (4L-PEG) in 5 Italian centers. Preparation was assessed with the Boston Bowel Preparation Scale (BBPS) by local endoscopists and centralized reading, both blinded to the randomization arm. The primary endpoint was noninferiority of 1L-PEG+ASC in colon cleansing. Secondary endpoints were superiority of 1L-PEG+ASC, patient compliance, segmental colon cleansing, adenoma detection rate, tolerability, and safety. Results: Three hundred eighty-eight patients (median age, 59.8 years) were randomized between January 2019 and October 2019: 195 to 1L-PEG+ASC and 193 to 4L-PEG. Noninferiority of 1L-PEG+ASC was demonstrated for cleansing in both the entire colon (BBPS≥ 6: 97.9% vs 93%; relative risk [RR], 1.03; 95% confidence interval [CI], 1.001-1.04; P superiority= .027) and in the right-sided colon segment (98.4% vs 96.0%; RR, 1.02; 95% CI, .99-1.02; P noninferiority= .013). Compliance was higher with 1L-PEG+ASC than with 4L-PEG (178/192 [92.7%] vs 154/190 patients [81.1%]; RR, 1.10; 95% CI, 1.05-1.12), whereas no difference was found regarding safety (moderate/severe side effects: 20.8% vs 25.8%; P= .253). No difference in adenoma detection rate (38.8% vs 43.0%) was found. Conclusions: One-liter PEG+ASC showed noninferiority compared with 4L-PEG in achieving adequate colon cleansing and provided a higher patient compliance. No differences in tolerability and safety were detected. (Clinical trial registration number: NCT03742232.).

Background and study aims The impact of COVID-19 mitigation measures on stent placement procedures has not yet been reported. The aim of this study was to assess the impact of COVID-19 mitigation measures on upper stenting during SARS-CoV-2 outbreak, as well as the use of personal protection equipment (PPE) and risk of contamination for patients and staff. Patients and methods This was a multicenter, retrospective study of consecutive patients who underwent stent placement for upper gastrointestinal obstruction during the second half of SARS-CoV-2 outbreak period in comparison to same period one year before. Results A total of 29 stents were placed for upper gastrointestinal obstruction during the study period, corresponding to an increase of 241 % comparing to the same period in 2019 (n = 12). No significant major differences were found between the two time periods regarding patients’ baseline characteristics, post-stenting management and number of staff involved in stent placement. Fellows’ involvement was significantly lower in 2020 compared to 2019 (21 % vs 67 %; P = 0.01). The majority of procedures were performed using FFP2 /FFP3 mask (76 %), protective eyewear (86 %), two pairs of gloves (65 %), hairnet (76 %) and full disposable gowns (90 %). One patient tested positive for SARS-CoV-2 after the procedure. None of the medical staff involved in stenting procedures developed COVID-19 14 days after procedure. Conclusion Upper gastrointestinal stenting increased during the SARS-CoV-2 outbreak period, which could be related to yearly variation on the number of procedures or reflect a change of oncologic treatment practice during COVID times.

Endoscopy plays a key role in the management of inflammatory bowel disease (IBD). There is an increased need for quality assurance programs that evaluate the quality, safety and patient experiences of endoscopy, by assessing procedural and clinical outcomes.This review aims to summarize the most important quality indicators of endoscopy in IBD patients and could serve as the basis to improve quality endoscopic procedures and patients' perception of endoscopy in the future. However, further studies and consensus reports are necessary to standardize the quality of care in the endoscopy unit of all IBD centers.Developing an understanding of the patient-reported perception is important for both clinicians and patients, as it facilitates patient engagement with their care. Moreover, implementing education in reporting is crucial f and the use of verifiable databases, generated from electronic reporting systems, should be encouraged rather than unverified self-reporting, to have greater validity for documenting and to formally evaluate endoscopic practice data with audits. The use of artificial intelligence may improve the quality of endoscopy, by increasing the adenoma detection rate and helping endoscopists in the challenging differentiation between inflammatory and neoplastic lesions.

Risk factors for hepatic immune-related adverse events (HIRAEs) in patients with advanced/unresectable hepatocellular carcinoma (HCC) treated with immune checkpoint inhibitors (ICIs) are unclear. We investigated: (i) clinical and morpho-pathological predictors of HIRAEs in 27 pretreatment tumor specimens, including surrogate biomarkers of the HCC immune class (based on intratumoral tertiary lymphoid structures, and glutamine synthase, CD3, and CD79 expression), and (ii) the relationship between HIRAE onset and subsequent treatment outcomes. Fifty-eight patients were included—20 (34%) received ICIs alone, and 38 (66%) received ICIs plus targeted agents as first- or further-line treatment. After a median time of 0.9 months (range, 0.4–2.7), nine patients (15.5%) developed grade ≥ 3 hepatitis, which was significantly associated with higher baseline ALT levels (p = 0.037), and an infectious HCC etiology (p = 0.023). ICIs were safely resumed in six out of nine patients. Time to treatment failure (TTF) was not significantly different in patients developing grade ≥ 3 hepatitis vs. lower grades (3.25 vs. 3.91 months, respectively, p = 0.81). Biomarker surrogates for the HCC immune class were not detected in patients developing grade ≥ 3 hepatitis. Grade ≥ 3 hepatitis has a benign course that does not preclude safe ICI reintroduction, without any detrimental effect on TTF.

Background and Aims Therapeutic endoscopy plays a critical role in the management of upper GI (UGI) postsurgical leaks. Data are scarce regarding clinical success and safety. Our aim was to evaluate the effectiveness of endoscopic therapy for UGI postsurgical leaks and associated adverse events (AEs) and to identify factors associated with successful endoscopic therapy and AE occurrence. Methods This was a retrospective, multicenter, international study of all patients who underwent endoscopic therapy for UGI postsurgical leaks between 2014 and 2019. Results Two hundred six patients were included. Index surgery most often performed was sleeve gastrectomy (39.3%), followed by gastrectomy (23.8%) and esophagectomy (22.8%). The median time between index surgery and commencement of endoscopic therapy was 16 days. Endoscopic closure was achieved in 80.1% of patients after a median follow-up of 52 days (interquartile range, 33-81.3). Seven hundred seventy-five therapeutic endoscopies were performed. Multimodal therapy was needed in 40.8% of patients. The cumulative success of leak resolution reached a plateau between the third and fourth techniques (approximately 70%-80%); this was achieved after 125 days of endoscopic therapy. Smaller leak initial diameters, hospitalization in a general ward, hemodynamic stability, absence of respiratory failure, previous gastrectomy, fewer numbers of therapeutic endoscopies performed, shorter length of stay, and shorter times to leak closure were associated with better outcomes. Overall, 102 endoscopic therapy–related AEs occurred in 81 patients (39.3%), with most managed conservatively or endoscopically. Leak-related mortality rate was 12.4%. Conclusions Multimodal therapeutic endoscopy, despite being time-consuming and requiring multiple procedures, allows leak closure in a significant proportion of patients with a low rate of severe AEs.

341 Background: In patients with hepatocellular carcinoma (HCC) and baseline liver dysfunction, hepatic immune-related adverse events (HIRAEs) during immunotherapy have not been adequately characterized and their impact on subsequent treatment outcomes is not known. Methods: 40 patients with advanced/unresectable HCC and Child Pugh score A have been enrolled in first and second-line clinical trials of anti-programmed cell death protein 1 (PD-1) monoclonal antibodies (mAbs). HCC etiologies were: hepatitis C (32.5%), hepatitis B (7.5%), alcohol abuse (27.5%), other (32.5%). 7 received anti-PD-1 mAbs alone and 33 received combined regimens that included anti-PD-1 mAbs plus either anti-cytotoxic T lymphocyte antigen 4 (30.4%) or tyrosine kinase inhibitors (TKIs) (54.5%), or both (15.1%). We reviewed their liver function tests and HIRAEs onset was related to time to treatment failure (TTF). Results: Overall, 12 patients (30%) developed grade ≥ 3 hepatitis according to Common Toxicity Criteria for Adverse Events v. 4.03, resulting in 4 cases of grade 2 drug-induced liver injury per DILI Working Group criteria. Time between therapy initiation and hepatitis onset was 1.4 months (0.4-2.8) and median peak aminotransferase (AT) level was 258 IU/L (85-869). Out of 6 permanent treatment discontinuations due to adverse events (AEs), 4 were linked to hepatitis. Higher AT median levels at baseline were significantly linked to grade ≥ 3 hepatitis compared with lower grades (95 IU/L vs. 36 IU/L, respectively; p = 0.008). Etiology, age, treatment did not predict HIRAEs onset. TTF in patients in patients with grade ≥ 3 hepatitis was shorter than in the whole cohort (1.4 vs. 3.8 months, p = 0.041), while overall survival did not differ (p = 0.125). Conclusions: We observed a 30% incidence of clinically significant HIRAEs. HIRAEs represent the most frequent AEs leading to treatment discontinuation in patients with HCC undergoing treatments with immune checkpoint inhibitors. Baseline AT levels may identify patients at increased risk of grade ≥ 3 hepatitis.