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Background and study aims Use of fluoroscopy in gastrointestinal endoscopy is an essential aid in advanced endoscopic interventions. However, it also raises concerns about radiation exposure. This study aimed to develop consensus-based statements for safe and effective use of fluoroscopy in gastrointestinal endoscopy, prioritizing the safety and well-being of healthcare workers and patients. Methods A modified Delphi approach was employed to achieve consensus over three rounds of surveys. Proposed statements were generated in Round 1. In the second round, panelists rated potential statements on a 5-point scale, with consensus defined as ≥80% agreement. Statements were subsequently prioritized in Round 3, using a 1 (lowest priority) to 10 (highest priority) scale. Results Forty-six experts participated, consisting of 34 therapeutic endoscopists and 12 endoscopy nurses from six continents, with an overall 45.6% female representation (n = 21). Forty-three item statements were generated in the first round. Of these, 31 statements achieved consensus after the second round. These statements were categorized into General Considerations (n = 6), Education (n = 10), Pregnancy (n = 4), Family Planning (n = 2), Patient Safety (n = 4), and Staff Safety (n = 5). In the third round, accepted statements received mean priority scores ranging from 7.28 to 9.36, with 87.2% of statements rated as very high priority (mean score ≥ 9). Conclusions This study presents consensus-based statements for safe and effective use of fluoroscopy in gastrointestinal endoscopy, addressing the well-being of healthcare workers and patients. These consensus-based statements aim to mitigate risks associated with radiation exposure while maintaining benefits of fluoroscopy, ultimately promoting a culture of safety in healthcare settings., Competing Interests: Conflict of Interest Tyler Berzin - Consultant for: Medtronic, Boston Scientific, Wision AI, Microtech. Alan N. Barkun - Consultant for Olympus Inc and Medtronic Inc. Cecilia Binda – Lecturer for Steris, Fujifilm, Boston Scientific, Q3 Medical. Alessandro Fugazza – Consultant for Boston Scientific. Rogier P. Voermans - Consultancy and research grant for Boston Scientific, Research grant Prion Medical; Consultancy fee form from Cook Medical. Lecturer Viatris and Zambon. Nauzer Forbes – Speaker for Boston Scientific, Pentax Medical. Consultant for Boston Scientific, Pentax Medical and AstraZeneca. Mariano Villarroel – Consultant for Boston Scientific. Yen-I Chen – Consultant for Boston Scientific. President of Chess Medical. Robert Bechara – Consultant for Olympus, Pentax, Vantage, Medtronic, Pendopharm. Payal Saxena – Consultant for Boston Scientific, Ambu, Erbe. Amrita Sethi – Consultant for Boston Scientific, Interscope, Medtronic, Olympus; Research Support for Boston Scientific, Fujifilm and ERBE. Cesare Hassan: Fujifilm Co. (consultancy); Medtronic Co. (consultancy). Alessandro Repici: Fujifilm Co. (consultancy); Olympus Corp (consultancy); Medtronic Co. (consultancy). Bret Peterson – Consultant for Olympus, Pentax. Investigator for Boston Scientific and Ambu. Silvia Carrara – Consultant for Olympus and Aboca. Jeffrey D. Mosko – Speaker for Boston Scientific, Pendopharm, SCOPE rounds, Vantage, Medtronic. Medical Advisory Board for Pendopharm, Boston Scientific, Janssen, Pentax, Fuji. Grants and Research support from CAG. Christopher W. Teshima – Speaker for Medtronic and Boston Scientific, Consultant for Boston Scientific. Gary R. May – Consultant for Olympus. Speaker for Pentax, Fuji and Medtronic. Samir C Grover –Research grants and personal fees from AbbVie and Ferring Pharmaceuticals, personal fees from Takeda, Sanofi, and BioJAMP, education grants from Janssen, and has equity in Volo Healthcare. All the authors have no relevant financial disclosures or conflicts of interest to declare., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background and study aims The optimal number of needle passes during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) is not yet established. We aimed to perform a per-pass analysis of the diagnostic accuracy of EUS-FNB of solid pancreatic lesions using a 22G Franseen needle. Patients and methods Consecutive patients with solid pancreatic lesions referred to 11 Italian centers were prospectively enrolled. Three needle passes were performed; specimens were collected after each pass and processed individually as standard histology following macroscopic on-site evaluation (MOSE) by the endoscopist. The primary endpoint was diagnostic accuracy of each sequential pass. Final diagnosis was established based on surgical pathology or a clinical course of at least 6 months. Secondary endpoints were specimen adequacy, MOSE reliability, factors impacting diagnostic accuracy, and procedure-related adverse events. Results A total of 504 samples from 168 patients were evaluated. Diagnostic accuracy was 90.5% (85.0%-94.1%) after one pass and 97.6% (94.1%-99.3%) after two passes ( P =0.01). Similarly, diagnostic sensitivity and sample adequacy were significantly higher adding the second needle pass (90.2%, 84.6%-94.3% vs 97.5%, 93.8%-99.3%, P =0.009 and 91.1%, 85.7%-94.9% vs 98.2%, 95.8%-99.3%, P =0.009, one pass vs two passes, respectively). Accuracy, sensitivity, and adequacy remained the same after the third pass. The concordance between MOSE and histological evaluation was 89.9%. The number of passes was the only factor associated with accuracy. One case of mild acute pancreatitis (0.6%) was managed conservatively. Conclusions At least two passes should be performed for the diagnosis of solid pancreatic lesions. MOSE is a reliable tool to predict the histological adequacy of specimens., Competing Interests: Conflict of Interest The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background and study aims EUS-guided choledochoduodenostomy (EUS-CDS) is a minimally invasive procedure used to treat malignant biliary obstruction (MBO) by transduodenal placement of a lumen-apposing metal stent (LAMS) into the extrahepatic bile duct. To identify factors that contribute to safe and effective EUS-CDS using LAMS, we performed a systematic review of the literature and meta-analysis. Methods The methodology of our analysis was based on PRISMA recommendations. Electronic databases (Medline, Scopus, EMBASE) were searched up to November 2022. Full articles that included patients with distal malignant biliary obstruction who underwent EUS-CDS using LAMS after failed endoscopic retrograde cholangiopancreatography were eligible. Random-effect meta-analysis was performed reporting pooled rates of technical success, clinical success, and adverse events (AEs) by means of a random model. Multivariate meta-regression and subgroup analysis were performed to assess possible associations between the outcomes and selected variables to assess the correlation between outcomes and different variables. Results were also stratified according to stent size. Results Twelve studies with 845 patients were included in the meta-analysis. Pooled technical and clinical success rates were 96% (95% confidence interval [CI] 94%-98%; I 2 = 52.29%) and 96% (95%CI 95%-98%), respectively, with no significant association with baseline characteristics, such are sex, age, common bile duct diameter, or stent size. The pooled AE rate was 12% (95%CI: 8%-16%; I 2 = 71.62%). The AE rate was significantly lower when using an 8 × 8 mm stent as compared with a 6 × 8 mm LAMS (odds ratio 0.59, 0.35-0.99; P = 0.04), with no evidence of heterogeneity (I 2 = 0%). Conclusions EUS-CDS with LAMS is a safe and effective option for relief of MBO. Selecting an appropriate stent size is crucial for achieving optimal safety outcomes., Competing Interests: Conflict of Interest Alessandro Fugazza: Consulting fees for Boston Scientific, Cecilia Binda Lecturer for Steris, Q3 Medical, and Boston Scientific, Carlo Fabbri Lecturer for Steris, Q3 Medical, Fuji, and Boston Scientific, Andrea Anderloni: Consulting fees for Olympus and Boston Scientific, Cesare Hassan: Consulting fees for Fuji, and Medtronic, Todd H Baron: Consultant and speaker for Boston Scientific, Cook Endoscopy, Olympus, W.L. Gore, Medtronic, ConMed, Alessandro Repici: Consulting fees for Fuji, Olympus, and Medtronic and receiving research grant and speaker fees from Boston Scientific, ERBE, Alfasigma, Norgine. Other authors have no conflict of interests., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background and study aims  Artificial intelligence (AI) is set to impact several fields within gastroenterology. In gastrointestinal endoscopy, AI-based tools have translated into clinical practice faster than expected. We aimed to evaluate the status of research for AI in gastroenterology while predicting its future applications. Methods  All studies registered on Clinicaltrials.gov up to November 2021 were analyzed. The studies included used AI in gastrointestinal endoscopy, inflammatory bowel disease (IBD), hepatology, and pancreatobiliary diseases. Data regarding the study field, methodology, endpoints, and publication status were retrieved, pooled, and analyzed to observe underlying temporal and geographical trends. Results  Of the 103 study entries retrieved according to our inclusion/exclusion criteria, 76 (74 %) were based on AI application to gastrointestinal endoscopy, mainly for detection and characterization of colorectal neoplasia (52/103, 50 %). Image analysis was also more frequently reported than data analysis for pancreaticobiliary (six of 10 [60 %]), liver diseases (eight of nine [89 %]), and IBD (six of eight [75 %]). Overall, 48 of 103 study entries (47 %) were interventional and 55 (53 %) observational. In 2018, one of eight studies (12.5 %) were interventional, while in 2021, 21 of 34 (61.8 %) were interventional, with an inverse ratio between observational and interventional studies during the study period. The majority of the studies were planned as single-center (74 of 103 [72 %]) and more were in Asia (45 of 103 [44 %]) and Europe (44 of 103 [43 %]). Conclusions  AI implementation in gastroenterology is dominated by computer-aided detection and characterization of colorectal neoplasia. The timeframe for translational research is characterized by a swift conversion of observational into interventional studies., Competing Interests: Competing interets The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background and study aims  The role of endoscopic submucosal dissection (ESD) for colorectal lesions in Western communities is unclear and its adoption is still limited. The aim of this study is to assess the long-term outcomes of a large cohort of patients treated with colorectal ESD in a tertiary Western center. Patients and methods  A retrospective analysis was conducted on patients treated by ESD for superficial colorectal lesions between February 2011 and November 2019. The primary outcome was the recurrence rate. Secondary outcomes were en-bloc and R0 resection rates, procedural time, adverse events (AEs), and need for surgery. The curative resection rate was assessed for submucosal invasive lesions. Results  A total of 327 consecutive patients, median age 69 years (IQR 60-76); 201 men (61.5 %) were included in the analysis. Of the lesions, 90.8 % were resected in an en-bloc fashion. The rate of R0 resection was 83.1 % (217/261) and 44.0 % (29/66) for standard and hybrid ESD techniques, respectively. Submucosal invasion and piecemeal resection independently predicted R1 resections. A total of 18(5.5 %) intra-procedural AEs (perforation:11, bleeding:7) and 12(3.7 %) post-procedural AEs occurred (perforation:2, bleeding: 10). Eighteen adenoma recurrences per 1,000 person-years (15cases, 5.6 %) were detected after a median follow-up time of 36 months. All recurrences were detected within 12 months. No carcinoma recurrences were observed. R1 resection status and intra-procedural AEs independently predicted recurrences with seven vs 150 recurrences per 1,000 person-years in the R0 vs R1 group, respectively. Conclusions  Colorectal ESD is a safe and effective option for managing superficial colorectal neoplasia in a Western setting, with short and long-terms outcomes comparable to Eastern studies. En-bloc R0 resection and absence of intra-procedural AEs are associated with reduced risk of recurrence., Competing Interests: Competing interests The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background and study aims  The standard method for obtaining samples during endoscopic ultrasonography (EUS) is fine-needle aspiration (FNA), the accuracy of which can be affected by the presence of a cytopathologist in endoscopy room (rapid on-site evaluation [ROSE]). With the introduction of fine-needle biopsy (FNB), macroscopic on-site evaluation (MOSE) of a acquired specimen has been proposed. Only a few studies have evaluated the role of MOSE and in all except one, a 19G needle was used. Our primary aim was to evaluate the diagnostic yield and accuracy of MOSE with different needle sizes and the secondary aim was to identify factors influencing the yield of MOSE. Patients and methods  Data from patients who underwent EUS-FNB for solid lesions, with MOSE evaluation of the specimen, were collected in six endoscopic referral centers. Results  A total of 378 patients (145 F and 233 M) were enrolled. Needles sizes used during the procedures were 20G (42 %), 22G (45 %), and 25G (13 %). The median number of needle passes was two (IQR 2-3). The overall diagnostic yield of MOSE was of 90 % (confidence interval [CI] 86 %-92 %). On multivariable logistic regression analysis, variables independently associated with the diagnostic yield of MOSE were a larger needle diameter (20G vs. 25G, OR 11.64, 95 %CI 3.5-38.71; 22G vs. 25G, OR 6.20, 95 %CI 2.41-15.90) and three of more needle passes (OR 3.39, 95 %CI 1.38-8.31). Conclusions  MOSE showed high diagnostic yield and accuracy. Its yield was further increased if performed with a large size FNB needles and more than two passes., Competing Interests: Competing interests The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

One of the main challenges encountered by endosonographers is performing diagnostic and interventional pancreato-biliary endoscopic ultrasound (EUS) procedures in the presence of surgically altered upper gastrointestinal anatomy. We describe the water-filled technique (WFT) for EUS examination and treatment of the pancreato-biliary region in patients with surgically altered upper gastrointestinal anatomy. Using the WFT, the scope is advanced up to the gastro-jejunal anastomosis and, after placing the tip of the scope 2 cm beyond it, enlargement of the jejunal lumen is obtained by water instillation of the jejunal loop. An enlargement of more than 1.5 cm allows advancement of the tip of the scope under EUSguidance up to the duodenum, in a retrograde way. The WFT is useful for reaching the ampullary area and performing diagnostic and therapeutic EUS in patients with surgically altered anatomy. The technique is also reproducible and can be easily used by endoscopists who regularly perform EUS., Competing Interests: Competing interests The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background and study aims  Pancreatic cancer represents the fourth most common cause of cancer-related deaths in Western countries and the need of a low-risk investigation to obtain an accurate histopathological diagnosis has become increasingly pressing. Endoscopic ultrasonography (EUS) with fine-needle aspiration (FNA) is the standard method for obtaining samples from pancreatic masses. In recent years, there has been an increasing need to obtain histological specimens during EUS procedures, rather than cytological ones, to guide oncological treatment options, leading to the so-call "FNB concept." Different needles have been developed for fine-needle biopsy (FNB) in recent years, enabling acquisition of larger specimens on which to perform histological and molecular analyses. The aim of this narrative review was to assess the role of EUS-guided FNA and FNB in patients with pancreatic masses, and to identify which needle and which acquisition technique should be used to improve tissue acquisition., Competing Interests: Competing interests The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background and study aims  Little is known about outcomes of biliopancreatic endosonography (EUS) in patients with surgically altered upper gastrointestinal (gastrointestinal) anatomy. We aimed to assess the rate of procedural success and EUS-related adverse events (AEs), according to post-surgical anatomies. Patients and methods  Retrospective study including patients with post-surgical altered upper gastrointestinal anatomy who underwent EUS for evaluation of the biliopancreatic region between January 2008 and June 2018 at eight European centers. Results  Of 242 patients (162 males, mean age 66.4 ± 12.5), 86 had (35.5 %) Billroth II, 77 (31.8 %) pancreaticoduodenectomy, 23 (9.5 %) Billroth I, 19 (7.9 %) distal esophagectomy, 15 (6.2 %) total gastrectomy, 14 (5.8 %) sleeve gastrectomy, and eight (3.3 %) Roux-en-Y. Sleeve gastrectomy, Billroth I, and pancreaticoduodenectomy were associated with high rates of success (100 %, 95.7 %, and 92.2 %, respectively). Visualization of the head of the pancreas was significantly impacted by total gastrectomy, Billroth II, and Roux-en-Y (success rates 6.7 %, 53.7 %, and 57.1 %, respectively). Examination of the pancreatic body and tail was impaired in esophagectomy and total gastrectomy (82.4 % and 71.4 %, respectively). Technical success and diagnostic accuracy of EUS-guided tissue acquisition (EUS-TA) was 78.2 % and 71.3 % (95 % CI, 60.6-80.5), respectively. Four (1.6 %) AEs were observed: one mucosal tearing in a Billroth II patient, one cardiac arrest in a distal esophagectomy patient, one bleed after EUS-TA in a Billroth I patient, and one acute pancreatitis after EUS-TA in a sleeve gastrectomy patient. Conclusions  The yield of bilio-pancreatic EUS is dependent on lesion location and surgery type. Before considering EUS in these patients, one must carefully consider whether the lesion may be approachable by EUS., Competing Interests: Competing interests The authors declare that they have no conflict of interest.

Background and study aims  EUS-FNA has suboptimal accuracy in diagnosing gastrointestinal subepithelial tumors (SETs). EUS-guided 22-gauge fine needle biopsy (EUS-FNB) and single-incision with needle knife (SINK) were proposed to increase accuracy of diagnosis. This study aimed to prospectively compare the diagnostic accuracy and safety of EUS-FNB with SINK in patients with upper gastrointestinal SETs. Patients and methods  All adult patients referred for EUS evaluation of upper gastrointestinal SETs ≥ 15 mm in size were eligible for inclusion. Patients were randomized to undergo EUS-FNB or SINK. Lesions were sampled with a 22-gauge reverse beveled core needle in the EUS-FNB group and by a conventional needle-knife sphincterotome and biopsy forceps in the SINK group. Patients were blinded to the technique used. The primary outcome was diagnostic accuracy. Secondary outcomes included adverse events, histological yield and procedure duration. Study enrollment was terminated early due to poor recruitment. Results  A total of 56 patients (31 male (55.37 %); mean age, 67.41 ± 12.70 years) were randomized to either EUS-FNB (n = 26) or SINK (n = 30). Technical success was 96.15 % and 96.66 %, respectively. The majority of lesions were gastrointestinal stromal tumors (51.78 %). No significant difference was found between EUS-FNB and SINK in terms of diagnostic accuracy for a malignant or benign disease (76 % vs. 89.28 %, respectively; P  = 0.278). The rate of adverse events (none severe) was also comparable (7.69 % vs. 10 %, respectively; P =  1.0) including two abdominal pain episodes in the EUS-FNB group compared to two delayed bleeding (one requiring hospitalization and radiologic embolization) and 1 abdominal pain in the SINK group. Conclusion  EUS-FNB and SINK are equally effective techniques for upper gastrointestinal SETs sampling. SINK can be associated with mild to moderate delayed bleeding., Competing Interests: Competing interests Dr. Khashab is a consultant and on medical advisory board for Boston Scientific and Olympus and a consultant for Medtronic. Dr. Carrara is a consultant, speaker and teacher for Olympus, recipient of Grant/Research support from Boston Scientific. Dr. Fernández-Esparrach is a consultant for CDx Diagnostics and teacher for Norgine Iberia and Olympus Spain. Dr. Kumbhari is a consultant for Boston Scientific, Apollo Endosurgery, Medtronic, Pentax Medical and ReShape Medical, and recipient of research support from ERBE and Apollo Endosurgery. Dr. Ginès is a consultant for Cook Medical. Dr. Repici is a consultant and on advisory board for Norgine and Lumendi, recipient of Grant/Research Support from Boston Scientific and Fujifilm. Dr. Shin is a consultant for Boston Scientific, Medtronic and C2 Therapeutics. Dr. Kalloo is a founding member, equity holder, and consultant for Apollo Endosurgery. Dr. Singh is a consultant for Abbvie, Ariel Precision Medicine, and Akcea Therapeutics. Dr. Canto is a recipient of Grant/Research Support from C2 Therapeutics.

Background  Recently, a novel lumen-apposing fully covered self-expanding metal stent (LA-FCSEMS) mounted on an electrocautery-enhanced delivery system has been developed to perform endoscopic ultrasound (EUS)-guided transluminal drainage. From early experience, however, release of the proximal flange of the stent has mostly been done using endoscopic view guidance to ensure proper positioning. Aim  We describe a new technique that we have named the Intra-Channel Stent Release Technique (ICSRT) to perform stent placement under complete EUS control, without the use of either fluoroscopic or endoscopic views. Material and methods  Data on all consecutive patients who underwent EUS-guided drainage using the new ICSRT between June 2014 and April 2016 were retrospectively retrieved from two institution databases. All EUS procedures were performed by experienced endoscopists with the patient under conscious or deep sedation. The total procedure and stent deployment time, and adverse events related to stent positioning with the ICSRT were evaluated. Results  One hundred consecutive patients (51 women; mean age ± SD, 66 ± 15.2 years, range 34 - 95) underwent EUS-guided transluminal drainage with the Hot AXIOS™ device using the new ICSRT. The procedure was technically successful in all but one patient (1 %). The mean total procedural time was 21.9 minutes (range 7 - 50), while the mean time for stent placement was 3.2 minutes (range 1 - 15). No major adverse events occurred. Discussion  The ICSRT has been used to deploy the newly developed lumen-apposing FCSEMS under complete EUS guidance without fluoroscopic and/or endoscopic assistance. The technique appears to be safe and highly effective and should be learned by all interventional endosonographers in order to be able to perform drainage in all clinical scenarios.