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Background: Zenker's diverticulum (ZD) per-oral endoscopic myotomy (Z-POEM) is an effective treatment for symptomatic (ZD). A modification to Z-POEM is the mucosal flap incision (MFI). We describe the technical and clinical success of patients who underwent Z-POEM with MFI., Methods: We included patients who underwent Z-POEM with MFI for ZD at 8 international centers. The primary outcome was the rate of clinical success, assessed by post-procedure Kothari-Haber symptom score (KHSS) without retreatment. Secondary outcomes included technical success, serious adverse events, and clinical recurrence with need for retreatment., Results: 36 patients (69% male, age 69 + 9 years) underwent Z-POEM with MFI for symptomatic ZD. Mean ZD size was 32 mm (+ 14). Clinical success was achieved in 35 (97%) cases. Median pre-procedure KHSS was 6 and median post-procedure KHSS was 1 (P <0.0001). Technical success was achieved in all cases. Mean procedure time was 57 minutes (+ 32), median follow up time was 196 days (IQR 39-499). There was one adverse event (3%) which was treated endoscopically., Conclusion: Z-POEM with MFI has a high rate of technical and clinical success. Prospective evaluation is needed to further validate this technique in patients with large ZD., Competing Interests: Dr. Ray Kim is a consultant for Medtronic, Cook Medical, and Apollo Endosurgery. Dr. Dennis Yang is a consultant for Olympus America, Fujifilm, Apollo Endosurgery, and Medtronic. Dr. Michael Kaminski is a consultant for Alfasigma USA, Fujifilm, and Olympus, and is a speaker for Boston Scientific. Dr. Prashant Kedia is a consultant for Olympus America, Boston Scientific, Medtronic, and Apollo Endosurgery. Dr. Mouen Khashab is a consultant for Boston Scientific, Olympus America, Medtronic, Apollo Endosurgery, and GI supply. The remaining Authors declare that there is no conflict of interest, (Thieme. All rights reserved.)

Background and study aims Artificial intelligence (AI) models have demonstrated high diagnostic performance identifying neoplasia during digital single-operator cholangioscopy (DSOC). To date, there are no studies directly comparing AI vs. DSOC-guided probe-base confocal laser endomicroscopy (DSOC-pCLE). Thus, we aimed to compare the diagnostic accuracy of a DSOC-based AI model with DSOC-pCLE for identifying neoplasia in patients with indeterminate biliary strictures. Patients and methods This retrospective cohort-based diagnostic accuracy study included patients ≥ 18 years old who underwent DSOC and DSOC-pCLE (June 2014 to May 2022). Four methods were used to diagnose each patient's biliary structure, including DSOC direct visualization, DSOC-pCLE, an offline DSOC-based AI model analysis performed in DSOC recordings, and DSOC/pCLE-guided biopsies. The reference standard for neoplasia was a diagnosis based on further clinical evolution, imaging, or surgical specimen findings during a 12-month follow-up period. Results A total of 90 patients were included in the study. Eighty-six of 90 (95.5%) had neoplastic lesions including cholangiocarcinoma (98.8%) and tubulopapillary adenoma (1.2%). Four cases were inflammatory including two cases with chronic inflammation and two cases of primary sclerosing cholangitis. Compared with DSOC-AI, which obtained an area under the receiver operator curve (AUC) of 0.79, DSOC direct visualization had an AUC of 0.74 ( P = 0.763), DSOC-pCLE had an AUC of 0.72 ( P = 0.634), and DSOC- and pCLE-guided biopsy had an AUC of 0.83 ( P = 0.809). Conclusions The DSOC-AI model demonstrated an offline diagnostic performance similar to that of DSOC-pCLE, DSOC alone, and DSOC/pCLE-guided biopsies. Larger multicenter, prospective, head-to-head trials with a proportional sample among neoplastic and nonneoplastic cases are advisable to confirm the obtained results., Competing Interests: Conflict of Interest Carlos Robles-Medranda is a key opinion leader and consultant for Pentax Medical, Steris, Medtronic, Motus, Micro-tech, G-Tech Medical Supply, CREO Medical, EndoSound, and mdconsgroup. The other authors declare no conflicts 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 Aims: Patients with sigmoid-type achalasia can be challenging to treat with peroral endoscopic myotomy (POEM). A short myotomy improves technical success; however, outcomes have not previously been evaluated., Methods: This was a multicenter, international, retrospective study of patients who underwent POEM with short (≤4 cm) or standard esophageal myotomy. Outcomes included clinical and technical success, procedural adverse events, and reflux rates., Results: A total of 109 patients with sigmoid achalasia (sigmoid, n = 74; advanced sigmoid, n = 35) underwent POEM across 13 centers (short myotomy, n = 59; standard, n = 50). Technical success was 100% across both groups. Patients who underwent short myotomy had a significantly shorter mean procedure time (57.7 ± 27.8 vs 83.1 ± 44.7 minutes, P = .0005). A total of 6 adverse events were recorded in 6 patients (5.5%; 4 mild, 2 moderate); the adverse event rate was not significantly different between short and standard groups. Ninety-eight patients had follow-up data (median, 3.6 months; interquartile range, 1-14 months). Clinical success was 94% (short, 93%; standard, 95%; P = .70) and did not differ based on achalasia subtype or sigmoid achalasia severity. Twenty-one (22%) patients reported post-POEM reflux and 44% (16 of 36) had objective evidence of pathologic reflux. Rates of pathologic reflux were significantly increased in the standard versus short group (odds ratio, 18.0; 95% confidence interval, 2.0-159.0; P = .009)., Conclusions: POEM with short myotomy is effective and safe for the short-term treatment of sigmoid and advanced sigmoid achalasia. Short myotomy may lead to less reflux than standard myotomy., Competing Interests: Disclosure The following authors disclosed financial relationships: A. Schlachterman: Consultant for Olympus Medical, Fujifilm Healthcare, Boston Scientific, Lumendi, and Laborie. P. Kedia: Consultant for Boston Scientific, Olympus Medical, and Medtronic. R. Pawa: Consultant for Boston Scientific and Cook Medical. P.G. Arcidiacono: Consultant for Pentax Medical, Boston Scientific, and FujiFilm. Advisory Board for MediGlobe and AMBU. S. Nagi: Lecture fees from Falk Pharmaceuticals, Pfizer, and Sanofi. R Sharaiha: Consultant for Boston Scientific, Olympus, and Intuitive Surgical. S. Irani: Consultant for Boston Scientific, Conmed, and Gore. C.-R. Medranda: Key opinion leader for Pentax Medical, Steris, Micro-Tech, G-Tech Medical Supply, EndoSound, and Mdconsgroup. M. Khashab: Consultant for Boston Scientific and Olympus and he receives royalties from Elsevier and UpToDate. All other authors disclosed no financial relationships., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Competing Interests: C. Robles-Medranda is a consultant and key opinion leader for Pentax Medical, Boston Scientific, Steris, Medtronic, Motus, Microtech, G-Tech Medical Supply, CREO Medical, EndoSound and mdconsgroup. All other authors disclosed no financial relationships. The other authors have no conflicts of interest to disclose.

Competing Interests: C. Robles-Medranda is a consultant and key opinion leader for Pentax Medical, Steris, Medtronic, Motus, Micro-Tech, G-Tech Medical Supply, CREO Medical, and mdconsgroup. M. Egas-Izquierdo, J. Alcivar-Vasquez, M. Puga-Tejada, M. Arevalo-Mora, D. Cunto, and J. Baquerizo-Burgos declare that they have no conflict of interest.

Background and Aims: EUS-guided radiofrequency ablation (EUS-RFA) has emerged as an alternative for the local treatment of unresectable pancreatic ductal adenocarcinoma (PDAC). We assessed the feasibility and safety of EUS-RFA in patients with unresectable PDAC., Methods: This study followed an historic cohort compounded by locally advanced (LA-) and metastatic (m)PDAC-naïve patients who underwent EUS-RFA between October 2019 and March 2022. EUS-RFA was performed with a 19-gauge needle electrode with a 10-mm active tip for energy delivery. Study primary endpoints were feasibility, safety, and clinical follow-up, whereas secondary endpoints were performance status (PS), local control, and overall survival (OS)., Results: Twenty-six patients were selected: 15 with locally advanced pancreatic duct adenocarcinoma (LA-PDAC) and 11 with metastatic pancreatic duct adenocarcinoma (mPDAC). Technical success was achieved in all patients with no major adverse events. Six months after EUS-RFA, OS was seen in 11 of 26 patients (42.3%), with significant PS improvement (P = .03). Local control was achieved, with tumor reduction from 39.5 mm to 26 mm (P = .04). A post-treatment hypodense necrotic area was observed at the 6-month follow-up in 11 of 11 patients who were still alive. Metastatic disease was a significant factor for worsening OS (hazard ratio, 5.021; 95% confidence interval, 1.589-15.87; P = .004)., Conclusions: EUS-RFA for the treatment of pancreatic adenocarcinoma is a minimally invasive and safe technique that may have an important role as targeted therapy for local treatment of unresectable cases and as an alternative for poor surgical candidates. Also, RFA may play a role in downstaging cancer with a potential increase in OS in nonmetastatic cases. Large prospective cohorts are required to evaluate this technique in clinical practice., Competing Interests: Disclosure The following author disclosed financial relationships: C. Robles-Medranda: Key opinion leader and consultant for Pentax Medical, Steris, Micro-Tech, G-Tech Medical Supply, CREO Medical, EndoSound, and mdconsgroup. All other authors disclosed no financial relationships., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and study aims Digital single-operator cholangioscopy (DSOC) allows the diagnosis of biliary duct disorders and treatment for complicated stones. However, these technologies have limitations such as the size of the probe and working channel, excessive cost, and low image resolution. Recently, a novel DSOC system (eyeMAX, Micro-Tech, Nanjing, China) was developed to address these limitations. We aimed to evaluate the usefulness and safety of a novel 9F and 11F DSOC system in terms of neoplastic diagnostic accuracy based on visual examination, ability to evaluate tumor extension and to achieve complete biliary stone clearance, and procedure-related adverse events (AEs). Patients and methods Data from ≥ 18-year-old patients who underwent DSOC from July 2021 to April 2022 were retrospectively recovered and divided into a diagnostic and a therapeutic cohort. Results A total of 80 patients were included. In the diagnostic cohort (n = 49/80), neovascularity was identified in 26 of 49 patients (46.9%). Biopsy was performed in 65.3% patients with adequate tissue sample obtained in 96.8% of cases. Biopsy confirmed neoplasia in 23 of 32 cases. DSOC visual impression achieved 91.6% sensitivity and 87.5% specificity in diagnosing neoplasms. In the therapeutic cohort (n = 43/80), 26 of 43 patients required lithotripsy alone. Total stone removal was achieved in 71% patients in the first session. Neither early nor late AEs were documented in either the diagnostic or therapeutic cohort. Conclusions The novel DSOC device has excellent diagnostic accuracy in distinguishing neoplastic biliary lesions as well as therapeutic benefits in the context of total stone removal, with no documented AEs., Competing Interests: Conflict of Interest Carlos Robles-Medranda is a key opinion leader and consultant for Pentax Medical, Steris, Medtronic, Motus, Micro-tech, G-Tech Medical Supply, CREO Medical, and mdconsgroup. Michel Kahaleh is a consultant for Boston Scientific, Interscope Med, and Abbvie; grant recipient from Boston Scientific, Conmed, Gore, Pinnacle, Merit Medical, Olympus Medical, and Ninepoint Medical; chief executive officer and founder of Innovative Digestive Health Education & Research Inc. Issac Raijman is a speaker for BostonScientific, ConMed, Medtronic, and GI Supplies; advisory board member for Micro-Tech; co-owner of EndoRx. The other authors declare no conflicts 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 Aims: EUS is a high-skill technique that requires numerous procedures to achieve competence. However, training facilities are limited worldwide. Convolutional neural network (CNN) models have been previously implemented for object detection. We developed 2 EUS-based CNN models for normal anatomic structure recognition during real-time linear- and radial-array EUS evaluations., Methods: The study was performed from February 2020 to June 2022. Consecutive patient videos of linear- and radial-array EUS videos were recorded. Expert endosonographers identified and labeled 20 normal anatomic structures within the videos for training and validation of the CNN models. Initial CNN models (CNNv1) were developed from 45 videos and the improved models (CNNv2) from an additional 102 videos. CNN model performance was compared with that of 2 expert endosonographers., Results: CNNv1 used 45,034 linear-array EUS frames and 21,063 radial-array EUS frames. CNNv2 used 148,980 linear-array EUS frames and 128,871 radial-array EUS frames. Linear-array CNNv1 and radial-array CNNv1 achieved a 75.65% and 71.36% mean average precision (mAP) with a total loss of .19 and .18, respectively. Linear-array CNNv2 obtained an 88.7% mAP with a .06 total loss, whereas radial-array CNNv2 achieved an 83.5% mAP with a .07 total loss. CNNv2 accurately detected all studied normal anatomic structures with a >98% observed agreement during clinical validation., Conclusions: The proposed CNN models accurately recognize the normal anatomic structures in prerecorded videos and real-time EUS. Prospective trials are needed to evaluate the impact of these models on the learning curves of EUS trainees., Competing Interests: Disclosure The following author disclosed financial relationships: C. Robles-Medranda: Consultant and key opinion leader for Pentax Medical, Boston Scientific, Steris, Medtronic, Motus, Micro-tech, G-Tech Medical Supply, CREO Medical, EndoSound, and mdconsgroup. All other authors disclosed no financial relationships., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Digital single-operator cholangioscopy (DSOC) plays a critical role in directly visualizing and treating the bile duct system. Although various cholangioscopes with different external diameters are available for DSOC, certain challenging scenarios persist in which existing scopes fail to complete a thorough evaluation of the bile ducts. To overcome these limitations, we aimed to introduce and highlight the application of a novel 7F cholangioscope., Methods: In this review article we describe the novel 7F cholangioscope, provide its assembly and setup, and review cases in which the 7F cholangioscope was used for diagnostic and therapeutic guidance., Results: Four cases involving challenging biliary assessments were presented, all of which achieved technical and clinical success. No procedure-related adverse events were reported in any of these cases., Conclusions: The 7F cholangioscope can provide additional information regarding the biliary tree and guidance for treatment, overcoming the challenging assessment of small pancreatobiliary ducts and its strictures. Its potential use in cases of severe bile duct stenosis is recommended. However, further studies evaluating safety and efficacy are needed., Competing Interests: Dr Robles-Medranda is a consultant for Pentax Medical, Steris, Microtech, G-Tech Medical Supply, CREO Medical, EndoSound, and mdconsgroup. All other authors disclosed no financial relationships relevant to this publication., (© 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc.)

Video 1Customization of pediatric bronchoscope and peroral endoscopic myotomy settings., (© 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc.)

Video 1Application of a novel digital single-operator cholangioscopy-based convolutional neuronal network to detect neoplastic lesions as a second-opinion consultation tool between 2 hospitals and biopsy sampling., (© 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc.)

Background: We aimed to develop a convolutional neural network (CNN) model for detecting neoplastic lesions during real-time digital single-operator cholangioscopy (DSOC) and to clinically validate the model through comparisons with DSOC expert and nonexpert endoscopists., Methods: In this two-stage study, we first developed and validated CNN1. Then, we performed a multicenter diagnostic trial to compare four DSOC experts and nonexperts against an improved model (CNN2). Lesions were classified into neoplastic and non-neoplastic in accordance with Carlos Robles-Medranda (CRM) and Mendoza disaggregated criteria. The final diagnosis of neoplasia was based on histopathology and 12-month follow-up outcomes., Results: In stage I, CNN2 achieved a mean average precision of 0.88, an intersection over the union value of 83.24 %, and a total loss of 0.0975. For clinical validation, a total of 170 videos from newly included patients were analyzed with the CNN2. Half of cases (50 %) had neoplastic lesions. This model achieved significant accuracy values for neoplastic diagnosis, with a 90.5 % sensitivity, 68.2 % specificity, and 74.0 % and 87.8 % positive and negative predictive values, respectively. The CNN2 model outperformed nonexpert #2 (area under the receiver operating characteristic curve [AUC]-CRM 0.657 vs. AUC-CNN2 0.794, P  < 0.05; AUC-Mendoza 0.582 vs. AUC-CNN2 0.794, P  < 0.05), nonexpert #4 (AUC-CRM 0.683 vs. AUC-CNN2 0.791, P  < 0.05), and expert #4 (AUC-CRM 0.755 vs. AUC-CNN2 0.848, P  < 0.05; AUC-Mendoza 0.753 vs. AUC-CNN2 0.848, P  < 0.05)., Conclusions: The proposed CNN model distinguished neoplastic bile duct lesions with good accuracy and outperformed two nonexpert and one expert endoscopist., Competing Interests: C. Robles-Medranda is a key opinion leader and consultant for Pentax Medical, Steris, Micro-tech, G-Tech Medical Supply, CREO Medical, and mdconsgroup, and is a board member and consultant for EndoSound. M. Kahaleh is a consultant for Boston Scientific, Interscope Med, and Abbvie; a grant recipient from Boston Scientific, Conmed, Gore, Pinnacle, Merit Medical, Olympus Medical, and Ninepoint Medical; and the chief executive officer and founder of Innovative Digestive Health Education & Research Inc. A. Tyberg is a consultant for Ninepoint Medical, EndoGastric Solutions, and Obalon Therapeutics. I. Raijman is a speaker for Boston Scientific, ConMed, Medtronic, and GI Supplies; an advisory board member for Microtech; and a co-owner of EndoRx. R. Kunda is a consultant for Olympus, Boston Scientific, Omega Medical Imaging, M.I. Tech, Tigen Pharma, and Ambu. J. Baquerizo-Burgos, J. Alcivar-Vasquez, M. Puga-Tejada, M. Egas-Izquierdo, M. Arevalo-Mora, J.C. Mendez, A. Sarkar, H. Shahid, R. del Valle-Zavala, J. Rodriguez, R.C. Merfea, J. Barreto-Perez, G. Saldaña-Pazmiño, D. Calle-Loffredo, H. Alvarado, and H.P. Lukashok 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/).)

Video 1EUS-guided FNA and lumen-apposing metallic stent deployment., (© 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc.)

Background: Chronic esophageal conditions (CEC) are associated with significant disease-related burden, disability, and costs. Health-related quality of life (HRQOL) constructs are intended to capture the physical, mental, social, and emotional aspects of a patient's life and how health status impacts these domains. The Northwestern Esophageal Quality of Life (NEQOL) can be used among esophageal diseases while maintaining sensitivity to specific conditions. We aimed to translate, cross-cultural adapt, and validate the NEQOL into Spanish., Methods: After language and cross-cultural adaptation, the NEQOL was applied to an outpatient clinic-based population in a single tertiary center. We analyzed the internal consistency, construct, criterion validity, and test-retest reliability of the questionnaire. The criterion validity was tested against the SF-12 questionnaire., Key Results: After completing the translation process, no item was considered problematic. A total of 385 patients were included in the validation study. The internal consistency (Cronbach's alpha) for the total NEQOL-S score was 0.89. The NEQOL-S questionnaire showed moderate test-retest reliability (ICC = 0.828; 95% CI 0.755-0.881; p < 0.001). Criterion validity showed good coherence when correlated with the SF-12 survey (R 2  = 0.538; 95% CI 0.491-0.585, p < 0.001)., Conclusions and Inferences: The translated and cross-culturally adapted NEQOL-S showed good psychometric properties that allow its use in Spanish-speaking patients suffering from CEC., (© 2022 John Wiley & Sons Ltd.)

Background and Aims: Patients with distal malignant biliary obstruction (MBO) and cystic duct orifice tumoral involvement have an increased risk for the development of acute cholecystitis after self-expandable metallic stent (SEMS) placement. We aimed to determine whether primary EUS-guided gallbladder drainage prevents acute cholecystitis in these patients., Methods: This was a single-center, randomized control trial in patients with distal MBO enrolled from July 2018 to July 2020. Patients were randomized into 2 groups: an interventional group treated with conventional ERCP biliary drainage with SEMS placement and subsequent primary EUS-guided gallbladder drainage (EUS-GBD) and a control group treated with conventional biliary drainage alone. The primary outcome of the study was the occurrence of post-treatment acute cholecystitis, assessed for ≤12 months or until death. The secondary outcomes were hospitalization length and median survival time., Results: Forty-four patients were included in the study: 22 in each group. Five patients in the control group (22.7%) and none in the intervention group experienced acute cholecystitis. The median hospitalization time was significantly lower in the interventional group than in the control group (2 days vs 1 day, P = .017). There was no difference in the observed median survival rates in the primary EUS-GBD group (2.9 months) and the control group (2.8 months) (P = .580)., Conclusion: In this single-center study of patients with unresectable MBO and occlusion of the cystic duct orifice, prophylactic EUS-GBD demonstrated a reduced incidence of acute cholecystitis., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Endoscopic ultrasound (EUS) can detect small lesions throughout the digestive tract; however, it remains challenging to accurately identify malignancies with this approach. EUS elastography measures tissue hardness, by which malignant and nonmalignant pancreatic masses (PMs) and lymph nodes (LNs) can be differentiated. However, there is currently little information regarding the strain ratio (SR) cutoff in Hispanic populations., Aim: To determine the diagnostic accuracy of EUS elastography for PMs and LNs with an SR cutoff value in Hispanics., Methods: A retrospective study of patients who underwent EUS elastography for PMs between December 2013 and December 2014. A qualitative (analysis of color maps) and quantitative (SR) analysis of PMs and their associated LNs was performed. The accuracy of EUS elastography in identifying malignant PMs and LNs and cutoff value for SR were analyzed. A PM and/or its associated LNs were considered malignant based on histopathological findings from fine-needle aspiration biopsy samples., Results: A sample of 121 patients was included, 45.4% of whom were female. 69 (57.0%) PMs were histologically malignant, with a median SR of 50.4 vs 33.0 for malignant vs nonmalignant masses ( P < 0.001). EUS evaluation identified associated LNs in 43/121 patients (35.5%), in whom 22/43 (51.2%) patients had histologically confirmed malignant diagnosis, with a median SR of 30 vs 40 for malignant vs nonmalignant LNs ( P = 0.7182). In detecting malignancy in PMs, an SR cutoff value of > 21.5 yielded a sensitivity of 94.2%, while a cutoff value of > 121 yielded a specificity of 96.2.2%. There were significant differences in the Giovannini scores, a previously established elastic score system, between the patients grouped by their final histology results ( P < 0.001). For LNs, SR cutoff values of > 14.0 and > 155 yielded a sensitivity of 90.9% and a specificity of 95.2%, respectively, in detecting malignancy., Conclusion: EUS elastography is a helpful technique for the diagnosis of solid PMs and their associated LNs. The proposed SR cutoff values have a high sensitivity and specificity for the detection of malignancy., Competing Interests: Conflict-of-interest statement: Carlos Robles-Medranda is a key opinion leader and consultant for Pentax Medical, Boston Scientific, Steris, Medtronic, Motus, Microtech, G-Tech Medical Supply, CREO Medical, EndoSound, and Mdconsgroup. The other authors declare no conflicts of interest., (©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background and study aims  Probe-based confocal laser endomicroscopy (pCLE) can provide high magnification to evaluate chronic atrophic gastritis (CAG), but the current pCLE criteria are qualitative and prone to variability. We aimed to propose a quantitative CAG criterion based on pCLE to distinguish non-atrophic gastritis (NAG) from CAG. Patients and methods  This observational, exploratory pilot study included patients with NAG and CAG evaluated via esophagogastroduodenoscopy, pCLE, and histology. We measured the gastric glands density, gastric gland area, and inter-glandular distance during pCLE. Results  Thirty-nine patients (30/39 with CAG) were included. In total, 194 glands were measured by pCLE, and 18301 were measured by histology, with a median of five glands per NAG patient and 4.5 per CAG patient; pCLE moderately correlate with histology (rho = 0.307; P  = 0.087). A gland area of 1890-9105 µm 2 and an inter-glandular distance of 12 to 72 µm based on the values observed in the NAG patients were considered normal. The proposed pCLE-based CAG criteria were as follows: a) glands density < 5; b) gland area < 1/16 the pCLE field area (< 1890 µm 2 ) or > 1/4 the pCLE field area (> 9105 µm 2 ); or c) inter-glandular distance < 12 or > 72 µm; CAG was diagnosed by the presence of at least one criterion. The proposed criteria discriminated CAG with a ranged sensitivity of 76.9 % to 92.3 %, a negative predictive value of 66.6 % to 80.0 %, and 69.6 % to 73.9% accuracy. Conclusions  The proposed pCLE criteria offer an accurate quantitative measurement of CAG with high sensitivity and excellent interobserver agreement. Larger studies are needed to validate the proposed criteria., Competing Interests: Competing interests Dr. Robles-Medranda is a key opinion leader and consultant for Pentax Medical, Boston Scientific, G-tech Medical Supply, and MD Consulting Group., (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: Currently, there is insufficient data about the accuracy in the diagnosing of pancreatic cystic lesions (PCLs), especially with novel endoscopic techniques such as with direct intracystic micro-forceps biopsy (mFB) and needle-based confocal laser-endomicroscopy (nCLE)., Aim: To compare the accuracy of endoscopic ultrasound (EUS) and associated techniques for the detection of potentially malignant PCLs: EUS-guided fine needle aspiration (EUS-FNA), contrast-enhanced EUS (CE-EUS), EUS-guided fiberoptic probe cystoscopy (cystoscopy), mFB, and nCLE., Methods: This was a single-center, retrospective study. We identified patients who had undergone EUS, with or without additional diagnostic techniques, and had been diagnosed with PCLs. We determined agreement among malignancy after 24-mo follow-up findings with detection of potentially malignant PCLs via the EUS-guided techniques and/or EUS-guided biopsy when available (EUS malignancy detection)., Results: A total of 129 patients were included, with EUS performed alone in 47/129. In 82/129 patients, EUS procedures were performed with additional EUS-FNA (21/82), CE-EUS (20/82), cystoscopy (27/82), mFB (36/82), nCLE (44/82). Agreement between EUS malignancy detection and the 24-mo follow-up findings was higher when associated with additional diagnostic techniques than EUS alone [62/82 (75.6%) vs 8/47 (17%); OR 4.35, 95%CI: 2.70-7.37; P < 0.001]. The highest malignancy detection accuracy was reached when nCLE and direct intracystic mFB were both performed, with a sensitivity, specificity, positive predictive value, negative predictive value and observed agreement of 100%, 89.4%, 77.8%, 100% and 92.3%, respectively ( P < 0.001 compared with EUS-alone)., Conclusion: The combined use of EUS-guided mFB and nCLE improves detection of potentially malignant PCLs compared with EUS-alone, EUS-FNA, CE-EUS or cystoscopy., Competing Interests: Conflict-of-interest statement: Robles-Medranda C reports other from Pentax Medical, other from Boston Scientific, other from Steris, other from Medtronic, other from Motus, other from Micro-tech, other from G-Tech Medical Supply, other from CREO Medical, other from Mdconsgroup, outside the submitted work; The other authors declare no conflicts of interest., (©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background: Effective hemostasis is essential to prevent rebleeding. We evaluated the efficacy and feasibility of the Over-The-Scope Clip (OTSC) system compared to combined therapy (through-the-scope clips with epinephrine injection) as a first-line endoscopic treatment for high-risk bleeding peptic ulcers., Methods: We retrospectively analyzed data of 95 patients from a single, tertiary center and underwent either OTSC (n = 46) or combined therapy (n = 49). The primary outcome of the present study was the efficacy of the OTSC system as a first-line therapy in patients with high-risk bleeding peptic ulcers compared to combined therapy with TTS clips and epinephrine injection. The secondary outcomes included the rebleeding rate, perforation rate, mean procedure time, reintervention rate, mean procedure cost and days of hospitalization in the two study groups within 30 days of the index procedure., Results: All patients achieved hemostasis within the procedure; two patients in the OTSC group and four patients in the combined therapy group developed rebleeding (p = 0.444). No patients experienced gastrointestinal perforation. OTSC had a shorter median procedure time than combined therapy (11 min versus 20 min; p < 0.001). The procedure cost was superior for OTSC compared to combined therapy ($102,000 versus $101,000; p < 0.001). We found no significant difference in the rebleeding prevention rate (95.6% versus 91.8%, p = 0.678), hospitalization days (3 days versus 4 days; p = 0.215), and hospitalization costs ($108,000 versus $240,000, p = 0.215) of the OTSC group compared to the combined therapy group., Conclusion: OTSC treatment is an effective and feasible first-line therapy for high-risk bleeding peptic ulcers. OTSC confers comparable costs and patient outcomes as combined treatments, with a shorter procedure time.

Background and Aims: Various macroscopic features are proposed for the diagnosis of biliary lesions during digital single-operator cholangioscopy (DSOC); however, neovasculature may be one of the most reliable features of neoplasia. We aimed to evaluate the detection of neovasculature during DSOC to distinguish neoplastic from non-neoplastic bile duct lesions., Methods: A retrospective, single-center, cohort study was used. Neovasculature was defined as the presence of irregular or "spider" vascularity on bile duct lesions. The accuracy of detection of neovasculature for the identification of neoplastic lesions was estimated using the histologic results, surgical specimens, and/or 6-month follow-up as the criterion standard. Interobserver agreement analysis (kappa value) was performed between 2 expert endoscopists and 3 nonexpert physicians., Results: Ninety-five patients were included; the median age was 65.6 years (range, 20-93 years), and 51 (53.7%) patients were female. Signs of neovasculature were observed in 65 of 95 (68.4%) patients. Histology confirmed neoplasia in 48 of 95 (50.5%) patients, and 6-month follow-up survival confirmed neoplasia in 52 of 95 (54.7%) patients. The use of vascularity for identifying neoplastic lesions achieved an accuracy of 80%, sensitivity of 94%, specificity of 63%, positive predictive value of 75%, negative predictive value of 90%, positive likelihood ratio of 2.53 (95% confidence interval, 1.71-3.76), and negative likelihood ratio of 0.09 (95% confidence interval, 0.03-0.28). The interobserver and intraobserver agreement were excellent (κ > 80%; P < .001) between expert endoscopists and nonexpert physicians., Conclusion: Detection of irregular or spider vascularity on bile duct lesions during DSOC evaluations accurately identifies biliary neoplastic lesions. Prospective multicenter trials are required to evaluate neovasculature as a single factor for predicting neoplasia., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Cyanoacrylate (CYA) injection can be performed using a standard upper endoscopy technique or under endoscopic ultrasound (EUS) guidance alone or in combination with coils. There is little information available on the economic impact of these treatment methods., Aim: To compare the cost-effectiveness of treating gastric varices by CYA injection via upper endoscopy vs coils plus CYA guided by EUS., Methods: This was an observational, descriptive, and retrospective study. Patients were allocated into two groups: A CYA group and coils plus CYA group. The baseline characteristics were compared, and a cost analysis was performed., Results: Overall, 36 patients were included (19 in the CYA group and 17 in the coils + CYA group). All patients in the CYA group had acute bleeding. They underwent a higher mean number of procedures (1.47 vs 1, P = 0.025), and the mean volume of glue used was 2.15 vs 1.65 mL, P = 0.133. The coils + CYA group showed a higher technical success rate (100% vs 84.2%), with a complication rate similar to the CYA group. The majority of CYA patients required hospitalization, and although the mean total per procedure cost was lower (United States $ 1350.29 vs United States $ 2978), the mean total treatment cost was significantly different (United States $ 11060.89 for CYA vs United States $ 3007.13 for coils + CYA, P = 0.03)., Conclusion: The use of EUS-guided coils plus cyanoacrylate is more cost-effective than cyanoacrylate injection when the total costs are evaluated. Larger, randomized trials are needed to validate the cost-effectiveness of the EUS-guided approach to treat gastric varices., Competing Interests: Conflict-of-interest statement: Carlos Robles-Medranda is a key opinion leader and consultant for Pentax Medical, Boston Scientific, G-tech medical supply and MD consulting group. The other authors have nothing to disclose., (©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background and study aims  Digital, per-oral cholangioscopy (POCS) allows diagnosis of biliary ducts disorders and treatment for complicated stones. We aimed to determine the diagnostic accuracy of digital POCS systems for stricture lesions and the factors precluding complete biliary stone clearance. Patients and methods  We performed a retrospective analysis of a prospective database of 265 consecutive patients referred for POCS between December 2016 and July 2018. We first analyzed the diagnostic accuracy of digital POCS for malignant and benign stricture lesions in 147 patients. Then, we analyzed the factors associated with complete or partial biliary stone clearance achieved with electrohydraulic lithotripsy (EHL) delivered via POCS in 118 patients. Results  In the diagnostic group, digital POCS achieved 91 % visual-impression sensitivity, 99 % specificity, 99 % positive and 91 % negative predictive values, and 63.64 positive and 0.09 negative likelihood ratios for malignancy diagnosis. In the therapeutic group, complete biliary stone clearance was achieved by EHL in 94.9 % patients; the mean stone size was 20 mm (10-40 mm). In multivariable analyses, a stone size > 20 mm (OR: 1.020, P  < 0.001) and the number of stones ≥ 3 (OR: 1.276, P  < 001) was associated with partial biliary stone clearance. Adverse events were reported in 3.3 % patients; no deaths were reported 30 days after the procedure. Conclusions  Digital POCS has excellent diagnostic efficacy for biliary lesions. EHL via POCS is effective for complicated biliary stone clearance. Stone size (> 20 mm) and the number of stones (≥ 3) are associated with partial biliary stone clearance., Competing Interests: Competing interests Dr. Robles-Medranda is a key opinion leader and consultant for Pentax Medical, Boston Scientific, GTech Medical Supply and MD Consulting Group. The other authors have no conflicts of interest.

Background: Gastric variceal bleeding is a life-threating condition with challenging management. We aimed to compare the efficacy and safety of endoscopic ultrasonography (EUS)-guided coil embolization and cyanoacrylate injection versus EUS-guided coil embolization alone in the management of gastric varices., Methods: A single-center, parallel-randomized controlled trial involving 60 participants with gastric varices (GOV II and IGV I) who were randomly allocated to EUS-guided coil embolization and cyanoacrylate injection (n = 30) or EUS-guided coil embolization alone (n = 30). The primary end points were the technical and clinical success rates of both procedures. The secondary end points were the reappearance of gastric varices during follow-up, along with rebleeding, the need for reintervention, and complication and survival rates., Results: The technical success rate was 100 % in both groups. Immediate disappearance of varices was observed in 86.7 % of patients treated with coils and cyanoacrylate, versus 13.3 % of patients treated with coils alone ( P  < 0.001). Median survival time was 16.4 months with coils and cyanoacrylate versus 14.2 months with coils alone ( P  = 0.90). Rebleeding occurred in 3.3 % of patients treated with combined treatment and 20 % of those treated with coils alone ( P  = 0.04). With combined treatment, 83.3 % of patients were free from reintervention versus 60 % with coils alone (hazard ratio 0.27; 95 % confidence interval 0.095 - 0.797; P  = 0.01)., Conclusions: EUS-guided coil embolization with cyanoacrylate injection achieved excellent clinical success, with lower rates of rebleeding and reintervention than coil treatment alone. Multicenter studies are required to define the most appropriate technique for gastric variceal obliteration., Competing Interests: The authors declare that they have no conflict of interest., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background and aims  Irritable bowel syndrome (IBS) is considered to be a functional disease, but recent data indicate measurable organic alterations. We aimed to determine the presence of colorectal mucosa microinflammation in vivo via probe-confocal laser endomicroscopy (pCLE) and histological evaluation in IBS patients. Methods  This was a prospective, controlled, nonrandomized single-blind diagnostic trial performed in a tertiary institution. pCLE images and targeted biopsy of each colon segment obtained during colonoscopies of IBS patients and controls were analyzed for inflammatory changes. Biopsies were classified using the Geboes scale, and the odds ratio and overall diagnostic accuracy were calculated. Results  During the 15-month study period, 37 patients were allocated to each group. The mean age was 53.1 ± 14.3 years; 64.9 % were female. Signs of colonic mucosa inflammation were evident on 65.8 % of pCLE images from IBS patients compared to 23.4 % of images from controls (OR 6.28; 4.14-9.52; P  < 0.001). In total, 20/37 patients had microinflammation via pCLE in ≥ 3 colon segments in the IBS group, compared to 1/37 in the control group. A Geboes score > 0 was attributed to 60.8 % of biopsies from patients in the IBS group compared to 27.5 % of biopsies from the control group. The sensitivity, specificity, positive and negative predictive values, observed and interrater agreement of pCLE-detected inflammatory changes in IBS using histology as gold standard were 76 %, 91 %, 76 %, 91 %, 86.5 %, and 66.8 %, respectively. Conclusions  Patients with IBS have a six-fold higher prevalence of colorectal mucosa microinflammation than healthy controls. pCLE might be a reliable method to detect colorectal mucosa microinflammation in IBS patients., Competing Interests: Competing interests The authors declare that they have no conflicts of interest.

Background: Accurate detection of gastric infection by Helicobacter pylori ( H. pylori ) and premalignant lesions are important for effective provision of treatment, preventing the development of gastric neoplasia. Optical enhancement systems with optical magnification improved the identification of mucosal superficial and vascular patterns in patients with dyspepsia., Aim: To evaluate an optical enhancement system with high-definition magnification, for diagnosis of normal gastric mucosa, H. pylori -associated gastritis, and gastric atrophy., Methods: A cross-sectional, nonrandomized study from November 2015 to April 2016 performed in a single-tertiary academic center from Ecuador. Seventy-two consecutive patients with functional dyspepsia according to the Rome III criteria, were tested for H. pylori using a stool antigen test and were assigned to an Hp + group or an Hp - control group. Esophagogastroduodenoscopy with high-definition optical magnification and digital chromoendoscopy was performed, and patients were classified into 4 groups, in accordance to the microvascular-architecture pattern of the mucosa. Interobserver and intraobserver agreement among operators were calculated., Results: Of the 72 participants, 35 were Hp + and 37 were Hp - . Among 10 patients with normal mucosal histology in biopsy samples, 90% had a Type I pattern of microvascular architecture by endoscopy. Among participants with type IIa and type IIb patterns, significantly more were Hp + than Hp - (32 vs 8), and most (31 out of 40) had histological diagnoses of chronic active gastritis. Two of the three participants with a histological diagnosis of atrophy had a type III microvascular pattern. The type I pattern predicted normal mucosa, type IIa-IIb predicted H. pylori infection, and type III predicted atrophy with sensitivities of 90.0%, 91.4%, and 66.7%, respectively. The intraobserver and interobserver agreements had kappa values of 0.91 and 0.89, respectively., Conclusion: High-definition optical magnification with digital chromoendoscopy is useful for diagnosis of normal gastric mucosa and H. pylori -associated gastritis with high accuracy, but further studies are needed to determine whether endoscopic diagnosis of gastric atrophy is feasible., Competing Interests: Conflict-of-interest statement: Robles-Medranda C is a key opinion leader for Pentax Medial and Boston Scientific. The other authors declare that they have no conflicts of interest., (©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.)

Aim: The aim of the study was to determine the usefulness of known biomarkers as pre-operative predictors of complicated acute appendicitis (CAA) and perforated appendicitis (PA)., Materials and Methods: This was an observational, analytic, cross-sectional, and prospective study at Hospital Teodoro Maldonado Carbo (August 2016-December 2017). Evaluated biomarkers: white blood cells count, neutrophil percentage (N%), neutrophil-to-lymphocyte ratio, glucose, total bilirubin, C-reactive protein, and procalcitonin (PCT). The statistical analysis was performed by means of the area under the receiver operating characteristics (AUROC) curve estimation. Biomarkers' cutoff point was identified using Youden's index. Sensitivity, specificity, positive, and negative predictive value (NPV) (positive predictive value [PPV] and NPV) were estimated., Results: One hundred and twenty-eight cases were included (median age 30 years, 44% female), 70 cases (54%) corresponded to CAA (PA 38/70). N% and PCT obtained an AUROC of 78% and 80% for CAA (PA 76% and 81%), respectively. A N% > 78.1% predicted CAA with a sensitivity, specificity, PPV, and NPV of 82%, 62%, 72%, and 72% (> 74.9%, PA: 94%, 53%, 46%, and 96%), respectively. PCT > 0.14 ng/dL predicted CAA with sensitivity, specificity, PPV, and NPV of 69%, 79%, 80%, and 68% (PA: 84%, 69%, 53%, and 91%)., Conclusion: The N% and PCT represent useful pre-operative biomarkers for discarding PA when an acute appendicitis is suspected., (Copyright: © 2020 Permanyer.)

Background: After appendectomy due to complicated acute appendicitis (CAA), there are some alternatives as antibiotic scheme: ciprofloxacin/metronidazole; as well as monoscheme based on carbapenems: ertapenem, meropenem, and imipenem., Aim: This study aims to prove the efficacy of carbapenems versus ciprofloxacin/metronidazole in CAA post-operative management in terms of preventing complications during post-operative period and decreasing hospital stay., Materials and Methods: This was an observational, analytical, longitudinal, and prospective cohort study (March 2014-November 2016). Patients were classified into two groups, according to the prescribed antibiotic scheme: some carbapenems or ciprofloxacin/metronidazole., Results: Ninety-eight patients were enrolled. There was an requirement for antibiotic therapy rotation only in the ciprofloxacin/metronidazole (7/49, 14.3%; p = 0.004). Carbapenems reached a mean hospital stay of 4.45 days, in contrast with ciprofloxacin/metronidazole, 8.29 days (p = 0.020). In post-surgical follow-up, there were more cases of curative resolution in the group in the carbapenems group (35/49 vs. 15/49 p < 0.001) as well as a greater number of cases with some late infection in the ciprofloxacin/metronidazole group (1/49 vs. 10/49, p = 0.010)., Conclusion: In the post-operative management of CAA, carbapenems represent an important indication to be considered as first-line antibiotic therapy., (Copyright: © 2020 Permanyer.)

Goals: The goal of this study was to evaluate the safety and feasibility of routine segmental retroflexed withdrawal viewing (RV) of the colon with the RetroView colonoscope., Materials and Methods: This was a prospective, single-center, 2-stage diagnostic trial. After cecal intubation, mucosal evaluation by forward viewing (FV) and RV was performed by segment (right, transverse, left, and sigmoid colon, and rectum). Lesions detected during FV were removed and/or marked before retroflexion. Safety and feasibility were measured through adverse event and technical success rates. All lesions detected and removed endoscopically were recorded., Results: Two hundred twenty-five patients underwent colonoscopy with the RetroView colonoscope. Retroflexion by segment was successful in the right, transverse, left, and sigmoid colon, and rectum in 98.9%, 100%, 100%, 82.6%, and 100% of cases, respectively. The mean total procedure time was 16.6 minutes. Ninety-four lesions were detected through retroflexion evaluation, for an increase in the lesions' detection rate of 30.7%. The per-adenoma miss rate of standard colonoscopy (FV) was 35.71%. The adenoma detection rate (ADR) for FV was 16%, whereas, when performing FV and RV, the ADR increased to 24.9%. Adverse events were recorded in 0.4% of cases. Therapeutic procedures were performed successfully through the retroflexed position in 81/225 patients., Conclusions: Routine retroflexion evaluation of the colonic mucosa by segment using the RetroView colonoscope is safe and feasible. Retroflexion evaluation increases the detection rate of colonic lesions behind folds, including the number of adenomas per colonoscopy and ADR, offering a complete screening colonoscopy. All therapeutic procedures are feasible through retroflexion.

Background and study aims  The aim of this study was to evaluate the diagnostic yield of endoscopy using optical enhancement (OE system) with optical magnification to predict reflux in non-erosive reflux disease (NERD) patients. Patients and methods  A prospective, non-randomized, single-blind study was performed from September 2015 to January 2016. Participants suffered from gastroesophageal reflux disease (GERD) symptoms and were assigned to the NERD group or the non-reflux disease control group based on endoscopic findings and a 24-hour pH-impedance-monitoring test. Endoscopy using the OE system with optical magnification was performed in all patients to detect minimal mucosal esophageal lesions (MMEL), specifically abnormalities in the numbers, dilation, and tortuosity of intrapapillary capillary loops (IPCLs). Biopsies were obtained from each esophageal segment, and diagnoses from images were compared to diagnoses of reflux and inflammation using 24-hour pH-impedance monitoring and histology, respectively. Results  Fifty-seven patients were included (36 in the NERD group, 21 in the control group). IPCLs were observed in 94.4 % of cases in the NERD group and 38 % of cases in the control group ( P  < 0.05). There were significant differences in IPCL abnormalities between groups that were associated with histologically identified inflammation. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 94.4 %, 61.9 %, 80.9 %, 86.6 %, and 82.4 %, respectively. The 24-hour pH-impedance-monitoring test was used as the gold standard. The Kappa interobserver and intraobserver values were 0.85 and 0.90, respectively. Conclusion  The OE system with optical magnification can detect MMEL and predict NERD with high sensitivity, accuracy, and interobserver and intraobserver agreement. Presence of IPCLs highly correlates with histologically identified inflammation.

Background: Bougies dilation is considered an effective technique for the treatment of simple benign esophageal strictures. The "rule of three" has been advocated to prevent reported adverse events such as bleeding and perforation. However, adherence to this rule has increased the cost and duration of treatment., Objective: To demonstrate the safety and long-term benefits of progressive bougie dilations until reaching 15 mm (45Fr) in one single session endoscopy with non-adherence to the rule of three., Methods: A retrospective analysis of a prospectively collected data of patients with simple benign esophageal strictures treated with multiple progressive bougie dilators until reaching 15 mm (45Fr) in one single session., Results: The median age was 58 years (range 28-89), and 83.3% of patients were female. The main presenting symptom was dysphagia for solids in 11/12 cases (91.6%). The cause of their simple benign esophageal stricture was distributed as follows: 7/12 esophageal webs, 2/12 peptic stenosis, 2/12 Schatzki rings and one caustic injury. 75% required only one session for clinical success. No serious adverse events were described. No recurrence of symptoms was noted in a median follow-up of 20 months., Conclusion: The rule of three in patients with simple benign esophageal strictures secondary to esophageal webs, Schatzki rings and peptic strictures treated with Savary-Gilliard dilators is not necessary, showing good clinical results. Prospective studies with more patients are necessary.

Background: The aim of this study was to propose a novel, comprehensive, macroscopic classification for bile duct lesions., Methods: A two-stage protocol was designed. In Stage I, a retrospective study (September 2013 to September 2015) of patients with bile duct lesions detected by peroral cholangioscopy (POCS) was performed. A total of 315 images with at least 6 months of follow-up were recorded, analyzed, and correlated to histology, and were classified as non-neoplastic (one of three types, 1 - 3) or neoplastic (one of four types, 1 - 4) based on morphological and vascular patterns. In Stage II, a prospective, nonrandomized, double-blind study was performed from December 2015 to December 2016 to validate the proposed classification. Sensitivity, specificity, positive and negative predictive values (PPV and NPV, respectively), and positive and negative likelihood ratios (LR + and LR - , respectively) were calculated (gold standard: 6-month follow-up). Inter- and intraobserver agreement (kappa value, κ) among experts and non-experts were calculated., Results: 171 patients were included (65 retrospective; 106 prospective). In Stage I, 28/65 cases were neoplastic and 37 /65 were non-neoplastic, according to the final diagnosis. In Stage II, 56/106 were neoplastic with a sensitivity, specificity, PPV, NPV, LR + , and LR - for neoplastic diagnosis of 96.3 %, 92.3 %, 92.9 %, 96 %, 12.52, and 0.04, respectively. The proposed classification presented high reproducibility among observers, for both neoplastic and subtypes categories. However, it was better for experts (κ > 80 %) than non-experts (κ 64.7 % - 81.9 %)., Conclusion: The novel classification system could help physicians to distinguish non-neoplastic from neoplastic bile duct lesions., Competing Interests: None, (© Georg Thieme Verlag KG Stuttgart · New York.)

Background/aims: Capsule endoscopy is a diagnostic method for evaluating the small bowel lumen and can detect undiagnosed lesions. The aim of this study was to evaluate the diagnostic yield and clinical impact of capsule endoscopy in patients with refractory diarrhea-predominant irritable bowel syndrome and functional abdominal pain., Methods: This study involved a retrospective analysis of prospectively collected data, maintained in a database. Patients with refractory diarrhea-predominant irritable bowel syndrome and functional abdominal pain within the period of March 2012 to March 2014 were included. Capsule endoscopy was used to detect small bowel pathologies in both groups., Results: Sixty-five patients (53.8% female) fulfilled the inclusion criteria and had a mean (±standard deviation) age of 50.9±15.9 years. Clinically significant lesions were detected via capsule endoscopy in 32.5% of the patients in the abdominal pain group and 54.5% of the patients in the diarrhea group. Overall, 48% of patients had small bowel pathologies detected during the capsule endoscopy study. Inflammatory lesions and villous atrophy were the most frequent lesions identified in 16.9% and 15.3% of patients in the abdominal pain and the diarrhea groups, respectively., Conclusion: Routine use of capsule endoscopy in patients with irritable bowel syndrome should not be recommended. However, in patients with refractory conditions, capsule endoscopy may identify abnormalities.