Accurate and safe diagnosis and treatment of neoplastic biliary lesions using a novel 9F and 11F digital single-operator cholangioscope.

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.

Assessing Endoscopic Ultrasound-Guided Radiofrequency Ablation in Unresectable Pancreatic Ductal Adenocarcinoma: A Single-Center Historic Cohort Study.

BACKGROUND: /aims: Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) has emerged as an alternative for the local treatment of unresectable pancreatic ductal adenocarcinoma (PDAC). We aim to assess the feasibility and safety of EUS-RFA in patients with unresectable PDAC. METHODS: The following was a historic cohort compounded by locally advanced (LA) and metastatic (m) PDAC naïve patients, who underwent EUS-RFA between October 2019 to March 2022. EUS-RFA was performed with a 19-g needle electrode with a 10 mm active tip for energy delivery. Study primary endpoints were feasibility, safety, and clinical follow-up; secondary endpoints were performance status (PS), local control (LC) and overall survival (OS). RESULTS: Twenty-six patients were selected: 15/26 LA-PDAC and 11/26 mPDAC. Technical success was achieved in all patients with no major adverse events. Six months after EUS-RFA, OS was 11/26 (42.3%), with significant PS improvement (P=.03). LC was achieved, with tumor reduction from 39.5 to 26 mm (P=.04). Post-treatment hypodense necrotic area was observed at six-month follow-up in 11/11 alive cases. Metastatic disease was a significant factor for OS worsening (HR 5.021; IC 95% 1.589 - 15.87; P=.004) CONCLUSIONS: EUS-RFA 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, as well as an alternative for poor surgical candidates. Also, RFA may play a role in downstaging cancer with potential OS increase in non-metastatic cases. Large prospective cohorts are required to evaluate this technique in clinical practice.

Full-depth evaluation of the bile duct with a 7F cholangioscope and its possibility for guiding therapeutics.

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.

Development of convolutional neural network models that recognize normal anatomic structures during real-time radial-array and linear-array EUS (with videos).

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.

Use of an adapted bronchoscope for peroral endoscopic myotomy in a pediatric patient weighing less than 10 kg.

Video 1Customization of pediatric bronchoscope and peroral endoscopic myotomy settings.

Artificial intelligence for diagnosing neoplasia on digital cholangioscopy: development and multicenter validation of a convolutional neural network model.

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.

Spanish translation and validation of a hybrid, health-related quality of life questionnaire for chronic esophageal conditions: NEQOL-S.

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 (R2  = 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.

Prophylactic EUS-guided gallbladder drainage prevents acute cholecystitis in patients with malignant biliary obstruction and cystic duct orifice involvement: a randomized trial (with video).

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.

Endoscopic ultrasound elastography for malignant pancreatic masses and associated lymph nodes: Critical evaluation of strain ratio cutoff value.

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.

Relation between serum uric acid levels with the degree of coronary artery disease: A prospective study from Ecuador / Relación entre los niveles séricos de ácido úrico y el grado de enfermedad arterial coronaria: un estudio prospectivo en Ecuador

To analyze the relationship between serum levels of uric acid and the severity of coronary disease. Methods: This observational, descriptive and cross-sectional study included 77 patients previously selected using inclusion criteria, from September 2014 to May 2015. It was conducted in a third level regional hospital from Guayaquil, Ecuador. Patients enrolled in this study were older than 30 years with coronary disease undergoing coronary angiography, without prior diagnosis of any other condition that could influence in serum uric acid values. Results: (1) Direct relation between serum uric acid levels and the severity of coronary disease, with a 0.600 Spearman correlation coefficient (p < 0.001); (2) other variables such as hypertension and medical history did not have an influence on the study's results; (3) serum uric acid levels didn't show difference among the different groups (p>0.05). Conclusions: Based on the results, it was possible to conclude that there is a relation between serum uric acid level and the severity of coronary artery disease; this relation was independent of clinical diagnosis and hypertension. According to this, serum uric acid levels can be taken as a practical and inexpensive parameter related to the severity of coronary artery disease. As a primary preventive intervention, we recommend maintaining levels within normal parameters in patients with cardiovascular risk

Objetivo: Analizar la relación entre los niveles séricos de ácido úrico y la severidad de la enfermedad coronaria. Métodos: Este estudio observacional, descriptivo y transversal incluyó 77 pacientes previamente seleccionados mediante criterios de inclusión, desde septiembre de 2014 a mayo de 2015. Se realizó en un hospital regional de tercer nivel de Guayaquil, Ecuador. Los pacientes incluidos en este estudio eran mayores de treinta años, con enfermedad coronaria sometidos a angiografía coronaria, sin diagnóstico previo de ninguna otra condición que pudiera influir en los valores de ácido úrico sérico. Resultados: 1) Relación directa entre los niveles séricos de ácido úrico y la gravedad de la enfermedad coronaria, con un coeficiente de correlación de Spearman de 0.600 (p < 0.001); 2) Otras variables como la hipertensión y el historial médico no influyeron en los resultados del estudio; 3) Los niveles séricos de ácido úrico no mostraron variabilidad entre los diferentes grupos (p > 0.05). Conclusiones: de acuerdo con los resultados, fue posible concluir que existe una relación entre el nivel sérico de ácido úrico y la severidad de la enfermedad coronaria; esta relación fue independiente del diagnóstico clínico y la hipertensión. De acuerdo con esto, los niveles séricos de ácido úrico se pueden tomar como un parámetro práctico y económico relacionado con la gravedad de la enfermedad arterial coronaria. Como intervención preventiva primaria, recomendamos mantener los niveles dentro de los parámetros normales en pacientes con riesgo cardiovascular

Relation between serum uric acid levels with the degree of coronary artery disease: A prospective study from Ecuador.

To analyze the relationship between serum levels of uric acid and the severity of coronary disease. METHODS: This observational, descriptive and cross-sectional study included 77 patients previously selected using inclusion criteria, from September 2014 to May 2015. It was conducted in a third level regional hospital from Guayaquil, Ecuador. Patients enrolled in this study were older than 30 years with coronary disease undergoing coronary angiography, without prior diagnosis of any other condition that could influence in serum uric acid values. RESULTS: (1) Direct relation between serum uric acid levels and the severity of coronary disease, with a 0.600 Spearman correlation coefficient (p<0.001); (2) other variables such as hypertension and medical history did not have an influence on the study's results; (3) serum uric acid levels didn't show difference among the different groups (p˃0.05). CONCLUSIONS: Based on the results, it was possible to conclude that there is a relation between serum uric acid level and the severity of coronary artery disease; this relation was independent of clinical diagnosis and hypertension. According to this, serum uric acid levels can be taken as a practical and inexpensive parameter related to the severity of coronary artery disease. As a primary preventive intervention, we recommend maintaining levels within normal parameters in patients with cardiovascular risk.