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Closure of mucosal defects following colorectal endoscopic submucosal dissection (C-ESD) is often performed to prevent post-C-ESD adverse events. However, large mucosal defect closure using conventional clips remains technically challenging. Here, we evaluated the feasibility of the novel endoclip with anchor prongs, called the MANTIS Clip (Boston Scientific, Tokyo, Japan), for mucosal defect closure after C-ESD. This high-volume retrospective study was conducted at a single center. From March until December 2023, consecutive patients who underwent post-C-ESD mucosal defect closure using MANTIS Clip to achieve complete closure were enrolled. Patient clinical characteristics and outcomes were evaluated. Closure of the mucosal defect using the MANTIS Clip was attempted following C-ESD in 32 lesions. The median sizes of the resection specimens and the tumors were 32 mm (range, 17-100 mm) and 23.5 mm (range, 5-96 mm), respectively. The lesions were distributed between the cecum, ascending, transverse, descending, sigmoid, and rectum. Complete closure was achieved in 96.9% of cases (31/32). All lesions up to 61 mm in defect size were completely closed. The median closure time was 7.9 (range, 3.3-18.0) min. The median numbers of MANTIS Clip and additional conventional clips were 3 (range, 1-4) and 5 (range, 1-11), respectively. No adverse events associated with closure, post-ESD bleeding, and delayed perforation occurred. MANTIS Clip closure for large post-C-ESD mucosal defects was found to be feasible and reliable with a high complete closure rate and a short procedure time.
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BACKGROUND AND AIMS: Artificial intelligence (AI) tools aimed at improving polyp detection have been shown to increase the adenoma detection rate during colonoscopy. However, it is unknown how increased polyp detection rates by AI affect the burden of patient surveillance after polyp removal. METHODS: We conducted a pooled analysis of 9 randomized controlled trials (5 in China, 2 in Italy, 1 in Japan, and 1 in the United States) comparing colonoscopy with or without AI detection aids. The primary outcome was the proportion of patients recommended to undergo intensive surveillance (ie, 3-year interval). We analyzed intervals for AI and non-AI colonoscopies for the U.S. and European recommendations separately. We estimated proportions by calculating relative risks using the Mantel-Haenszel method. RESULTS: A total of 5796 patients (51% male, mean 53 years of age) were included; 2894 underwent AI-assisted colonoscopy and 2902 non-AI colonoscopy. When following U.S. guidelines, the proportion of patients recommended intensive surveillance increased from 8.4% (95% CI, 7.4%-9.5%) in the non-AI group to 11.3% (95% CI, 10.2%-12.6%) in the AI group (absolute difference, 2.9% [95% CI, 1.4%-4.4%]; risk ratio, 1.35 [95% CI, 1.16-1.57]). When following European guidelines, it increased from 6.1% (95% CI, 5.3%-7.0%) to 7.4% (95% CI, 6.5%-8.4%) (absolute difference, 1.3% [95% CI, 0.01%-2.6%]; risk ratio, 1.22 [95% CI, 1.01-1.47]). CONCLUSIONS: The use of AI during colonoscopy increased the proportion of patients requiring intensive colonoscopy surveillance by approximately 35% in the United States and 20% in Europe (absolute increases of 2.9% and 1.3%, respectively). While this may contribute to improved cancer prevention, it significantly adds patient burden and healthcare costs.
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Adenoma , Pólipos del Colon , Neoplasias Colorrectales , Humanos , Masculino , Femenino , Pólipos del Colon/diagnóstico , Pólipos del Colon/cirugía , Pólipos del Colon/epidemiología , Inteligencia Artificial , Ensayos Clínicos Controlados Aleatorios como Asunto , Colonoscopía/métodos , Adenoma/diagnóstico , Adenoma/cirugía , Adenoma/epidemiología , Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/cirugía , Neoplasias Colorrectales/epidemiologíaRESUMEN
BACKGROUND AND AIMS: The need for mastering standard imaging techniques for convex EUS in the biliopancreatic regions has been increasing; however, large variations in the aptitude for achieving EUS competency hinder expert development. Therefore, we investigated the factors influencing the achievement of expert competency in EUS using a new assessment tool for multiple imaging items. METHODS: Between January 2018 and February 2022, 3277 consecutive EUS procedures conducted by 5 beginners (EUS procedures <250), 7 intermediate trainees (250-749), and 2 experts (≥750) were prospectively evaluated. Immediately after each EUS procedure, the success or failure of imaging for each item was recorded using a newly developed EUS assessment tool that requires 17 items to be photographed. After correcting for missing values using multiple imputation, learning curves of EUS scores were created, and a competency was set based on expert scores. Finally, a comparative analysis between high and low performers was performed to extract factors influencing EUS scores. RESULTS: Although 3 of 7 intermediates (43%; mean, 317 cases) achieved competency, none of the beginners achieved competency. During a comparative analysis, although no significant difference in the number of EUS procedures performed was observed between the high and low performers, the former had significantly higher scores in the written test (theoretical knowledge). CONCLUSIONS: Our results showed that theoretical knowledge, rather than the number of EUS cases, may be a possible influencing factor for distinguishing high and low performers after treating 250 cases. (Clinical trial registration number: UMIN 000043271.).
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Competencia Clínica , Curva de Aprendizaje , Humanos , Estudios Prospectivos , Endosonografía/métodosRESUMEN
BACKGROUND: Texture and color enhancement imaging (TXI) enhances the changes in endoscopic features caused by gastric neoplasms, such as redness/whiteness and elevation/depression. This study aimed to demonstrate the effectiveness of TXI in improving the visibility of gastric neoplasms compared with white light imaging (WLI) using conventional (CE) and newly developed endoscopes (NE). METHODS: We recruited patients who were histologically diagnosed with gastric neoplasms; endoscopy was performed, and gastric neoplasms photographed using three imaging modalities, including WLI, TXI mode 1 (TXI-1) and TXI mode 2 (TXI-2). Two different endoscopes (CE and NE) were used for the same patients. Six endoscopists provided the visibility scale scores ranging from 1 (poor) to 4 (excellent) for gastric neoplasms. The primary outcome was the visibility scale scores based on each modality and endoscope. The secondary outcome was the identification of factors including H. pylori infection, atrophy, location, size, morphology, histological diagnosis and intestinal metaplasia that affect the differences in visibility scale scores between TXI-1/TXI-2 and WLI. RESULTS: Fifty-two gastric neoplasms were analyzed. The mean visibility scale scores with the NE were 2.79 ± 1.07, 3.23 ± 0.96 and 3.14 ± 0.92 for WLI, TXI-1 and TXI-2, respectively. The mean visibility scales with the CE were 2.53 ± 1.10, 3.04 ± 1.05 and 2.96 ± 1.92 for WLI, TXI-1 and TXI-2, respectively. For both endoscopes, significant differences were observed in visibility scale scores between WLI and TXI-1 (p < 0.001) and between WLI and TXI-2 (p < 0.001). The visibility scale scores of NE were superior to those of CE in all modalities. In the secondary outcome, there was no factor affected the differences of visibility scale scores between TXI-1/TXI-2 and WLI. CONCLUSIONS: This study demonstrated that TXI-1 and TXI-2 enhanced the visibility scale scores of gastric neoplasms compared with that of WLI. Moreover, newly developed endoscope has the potential to improve visibility compared to conventional endoscope. TRIAL REGISTRATION: This study was registered with the University Hospital Medical Information Network (UMIN000042429, 16/11/2020).
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Endoscopía Gastrointestinal , Aumento de la Imagen , Neoplasias Gástricas , Humanos , Endoscopios , Endoscopía Gastrointestinal/métodos , Aumento de la Imagen/métodos , Luz , Neoplasias Gástricas/diagnóstico por imagen , Neoplasias Gástricas/patologíaRESUMEN
OBJECTIVES: We aimed to evaluate the efficacy of texture and color enhancement imaging (TXI), which allows the acquisition of brighter images with enhanced color and surface structure in colorectal polyp detection compared to white light imaging. METHODS: Patients who underwent colonoscopy with repeated ascending colon observation using TXI and white light imaging between August 2020 and January 2021 were identified in three institutions. The outcomes included the mean number of adenomas detected per procedure (MAP), adenoma detection rate (ADR), and ascending colonic adenoma miss rate (Ac-AMR). Logistic regression was used to determine the effects of the variables on the outcomes. RESULTS: We included 1043 lesions from 470 patients in the analysis. The MAP, ADR, flat polyp detection rate, and Ac-AMR in TXI and white light imaging were 1.5% (95% confidence interval 1.3-1.6%) vs. 1.0% (0.9-1.1%), 58.2% (51.7-64.6%) vs. 46.8% (40.2-53.4%), 66.2% (59.8-72.2%) vs. 49.8% (43.2-56.4%), and 17.9% (12.1-25.2%) vs. 28.2% (20.0-37.6%), respectively. TXI, age, withdrawal time, and endoscopy type were identified as significant factors affecting the MAP and the ADR using multivariate regression analysis. CONCLUSIONS: Our study indicates that TXI improve the detection of colorectal neoplastic lesions. However, prospective randomized trials are required to confirm these findings.
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Adenoma , Neoplasias del Colon , Pólipos del Colon , Neoplasias Colorrectales , Humanos , Estudios Prospectivos , Neoplasias Colorrectales/diagnóstico por imagen , Neoplasias Colorrectales/patología , Colonoscopía/métodos , Pólipos del Colon/diagnóstico por imagen , Pólipos del Colon/patología , Adenoma/diagnóstico por imagen , Adenoma/patología , ColorRESUMEN
OBJECTIVES: Early gastric cancer endoscopic resection (ER) is prominent in Japan. However, evidence regarding ER of gastric submucosal tumors (SMT) is limited. This prospective multicenter phase II study investigated the efficacy and safety of endoscopic full-thickness resection (EFTR) for gastric SMT. METHODS: Endoscopic full-thickness resection indication for gastric SMT was 11-30 mm, histologically proven or clinically suspicious (irregular margin, increasing size, or internal heterogeneity) gastrointestinal stromal tumors (GIST), with no ulceration and intraluminal growth type. The primary end-point was the complete ER (ER0) rate, with a sample size of 42. RESULTS: We enrolled 46 patients with 46 lesions between September 2020 and May 2023 at seven Japanese institutions. The mean ± SD (range) endoscopic tumor size was 18.8 ± 4.5 (11-28) mm. The tumor resection and defect closure times were 54 ± 26 (22-125) min and 33 ± 28 (12-186) min, respectively. A 100% ER0 was achieved in all 46 patients. The EFTR procedure was accomplished in all patients without surgical intervention. One patient had delayed perforation and was managed endoscopically. GIST accounted for 76% (n = 35) of the cases. R0, R1, and RX rates were 33 (77%), 3 (6.5%), and 7 (15%), respectively. CONCLUSION: Endoscopic full-thickness resection for gastric SMT of 11-30 mm is efficacious. It warrants further validation in a large-scale cohort study to determine the long-term outcome of this treatment for patients with gastric GIST.
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BACKGROUND: Endoscopic submucosal dissection (ESD) is technically difficult and requires considerable training. The authors have developed a multi-loop traction device (MLTD), a new traction device that offers easy attachment and detachment. We aimed to evaluate the utility of MLTD in ESD. METHODS: This ex vivo pilot study was a prospective, block-randomized, comparative study of a porcine stomach model. Twenty-four lesions were assigned to a group that undertook ESD using the MLTD (M-ESD group) and a group that undertook conventional ESD (C-ESD group) to compare the speed of submucosal dissection. In addition, the data of consecutive 10 patients with eleven gastric lesions was collected using electronic medical records to clarify the inaugural clinical outcomes of gastric ESD using MLTD. RESULTS: The median (interquartile range) speed of submucosal dissection in the M-ESD and C-ESD groups were 141.5 (60.9-177.6) mm2/min and 35.5 (20.8-52.3) mm2/min, respectively; submucosal dissection was significantly faster in the M-ESD group (p < 0.05). The rate of en bloc resection and R0 resection was 100% in both groups, and there were no perforation in either group. The MLTD attachment time was 2.5 ± 0.9 min and the MLTD extraction time was 1.0 ± 1.1 min. Clinical outcomes of MLTD in gastric ESD were almost the same as those of ex vivo pilot study. CONCLUSIONS: MLTD increased the speed of submucosal dissection in ESD and was similarly effective when used by expert and trainee endoscopists without perforation. MLTD can potentially ensure a safer and faster ESD.
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Resección Endoscópica de la Mucosa , Animales , Humanos , Resección Endoscópica de la Mucosa/efectos adversos , Proyectos Piloto , Estudios Prospectivos , Estómago , Porcinos , Tracción , Resultado del TratamientoRESUMEN
The sample storage environment affects gut microbial profiles as assessed using 16S rRNA sequencing. However, the influence of storage condition on human salivary microbial profiles has not been well characterized. Here, we performed an observational study to assess the robustness of microbiota profiles in three different storage environments (-80°C after flash-freezing, -80°C, and -15°C; all for 14 days) compared to immediate DNA extraction using the MiSeq Illumina platform. Notably, the 16S rRNA V1-V2 region amplicon sequencing revealed no difference in microbiota profiles between the immediate extraction and each of three storage conditions. An almost perfect correlation was shown between the immediate extraction and the -15°C storage group for relative abundance at the genus and operational taxonomic unit levels. The intraindividual UniFrac distances among storage methods were significantly shorter than those of interindividual distances. None of the amount of extracted DNA, the α-diversity indices, or the relative abundance at the phylum/genus/operational taxonomic unit level differed among storage methods. These findings indicate that a storage temperature of -15°C without flash-freezing may be optimal in terms of cost advantage and simplicity in 16S rRNA sequencing-based salivary microbial research.
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Microbioma Gastrointestinal , Microbiota , ADN Bacteriano , Heces , Congelación , Microbioma Gastrointestinal/genética , Humanos , ARN Ribosómico 16S/genética , TemperaturaRESUMEN
BACKGROUND AND AIMS: Delayed bleeding after gastric endoscopic submucosal dissection (ESD) in patients receiving anticoagulants remains an unpreventable adverse event. Although direct-acting oral anticoagulants (DOACs) have superior efficacy in preventing thromboembolism, their effects on the occurrence of delayed bleeding remain unclear. This study aimed to elucidate the clinical effect of DOACs on delayed bleeding after gastric ESD. PATIENTS AND METHODS: We retrospectively examined 728 patients who received anticoagulants and were treated for gastric neoplasms with ESD in 25 institutions across Japan. Overall, 261 patients received DOACs, including dabigatran (92), rivaroxaban (103), apixaban (45) and edoxaban (21), whereas 467 patients were treated with warfarin. RESULTS: Delayed bleeding occurred in 14% of patients taking DOACs, which was not considerably different in patients receiving warfarin (18%). Delayed bleeding rate was significantly lower in patients receiving dabigatran than in those receiving warfarin and lower than that observed for other DOACs. Multivariate analysis showed that age ≥ 65, receiving multiple antithrombotic agents, resection of multiple lesions and lesion size ≥ 30 mm were independent risk factors, and that discontinuation of anticoagulants was associated with a decreased risk of bleeding. In multivariate analysis among patients taking DOACs, dabigatran therapy was associated with a significantly lower risk of delayed bleeding. CONCLUSIONS: The effects of DOACs on delayed bleeding varied between agents, but dabigatran therapy was associated with the lowest risk of delayed bleeding. Switching oral anticoagulants to dabigatran during the perioperative period could be a reasonable option to reduce the risk of delayed bleeding after gastric ESD.
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Anticoagulantes/efectos adversos , Resección Endoscópica de la Mucosa/efectos adversos , Hemorragia Posoperatoria/inducido químicamente , Neoplasias Gástricas/cirugía , Estómago/cirugía , Anciano , Anciano de 80 o más Años , Dabigatrán/efectos adversos , Femenino , Humanos , Japón , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/prevención & control , Pirazoles/efectos adversos , Piridinas/efectos adversos , Piridonas/efectos adversos , Estudios Retrospectivos , Rivaroxabán/efectos adversos , Tiazoles/efectos adversos , Tromboembolia/prevención & control , Warfarina/efectos adversosRESUMEN
BACKGROUND AND AIMS: In gastrointestinal neuroendocrine tumors (GI-NETs), tumor size and grading based on cellular proliferative ability indicate biological malignancy but not necessarily clinically efficient prognostic stratification. We analyzed tumor size- and grading-based prevalence of lymphovascular invasion in GI-NETs to establish whether these are true biological malignancy indicators. METHODS: We included 155 cases (165 lesions), diagnosed histologically with GI-NETs, that had undergone endoscopic or surgical resection. Patient age, sex, method of treatment, tumor size, invasion depth, lymphovascular invasion positivity according to Ki-67 index-based neuroendocrine tumor grading, distant metastases, and outcome were evaluated. The primary endpoints were the prevalence of lymphovascular invasion according to tumor size and grading. RESULTS: Overall, 24.8% were positive for lymphovascular invasion. There was a high rate of lymphovascular invasion positivity even among grade 1 cases (22.8%). The rate of lymphovascular invasion was 3.4% for grade 1 cases <5 mm, with a lymphovascular invasion rate of 8.7% for those 5-10 mm. Lymphovascular invasion ≤10% required a tumor size ≤8 mm, and lymphovascular invasion ≤5% required a tumor size ≤6 mm. A cutoff of 6 mm was identified, which yielded a sensitivity of 79% and a specificity of 63%. Even small GI-NETs grade 1 of the whole GI tract also showed positive for lymphovascular invasion. CONCLUSIONS: GI-NETs ≤10 mm had a lymphovascular invasion prevalence exceeding 10%. The lymphovascular invasion impact in GI-NET development is incompletely understood, but careful follow-up, including consideration of additional surgical resection, is crucial in cases with lymphovascular invasion.
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Tumores Neuroendocrinos , Endoscopía Gastrointestinal , Tracto Gastrointestinal , Humanos , Clasificación del Tumor , Invasividad Neoplásica , Tumores Neuroendocrinos/cirugía , Estudios RetrospectivosRESUMEN
BACKGROUND: Post-ERCP pancreatitis (PEP) with trans-papillary approach remains a major issue, and the multi-factorial etiology can lead to the development of unpredictable PEP. Therefore, the early identification of PEP is highly desirable to assist with the health cost containment, the reduction in unnecessary admissions, earlier appropriate primary care, and intensive care for preventing progression of severe pancreatitis. This study aimed to establish a simplified predictive scoring system for PEP. METHODS: Between January 1, 2012, and December 31, 2019, 3362 consecutive trans-papillary ERCP procedures were retrospectively analyzed. Significant risk factors were extracted by univariate, multivariate, and propensity score analyses, and the probability of PEP in the combinations of each factor were quantified using propensity score analysis. The results were internally validated using bootstrapping resampling. RESULTS: In the scoring system with four stratifications using combinations of only five extracted risk factors, the very high-risk group showed 28.79% (95% confidence interval [CI], 18.30%-41.25%; P < 0.001) in the predicted incidence rate of PEP, and 9.09% (95% CI, 3.41%-18.74%; P < 0.001) in that of severe PEP; although the adjusted prevalence revealed 3.74% in PEP and 0.90% in severe PEP, respectively. The prediction model had an area under the curve of 0.86 (95% CI, 0.82-0.89) and the optimism-corrected model as an internal validation had an area under the curve of 0.81 (95% CI, 0.77-0.86). CONCLUSIONS: We established and validated a simplified predictive scoring system for PEP using five risk factors immediately after ERCP to assist with the early identification of PEP.
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Colangiopancreatografia Retrógrada Endoscópica , Pancreatitis , Colangiopancreatografia Retrógrada Endoscópica/efectos adversos , Humanos , Pancreatitis/etiología , Pancreatitis/prevención & control , Puntaje de Propensión , Estudios Retrospectivos , Factores de RiesgoRESUMEN
BACKGROUND: Blood group O of ABO blood group system is considered as a risk factor for various bleeding events, but the relationship with endoscopic treatment-associated bleeding has yet to be investigated. This study aimed to evaluate whether blood group O is associated with delayed bleeding after colorectal endoscopic resection. METHODS: This was a retrospective observational study based on medical records at four university hospitals in Japan. We reviewed the records for consecutive patients who underwent colorectal endoscopic resection from January 2014 through December 2017. The primary outcome was the incidence of delayed bleeding, defined as hematochezia or melena, requiring endoscopy, transfusion, or any hemostatic intervention up to 28 days after endoscopic resection. Multivariate logistic regression analysis was performed to adjust the impact of blood group O on the delayed bleeding. RESULTS: Among 10,253 consecutive patients who underwent colorectal endoscopic resection during the study period, 8625 patients met the criteria. In total, delayed bleeding occurred in 255 patients (2.96%). The O group had significantly more bleeding events compared with the non-O group (A, B, and AB) (relative risk, 1.62 [95% confidence interval, 1.24-2.10]; P < 0.001). In multivariate logistic regression analysis, blood group O remained an independent risk factor for the bleeding (adjusted odds ratio, 1.60 [95% confidence interval, 1.18-2.17]; P = 0.002). CONCLUSIONS: Blood group O was associated with an increased risk of delayed bleeding in patients undergoing colorectal endoscopic resection. Preoperative screening for ABO blood group could improve risk assessments.
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Antígenos de Grupos Sanguíneos , Neoplasias Colorrectales , Hemorragia Gastrointestinal/epidemiología , Hemorragia Gastrointestinal/etiología , Humanos , Hemorragia Posoperatoria/epidemiología , Hemorragia Posoperatoria/etiología , Estudios Retrospectivos , Factores de RiesgoRESUMEN
BACKGROUND: Our group previously proved that the human enteric nervous system can be visualized with confocal laser endomicroscopy after topical application of cresyl violet using surgically resected intestine specimens. The present report documents the first in vivo visualization of the human enteric nervous system with confocal laser endomicroscopy using local cresyl violet staining. The aim of this study was to evaluate the technical feasibility and clinical efficiency of confocal laser endomicroscopy in patients with Hirschsprung's disease and allied disorders in vivo. METHODS: Confocal laser endomicroscopy was performed in vivo in two patients to confirm the presence of the enteric nervous system during surgery in patients with Hirschsprung's disease and allied disorders. Cresyl violet was gently injected from the serosal side into the muscular layer of the intestine, and scanning was performed within 30 min. Then, the scanned intestines were resected, and the visualized area of the specimens was pathologically evaluated. RESULTS: The ganglion cell nuclei and the enteric nervous system network were clearly visualized intraoperatively in both cases. The morphological findings were similar to the pathological findings of the enteric nervous system in both cases although the period of visibility was brief. CONCLUSION: This study demonstrated the first, real-time observation of the enteric nervous system in humans using confocal laser endomicroscopy and suggest the potential to identify the enteric nervous system intra-operatively during surgery for Hirschsprung's disease and allied disorders.
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Sistema Nervioso Entérico/diagnóstico por imagen , Enfermedad de Hirschsprung/diagnóstico por imagen , Microscopía Confocal/métodos , Administración Tópica , Benzoxazinas/administración & dosificación , Preescolar , Colon/inervación , Colorantes/administración & dosificación , Procedimientos Quirúrgicos del Sistema Digestivo , Estudios de Factibilidad , Femenino , Ganglios/diagnóstico por imagen , Enfermedad de Hirschsprung/cirugía , Humanos , Lactante , Cuidados Intraoperatorios , MasculinoRESUMEN
Artificial intelligence (AI) has been attracting considerable attention as an important scientific topic in the field of medicine. Deep-leaning (DL) technologies have been applied more dominantly than other traditional machine-learning methods. They have demonstrated excellent capability to retract visual features of objectives, even unnoticeable ones for humans, and analyze huge amounts of information within short periods. The amount of research applying DL-based models to real-time computer-aided diagnosis (CAD) systems has been increasing steadily in the GI endoscopy field. An array of published data has already demonstrated the advantages of DL-based CAD models in the detection and characterization of various neoplastic lesions, regardless of the level of the GI tract. Although the diagnostic performances and study designs vary widely, owing to a lack of academic standards to assess the capability of AI for GI endoscopic diagnosis fairly, the superiority of CAD models has been demonstrated for almost all applications studied so far. Most of the challenges associated with AI in the endoscopy field are general problems for AI models used in the real world outside of medical fields. Solutions have been explored seriously and some solutions have been tested in the endoscopy field. Given that AI has become the basic technology to make machines react to the environment, AI would be a major technological paradigm shift, for not only diagnosis but also treatment. In the near future, autonomous endoscopic diagnosis might no longer be just a dream, as we are witnessing with the advent of autonomously driven electric vehicles.
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Inteligencia Artificial , Endoscopía , Diagnóstico por Computador , Humanos , Aprendizaje AutomáticoRESUMEN
BACKGROUND AND STUDY AIMS: An automatic carbon dioxide (CO2) insufflating system (SPACE) was developed to stabilize intra-lumenal pressure (ILP) during endoscopic interventions. This study investigated whether SPACE could improve the control and monitoring of extra-lumenal intra-abdominal pressure (IAP) after establishing a perforation during endoscopic full-thickness resection (EFTR) of the gastric wall in porcine models. MATERIALS AND METHODS: After first establishing the optimal preset pressure for gastric EFTR in four pigs, we compared IAP dynamics during EFTR between manual insufflation and SPACE using a block-randomized study (n = 10). IAP was percutaneously monitored and plotted on a timeline graph every 5 s. The maximal IAP and the area under the IAP curve exceeding 10 mmHg (AUC≥10 mmHg) were compared between groups, with the agreement between IAP and endolumenally monitored ILP also analyzed for animals in the SPACE group. RESULTS: In the first study, 8 mmHg was identified as the most preferable preset pressure after establishment of the perforation. In the randomized study, the mean maximal IAP in the SPACE group was significantly lower than that in the manual insufflation group (11.0 ± 2.0 mmHg vs. 17.0 ± 3.5 mmHg; P = 0.03). The mean AUC≥10 mmHg was also significantly smaller in the SPACE group. Bland-Altman analysis demonstrated agreement between IAP and ILP within a range of ± 1.0 mmHg. CONCLUSIONS: SPACE could be used to control and safely monitor IAP during gastric EFTR by measuring ILP during perforation of the gastric wall.
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Endoscopía , Insuflación , Monitoreo Intraoperatorio , Animales , Femenino , Dióxido de Carbono , Endoscopía/métodos , Insuflación/métodos , Monitoreo Intraoperatorio/instrumentación , Monitoreo Intraoperatorio/métodos , Presión , PorcinosRESUMEN
BACKGROUND: Ultrasound-targeted microbubble destruction (UTMD) induces cellular inflow of drugs at low intensity, while high intensity eradicates tumor vessels. Since vascular endothelial growth factor receptor 2 (VEGFR2) is highly expressed in pancreatic ductal adenocarcinoma (PDAC), VEGFR2-targeted microbubble (MB) might additionally increase the tissue specificity of drugs and thus improve antitumor effects. In addition, fixing the dual pulse intensity could maximize MB properties. This study evaluated the one-off (experiment 1) and cumulative (experiment 2) treatment effect of UTMD by regulating the dual pulse output applied to PDAC using VEGFR2-targeted MB. METHODS: C57BL/6 mice inoculated with Pan-02 cells were allocated to five groups: VEGFR2-targeted MB+ gemcitabine (GEM), VEGFR2-targeted MB, non-targeted MB+GEM, GEM, and control groups. After injection of GEM or GEM and either VEGFR2-targeted or non-targeted MB, UTMD was applied for several minutes at low intensity followed by high intensity application. In experiment 1, mice were treated by the protocol described above and then euthanized immediately or at the tumor diameter doubling time (TDT). In experiment 2, the same protocol was repeated weekly and mice were euthanized at TDT regardless of protocol completion. Histological analysis by CD31 and VEGFR2 staining provided microvascular density (MVD) and VEGFR2 expression along vessels (VEGFR2v) or intra/peripheral cells (VEGFR2c). RESULTS: In experiment 1, TDT was significantly longer in the VEGFR2-targeted MB+GEM group compared to the non-targeted MB+GEM, GEM, and control groups, while the VEGFR2-targeted MB group showed no statistical significance. MVD and VEGFR2v in the immediate euthanasia was significantly lower in the VEGFR2-targeted MB+GEM and VEGFR2-targeted MB groups than other conditions. In experiment 2, the VEGFR2-targeted MB+GEM group produced significantly longer TDT than the GEM or control groups, whereas the VEGFR2-targeted MB group showed no significant difference. Histology revealed significantly reduced VEGFR2v and VEGFR2c in the VEGFR2-targeted and non-targeted MB+GEM groups, while only VEGFR2v was significantly less in the VEGFR2-targeted MB group. CONCLUSIONS: UTMD-mediated GEM therapy with the dual pulse application using VEGFR2-targeted MB substantially suppresses PDCA growth.
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Antimetabolitos Antineoplásicos/farmacología , Carcinoma Ductal Pancreático/terapia , Desoxicitidina/análogos & derivados , Endosonografía , Microburbujas , Neoplasias Pancreáticas/terapia , Terapia por Ultrasonido/instrumentación , Receptor 2 de Factores de Crecimiento Endotelial Vascular/metabolismo , Animales , Carcinoma Ductal Pancreático/diagnóstico por imagen , Carcinoma Ductal Pancreático/metabolismo , Carcinoma Ductal Pancreático/patología , Línea Celular Tumoral , Medios de Contraste , Desoxicitidina/farmacología , Femenino , Compuestos Férricos , Hierro , Ratones Endogámicos C57BL , Óxidos , Neoplasias Pancreáticas/diagnóstico por imagen , Neoplasias Pancreáticas/metabolismo , Neoplasias Pancreáticas/patología , Carga Tumoral/efectos de los fármacos , GemcitabinaRESUMEN
Although esophagogastroduodenoscopy (EGD) is the most commonly used procedure in the gastrointestinal (GI) tract, the method of esophageal, gastric and duodenal mucosa photodocumentation varies considerably worldwide. One probable explanation is that for generations, EGD has primarily been taught by GI faculty and instructors based on their perceptions and experience, which has resulted in EGD being a non-standardized procedure. Currently, the procedure is facing a challenging scenario as endoscopy societies are implementing procedure-associated quality indicators aiming for best practice among practitioners and evidence-based care for patients. Contrary to colonoscopy where cecum landmarks photodocumentation is considered proof of completeness, there are currently no reliable performance measures to gauge the completeness of an upper endoscopy nor guidance for complete photodocumentation. This World Endoscopy Organization (WEO) position statement aims to provide practical guidance to practitioners to carry out complete EGD photodocumentation. Hence, an international group of experts from the WEO Upper GI Cancer Committee formulated the following document using the body of evidence established through literature reviews, expert opinions, and other scientific sources. The group acknowledged that although the procedure should be feasible in any facility, what is needed to achieve a global shift on the concept of completeness is a common written statement of agreement on its potential impact and added value. This best practice statement offers endoscopists principles and practical guidance in order to carry out complete photodocumentation from the hypopharynx to the second duodenal portion.
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Documentación/métodos , Endoscopía del Sistema Digestivo/normas , Fotograbar/estadística & datos numéricos , Guías de Práctica Clínica como Asunto , Tracto Gastrointestinal Superior/diagnóstico por imagen , Femenino , Humanos , Masculino , Organización Mundial de la SaludRESUMEN
Objectives: An endoscopic technique that provides ≥90% negative predictive value (NPV) for differentiating neoplastic polyps is needed for the management of diminutive (≤5 mm) rectosigmoid polyps. This study aimed to assess whether a newly developed software can achieve ≥90% NPV for differentiating rectosigmoid diminutive polyps based on the green-to-red (G/R) ratio, obtained by dividing the green color tone intensity by the red color tone intensity on autofluorescence imaging (AFI). Methods: From December 2017 to May 2018, consecutive patients with known polyps who were scheduled for endoscopic treatment at our institution were prospectively recruited. All colorectal diminutive polyps were differentiated by computer-aided diagnosis using autofluorescence imaging (CAD-AFI) using a novel software-based automatic color intensity analysis; subsequent diagnosis was made by endoscopists based on trimodal imaging endoscopy (TME), which combines AFI, white-light imaging (WLI) and magnifying narrow-band imaging (M-NBI) findings. Thereafter, all polyps were removed endoscopically, and the histopathological diagnosis was evaluated. Results: Ninety-five patients with 258 diminutive rectosigmoid polyps and 171 diminutive non-rectosigmoid polyps were enrolled. Regarding diminutive rectosigmoid polyps, the NPV for differentiating neoplastic polyps was 93.4% (184/197) [95% confidence interval (CI), 89.0%-96.4%] with CAD-AFI and 94.9% (185/195) (95% CI, 90.8%-97.5%) with TME. The accuracy, sensitivity, specificity, and positive predictive value for differentiating diminutive rectosigmoid neoplastic polyps by CAD-AFI were 91.5%, 80.0%, 95.3% and 85.2%, respectively. Conclusions: Real-time CAD-AFI was effective for differentiating diminutive rectosigmoid polyps. This objective technology, which does not require extensive training or endoscopic expertise, can contribute to the effective management of diminutive rectosigmoid polyps.
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Pólipos del Colon/diagnóstico por imagen , Colonoscopía/métodos , Neoplasias Colorrectales/diagnóstico por imagen , Diagnóstico por Computador , Imagen de Banda Estrecha/métodos , Anciano , Pólipos del Colon/patología , Pólipos del Colon/cirugía , Color , Neoplasias Colorrectales/patología , Neoplasias Colorrectales/cirugía , Diagnóstico Diferencial , Detección Precoz del Cáncer , Femenino , Fluorescencia , Humanos , Aumento de la Imagen/métodos , Japón , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Curva ROC , Sensibilidad y Especificidad , Programas InformáticosRESUMEN
BACKGROUND: Objective assessment of endoscopist competency is important. Recently, the endoscopic part-task training box (Thompson Endoscopic Skills Trainer [TEST]) was developed to assess endoscopist competency. We aimed to evaluate the ability of the TEST to assess competency during endoscopic procedures, especially endoscopic submucosal dissection (ESD). METHODS: Twenty-three physicians were included in this study. Correlations between TEST scores and the following factors were evaluated: years of endoscopic experience, number of esophagogastroduodenoscopies (EGDs) performed, number of colonoscopies (CSs) performed, cecal intubation rate, number of gastric ESDs performed, gastric ESD procedure time/lesion size (min/mm2), and gastric ESD self-completion rate. Also, correlation coefficients between the number of gastric ESDs performed and each of gastric ESD procedure time/lesion size and gastric ESD self-completion rate were calculated. RESULTS: TEST scores showed strong correlations to different factors: years of experience in endoscopy: 0.957 (p < 0.01); number of EGDs: 0.947 (p < 0.01); number of CSs: 0.947, (p < 0.01); number of gastric ESDs: 0.924 (p < 0.01); gastric ESD procedure time/lesion size: - 0.9 (p < 0.01); self-completion rate of gastric ESDs: 0.857 (p < 0.005). The number of gastric ESDs performed was not more strongly correlated to procedure time of gastric ESDs or self-completion rate of gastric ESDs compared to TEST scores (- 0.824 (p < 0.01) and 0.704 (p < 0.05), respectively). TEST scores of endoscopists with a cecal intubation rate ≥ 90% were > 380, while the scores of physicians with a gastric ESD self-completion rate ≥ 90% were > 700. CONCLUSIONS: TEST score correlates with both basic and advanced endoscopic procedures. TEST is therefore a promising option for assessing endoscopist competency, and might be useful for providing threshold scores as competency markers for specific endoscopic procedures such as gastric ESD.
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Competencia Clínica , Evaluación Educacional/métodos , Resección Endoscópica de la Mucosa/educación , Resección Endoscópica de la Mucosa/métodos , Mucosa Gástrica/cirugía , Humanos , EnseñanzaRESUMEN
OBJECTIVE: Endoscopic submucosal dissection (ESD) allows for en bloc resection of superficial gastrointestinal neoplasms; however, US experience has been limited. We aimed to evaluate our clinical outcomes in colorectal ESD. DESIGN: This prospective study included consecutive patients undergoing colorectal ESD at a major US center. Demographics, lesion and technical characteristics, outcomes, adverse events, and pathological diagnoses were recorded. Factors affecting resection outcomes and procedure time were evaluated. RESULTS: 77 patients who underwent colorectal ESD were analyzed. Mean colorectal lesion diameter was 49.4 mm. Mean procedure time was 104.7 min, and 97.4% of patients were discharged home on the same day. En bloc, complete, and curative resection was achieved in 97.4%, 97.4%, and 93.5% of colorectal ESD cases. Microperforation and delayed bleeding rates were 1.3% and 3.9%. On univariable analysis, the presence of tattoo adversely affected en bloc resection (p = 0.002), complete resection (p = 0.002), and curative resection (p = 0.008). Prior EMR attempts adversely affected en bloc resection (p = 0.028), complete resection (p = 0.028), and procedure time (p = 0.008). On multivariable analysis, the presence of tattoo predicted failure to achieve curative resection (OR 0.13; 95% CI 0.02-0.98; p = 0.048). Lesion size > 50 mm (OR 3.89; 95% CI 1.13-13.41; p = 0.031), presence of tattoo (OR 9.38; 95% CI 1.05-83.83; p = 0.045), and prior EMR attempts (OR 7.13; 95% CI 1.76-28.90; p = 0.006) predicted procedure time ≥ 90 min. A scoring system was created to predict prolonged ESD procedure time and was externally validated, with AUC 0.78 (95% CI 0.73-0.83). CONCLUSION: This study demonstrates the effects of multiple risk factors on resection outcomes and procedure time in colorectal ESD. Tattoo placement and attempted EMR should be avoided for lesions being considered for ESD.