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This editorial elaborates on the current and future applications of linear endoscopic ultrasound (EUS), a substantial diagnostic and therapeutic modality for various anatomical regions. The scope of endosonographic assessment is broad and, among other factors, allows for the evaluation of the mediastinal anatomy and related pathologies, such as mediastinal lymphadenopathy and the staging of central malignant lung lesions. Moreover, EUS assessment has proven more accurate in detecting small lesions missed by standard imaging examinations, such as computed tomography or magnetic resonance imaging. We focus on its current uses in the mediastinum, including lung and esophageal cancer staging, as well as evaluating mediastinal lymphadenopathy and submucosal lesions. The editorial also explores future perspectives of EUS in mediastinal examination, including ultrasound-guided therapies, artificial intelligence integration, advancements in mediastinal modalities, and improved diagnostic approaches for various mediastinal lesions.
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Endossonografia , Mediastino , Humanos , Endossonografia/métodos , Endossonografia/tendências , Mediastino/diagnóstico por imagem , Estadiamento de Neoplasias , Neoplasias do Mediastino/diagnóstico por imagem , Neoplasias do Mediastino/patologia , Neoplasias Pulmonares/diagnóstico por imagem , Neoplasias Pulmonares/patologia , Doenças do Mediastino/diagnóstico por imagem , Neoplasias Esofágicas/diagnóstico por imagem , Neoplasias Esofágicas/patologia , Linfadenopatia/diagnóstico por imagem , Linfadenopatia/patologia , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico/métodos , Tomografia Computadorizada por Raios X/métodos , Tomografia Computadorizada por Raios X/tendênciasRESUMO
BACKGROUND: The diagnosis of peripheral isolated nodular lesions that are suspected as pulmonary tuberculosis (PTB) is challenging, which are not easily accessible via conventional bronchoscopy. This study evaluated the combined use of Xpert MTB/RIF assay and endobronchial ultrasonography with a guide sheath (EBUS-GS) for detecting MTB infection in peripheral lung bands, for early detection of PTB. METHODS: The clinical data of 232 patients with suspected peripheral nodular PTB who underwent EBUS-GS between June 2020 and October 2023 were retrospectively reviewed. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) of acid-fast bacilli smear, culture, Xpert MTB/RIF assay, and pathological examination were calculated. To assess diagnostic accuracy, the results of the four methods were directly compared with the final clinical diagnosis. RESULTS: In total, 146 and 86 patients were clinically diagnosed with peripheral nodular PTB and non-PTB, respectively. The sensitivity, specificity, PPV, NPV, and AUC values of combined Xpert MTB/RIF assay and EBUS-GS were 47.26%, 100.0%, 100.0%, 52.76%, and 0.74; those of acid-fast bacilli smear were 8.22%, 97.67%, 85.71%, 38.53%, and 0.53; those of culture were 31.51%, 100.0%, 100.0%, 46.24%, and 0.66; and those of pathological examination were 23.97%, 97.67%, 94.59%, 43.08%, and 0.61, respectively. CONCLUSION: The diagnostic accuracy of the combined Xpert MTB/RIF assay and EBUS-GS was significantly better than that of other conventional tests. Hence, this novel technique can be routinely applied for diagnosing and managing peripheral nodular PTB.
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Mycobacterium tuberculosis , Sensibilidade e Especificidade , Tuberculose Pulmonar , Humanos , Tuberculose Pulmonar/diagnóstico , Tuberculose Pulmonar/microbiologia , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Retrospectivos , Mycobacterium tuberculosis/isolamento & purificação , Mycobacterium tuberculosis/genética , Adulto , Idoso , Broncoscopia/métodos , Endossonografia/métodos , Técnicas de Diagnóstico Molecular/métodos , Valor Preditivo dos Testes , Pulmão/microbiologia , Pulmão/diagnóstico por imagem , Pulmão/patologiaRESUMO
BACKGROUND: Most malignant peripheral pulmonary lesions (PPLs) are situated in the peripheral region of the lung. Although the ultrathin bronchoscope (UTB) can access these areas, a robust navigation system is essential for precise localisation of these small peripheral PPLs. Since many UTB procedures rely on automated virtual bronchoscopic navigation (VBN), this study aims to determine the accuracy and diagnostic yield of the manual bronchial branch tracing (BBT) navigation in UTB-guided radial endobronchial ultrasound (rEBUS) procedures. METHODS: Single-centre retrospective study of UTB-rEBUS patients with PPLs smaller than 3 cm over a two year period. RESULTS: Our cohort consisted of 47 patients with a mean age of 61.6 (SD 9.53) years and a mean target size of 1.91 (SD 0.53) cm. Among these lesions, 46.8% were located in the 6th airway generation, and 78.7% exhibited a direct bronchus sign. Navigation success using BBT was 91.5% based on positive rEBUS identification. The index diagnostic yield was 82.9%, increasing to 91.5% at 12 months of follow-up. Malignant lesions accounted for 65.1% of cases, while 34.9% were non-malignant. The presence of a direct bronchus sign was the sole factor associated with higher navigation success and diagnostic yield. Cryobiopsy outperformed forceps biopsy in non-concentric rEBUS lesions (90.9% vs. 50.0%, p < 0.05), but not in concentric orientated lesions. One pneumothorax occurred in our cohort. CONCLUSIONS: BBT as an exclusive navigation method for small PPLs in UTB-rEBUS procedures has proved to be safe and feasible. Combination of UTB with cryobiopsy remains efficient for eccentric and adjacently oriented rEBUS lesions.
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Broncoscopia , Endossonografia , Neoplasias Pulmonares , Humanos , Pessoa de Meia-Idade , Broncoscopia/métodos , Masculino , Feminino , Estudos Retrospectivos , Idoso , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/diagnóstico por imagem , Endossonografia/métodos , Nódulo Pulmonar Solitário/patologia , Nódulo Pulmonar Solitário/diagnóstico por imagem , Brônquios/patologia , Brônquios/diagnóstico por imagemRESUMO
Acute cholecystitis, cholelithiasis, and gallbladder polyps represent the most gallbladder benign diseases. Endoscopic approaches for the management of these diseases were an alternative to standard laparoscopic cholecystectomy. These endoscopic approaches include transpapillary approaches via endoscopic retrograde cholangiopancreatography, transmural access approaches via endoscopic ultrasound, and endoscopic surgical approaches using natural orifice transluminal endoscopic surgery approaches. However, it's still uncertain which approach is associated with the superior clinical outcomes due to the lack of high-level evidence. Our review provides new insight into the endoscopic approaches for the management of gallbladder benign diseases, with the latest evidence included.
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Colangiopancreatografia Retrógrada Endoscópica , Colelitíase , Doenças da Vesícula Biliar , Pólipos , Humanos , Doenças da Vesícula Biliar/cirurgia , Colangiopancreatografia Retrógrada Endoscópica/métodos , Pólipos/cirurgia , Colelitíase/cirurgia , Endossonografia/métodos , Cirurgia Endoscópica por Orifício Natural/métodos , Colecistite Aguda/cirurgia , Colecistectomia Laparoscópica/métodosRESUMO
BACKGROUND: Biliary dilatation without obvious etiology on cross sectional imaging warrants further investigation. This study aimed to assess yield of endoscopic ultrasound in providing etiologic diagnosis in such situation. METHODS: Prospective cohort of consecutive patients with biliary dilatation & non diagnostic computed tomography (CT) and /or magnetic resonance imaging (MRI) underwent endoscopic ultrasound (EUS) with/without fine needle aspiration cytology (FNAC) and were followed clinically, biochemically with/without radiology for up to six months. The findings of EUS were corroborated with histopathology of surgical specimens and endoscopic retrograde cholangiography (ERCP) findings in relevant cases. RESULTS: Median age of 121 patients completing follow up was 55 years. 98.2% patients were symptomatic and median common bile duct (CBD) diameter was 13 mm. EUS was able to identify lesions attributable for biliary dilatation in (67 out of 121) 55.4% cases with ampullary neoplasm being the commonest (29 out of 67 i.e. 43%). Multivariate logistic regression analysis identified jaundice as the predictor of positive diagnosis on EUS, of finding ampullary lesion and pancreatic lesion on EUS. EUS had sensitivity, specificity, positive predictive value and diagnostic accuracy of 95.65%, 94.23%, 95.65% and 95.04% respectively in providing etiologic diagnosis. Threshold value for baseline bilirubin of 10 mg%, for baseline CA 19.9 of 225 u/L and for largest CBD diameter of 16 mm were determined to have specificity of 98%, 95%, 92.5% respectively of finding a positive diagnosis on EUS. CONCLUSION: EUS provides considerable diagnostic yield with high accuracy in biliary dilatation when cross sectional imaging fails to provide etiologic diagnosis.
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Ducto Colédoco , Endossonografia , Humanos , Pessoa de Meia-Idade , Masculino , Feminino , Endossonografia/métodos , Estudos Prospectivos , Ducto Colédoco/diagnóstico por imagem , Ducto Colédoco/patologia , Idoso , Dilatação Patológica/diagnóstico por imagem , Adulto , Sensibilidade e Especificidade , Imageamento por Ressonância Magnética , Tomografia Computadorizada por Raios X , Idoso de 80 Anos ou mais , Colangiopancreatografia Retrógrada Endoscópica , Doenças do Ducto Colédoco/diagnóstico por imagem , Doenças do Ducto Colédoco/patologiaAssuntos
Remoção de Dispositivo , Stents , Humanos , Remoção de Dispositivo/métodos , Endossonografia/métodos , Masculino , Feminino , Plásticos , EndoscópiosRESUMO
Previous studies have shown that rapid on-site evaluation (ROSE) improves the diagnostic yield of bronchoscopy using endobronchial ultrasound with a guide sheath (EBUS-GS) for peripheral pulmonary lesions (PPL). While ROSE of imprint cytology from forceps biopsy has been widely discussed, there are few reports on ROSE of brush cytology. This study investigated the utility of ROSE of brush cytology during bronchoscopy. We retrospectively analyzed data from 214 patients who underwent bronchoscopy with EBUS-GS for PPL. The patients in the ROSE group had significantly higher diagnostic sensitivity through the entire bronchoscopy process than in the non-ROSE group (96.8% vs. 83.3%, P = 0.002). The use of ROSE significantly increased the sensitivity of brush cytology with Papanicolaou staining (92.9% vs. 75.0%, P < 0.001). When ROSE was sequentially repeated on brushing specimens, initially negative ROSE results converted to positive in 79.5% of cases, and the proportion of specimens with high tumor cell counts increased from 42.1 to 69.0%. This study concludes that ROSE of brush cytology improves the diagnostic accuracy of bronchoscopy and enhances specimen quality through repeated brushing.
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Broncoscopia , Neoplasias Pulmonares , Humanos , Broncoscopia/métodos , Masculino , Feminino , Idoso , Pessoa de Meia-Idade , Estudos Retrospectivos , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/diagnóstico por imagem , Avaliação Rápida no Local , Endossonografia/métodos , Citodiagnóstico/métodos , Idoso de 80 Anos ou mais , Adulto , Sensibilidade e Especificidade , CitologiaAssuntos
Anastomose Cirúrgica , Endossonografia , Humanos , Masculino , Anastomose Cirúrgica/efeitos adversos , Anastomose Cirúrgica/métodos , Constrição Patológica/cirurgia , Constrição Patológica/etiologia , Endossonografia/métodos , Estenose Esofágica/cirurgia , Estenose Esofágica/etiologia , Esôfago/cirurgia , Esôfago/diagnóstico por imagem , Jejunostomia/métodos , Jejuno/cirurgia , Ultrassonografia de IntervençãoRESUMO
BACKGROUND: A 3.0-mm ultrathin bronchoscope (UTB) with a 1.7-mm working channel provides better accessibility to peripheral bronchi. A 4.0-mm thin bronchoscope with a larger 2.0-mm working channel facilitates the use of a guide sheath (GS), ensuring repeated sampling from the same location. The 1.1-mm ultrathin cryoprobe has a smaller diameter, overcoming the limitation of the size of biopsy instruments used with UTB. In this study, we compared the endobronchial ultrasound localization rate and diagnostic yield of peripheral lung lesions by cryobiopsy using UTB and thin bronchoscopy combined with GS. METHODS: We retrospectively evaluated 133 patients with peripheral pulmonary lesions with a diameter less than 30 mm who underwent bronchoscopy with either thin bronchoscope or UTB from May 2019 to May 2023. A 3.0-mm UTB combined with rEBUS was used in the UTB group, whereas a 4.0-mm thin bronchoscope combined with rEBUS and GS was used for the thin bronchoscope group. A 1.1-mm ultrathin cryoprobe was used for cryobiopsy in the two groups. RESULTS: Among the 133 patients, peripheral pulmonary nodules in 85 subjects were visualized using r-EBUS. The ultrasound localization rate was significantly higher in the UTB group than in the thin bronchoscope group (96.0% vs. 44.6%, respectively; P < 0.001). The diagnostic yield of cryobiopsy specimens from the UTB group was significantly higher compared to the thin bronchoscope group (54.0% vs. 30.1%, respectively; p = 0.006). Univariate analysis demonstrated that the cryobiopsy diagnostic yields of the UTB group were significantly higher for lesions ≤ 20 mm, benign lesions, upper lobe lesions, lesions located lateral one-third from the hilum, and lesions without bronchus sign. CONCLUSIONS: Ultrathin bronchoscopy combined with cryobiopsy has a superior ultrasound localization rate and diagnostic yield compared to a combination of cryobiopsy and thin bronchoscopy.
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Broncoscópios , Broncoscopia , Endossonografia , Neoplasias Pulmonares , Humanos , Masculino , Feminino , Estudos Retrospectivos , Pessoa de Meia-Idade , Idoso , Broncoscopia/métodos , Broncoscopia/instrumentação , Endossonografia/métodos , Endossonografia/instrumentação , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/diagnóstico por imagem , Neoplasias Pulmonares/diagnóstico , Criocirurgia/métodos , Criocirurgia/instrumentação , Nódulos Pulmonares Múltiplos/patologia , Nódulos Pulmonares Múltiplos/diagnóstico por imagem , Pulmão/patologia , Pulmão/diagnóstico por imagem , Biópsia/métodos , Biópsia/instrumentação , AdultoRESUMO
The field of digestive endoscopy evolves continuously, offering -patients significant advances both in the diagnostic and therapeutic fields. The introduction of lumen--apposing metal stents has enabled innovation in several endoscopic techniques, including endoscopic ultrasound--guided gallbladder drainage, choledochoduodeno-stomy, gastroenteroanastomosis, and transgastric endoscopic retrograde cholangiopancreatography (EDGE). Compared to traditional treatment methods, these procedures have shown excellent success rates, coupled with a reduced risk of postoperative morbidity and lower costs.
L'endoscopie digestive connaît une évolution continue, offrant ainsi aux patients des avancées significatives, tant d'un point de vue diagnostique que thérapeutique. L'apparition des stents métalliques d'apposition luminale a permis le développement de plusieurs techniques endoscopiques innovantes telles que le drainage de la vésicule biliaire, la cholédocoduodénostomie, la gastro-entéro-anastomose et la cholangiopancréatographie rétrograde endoscopique transgastrique guidée par échoendoscopie (EDGE). Comparées aux méthodes de traitements traditionnelles, ces procédures ont montré d'excellents taux de réussite, un risque réduit de morbidité postopératoire et des coûts moindres.
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Endossonografia , Humanos , Endossonografia/métodos , Endossonografia/instrumentação , Drenagem/métodos , Drenagem/instrumentação , Stents , Ultrassonografia de Intervenção/métodos , Colangiopancreatografia Retrógrada Endoscópica/métodosRESUMO
BACKGROUND: The diagnostic yield of peripheral pulmonary lesions (PPLs) through endobronchial ultrasonography with a guide sheath transbronchial biopsy (EBUS-GS TBB) under virtual bronchoscopic navigation is unsatisfactory because radial EBUS probe is not always located within the lesion. Transbronchial needle aspiration with a guide sheath (GS-TBNA) has the potential to overcome the lower diagnostic yield by improving the relationship between the probe and the lesion and enabling repeated sampling while maintaining the location of a GS near the lesion. However, there are few data regarding the diagnostic yield and safety for diagnosing PPLs in this procedure. METHODS: We retrospectively analyzed consecutive 363 lesions (83 lesions underwent GS-TBNA/EBUS-GS TBB and 280 lesions underwent EBUS-GS TBB) at our institution between April 1, 2019 and March 31, 2022. We investigated the diagnostic efficacy and complications of GS-TBNA/EBUS-GS TBB and compared them with those of EBUS-GS TBB. RESULTS: The lesion size, distance from the hilum, presence of bronchus leading to the lesion, and EBUS images during the examination differed significantly between the two procedures. Logistic regression analysis adjusted for these 4 covariates revealed that GS-TBNA/EBUS-GS TBB was a significant factor affecting the diagnostic success of PPLs compared with EBUS-GS TBB (odds ratio=2.43, 95% CI=1.16-5.07, P=0.018). Neither procedure differed significantly in terms of complications (6.0% vs. 5.7%, P>0.999). CONCLUSION: GS-TBNA performed in addition to EBUS-GS TBB might be a promising sampling method for improving the diagnostic yield for PPLs without increasing the incidence of complications.
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Broncoscopia , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico , Endossonografia , Neoplasias Pulmonares , Humanos , Masculino , Broncoscopia/métodos , Estudos Retrospectivos , Feminino , Idoso , Pessoa de Meia-Idade , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/diagnóstico por imagem , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico/métodos , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico/efeitos adversos , Endossonografia/métodos , Biópsia Guiada por Imagem/métodos , Biópsia Guiada por Imagem/efeitos adversos , Pulmão/patologia , Pulmão/diagnóstico por imagem , Idoso de 80 Anos ou maisRESUMO
BACKGROUND: Endoscopic ultrasound (EUS) is the most sensitive method for diagnosing chronic pancreatitis (CP) in its early stages, and Rosemont Classification (RC) is used for its evaluation. Data on the correlation between EUS features and pancreatic exocrine insufficiency (PEI) are limited. We investigated the correlation between the EUS findings and PEI. METHODS: This was a retrospective, monocentric cohort study involving patients prospectively enrolled from 2018 to 2022, with definite or probable CP according to the M-ANNHEIM criteria. All the patients underwent EUS and exocrine function investigations within 12 months of diagnosis. PEI was diagnosed using fecal elastase (FE) or when overt steatorrhea was reversed by pancreatic enzyme replacement therapy. Logistic regression analyses, rank correlation, ROC curve, and area under the curve (AUROC) were performed to evaluate the association between EUS features and PEI, and the accuracy of RC in predicting PEI. RESULTS: Among 128 patients examined (63.3 % male; mean age, 47 years), 69.5 % were diagnosed with PEI. In multivariate logistic regression among all the RC criteria, only lithiasis in the main pancreatic duct (MPD) was associated with increased risk of PEI (OR 2.92, 95 % CI 1.29-6.61; p = 0.01). Rank analysis showed a weak inverse correlation between RC and FE (Spearman's rho = -0.02; p = 0.03). The accuracy of RC was moderate (AUROC 0.62, p = 0.014). CONCLUSIONS: Among RC EUS features, lithiasis in the MPD is helpful for predicting the risk of PEI, while other findings are of limited utility in evaluating exocrine function.
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Endossonografia , Insuficiência Pancreática Exócrina , Pancreatite Crônica , Humanos , Pancreatite Crônica/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Feminino , Adulto , Insuficiência Pancreática Exócrina/diagnóstico por imagem , Estudos Retrospectivos , Idoso , Pâncreas Exócrino/diagnóstico por imagem , Pâncreas Exócrino/fisiopatologia , Testes de Função Pancreática , Estudos de Coortes , Elastase PancreáticaRESUMO
BACKGROUND: This is a retrospective cohort study from a single center of Chest Medical District of Nanjing Brain Hospital Affiliated to Nanjing Medical University, Jiangsu Province, China. It was aim to evaluate the diagnostic value of radial endobronchial ultrasound (R-EBUS) combination with rapid on-site evaluation (ROSE) guided transbronchial lung biopsy (TBLB) for peripheral pulmonary lesions in patients with emphysema. METHODS: All 170 patients who underwent PPLs with emphysema received an R-EBUS examination with or without the ROSE procedure, and the diagnostic yield, safety, and possible factors influencing diagnosis were analyzed between the two groups by the SPSS 25.0 software. RESULTS: The pooled and benign diagnostic yields were not different in the two groups (P = 0.224, 0.924), but the diagnostic yield of malignant PPLs was significantly higher in the group with ROSE than the group without ROSE (P = 0.042). The sensitivity of ROSE was 79.10%, the specificity, 91.67%, the positive predictive value, 98.15%, and the negative predictive value, 84.62%. The diagnostic accuracy, was 95.52%. In the group of R-EBUS + ROSE, the procedural time and the number of times of biopsy or brushing were both significantly reduced (all P<0.05). The incidence of pneumothorax (1.20%) and bleeding (10.84%) in the group of R-EBUS + ROSE were also less than those in the group of R-EBUS (P<0.05). The lesion's diameter ≥ 2 cm, the distance between the pleura and the lesion ≥ 2 cm, the positive air bronchograms sign, the location of the ultrasound probe within the lesion, and the even echo with clear margin feature of lesion ultrasonic image, these factors are possibly relevant to a higher diagnostic yield. The diagnostic yield of PPLs those were adjacent to emphysema were lower than those PPLs which were away from emphysema (P = 0.048) in the group without ROSE, however, in the group of R-EBUS + ROSE, there was no such difference whether the lesion is adjacent to emphysema or not (P = 0.236). CONCLUSION: Our study found that the combination of R-EBUS and ROSE during bronchoscopy procedure was a safe and effective modality to improve diagnostic yield of PPLs with emphysema, especially for malignant PPLs. The distance between the pleura and the lesion ≥ 2 cm, the positive air bronchograms sign, the location of the ultrasound probe within the lesion, and the even echo with clear margin feature of lesion ultrasonic image, these factors possibly indicated a higher diagnostic yield. Those lesions' position is adjacent to emphysema may reduce diagnostic yield but ROSE may make up for this deficiency.
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Broncoscopia , Endossonografia , Neoplasias Pulmonares , Enfisema Pulmonar , Humanos , Masculino , Estudos Retrospectivos , Feminino , Pessoa de Meia-Idade , Idoso , Neoplasias Pulmonares/diagnóstico por imagem , Neoplasias Pulmonares/patologia , Enfisema Pulmonar/diagnóstico por imagem , Endossonografia/métodos , Broncoscopia/métodos , China , Avaliação Rápida no Local , Sensibilidade e Especificidade , Pulmão/diagnóstico por imagem , Pulmão/patologia , Valor Preditivo dos Testes , Biópsia Guiada por Imagem/métodosRESUMO
BACKGROUND: Radial probe endobronchial ultrasound (radial EBUS) is widely used to diagnose pulmonary lesions; however, the diagnostic value of radial EBUS-guided transbronchial biopsy (TBB) varies, and its complications (especially the risk of bleeding) are not properly understood. OBJECTIVES: In this study, we evaluated the diagnostic performance and rate of complication of this procedure, and investigated the risk factors associated with the procedure-related bleeding events. DESIGN: A retrospective cohort study. METHODS: This was a retrospective study that included consecutive patients who underwent radial EBUS-guided TBB. Radial EBUS was performed under moderate sedation in inpatients or outpatients. The severity of bleeding was graded using the standardized definitions of bleeding. RESULTS: Of 133 patients (median age, 69 years; men 57.1%) included, 41 were outpatients (30.8%). The diagnostic accuracy, sensitivity, and specificity for malignancy were 76.1% (89/117), 71.1% (69/97), and 100% (20/20), respectively. The diagnostic accuracy ranged from 66.9% to 79.0%, depending on the classification of undiagnosed cases as either false negatives or true negatives. Twenty-seven patients (20.3%) developed complications (pneumothorax, 3; pneumonia, 5; complicated pleural effusion, 2; bleeding event grade 2 or higher, 21). Of the 41 outpatients, two developed complications (pneumothorax without intervention, 1; grade 2 bleeding event, 1). Of the 21 patients (15.8%) with procedure-related bleeding events, 18 had grade 2, and three had grade 3 bleeding complications. In multivariate analysis, a large size of ⩾30 mm (adjusted odds ratio (OR), 5.09; p = 0.03) and central lesion (adjusted OR, 3.67; p = 0.03) were significantly associated with the risk of grade 2 or higher bleeding events. CONCLUSION: Our results suggest that radial EBUS-guided TBB is an accurate and safe method for diagnosing pulmonary lesions. Clinically significant procedure-related bleeding was rare. The central location and larger size (⩾30 mm) of pulmonary lesions were risk factors for grade 2 or higher bleeding events.
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Broncoscopia , Hemorragia , Humanos , Masculino , Feminino , Estudos Retrospectivos , Idoso , Fatores de Risco , Pessoa de Meia-Idade , Hemorragia/etiologia , Broncoscopia/efeitos adversos , Biópsia Guiada por Imagem/efeitos adversos , Biópsia Guiada por Imagem/métodos , Endossonografia/efeitos adversos , Endossonografia/métodos , Ultrassonografia de Intervenção/efeitos adversos , Idoso de 80 Anos ou mais , Neoplasias Pulmonares/patologia , Valor Preditivo dos Testes , Medição de RiscoRESUMO
BACKGROUND: Endoscopic ultrasound (EUS)-guided transluminal drainage has become a first-line treatment modality for symptomatic pancreatic pseudocysts. Despite the increasing popularity of lumen-apposing metal stents (LAMSs), plastic stents may resolve non-necrotic fluid collections effectively with lower costs and no LAMS-specific adverse events. To date, there has been a paucity of data on the appropriate stent type in this setting. This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts. METHODS: The WONDER-02 trial is a multicentre, open-label, non-inferiority, randomised controlled trial, which will enrol pancreatic pseudocyst patients requiring EUS-guided treatment in 26 centres in Japan. This trial plans to enrol 80 patients who will be randomised at a 1:1 ratio to receive either plastic stents or a LAMS (40 patients per arm). In the plastic stent group, EUS-guided drainage will be performed using two 7-Fr double pigtail stents. In the LAMS group, the treatment will be performed in the same way except for LAMS use. The step-up treatment will be performed via endoscopic and/or percutaneous procedures at the trial investigator's discretion. The primary endpoint is clinical success, which is defined as a decrease in a pseudocyst size to ≤ 2 cm and an improvement in inflammatory indicators (i.e. body temperature, white blood cell count, and serum C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, pseudocyst recurrence, and medical costs. DISCUSSION: The WONDER-02 trial will investigate the efficacy and safety of plastic stents compared to a LAMS in EUS-guided treatment of symptomatic pancreatic pseudocysts with a particular focus on the non-inferior efficacy of plastic stents. The findings will help establish a new treatment algorithm for this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023.