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1.
Artigo em Inglês | MEDLINE | ID: mdl-38782173

RESUMO

BACKGROUND & AIMS: Conventional endoscopic mucosal resection (C-EMR) is established as the primary treatment modality for superficial nonampullary duodenal epithelial tumors (SNADETs), but recently underwater endoscopic mucosal resection (U-EMR) has emerged as a potential alternative. The majority of previous studies focused on Asian populations and small lesions (≤20 mm). We aimed to compare the efficacy and outcomes of U-EMR vs C-EMR for SNADETs in a Western setting. METHODS: This was a retrospective multinational study from 10 European centers that performed both C-EMR and U-EMR between January 2013 and July 2023. The main outcomes were the technical success, procedure-related adverse events (AEs), and the residual/recurrent adenoma (RRA) rate, evaluated on a per-lesion basis. We assessed the association between the type of endoscopic mucosal resection and the occurrence of AEs or RRAs using mixed-effects logistic regression models (propensity scores). Sensitivity analyses were performed for lesions ≤20 mm or >20 mm. RESULTS: A total of 290 SNADETs submitted to endoscopic resection during the study period met the inclusion criteria and were analyzed (C-EMR: n = 201, 69.3%; U-EMR: n = 89, 30.7%). The overall technical success rate was 95.5% and comparable between groups. In logistic regression models, compared with U-EMR, C-EMR was associated with a significantly higher frequency of overall delayed AEs (odds ratio [OR], 4.95; 95% CI, 2.87-8.53), postprocedural bleeding (OR, 7.92; 95% CI, 3.95-15.89), and RRAs (OR, 3.66; 95% CI, 2.49-5.37). Sensitivity analyses confirmed these results when solely considering either small (≤20 mm) or large (>20 mm) lesions. CONCLUSIONS: Compared with C-EMR, U-EMR was associated with a lower rate of overall AEs and RRAs, regardless of lesion size. Our results confirm the possible role of U-EMR as an effective and safe technique in the management of SNADETs.

2.
Gastrointest Endosc ; 99(2): 137-145.e3, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37673197

RESUMO

BACKGROUND AND AIMS: Digestive endoscopy is a resource-intensive activity with a conspicuous carbon footprint and an estimated rate of inappropriateness. However, the carbon costs of inappropriate endoscopic procedures still remain obscure. Here we evaluated the environmental impact of inappropriate endoscopic examinations. METHODS: We calculated the carbon cost of a standard endoscopic procedure (EGD and colonoscopy [CLS]), taking into account the items (eg, disposable materials, personal protective equipment) and energy required for the endoscopy procedure itself and the cleaning process. The rates of inappropriateness and the mortality cost of carbon (MCC) of endoscopic examinations in different scenarios were calculated. RESULTS: EGD and CLS presented a carbon cost of 5.43 kg and 6.71 kg of CO2, respectively. Different scenarios were evaluated, according to the number of endoscopic procedures performed in Italy per 1000 inhabitants and the reported data on their inappropriateness. The carbon cost of inappropriate EGD and CLS in Italy was 4133 CO2 metric tons per year (MCC, .93), ranging from 3527 to 4749, and equivalent to 1,760,446 L of gasoline consumed. Applying the same data to the European population, the estimated carbon footprint of inappropriate digestive endoscopy in Europe was 30,804 metric tons. CONCLUSIONS: The environmental impact of inappropriate endoscopic procedures in Europe is remarkable. These results highlight the need to adopt novel strategies aimed at reducing both the carbon footprint of digestive endoscopy and the rate of inappropriate procedures.


Assuntos
Dióxido de Carbono , Endoscopia Gastrointestinal , Humanos , Colonoscopia , Endoscopia , Europa (Continente) , Itália , Prescrição Inadequada
3.
Dig Endosc ; 36(2): 162-171, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37029779

RESUMO

OBJECTIVES: Blue rubber bleb nevus syndrome (BRBNS) is a rare challenging cause of gastrointestinal bleeding. We performed a systematic review of case reports and case series on BRBNS to gather information on the treatment options currently available. METHODS: All studies reporting a case of BRBNS in humans were evaluated. Papers were ruled out if CARE criteria and explanations on patient's selection, ascertainment, causality, and reporting were not respected or identified. PROSPERO 2021 CRD 42021286982. RESULTS: Blue rubber bleb nevus syndrome was treated in 106 cases from 76 reports. 57.5% of the population was under 18 years old, and up to 50% of the cases reported a previous treatment. Clinical success was achieved in 98 patients (92.4%). Three main types of interventions were identified: systemic drug therapy, endoscopy, and surgery. After BRBNS recurrence or previous therapy failure, systemic drug therapy emerged as a preferred second-line treatment over endoscopy (P = 0.01), but with a higher rate of reported adverse events when compared with surgery and endoscopy (P < 0.001). Endoscopic treatment was associated with a higher number of required sessions to achieve complete eradication when compared with surgery (P < 0.001). No differences between the three main areas were found in the overall follow-up time (P = 0.19) or in the recurrence rate (P = 0.45). CONCLUSION: Endoscopy, surgery, and systemic drug therapy are feasible treatment options for BRBNS. Systemic drug therapy was the favorite second-line treatment after endoscopic failure or recurrence of BRBNS, but adverse events were more frequently reported.


Assuntos
Neoplasias Gastrointestinais , Nevo Azul , Neoplasias Cutâneas , Humanos , Adolescente , Neoplasias Cutâneas/diagnóstico , Neoplasias Gastrointestinais/complicações , Neoplasias Gastrointestinais/cirurgia , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/terapia , Nevo Azul/complicações , Nevo Azul/diagnóstico , Síndrome
4.
Endoscopy ; 55(4): 332-341, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36228649

RESUMO

BACKGROUND: Endoscopic and histological remission (ER, HR) are therapeutic targets in ulcerative colitis (UC). Virtual chromoendoscopy (VCE) improves endoscopic assessment and the prediction of histology; however, interobserver variability limits standardized endoscopic assessment. We aimed to develop an artificial intelligence (AI) tool to distinguish ER/activity, and predict histology and risk of flare from white-light endoscopy (WLE) and VCE videos. METHODS: 1090 endoscopic videos (67 280 frames) from 283 patients were used to develop a convolutional neural network (CNN). UC endoscopic activity was graded by experts using the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) and Paddington International virtual ChromoendoScopy ScOre (PICaSSO). The CNN was trained to distinguish ER/activity on endoscopy videos, and retrained to predict HR/activity, defined according to multiple indices, and predict outcome; CNN and human agreement was measured. RESULTS: The AI system detected ER (UCEIS ≤ 1) in WLE videos with 72 % sensitivity, 87 % specificity, and an area under the receiver operating characteristic curve (AUROC) of 0.85; for detection of ER in VCE videos (PICaSSO ≤ 3), the sensitivity was 79 %, specificity 95 %, and the AUROC 0.94. The prediction of HR was similar between WLE and VCE videos (accuracies ranging from 80 % to 85 %). The model's stratification of risk of flare was similar to that of physician-assessed endoscopy scores. CONCLUSIONS: Our system accurately distinguished ER/activity and predicted HR and clinical outcome from colonoscopy videos. This is the first computer model developed to detect inflammation/healing on VCE using the PICaSSO and the first computer tool to provide endoscopic, histologic, and clinical assessment.


Assuntos
Colite Ulcerativa , Humanos , Colite Ulcerativa/diagnóstico por imagem , Colite Ulcerativa/patologia , Inteligência Artificial , Índice de Gravidade de Doença , Colonoscopia , Curva ROC
5.
J Hepatol ; 76(2): 464-469, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34699951

RESUMO

The entry inhibitor bulevirtide (BLV) received conditional approval from the EMA in July 2020 for the treatment of adult patients with compensated chronic hepatitis delta. However, the effectiveness and safety of BLV administered as monotherapy beyond 48 weeks in difficult-to-treat patients with HDV-related cirrhosis is presently unknown. Herein, we describe the first patients with HDV-related compensated cirrhosis who were treated with BLV (10 mg/day as a starting dose) for up to 3 years on a compassionate use program. Patients were also monitored for HBcrAg and HBV RNA levels, and HDV- and HBV-specific T-cell markers. In the patient who stopped BLV at week 48, after achieving a virological and biochemical response, the initial virological and biochemical rebound was followed by alanine aminotransferase normalization coupled with low HDV RNA and HBsAg levels. In the 2 patients treated continuously for 3 years, virological and biochemical responses were maintained throughout the treatment period even after dose reduction. In a patient with advanced compensated cirrhosis, liver function tests significantly improved, esophageal varices disappeared, and histological/laboratory features of autoimmune hepatitis resolved. Overall, no safety issues were recorded, as bile salt increase was asymptomatic. While serum HBV RNA levels remained undetectable in all patients, HBV core-related antigen levels showed a progressive, yet modest decline during long-term BLV treatment. No HDV-specific interferon-γ-producing T cells were detected, neither after HDV reactivation (after BLV withdrawn in Patient 1) nor during 3 years of BLV treatment. In conclusion, this report shows that continuous administration of BLV monotherapy for 3 years leads to excellent virological and clinical responses in patients with HDV-related cirrhosis who had contraindications to interferon-based therapies.


Assuntos
Lipopeptídeos/farmacologia , Cirrose Hepática/tratamento farmacológico , Adulto , Antivirais/farmacologia , Antivirais/uso terapêutico , Feminino , Hepatite D/complicações , Hepatite D/tratamento farmacológico , Humanos , Lipopeptídeos/uso terapêutico , Cirrose Hepática/etiologia , Testes de Função Hepática/métodos , Testes de Função Hepática/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Segurança do Paciente/normas , Segurança do Paciente/estatística & dados numéricos , Resultado do Tratamento
6.
J Hepatol ; 73(5): 1063-1071, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32526252

RESUMO

BACKGROUND & AIMS: Coronavirus disease 2019 (COVID-19) poses a major health threat to healthy individuals and those with comorbidities, but its impact on patients with cirrhosis is currently unknown. Herein, we aimed to evaluate the impact of COVID-19 on the clinical outcome of patients with cirrhosis. METHODS: In this multicentre retrospective study, patients with cirrhosis and a confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection were enrolled between 1st and 31th March 2020. Clinical and biochemical data at diagnosis of COVID-19 and at the last outpatient visit were obtained through review of medical records. RESULTS: Fifty patients with cirrhosis and confirmed SARS-CoV-2 infection were enrolled (age 67 years, 70% men, 38% virus-related, 52% previously compensated cirrhosis). At diagnosis, 64% of patients presented fever, 42% shortness of breath/polypnea, 22% encephalopathy, 96% needed hospitalization or a prolonged stay if already in hospital. Respiratory support was necessary in 71%, 52% received antivirals, 80% heparin. Serum albumin significantly decreased, while bilirubin, creatinine and prothrombin time significantly increased at COVID-19 diagnosis compared to last available data. The proportion of patients with a model for end-stage liver disease (MELD) score ≥15 increased from 13% to 26% (p = 0.037), acute-on-chronic liver failure and de novo acute liver injury occurred in 14 (28%) and 10 patients, respectively. Seventeen patients died after a median of 10 (4-13) days from COVID-19 diagnosis, with a 30-day-mortality rate of 34%. The severity of lung and liver (according to CLIF-C, CLIF-OF and MELD scores) diseases independently predicted mortality. In patients with cirrhosis, mortality was significantly higher in those with COVID-19 than in those hospitalized for bacterial infections. CONCLUSION: COVID-19 is associated with liver function deterioration and elevated mortality in patients with cirrhosis. LAY SUMMARY: Coronavirus disease 2019 (COVID-19) poses a major health threat to healthy individuals and those with comorbidities. Herein, we assessed its impact on patients with cirrhosis. Infection with COVID-19 was associated with liver function deterioration and elevated mortality in patients with cirrhosis.


Assuntos
Infecções por Coronavirus , Cirrose Hepática , Testes de Função Hepática , Pandemias , Pneumonia Viral , Idoso , Antivirais/administração & dosagem , Antivirais/efeitos adversos , Betacoronavirus/isolamento & purificação , COVID-19 , Teste para COVID-19 , Técnicas de Laboratório Clínico/métodos , Comorbidade , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/fisiopatologia , Feminino , Humanos , Itália/epidemiologia , Cirrose Hepática/diagnóstico , Cirrose Hepática/epidemiologia , Cirrose Hepática/fisiopatologia , Testes de Função Hepática/métodos , Testes de Função Hepática/estatística & dados numéricos , Masculino , Mortalidade , Pneumonia Viral/diagnóstico , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/mortalidade , Pneumonia Viral/fisiopatologia , Pneumonia Viral/virologia , Estudos Retrospectivos , Fatores de Risco , SARS-CoV-2
7.
Curr Opin Gastroenterol ; 36(3): 238-244, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32073507

RESUMO

PURPOSE OF REVIEW: The present review offers its readers a practical overview of protein-losing enteropathy, particularly with regard to diagnostic and therapeutic approaches. The aim is to support clinicians in their daily practice with a practical tool to deal with protein-losing enteropathy. RECENT FINDINGS: The literature covering protein-losing enteropathy does not appear to be quite recent and also guidelines are scanty. The main innovations during the last decade probably regard the introduction of enteroscopic techniques in the diagnostic flowchart. The use of video-capsule and device-assisted enteroscopy has enabled the direct exploration of the small bowel and the identification of the damage causing the loss of proteins from the gastrointestinal tract. Other innovations are to do with the therapies of the disorder underlying protein-losing enteropathy, although the support with nutritional supplementation are the direct remedies to tackle the protein loss. SUMMARY: Protein-losing enteropathy represents an important clinical aspect of different gastrointestinal and extra-intestinal diseases. An established flowchart is still unavailable, but the use of enteroscopy has deeply changed the modern diagnostic approach. Nutritional support and therapy of the underlying disease are pivotal to patients' management.


Assuntos
Enteropatias Perdedoras de Proteínas , Humanos , Enteropatias Perdedoras de Proteínas/diagnóstico , Enteropatias Perdedoras de Proteínas/fisiopatologia , Enteropatias Perdedoras de Proteínas/terapia
11.
Endoscopy ; 49(4): 365-370, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28107762

RESUMO

Background and study aims The thulium laser system (TLS) is an emerging surgical tool. The 2-µm wavelength provides a confined coagulation depth (0.2 - 0.4 mm) to reduce the potential for inadvertent injuries. For the first time ever, we assessed TLS feasibility for endoscopic hemostasis ex vivo in pigs. In addition, we performed the first in vivo hemostatic treatments in humans. Patients and methods Tissue damage induced by TLS using different settings and optical fibers was compared to that from argon plasma coagulation (APC) in established ex vivo animal models. Three consecutive patients with complex nonvariceal upper gastrointestinal bleedings were treated and followed up. Results No deep submucosal injury was observed in animal models. The TLS showed a progressive penetration depth with increased power outputs and tissue exposures but very limited vertical tissue injury (0.1 - 2.0 mm) and lateral spreading damage (0.1 - 0.3 mm and 0.2 - 0.7 mm using the 365-µm and 550-µm fibers, respectively). In vivo, endoscopic hemostasis with TLS was always successful without complications. Conclusions The TLS has proven to be very precise and easy to use. This novel technique appears to be a promising tool for advanced interventional endoscopy.


Assuntos
Hemorragia Gastrointestinal/terapia , Hemostase Endoscópica/métodos , Lasers de Estado Sólido/uso terapêutico , Neoplasias Peritoneais/complicações , Túlio , Idoso , Animais , Coagulação com Plasma de Argônio , Úlcera Duodenal/complicações , Endoscopia do Sistema Digestório , Estudos de Viabilidade , Ectasia Vascular Gástrica Antral/complicações , Ectasia Vascular Gástrica Antral/terapia , Mucosa Gástrica , Hemorragia Gastrointestinal/etiologia , Hemostase Endoscópica/efeitos adversos , Hemostase Endoscópica/instrumentação , Humanos , Terapia a Laser/instrumentação , Lasers de Estado Sólido/efeitos adversos , Masculino , Pessoa de Meia-Idade , Úlcera Péptica Hemorrágica/etiologia , Úlcera Péptica Hemorrágica/terapia , Neoplasias Peritoneais/patologia , Suínos
13.
Endosc Int Open ; 12(7): E842-E848, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38966319

RESUMO

Background and study aims International guidelines recommend real-time viewing (RTV) in capsule endoscopy for gastric emptying monitoring, yet it is often overlooked in clinical practice. We aimed to assess risk factors for incomplete small bowel capsule endoscopy (SBCE) and evaluate the clinical relevance and cost-effectiveness of RTV implementation. Methods We included consecutive SBCEs from 2013 to 2020. RTV was not applied per local protocol. We used multivariate logistic regression to identify risk factors for incomplete SBCE, including prolonged gastric transit time (GTT) and prolonged small bowel transit time (SBTT). Results Analyzing 858 SBCEs, we observed a completion rate of 94.6%. Prolonged GTT and SBTT were present in 4.9% and 18.2% of complete SBCEs, and in 13% ( P =0.03) and 10.8% ( P =0.24) of incomplete SBCEs, respectively. Only 0.7% (6 of 858) had incomplete SBCE with prolonged GTT. In both univariate and multivariate analysis, a modifiable (prolonged GTT odds ratio [OR] 2.9; 95% confidence interval [CI] 1.1-7.5) and two unmodifiable risk factors (inpatient status OR 2.3; 95% CI 1.1-4.5) and history of incomplete SBCE (OR 4.2; 95% CI 1.3-13.7) were independently linked to higher incomplete SBCE rates. The pretest completion probability was 90.5% and 95.8% in patients with and without unmodifiable risk factors, respectively ( P <0.01). The direct cost of systematic RTV adoption and prokinetics administration would be €5059, aiming to identify and treat each case of prolonged GTT associated with incomplete SBCE. Conclusions Modern devices make incomplete SBCE rare, usually not tied to prolonged GTT. In a low-incidence scenario, widespread RTV use brings high costs and uncertain effectiveness.

14.
Cancers (Basel) ; 16(2)2024 Jan 13.
Artigo em Inglês | MEDLINE | ID: mdl-38254841

RESUMO

A literature search of MEDLINE/PUBMED was conducted with the aim to highlight current endoscopic management of localised gastro-entero-pancreatic NETs. Relevant articles were identified through a manual search, and reference lists were reviewed for additional articles. The results of the research have been displayed in a narrative fashion to illustrate the actual state-of-the-art of endoscopic techniques in the treatment of NETs. Localised NETs of the stomach, duodenum and rectum can benefit from advanced endoscopic resection techniques (e.g., modified endoscopic mucosal resection, endoscopic full thickness resection, endoscopic submucosal dissection) according to centre expertise. Radiofrequency thermal ablation can be proposed as an alternative to surgery in selected patients with localised pancreatic NETs.

15.
Dig Liver Dis ; 2024 May 18.
Artigo em Inglês | MEDLINE | ID: mdl-38763794

RESUMO

INTRODUCTION: Endoscopic Submucosal Dissection (ESD) has been reported as a feasible and effective treatment for Rectal Neuroendocrine Tumours (R-NETs). However, most of the experience on the topic comes from retrospective tertiary centre from Eastern Asia. Data on ESD for R-NETs in Western centres are lacking. MATERIALS AND METHODS: This is a retrospective study, including patients who underwent endoscopic resection of R-NETS by ESD between 2015 and 2020 in Western Centres. Important clinical variables such as demographic, size of R-NETs, histological type, presence of lymphovascular invasion or distant metastasis, completeness of the endoscopic resection, recurrence, and procedure related complications were recorded. RESULTS: 40 ESD procedure on R-NETs from 39 patients from 8 centres were included. Mean R-NETs size was 10.3 mm (SD 4.01). Endoscopic en-bloc resection was achieved in 39/40 ESD (97.5 %), R0 margin resection was obtained in 87.5 % (35/40) of the procedures, one patient was referred to surgery for lymphovascular invasion, two procedures (5 %) reported significant episodes of bleeding, whereas a perforation occurred in one case (1/40, 2.5 %) managed endoscopically. Recurrence occurred in 1 patient (2.5 %). CONCLUSION: ESD is an effective and safe treatment for R-NETs in western centres.

16.
Dig Liver Dis ; 2023 Dec 05.
Artigo em Inglês | MEDLINE | ID: mdl-38057218

RESUMO

BACKGROUNDS AND AIMS: Mucosal healing (MH) in inflammatory bowel diseases (IBD) is an important landmark for clinical decision making. Artificial intelligence systems (AI) that automatically deliver the grade of endoscopic inflammation may solve moderate interobserver agreement and the need of central reading in clinical trials. METHODS: We performed a systematic review of EMBASE and MEDLINE databases up to 01/12/2022 following PRISMA and the Joanna Briggs Institute methodologies to answer the following question: "Can AI replace endoscopists when assessing MH in IBD?". The research was restricted to ulcerative colitis (UC), and a diagnostic odds ratio (DOR) meta-analysis was performed. Risk of bias was evaluated with QUADAS-2 tool. RESULTS: A total of 21 / 739 records were selected for full text evaluation, and 12 were included in the meta-analysis. Deep learning algorithms based on convolutional neural networks architecture achieved a satisfactory performance in evaluating MH on UC, with sensitivity, specificity, DOR and SROC of respectively 0.91(CI95 %:0.86-0.95);0.89(CI95 %:0.84-0.93);92.42(CI95 %:54.22-157.53) and 0.957 when evaluating fixed images (n = 8) and 0.86(CI95 %:0.75-0.93);0.91(CI95 %:0.87-0.94);70.86(CI95 %:24.63-203.86) and 0.941 when evaluating videos (n = 6). Moderate-high levels of heterogeneity were noted, limiting the quality of the evidence. CONCLUSIONS: AI systems showed high potential in detecting MH in UC with optimal diagnostic performance, although moderate-high heterogeneity of the data was noted. Standardised and shared AI training may reduce heterogeneity between systems.

17.
Dig Liver Dis ; 55(2): 235-242, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36096991

RESUMO

OBJECTIVES: Refractory celiac disease (RCeD) is a rare complication of celiac disease (CeD) with a severe prognosis. We describe a cohort of patients with RCeD, their clinical and histological features at diagnosis, after therapy and at lymphoma onset, and the rate and causes of death over a 17-year follow-up. METHODS: We retrospectively enrolled RCeD-I and RCeD-II patients attending our center between January 2002 and October 2019. Medical data were collected at diagnosis and during monitoring. Response to therapy, changes in RCeD molecular markers, number of hospitalizations, discharge diagnosis, and cause and date of death were evaluated. The control cohort consisted of 1015 responsive CeD patients. RESULTS: Compared with RCeD-I, RCeD-II more frequently exhibits diarrhea (83 vs 64%), anemia (61 vs 50%), hypoalbuminemia (70 vs 21%), parenteral nutrition need (48 vs 7%), ulcerative jejuno-ileitis (7 vs 39%), and extended small intestinal atrophy (62 vs 21%). One RCeD-I and six RCeD-II patients developed lymphoma. Ten RCeD-II patients died, four from lymphoma progression. Among RCeD-II patients, atrophy extension was the only parameter correlated with hypoalbuminemia and mortality. CONCLUSIONS: Clinical severity, response to therapy, and mortality differ between RCeD-I and RCeD-II. Atrophy extension, evaluated at capsule endoscopy, was associated with disease severity and mortality.


Assuntos
Doença Celíaca , Hipoalbuminemia , Linfoma , Humanos , Doença Celíaca/complicações , Doença Celíaca/terapia , Doença Celíaca/diagnóstico , Estudos Retrospectivos , Hipoalbuminemia/complicações , Linfoma/complicações , Atrofia
18.
Aliment Pharmacol Ther ; 55(3): 350-359, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34738664

RESUMO

BACKGROUND: Prothrombin induced by vitamin K absence or antagonist-II (PIVKA-II) and alpha fetoprotein (AFP) are biomarkers for hepatocellular carcinoma (HCC). However, their performance in patients with cirrhosis related to hepatitis C virus (HCV) treated with direct-acting antiviral agents (DAA) is unknown. AIM: To evaluate PIVKA-II and AFP as HCC predictors in DAA-treated patients with HCV-related cirrhosis METHODS: In this single centre study, patients with cirrhosis from chronic HCV infection and with a sustained virological response (SVR) to DAA were tested for PIVKA-II and AFP (Fujirebio, Japan) at the start of DAA treatment (baseline), end of treatment (EOT) and at HCC diagnosis. RESULTS: We included 400 patients with mean age 65 (24-92); 56% were men. From baseline to EOT, PIVKA-II did not change (35 vs 35 mAU/mL, P = 0.43) while AFP significantly decreased (12 vs 6 ng/mL, P < 0.0001). After 52 (3-66) months from baseline, 34 (8.5%) patients developed de novo HCC; median AFP 9 (2-12 868) ng/mL and PIVKA-II 80 (22-1813) mAU/mL. EOT-PIVKA-II (HR 3.05, P < 0.0001) and AFP (HR 2.77, P = 0.001) independently predicted HCC together with diabetes (HR 6.12, P < 0.001) and GGT (HR 1.01, P = 0.03). The 4-year cumulative probability of HCC was 24% vs 2% in patients with EOT-PIVKA-II > or ≤41 mAU/mL (P < 0.0001), and 26% vs 9% for EOT-AFP > or ≤15 ng/mL (P = 0.02). By combining EOT-PIVKA-II and AFP, the 4-year probabilities of HCC were 3% in patients testing negative for both markers, 18% in patients positive for both, and 38% in patients positive for at least one (P < 0.0001). CONCLUSIONS: In patients with HCV-related cirrhosis treated with DAA, PIVKA-II and AFP independently predicted HCC, while their combination improved risk stratification.


Assuntos
Antivirais , Carcinoma Hepatocelular , Hepatite C Crônica , Neoplasias Hepáticas , Protrombina , alfa-Fetoproteínas , Adulto , Idoso , Idoso de 80 Anos ou mais , Antivirais/uso terapêutico , Biomarcadores Tumorais , Carcinoma Hepatocelular/diagnóstico , Carcinoma Hepatocelular/virologia , Feminino , Hepatite C Crônica/complicações , Hepatite C Crônica/tratamento farmacológico , Humanos , Cirrose Hepática/diagnóstico , Cirrose Hepática/virologia , Neoplasias Hepáticas/diagnóstico , Neoplasias Hepáticas/virologia , Masculino , Pessoa de Meia-Idade , Precursores de Proteínas , Protrombina/análise , Curva ROC , Vitamina K , alfa-Fetoproteínas/análise
19.
Clin Transl Sci ; 15(1): 172-181, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34523800

RESUMO

Data regarding double switching from originator infliximab (IFX) to IFX biosimilars in inflammatory bowel diseases (IBDs) are lacking. The purpose of this study was to evaluate the safety and efficacy of switching from originator IFX to CT-P13 and subsequently to SB2 (double switch) in patients with IBD. Patients undergoing IFX-double switch in eight Centers in Lombardy (Italy) from November 2018 to May 2019 were retrospectively analyzed. The IFX discontinuation rate, incidence and type of adverse events (AEs), and clinical remission rate were recorded. A comparison with a control group of patients with IBD single-switched from originator IFX to CT-P13 was performed, before and after an inverse probability of treatment weighting (IPTW)-based propensity score analysis. Fifty-two double-switched patients with IBD were enrolled. The 24- and 52-week proportions of patients continuing on IFX therapy following the second switch (CTP13 â†’ SB2) were 98% (95% confidence interval [CI] 94%-100%) and 90% (95% CI 81%-99%), respectively. Four patients experienced a total of five AEs, all graded 1-3 according to Common Terminology Criteria for Adverse Events (CTCAE). No infusion reactions were observed. The 24-week and follow-up end clinical remission rates following the second switch were 94% and 88%, respectively. No differences were observed in the safety and efficacy outcomes by comparing the double-switch group with a single-switch group of 66 patients with IBD; all these results were confirmed by IPTW-adjusted analysis. The study suggests both the safety and efficacy of the double switch from originator IFX to CT-P13 and SB2 in patients with IBD is maintained. This strategy may be associated with potential cost implications.


Assuntos
Anticorpos Monoclonais/farmacologia , Anticorpos Monoclonais/uso terapêutico , Medicamentos Biossimilares/farmacologia , Medicamentos Biossimilares/uso terapêutico , Substituição de Medicamentos , Doenças Inflamatórias Intestinais/tratamento farmacológico , Infliximab/farmacologia , Infliximab/uso terapêutico , Resultado do Tratamento , Adolescente , Adulto , Estudos de Coortes , Feminino , Humanos , Masculino , Adulto Jovem
20.
Diagnostics (Basel) ; 12(7)2022 Jul 13.
Artigo em Inglês | MEDLINE | ID: mdl-35885608

RESUMO

(1) Background: Villous atrophy is an indication for small bowel capsule endoscopy (SBCE). However, SBCE findings are not described uniformly and atrophic features are sometimes not recognized; (2) Methods: The Delphi technique was employed to reach agreement among a panel of SBCE experts. The nomenclature and definitions of SBCE lesions suggesting the presence of atrophy were decided in a core group of 10 experts. Four images of each lesion were chosen from a large SBCE database and agreement on the correspondence between the picture and the definition was evaluated using the Delphi method in a broadened group of 36 experts. All images corresponded to histologically proven mucosal atrophy; (3) Results: Four types of atrophic lesions were identified: mosaicism, scalloping, folds reduction, and granular mucosa. The core group succeeded in reaching agreement on the nomenclature and the descriptions of these items. Consensus in matching the agreed definitions for the proposed set of images was met for mosaicism (88.9% in the first round), scalloping (97.2% in the first round), and folds reduction (94.4% in the first round), but granular mucosa failed to achieve consensus (75.0% in the third round); (4) Conclusions: Consensus among SBCE experts on atrophic lesions was met for the first time. Mosaicism, scalloping, and folds reduction are the most reliable signs, while the description of granular mucosa remains uncertain.

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