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1.
Gastroenterology ; 166(4): 690-703, 2024 04.
Artigo em Inglês | MEDLINE | ID: mdl-38158089

RESUMO

BACKGROUND & AIMS: Gastrointestinal angiodysplasias are vascular anomalies that may result in transfusion-dependent anemia despite endoscopic therapy. An individual patient data meta-analysis of cohort studies suggests that octreotide decreases rebleeding rates, but component studies possessed a high risk of bias. We investigated the efficacy of octreotide in reducing the transfusion requirements of patients with angiodysplasia-related anemia in a clinical trial setting. METHODS: The study was designed as a multicenter, open-label, randomized controlled trial. Patients with angiodysplasia bleeding were required to have had at least 4 red blood cell (RBC) units or parental iron infusions, or both, in the year preceding randomization. Patients were allocated (1:1) to 40-mg octreotide long-acting release intramuscular every 28 days or standard of care, including endoscopic therapy. The treatment duration was 1 year. The primary outcome was the mean difference in the number of transfusion units (RBC + parental iron) between the octreotide and standard of care groups. Patients who received at least 1 octreotide injection or followed standard of care for at least 1 month were included in the intention-to-treat analyses. Analyses of covariance were used to adjust for baseline transfusion requirements and incomplete follow-up. RESULTS: We enrolled 62 patients (mean age, 72 years; 32 men) from 17 Dutch hospitals in the octreotide (n = 31) and standard of care (n = 31) groups. Patients required a mean number of 20.3 (standard deviation, 15.6) transfusion units and 2.4 (standard deviation, 2.0) endoscopic procedures in the year before enrollment. The total number of transfusions was lower with octreotide (11.0; 95% confidence interval [CI], 5.5-16.5) compared with standard of care (21.2; 95% CI, 15.7-26.7). Octreotide reduced the mean number of transfusion units by 10.2 (95% CI, 2.4-18.1; P = .012). Octreotide reduced the annual volume of endoscopic procedures by 0.9 (95% CI, 0.3-1.5). CONCLUSIONS: Octreotide effectively reduces transfusion requirements and the need for endoscopic therapy in patients with angiodysplasia-related anemia. CLINICALTRIALS: gov, NCT02384122.


Assuntos
Anemia , Angiodisplasia , Doenças do Colo , Idoso , Humanos , Masculino , Anemia/tratamento farmacológico , Anemia/etiologia , Angiodisplasia/complicações , Angiodisplasia/diagnóstico , Angiodisplasia/terapia , Doenças do Colo/tratamento farmacológico , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/tratamento farmacológico , Hemorragia Gastrointestinal/etiologia , Ferro , Estudos Multicêntricos como Assunto , Octreotida/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Padrão de Cuidado , Feminino
2.
Gastroenterology ; 167(4): 778-787.e3, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38582271

RESUMO

BACKGROUND & AIMS: High-dose proton pump inhibitor (PPI) therapy has been recommended to prevent rebleeding of high-risk peptic ulcer (PU) after hemostasis. Vonoprazan has been proven to be noninferior to PPIs in various acid-related diseases. This study aimed to compare the efficacy of vonoprazan vs PPI for preventing high-risk PU rebleeding after hemostasis. METHODS: A multicenter, randomized, noninferiority study was conducted in 6 centers. Pre-endoscopic and endoscopic therapy were performed according to standard protocol. After successful hemostasis, patients with high-risk PU bleeding (Forrest class Ia/Ib, IIa/IIb) were randomized into 1:1 to receive vonoprazan (20 mg twice a day for 3 days, then 20 mg once a day for 28 days) or high-dose PPI (pantoprazole intravenous infusion 8 mg/h for 3 days, then omeprazole 20 mg twice a day for 28 days). The primary outcome was a 30-day rebleeding rate. Secondary outcomes included 3- and 7-day rebleeding rate, all-cause and bleeding-related mortality, rate of rescue therapy, blood transfusion, length of hospital stay, and safety. RESULTS: Of 194 patients, baseline characteristics, severity of bleeding, and stage of ulcers were comparable between the 2 groups. The 30-day rebleeding rates in vonoprazan and PPI groups were 7.1% (7 of 98) and 10.4% (10 of 96), respectively; noninferiority (within 10% margin) of vonoprazan to PPI was confirmed (%risk difference, -3.3; 95% confidence interval, -11.2 to 4.7; P < .001). The 3-day and 7-day rebleeding rates in the vonoprazan group remained noninferior to PPI (P < .001 by Farrington and Manning test). All secondary outcomes were also comparable between the 2 groups. CONCLUSION: In patients with high-risk PU bleeding, the efficacy of vonoprazan in preventing 30-day rebleeding was noninferior to intravenous PPI. (ClinicalTrials.gov, Number: NCT05005910).


Assuntos
Hemostase Endoscópica , Úlcera Péptica Hemorrágica , Inibidores da Bomba de Prótons , Pirróis , Recidiva , Sulfonamidas , Humanos , Inibidores da Bomba de Prótons/administração & dosagem , Inibidores da Bomba de Prótons/efeitos adversos , Sulfonamidas/administração & dosagem , Sulfonamidas/efeitos adversos , Masculino , Feminino , Pirróis/administração & dosagem , Pirróis/efeitos adversos , Idoso , Úlcera Péptica Hemorrágica/prevenção & controle , Úlcera Péptica Hemorrágica/diagnóstico , Úlcera Péptica Hemorrágica/terapia , Úlcera Péptica Hemorrágica/tratamento farmacológico , Hemostase Endoscópica/efeitos adversos , Pessoa de Meia-Idade , Resultado do Tratamento , Infusões Intravenosas , Prevenção Secundária/métodos , Fatores de Risco , Idoso de 80 Anos ou mais
3.
Gastroenterology ; 2024 Sep 18.
Artigo em Inglês | MEDLINE | ID: mdl-39304088

RESUMO

BACKGROUND & AIMS: Early identification and accurate characterization of overt gastrointestinal bleeding (GIB) enables opportunities to optimize patient management and ensures appropriately risk-adjusted coding for claims-based quality measures and reimbursement. Recent advancements in generative artificial intelligence, particularly large language models (LLMs), create opportunities to support accurate identification of clinical conditions. In this study, we present the first LLM-based pipeline for identification of overt GIB in the electronic health record (EHR). We demonstrate two clinically relevant applications: the automated detection of recurrent bleeding and appropriate reimbursement coding for patients with GIB. METHODS: Development of the LLM-based pipeline was performed on 17,712 nursing notes from 1,108 patients who were hospitalized with acute GIB and underwent endoscopy in hospital from 2014 to 2023. The pipeline was used to train an EHR-based machine learning model for detection of recurrent bleeding on 546 patients presenting to two hospitals and externally validated on 562 patients presenting to four separate hospitals. The pipeline was used to develop an algorithm for appropriate reimbursement coding on 7,956 patients who underwent endoscopy in hospital from 2019 to 2023. RESULTS: The LLM-based pipeline accurately detected melena (positive predictive value=0.972; sensitivity=0.900), hematochezia (0.900; 0.908), and hematemesis (0.859; 0.932). The EHR-based machine learning model identified recurrent bleeding with AUC=0.986, sensitivity=98.4%, and specificity=97.5%. The reimbursement coding algorithm resulted in an average per-patient reimbursement increase of $1,299 to 3,247 with a total difference of $697,460 to $1,743,649. CONCLUSION: An LLM-based pipeline can robustly detect overt GIB in the EHR with clinically relevant applications in detection of recurrent bleeding and appropriate reimbursement coding.

4.
Rev Med Virol ; 34(1): e2509, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38282392

RESUMO

Upper gastrointestinal bleeding (UGIB) in COVID-19 presents challenges in patient management. Existing studies lack comprehensive review due to varied designs, samples, and demographics. A meta-analysis can provide valuable insights into the incidence, features, and outcomes of UGIB in COVID-19. A comprehensive literature search was carried out using several databases. We considered all appropriate observational studies from all over the world. Mantel-Haenszel odds ratios and associated 95% confidence intervals (CIs) were produced to report the overall effect size using random effect models. Besides, Random effects models were used to calculate the overall pooled prevalence. Funnel plots, Egger regression tests, and Begg-Mazumdar's rank correlation test were used to appraise publication bias. Data from 21 articles consisting of 26,933 COVID-19 patients were considered. The pooled estimate of UGIB prevalence in patients admitted with COVID-19 across studies was 2.10% (95% CI, 1.23-3.13). Similarly, the overall pooled estimate for severity, mortality, and rebleeding in COVID-19 patients with UGIB was 55% (95% CI, 37.01-72.68), 29% (95% CI, 19.26-40.20) and 12.7% (95% CI, 7.88-18.42) respectively. Further, UGIB in COVID-19 patients was associated with increased odds of severity (OR = 3.52, 95% CI 1.80-6.88, P = 0.001) and mortality (OR = 2.16, 95% CI 1.33-3.51, P = 0.002) compared with patients without UGIB. No significant publication bias was evident in the meta-analysis. The results of our study indicate that UGIB in individuals with COVID-19 is linked to negative outcomes such as severe illness, higher mortality rates, and an increased risk of re-bleeding. These findings highlight the significance of identifying UGIB as a significant complication in COVID-19 cases and emphasise the importance of timely clinical assessment and proper treatment.


Assuntos
COVID-19 , Humanos , COVID-19/complicações , COVID-19/epidemiologia , Prevalência , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/terapia , Hospitalização , Incidência
5.
J Hepatol ; 80(4): 603-609, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38110003

RESUMO

BACKGROUND & AIMS: The prognostic impact of acute decompensation (AD), i.e. the development of complications that require hospitalization, has recently been assessed. However, complications of cirrhosis do not necessarily require hospitalization and can develop progressively, as in the recently defined non-acute decompensation (NAD). Nevertheless, there is no data regarding the incidence and prognostic impact of NAD. The aim of the study was to evaluate the incidence and the prognostic impact of NAD and AD in outpatients with cirrhosis. METHODS: A total of 617 outpatients with cirrhosis from two Italian tertiary centers (Padua and Milan) were enrolled from January 2003 to June 2021 and followed prospectively until the end of the study, death or liver transplantation. The complications registered during follow-up were considered as AD if they required hospitalization, or NAD if managed at the outpatient clinic. RESULTS: During follow-up, 154 patients (25.0% of total patients) developed complications, 69 patients (44.8%) developed NAD and 85 (55.2%) developed AD, while 29 patients with NAD (42.0%) developed a further episode of AD during follow-up. Sixty-month survival was significantly higher in patients with no decompensation than in patients with NAD or AD. On multivariable analysis, AD (hazard ratio [HR] 21.07, p <0.001), NAD (HR 7.13, p <0.001), the etiological cure of cirrhosis (HR 0.38, p <0.001) and model for end-stage liver disease score (HR 1.12, p = 0.003) were found to be independent predictors of mortality. CONCLUSIONS: The first decompensation is non-acute in almost 50% of outpatients, though such events are still associated with decreased survival compared to no decompensation. Patients who develop NAD must be treated with extreme care and monitored closely to prevent the development of AD. IMPACT AND IMPLICATIONS: This multicenter study is the first to investigate the role of non-acute decompensation (NAD) in patients with cirrhosis. In fact, while the unfavorable impact of acute decompensation is well known, there is currently a dearth of evidence on NAD, despite it being a common occurrence in clinical practice. Our data show that almost half of decompensations in patients with cirrhosis can be considered NAD and that such events are associated with a higher risk of mortality than no decompensation. This study has important clinical implications because it highlights the need to carefully consider patients who develop NAD, in order to prevent further decompensation and reduce mortality.


Assuntos
Doença Hepática Terminal , Humanos , Prognóstico , Doença Hepática Terminal/complicações , NAD , Índice de Gravidade de Doença , Cirrose Hepática/complicações , Cirrose Hepática/diagnóstico , Cirrose Hepática/epidemiologia
6.
Gastroenterology ; 165(3): 762-772.e2, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37277078

RESUMO

BACKGROUND & AIMS: Current guidelines vary as to their recommendations addressing the role of hemostatic powders when managing patients with malignant gastrointestinal (GI) bleeding because these are based on very-low- to low-quality evidence, in large part due to a paucity of randomized trial data. METHODS: This was a patient- and outcome assessor-blinded, multicenter, randomized controlled trial. Patients presenting with active bleeding from an upper or lower GI lesion suspected to be malignant at index endoscopy between June 2019 and January 2022 were randomly allocated to receive either TC-325 alone or standard endoscopic treatment (SET). The primary outcome was 30-day rebleeding, and secondary objectives included immediate hemostasis and other clinically relevant endpoints. RESULTS: Overall, 106 patients made up the study population (55 TC-325 and 51 SET, after 1 exclusion in the TC-325 group and 5 in the SET group). Baseline characteristics and endoscopic findings did not differ between the groups. Thirty-day rebleeding was significantly lower in the TC-325 (2.1% TC-325 vs 21.3% SET; odds ratio, 0.09; 95% confidence interval [CI], 0.01-0.80; P = .003). Immediate hemostasis rates were 100% in the TC-325 group vs 68.6% in the SET group (odds ratio, 1.45; 95% CI, 0.93-2.29; P < .001). Other secondary outcomes did not differ between the 2 groups. Independent predictors of 6-month survival included the Charlson comorbidity index (hazard ratio, 1.17; 95% CI, 1.05-1.32; P = .007) and receiving an additional nonendoscopic hemostatic or oncologic treatment during 30 days after the index endoscopy (hazard ratio, 0.16; 95% CI, 0.06-0.43; P < .001) after adjustment for functional status, Glasgow-Blatchford score, and an upper GI source of bleeding. CONCLUSION: The TC-325 hemostatic powder results in greater immediate hemostasis rates followed by lower 30-day rebleeding rates when compared to contemporary SET. (ClinicalTrials.gov, Number: NCT03855904).


Assuntos
Neoplasias Gastrointestinais , Hemostase Endoscópica , Hemostáticos , Humanos , Pós , Hemostase Endoscópica/efeitos adversos , Hemostase Endoscópica/métodos , Recidiva Local de Neoplasia/terapia , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/cirurgia , Neoplasias Gastrointestinais/complicações , Neoplasias Gastrointestinais/cirurgia , Endoscopia Gastrointestinal/efeitos adversos , Hemostáticos/uso terapêutico , Recidiva
7.
Clin Gastroenterol Hepatol ; 22(5): 981-993.e11, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38184099

RESUMO

BACKGROUND & AIMS: In patients with atrial fibrillation (AF) receiving direct oral anticoagulant (DOAC), upper gastrointestinal bleeding (UGIB) is a serious complication. There are limited data on the benefit of preventive proton pump inhibitor (PPI) use to reduce the risk of UGIB in DOAC users. METHODS: We included patients with AF receiving DOAC from 2015 to 2020 based on the Korean Health Insurance Review and Assessment database. The propensity score (PS) weighting method was used to compare patients with PPI use and those without PPI use. The primary outcome was hospitalization for UGIB. Weighted hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) were evaluated using the Cox proportional hazards regression model. RESULTS: A total of 165,624 patients were included (mean age: 72.2 ± 10.8 years; mean CHA2DS2-VASc score: 4.3 ± 1.8; mean HAS-BLED score: 3.3 ± 1.2). Among them, 99,868 and 65,756 were in the non-PPI group and PPI group, respectively. During a median follow-up of 1.5 years, the PPI group was associated with lower risks of hospitalization for UGIB and UGIB requiring red blood cell transfusion than non-PPI group (weighted HR, 0.825; 95% CI, 0.761-0.894 and 0.798; 95% CI, 0.717-0.887, respectively, both P < .001). The benefits of PPI on the risk of hospitalization for UGIB were greater in those with older age (≥75 years), higher HAS-BLED score (≥3), prior GIB history, and concomitant use of antiplatelet agent (all P-for-interaction < .1). Low-dose PPI was consistently associated with a lower risk of significant UGIB by 43.6-49.3% (P < .001). CONCLUSIONS: In this large Asian cohort of patients with AF on DOAC, PPI co-therapy is beneficial for reducing the risk of hospitalization for UGIB, particularly in high-risk patients.


Assuntos
Fibrilação Atrial , Hemorragia Gastrointestinal , Inibidores da Bomba de Prótons , Humanos , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , Inibidores da Bomba de Prótons/administração & dosagem , Inibidores da Bomba de Prótons/uso terapêutico , Inibidores da Bomba de Prótons/efeitos adversos , Masculino , Feminino , Idoso , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/prevenção & controle , República da Coreia , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Anticoagulantes/administração & dosagem , Anticoagulantes/uso terapêutico , Hospitalização/estatística & dados numéricos , Estudos de Coortes , Administração Oral , Estudos Retrospectivos
8.
Rev Cardiovasc Med ; 25(5): 189, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-39076474

RESUMO

Background: Limited studies have explored the association between blood urea nitrogen (BUN) levels and in-hospital mortality in patients with acute myocardial infarction (AMI) and subsequent gastrointestinal bleeding (GIB). Our objective was to explore this correlation. Methods: 276 individuals with AMI and subsequent GIB were retrospectively included between January 2012 and April 2023. The predictive value of BUN for in-hospital mortality was assessed through receiver operating characteristic (ROC) curve. Logistic regression models were constructed to assess the relationship between BUN and in-hospital mortality. Propensity score weighting (PSW), sensitivity and subgroup analyses were used to further explore the association. Results: Fifty-three (19.2%) patients died in the hospital. BUN levels were higher in non-survivors compared with the survivors [(11.17 ± 6.17) vs (8.09 ± 4.24), p = 0.001]. The ROC curve suggested that the optimal cut-off for BUN levels to predict in-hospital mortality was 8.45 mmol/L (AUC [area under the ROC curve] 0.678, 95% confidence interval [CI] 0.595-0.761, p < 0.001). Multivariable logistic regression showed that elevated BUN levels ( ≥ 8.45 mmol/L) were positively association with in-hospital mortality (odds ratio [OR] 4.01, 95% CI 1.55-10.42, p = 0.004). After PSW, sensitivity and subgroup analyses, the association remained significant. Conclusions: Elevated BUN levels were associated with in-hospital mortality in patients with AMI and subsequent GIB.

9.
Haemophilia ; 30(4): 970-980, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38751022

RESUMO

INTRODUCTION: Gastrointestinal (GI) bleeding events (BEs) in von Willebrand disease (VWD) are difficult to diagnose and often recurrent. Limited data from clinical trials has led to lack of consensus on treatment options. AIM: Describe current treatments and outcomes for GI BEs in people with VWD. METHODS: This retrospective, observational, multicentre chart review study was conducted from January 2018 through December 2019 and included patients with inherited VWD with ≥1 GI BE in the preceding 5 years. Baseline characteristics, number and aetiology of BEs, associated GI-specific morbidities/lesions, treatment and outcomes were analysed descriptively. RESULTS: Sixty bleeds were reported in 20 patients with type 1 (20%), type 2 (50%) and type 3 (30%) VWD. During the 5-year study period, 31 (52%) BEs had one identified or suspected cause; multiple causes were reported in 11 (18%). Most GI BEs (72%) were treated with a combination of von Willebrand factor (VWF), antifibrinolytics and/or other haemostatic or non-haemostatic treatments. Time to resolution did not differ by VWF treatment use; however, BEs treated with non-VWF treatments tended to resolve later. In patients with GI-specific morbidities/lesions, 84% resolved with first-line treatment; time to resolution tended to be longer than in patients without such morbidities/lesions. Thirteen BEs occurred in patients receiving prophylaxis and 47 in patients receiving on-demand treatment; 18 BEs resulted in a switch to prophylaxis after bleed resolution. CONCLUSIONS: This study confirms the unmet need for the management of recurrent GI BEs in people with VWD and the need for prospective data, especially on prophylaxis.


Assuntos
Hemorragia Gastrointestinal , Doenças de von Willebrand , Humanos , Doenças de von Willebrand/complicações , Estudos Retrospectivos , Hemorragia Gastrointestinal/etiologia , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Adulto Jovem , Adolescente , Idoso , Criança , Fator de von Willebrand/uso terapêutico , Pré-Escolar
10.
J Surg Res ; 296: 735-741, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38368774

RESUMO

INTRODUCTION: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a potential tool for the management of massive gastrointestinal bleeding (MGB). This study aims to describe the experience of the use of REBOA as adjunctive therapy in patients with MGB and to evaluate its effectiveness. METHODS: Serial cases of patients with hemorrhagic shock secondary to MGB in whom REBOA was placed were collected. Patient demographics, bleeding severity, etiology, management, and clinical outcomes were recorded. RESULTS: Between 2017 and 2020, five cases were analyzed. All patients had a severe gastrointestinal bleeding (Glasgow Blatchford Bleeding Score range 12-17; Clinical Rockal Score range 5-9). The etiologies of MGB were perforated gastric or duodenal ulcers, esophageal varices, and vascular lesions. Systolic blood pressure increased after REBOA placement and total occlusion time was 25-60 min. REBOA provided temporary hemorrhage control in all cases and allowed additional hemostatic maneuvers to be performed. Three patients survived more than 24 h. All patients died in index hospitalization. The main cause of death was related to hemorrhagic shock. CONCLUSIONS: Endovascular aortic occlusion can work as a bridge to further resuscitation and attempts at hemostasis in patients with MGB. REBOA provides hemodynamic support and may be used simultaneously with other hemostatic maneuvers, facilitating definitive hemorrhage control.


Assuntos
Oclusão com Balão , Procedimentos Endovasculares , Hemostáticos , Choque Hemorrágico , Humanos , Choque Hemorrágico/terapia , Aorta , Ressuscitação , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/terapia , Escala de Gravidade do Ferimento
11.
BMC Med Res Methodol ; 24(1): 109, 2024 May 04.
Artigo em Inglês | MEDLINE | ID: mdl-38704520

RESUMO

BACKGROUND: During the COVID-19 pandemic, many intensive care units (ICUs) halted research to focus on COVID-19-specific studies. OBJECTIVE: To describe the conduct of an international randomized trial of stress ulcer prophylaxis (Re-Evaluating the Inhibition of Stress Erosions in the ICU [REVISE]) during the pandemic, addressing enrolment patterns, center engagement, informed consent processes, data collection, a COVID-specific substudy, patient transfers, and data monitoring. METHODS: REVISE is a randomized trial among mechanically ventilated patients, comparing pantoprazole 40 mg IV to placebo on the primary efficacy outcome of clinically important upper gastrointestinal bleeding and the primary safety outcome of 90-day mortality. We documented protocol implementation status from March 11th 2020-August 30th 2022. RESULTS: The Steering Committee did not change the scientific protocol. From the first enrolment on July 9th 2019 to March 10th 2020 (8 months preceding the pandemic), 267 patients were enrolled in 18 centers. From March 11th 2020-August 30th 2022 (30 months thereafter), 41 new centers joined; 59 were participating by August 30th 2022 which enrolled 2961 patients. During a total of 1235 enrolment-months in the pandemic phase, enrolment paused for 106 (8.6%) months in aggregate (median 3 months, interquartile range 2;6). Protocol implementation involved a shift from the a priori consent model pre-pandemic (188, 58.8%) to the consent to continue model (1615, 54.1%, p < 0.01). In one new center, an opt-out model was approved. The informed consent rate increased slightly (80.7% to 85.0%, p = 0.05). Telephone consent encounters increased (16.6% to 68.2%, p < 0.001). Surge capacity necessitated intra-institutional transfers; receiving centers continued protocol implementation whenever possible. We developed a nested COVID-19 substudy. The Methods Centers continued central statistical monitoring of trial metrics. Site monitoring was initially remote, then in-person when restrictions lifted. CONCLUSION: Protocol implementation adaptations during the pandemic included a shift in the consent model, a sustained high consent rate, and launch of a COVID-19 substudy. Recruitment increased as new centers joined, patient transfers were optimized, and monitoring methods were adapted.


Assuntos
COVID-19 , Humanos , COVID-19/prevenção & controle , COVID-19/epidemiologia , Pantoprazol/uso terapêutico , SARS-CoV-2 , Unidades de Terapia Intensiva/estatística & dados numéricos , Pandemias/prevenção & controle , Feminino , Respiração Artificial/estatística & dados numéricos , Masculino , Protocolos Clínicos , Pessoa de Meia-Idade , Hemorragia Gastrointestinal/prevenção & controle , Antiulcerosos/uso terapêutico , Antiulcerosos/administração & dosagem
12.
Scand J Gastroenterol ; 59(4): 512-517, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38149333

RESUMO

BACKGROUND/AIMS: While current guidelines recommend performing endoscopy within 24 h in case of acute upper gastrointestinal bleeding (AUGIB), the precise timing remains an issue of debate. Lactate is an established parameter for risk stratification in a variety of medical emergencies. This study evaluated the predictive ability of elevated lactate levels in identifying patients with UGIB, who may benefit from emergent endoscopy. METHODS: We retrospectively analyzed all patients with elevated lactate levels, who presented to our emergency department between 01 January 2015 and 31 December 2019 due to suspected AUGIB. RESULTS: Of 134 included cases, 81.3% had an Charlson comorbidity index of ≥3 and 50.4% presented with shock. Fifteen (11.2%) patients died and mortality rates rose with increasing lactate levels. Emergent endoscopy within 6 h (EE) and non-EE were performed in 64 (47.8%) and 70 (52.2%) patients, respectively. Patients who underwent EE had lower systolic blood pressure (107.6 mmHg vs. 123.2 mmHg; p = 0.001) and received blood transfusions more frequently (79.7% vs 64.3%; p = 0.048), but interestingly need for endoscopic intervention (26.6% vs 20.0%; p = 0.37), rebleeding (17.2% vs. 15.7%; p = 0.82) and mortality (9.4% vs. 11.4%; p = 0.7) did not differ significantly. CONCLUSION: In conclusion, our findings support the recommendations of current guidelines to perform non-EE after sufficient resuscitation and management of comorbid illnesses.


Assuntos
Endoscopia Gastrointestinal , Hemorragia Gastrointestinal , Humanos , Estudos Retrospectivos , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/terapia , Doença Aguda , Ácido Láctico
13.
Scand J Gastroenterol ; 59(7): 781-787, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38629130

RESUMO

BACKGROUND: Thalidomide has been used for angioectasia-associated refractory gastrointestinal bleeding (GIB), with studies showing variable efficacy and side effects profile. We conducted a meta-analysis to reconcile the data. METHODS: Online databases were searched for studies evaluating thalidomide in patients with refractory/recurrent GIB due to angioectasias. The outcomes of interest were cessation of bleeding, rebleeding, need for blood transfusion, hospitalization and adverse events. Pooled proportions for incidence, and odds ratios (OR) for comparison with control were calculated along with 95% confidence interval (CI). RESULTS: A total of seven studies with 346 patients (n = 269 thalidomide, n = 77 control) were included. Thalidomide dose was usually started at 50-100mg/day. The mean age was 65 years, 45% patients were men, and mean follow-up was 1.8 years. The pooled clinical outcomes with thalidomide were: cessation of bleeding 42.2% (95% CI 36.02 to 48.41), rebleeding 30%, need for blood transfusion 20.1%, hospitalization 40% and adverse events 55.9%. When compared with the control group in 2 studies, patients on thalidomide had significantly higher odds of cessation of bleeding (OR 21.40, 95% CI 5.78 to 79.29, p < 0.00001) and adverse events, with lower need for blood transfusion and hospitalization. DISCUSSION: In patients with angioectasias-related refractory/recurrent GIB, the use of thalidomide results in significantly decreased bleeding risk and may play a role in the management of such patients.


Assuntos
Inibidores da Angiogênese , Hemorragia Gastrointestinal , Talidomida , Feminino , Humanos , Inibidores da Angiogênese/efeitos adversos , Inibidores da Angiogênese/uso terapêutico , Transfusão de Sangue/estatística & dados numéricos , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/tratamento farmacológico , Hospitalização/estatística & dados numéricos , Recidiva , Talidomida/uso terapêutico , Talidomida/efeitos adversos , Resultado do Tratamento
14.
Scand J Gastroenterol ; 59(9): 1081-1086, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39105571

RESUMO

OBJECTIVES: Upper gastrointestinal bleeding (GIB) in patients has been well-characterized in liver cirrhosis but studies on lower GIB are limited. The clinical characteristics, management and outcomes in patients with and without liver cirrhosis was compared to determine the overall features of GIB in patients with liver cirrhosis compared with non-cirrhotics. METHODS: A retrospective study on cirrhotics hospitalized for GIB 2010-2021, matched with control group of non-cirrhotics (1:4) for upper vs. lower GIB. Patients with overt bleeding leading to hospitalization were included. RESULTS: Overall, 396 patients had cirrhosis, 267 (67%) men, median age 62, alcoholic etiology 177/396 (45%), median MELD 12 (range 6-32). Overall 102 cirrhotics had GIB, matched with 391 non-cirrhotics. Overall 87 (85%) cirrhotic patients had upper and 15% lower GIB. Compared to non-cirrhotics, the cause of GIB was more commonly acute variceal bleeding (AVB) (42% vs. 1%), hemorrhoids 40% vs. 6% (p = 0.002), less commonly gastric ulcer 13% vs. 31% (p < 0.001), duodenal ulcer 9% vs. 29% (p < 0.001), 5% of cirrhotics used NSAIDs vs. 26% of controls (p < 0.001). Rebleeding occurred in 14% of cirrhotics vs. 3% in controls (p < 0.001). Only one cirrhotic patient (1%) died from GIB vs. 0.8% of controls within 45 days. Overall mortality 45 days after hospitalization was 10% in cirrhotics vs. 5% in controls (p < 0.001). CONCLUSIONS: Bleeding from gastric and duodenal ulcers were less common in cirrhotics than in controls. Bleeding from hemorrhoids was more common in cirrhotics. Mortality due to GIB was low in both groups but overall mortality was significantly higher in cirrhotics.


Assuntos
Varizes Esofágicas e Gástricas , Hemorragia Gastrointestinal , Cirrose Hepática , Humanos , Masculino , Feminino , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/mortalidade , Pessoa de Meia-Idade , Estudos Retrospectivos , Cirrose Hepática/complicações , Cirrose Hepática/mortalidade , Idoso , Varizes Esofágicas e Gástricas/complicações , Adulto , Hemorroidas/complicações , Hospitalização/estatística & dados numéricos , Estudos de Casos e Controles , Úlcera Gástrica/complicações , Úlcera Duodenal/complicações , Fatores de Risco
15.
Scand J Gastroenterol ; 59(10): 1172-1177, 2024 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-39264069

RESUMO

INTRODUCTION: Lower gastrointestinal bleeding (LGIB) is a common cause of emergency hospitalization and may require readmission for re-bleeding. A novel adhesive endoscopic hemostatic powder (UI-EWD/NexpowderTM, Nextbiomedical, Incheon, South Korea) has been developed and recently utilized for LGIB hemostasis. The aim of the current study was to assess the efficacy and safety of UI-EWD as a rescue therapy for the treatment of refractory LGIB. METHODS: In this study, a total of 59 consecutive patients with LGIB who experienced initial hemostasis failure with conventional endoscopic therapy were enrolled into this multicenter single-arm study. These patients subsequently underwent UI-EWD application for the refractory LGIB hemostasis. We evaluated the success rate of hemostasis, re-bleeding rate within 30 d, and adverse events related to UI-EWD. RESULTS: UI-EWD was successfully administered to the bleeding sites in all enrolled refractory bleeding patients. Hemostasis was achieved in the entirety of the 59 patients (100%). The cumulative re-bleeding rate within 30 d was 8.5% (5/59). There were no UI-EWD-related adverse events, such as perforation nor embolism. CONCLUSION: Based on our results, the utilization of UI-EWD demonstrated a remarkable success rate in achieving hemostasis for refractory LGIB, while also exhibiting promising outcomes in reducing the re-bleeding rate within a 30-day period. Particularly, UI-EWD exhibits a favorable safety profile across all segments of the colon in cases of refractory LGIB.


Assuntos
Hemorragia Gastrointestinal , Hemostase Endoscópica , Hemostáticos , Pós , Humanos , Masculino , Feminino , Hemorragia Gastrointestinal/terapia , Hemorragia Gastrointestinal/etiologia , Pessoa de Meia-Idade , Idoso , Hemostáticos/uso terapêutico , Hemostáticos/administração & dosagem , Hemostase Endoscópica/métodos , Resultado do Tratamento , República da Coreia , Adulto , Idoso de 80 Anos ou mais , Recidiva
16.
Scand J Gastroenterol ; 59(5): 615-622, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38305194

RESUMO

BACKGROUND: This retrospective study, conducted using the U.S. National Inpatient Sample (NIS), examines the outcomes and management of nonvariceal upper gastrointestinal bleeding (NVUGIB) in COVID-19 patients and identifies predictive factors to enhance patient prognosis. METHODS: We analyzed the 2020 U.S. NIS data involving adult patients (≥18 years) admitted with NVUGIB and categorized them based on the presence of COVID-19. Primary and secondary outcomes, NVUGIB-related procedures, and predictive factors were evaluated. RESULTS: Of 184,885 adult patients admitted with NVUGIB, 1.6% (2990) had COVID-19. Patients with NVUGIB and COVID-19 showed higher inpatient mortality, acute kidney injury, need for intensive care, and resource utilization metrics. Notably, there was a lower rate of early esophagogastroduodenoscopy (EGD). Multivariate logistic regression revealed conditions like peptic ulcer disease, mechanical ventilation, and alcohol abuse as significant positive predictors for NVUGIB in COVID-19 patients, whereas female gender and smoking were negative predictors. CONCLUSION: Our findings suggest that COVID-19 significantly increases the risk of mortality and complications in NVUGIB patients. The observed decrease in early EGD interventions, potentially contributing to higher mortality rates, calls for a review of treatment strategies. Further multicenter, prospective studies are needed to validate these results and improve patient care strategies.


Assuntos
COVID-19 , Hemorragia Gastrointestinal , Mortalidade Hospitalar , Humanos , COVID-19/complicações , COVID-19/epidemiologia , COVID-19/mortalidade , Masculino , Feminino , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/mortalidade , Hemorragia Gastrointestinal/terapia , Estudos Retrospectivos , Pessoa de Meia-Idade , Idoso , Estados Unidos/epidemiologia , Adulto , SARS-CoV-2 , Fatores de Risco , Pacientes Internados/estatística & dados numéricos , Idoso de 80 Anos ou mais , Prognóstico , Endoscopia do Sistema Digestório , Hospitalização/estatística & dados numéricos
17.
BMC Gastroenterol ; 24(1): 42, 2024 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-38254056

RESUMO

BACKGROUND/AIMS: Upper gastrointestinal bleeding (UGIB) is a frequent medical issue. The primary risk factors for bleeding peptic ulcers are Helicobacter pylori infection and non-steroidal anti-inflammatory drugs. The association between acute gastric/duodenal ulcer and opium use has been previously proposed; however, there is no available data on endoscopic findings of patients with acute UGIB who use opium. MATERIALS AND METHODS: In the present descriptive cross-sectional study, endoscopic data of 50 consecutive patients with oral opium use and 50 consecutive patients without any opium use who were admitted for UGIB were recorded. The size (5-10 mm, 11-20 mm, or more than 20 mm), number (single, double, or multiple), and location of the ulcers (esophagus, gastric corpus including the fundus and body, antrum, angulus, or duodenum) were examined by endoscopy in both groups. RESULTS: Three or more ulcers were observed in 46% and 16% of patients with oral opium use and without opium use, respectively (P-value = 0.001). The rate of giant ulcers (> 20 mm) was significantly higher in patients who used oral opium (40% vs. 12%; P-value = 0.007). Esophageal ulcers were also more common in oral opium users (30%) than non-users (8%) with UGIB (P-value = 0.01). Nevertheless, the location of the ulcers between the two groups generally was not statistically different. CONCLUSIONS: This study has demonstrated that multiple, large peptic ulcers in GIB are potential complications of oral opium use. This could aid the needed modifications in the treatment protocol for these patients.


Assuntos
Úlcera Duodenal , Infecções por Helicobacter , Helicobacter pylori , Dependência de Ópio , Úlcera Péptica , Úlcera Gástrica , Humanos , Ópio/efeitos adversos , Úlcera , Estudos Transversais , Infecções por Helicobacter/complicações , Úlcera Péptica/complicações , Hemorragia Gastrointestinal/induzido quimicamente , Úlcera Duodenal/complicações , Úlcera Gástrica/complicações
18.
BMC Gastroenterol ; 24(1): 216, 2024 Jul 05.
Artigo em Inglês | MEDLINE | ID: mdl-38969973

RESUMO

BACKGROUND: Stroke-associated pneumonia (SAP) and gastrointestinal bleeding (GIB) are common medical complications after stroke. The previous study suggested a strong association between SAP and GIB after stroke. However, little is known about the time sequence of SAP and GIB. In the present study, we aimed to verify the association and clarify the temporal sequence of SAP and GIB after ischemic stroke. METHODS: Patients with ischemic stroke from in-hospital Medical Complication after Acute Stroke study were analyzed. Data on occurrences of SAP and GIB during hospitalization and the intervals from stroke onset to diagnosis of SAP and GIB were collected. Multiple logistic regression was used to evaluate the association between SAP and GIB. Kruskal-Wallis test was used to compare the time intervals from stroke onset to diagnosis of SAP and GIB. RESULTS: A total of 1129 patients with ischemic stroke were included. The median length of hospitalization was 14 days. Overall, 86 patients (7.6%; 95% CI, 6.1-9.2%) developed SAP and 47 patients (4.3%; 95% CI, 3.0-5.3%) developed GIB during hospitalization. After adjusting potential confounders, SAP was significantly associated with the development of GIB after ischemic stroke (OR = 5.13; 95% CI, 2.02-13.00; P < 0.001). The median time from stroke onset to diagnosis of SAP was shorter than that of GIB after ischemic stroke (4 days vs. 5 days; P = 0.039). CONCLUSIONS: SAP was associated with GIB after ischemic stroke, and the onset time of SAP was earlier than that of GIB. It is imperative to take precautions to prevent GIB in stroke patients with SAP.


Assuntos
Hemorragia Gastrointestinal , AVC Isquêmico , Pneumonia , Humanos , Masculino , Feminino , AVC Isquêmico/epidemiologia , AVC Isquêmico/complicações , AVC Isquêmico/etiologia , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/epidemiologia , Idoso , Pneumonia/complicações , Pneumonia/epidemiologia , Pessoa de Meia-Idade , Fatores de Tempo , Fatores de Risco , Hospitalização/estatística & dados numéricos , Tempo de Internação/estatística & dados numéricos , Idoso de 80 Anos ou mais , Modelos Logísticos
19.
BMC Gastroenterol ; 24(1): 319, 2024 Sep 18.
Artigo em Inglês | MEDLINE | ID: mdl-39294584

RESUMO

OBJECTIVE: This study aims to assess the effects of antithrombotic therapy on the outcomes of lower gastrointestinal bleeding (LGIB) in ICU patients, focusing on in-hospital mortality, rebleeding, and length of hospital and ICU stays. METHOD: This retrospective observational study utilized the MIMIC-IV 2.2 database, which includes 513 ICU patients with LGIB. RESULT: The in-hospital mortality rate was 7.6%, and the rebleeding rate was 11.1%. The average Oakland risk score among the study population was 22.54. Multivariate Cox regression analysis identified the use of antiplatelet drugs as an independent protective factor for in-hospital mortality (HR = 0.37, 95% CI 0.15-0.90, p = 0.029). Patients on anticoagulants experienced significantly longer hospital stays (13.1 ± 12.2 days vs. 17.4 ± 12.6 days, p = 0.031) compared to those not using these drugs. Propensity score matching also supported these findings, indicating that antithrombotic therapy was associated with lower in-hospital mortality and longer hospital stays even after adjusting for factors like age, gender, and primary diagnosis. CONCLUSIONS: Our analysis using various statistical methods, including propensity score matching and multivariate regression, confirms that use of antithrombotic drugs in 2.3 days, particularly antiplatelets, are associated with a lower risk of in-hospital mortality. However, they may increase the risk of rebleeding and extend hospital stays in certain subgroups.


Assuntos
Hemorragia Gastrointestinal , Mortalidade Hospitalar , Unidades de Terapia Intensiva , Tempo de Internação , Inibidores da Agregação Plaquetária , Humanos , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/mortalidade , Masculino , Feminino , Estudos Retrospectivos , Tempo de Internação/estatística & dados numéricos , Idoso , Fatores de Risco , Pessoa de Meia-Idade , Unidades de Terapia Intensiva/estatística & dados numéricos , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/uso terapêutico , Recidiva , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Pontuação de Propensão , Fibrinolíticos/efeitos adversos , Fibrinolíticos/uso terapêutico
20.
BMC Gastroenterol ; 24(1): 287, 2024 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-39187770

RESUMO

BACKGROUND: Portal hypertensive enteropathy (PHE) is a small-bowel lesion observed in patients with portal hypertension. The clinical significance of endoscopic findings in PHE remains unclear. We aimed to clarify the clinical significance and predictive factors of capsule endoscopic findings in patients with PHE based on long-term outcomes. METHODS: This retrospective study enrolled 55 patients with PHE (33 males and 22 females; median age, 64 years; range, 23-87) followed for > 3 years using capsule endoscopy (CE) between February 2009 and May 2023. We evaluated the clinical factors affecting PHE exacerbations and the effects of PHE exacerbations on gastrointestinal bleeding by comparing exacerbated and unchanged PHE groups. RESULTS: Overall, 3 (5%) patients showed improvement, 33 (60%) remained unchanged, and 19 (35%) showed exacerbation on follow-up CE. In the exacerbated group, the rates of worsened fibrosis-4 index, exacerbated esophageal varices, and exacerbated portal hypertensive gastropathy were significantly higher than those in the unchanged group (21%, 32%, and 42% vs. 3%, 6%, and 12%, respectively; P < 0.05), and the rate of splenectomy was significantly lower in the exacerbated group than in the unchanged group (5% vs. 39%, respectively; P < 0.01). In multivariate analysis, exacerbation of esophageal varices and absence of splenectomy were significantly associated with PHE exacerbation. The rate of gastrointestinal bleeding after follow-up CE was significantly high in the exacerbated group (log-rank, P = 0.037). CONCLUSIONS: Exacerbation of esophageal varices and splenectomy were significantly associated with exacerbation of PHE. Exacerbated PHE requires specific attention to prevent gastrointestinal bleeding.


Assuntos
Endoscopia por Cápsula , Progressão da Doença , Varizes Esofágicas e Gástricas , Hemorragia Gastrointestinal , Hipertensão Portal , Humanos , Hipertensão Portal/etiologia , Hipertensão Portal/complicações , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Estudos Retrospectivos , Adulto , Hemorragia Gastrointestinal/etiologia , Idoso de 80 Anos ou mais , Varizes Esofágicas e Gástricas/etiologia , Adulto Jovem , Esplenectomia , Enteropatias/etiologia , Enteropatias/complicações , Intestino Delgado/patologia , Intestino Delgado/diagnóstico por imagem
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