Introduction: In the United States, hepatitis B virus (HBV)-associated hepatocellular carcinoma (HCC) is predominantly seen in patients from Sub-Saharian Africa and Eastern Asia where HBV infection is prevalent. Because of delayed diagnosis and resource-intensive management required to treat advanced disease, the prognosis of HCC is often very poor, even in otherwise healthy patients. Here, we present the case of a patient with advanced HBV-related HCC and aim to analyze the factors that led to this presentation in order to identify potential areas of intervention and develop strategies to prevent similar outcomes. Case Description/Methods: In 2019, a 52 year-old man from Ghana without any known medical history, initially presented to our hospital with complaint of dizziness. At the time, he was diagnosed with concomitant HIV and acute HBV infection, and discharged with infectious disease (ID) clinic follow-up. Antiviral therapy including TAF was started and Liver US was performed which showed coarse heterogeneous hepatic echotexture. He was enrolled in a retention and adherence program to assist with insurance, medication procurement, and appointment scheduling. After being successfully discharged from RAP in September 2020, the patient’s insurance coverage was lost for 7 consecutive months during which he was unable to procure antiviral medications or attend regular follow-up. With the involvement of social and financial services, in late December 2022, the patient’s insurance was re-instated and he was linked to ID clinic to re-establish care. However, in April 2023, he presented to the ER for severe right upper quadrant abdominal pain. Further imaging was performed and biopsy-proven advanced HBV-related HCC was diagnosed. He was discharged with close follow-up with oncology and is currently receiving durvalumab and tremelimumab in oncology clinic. Discussion: Overall this case highlights several hurdles and gaps that hamper care for immigrant patients in the United States. Lack of longitudinal follow-up and cancer surveillance screening is ultimately responsible for advanced disease presentations requiring resource-intensive therapies and leading to dismal outcomes. Immigrants with HBV/HIV infections remain at high risk for HCC and face unique challenges that require a comprehensive and multidisciplinary approach to improve outcomes. Further natural history studies of HCC in HIV-HBV coinfection within these populations are needed to better understand disease progression and develop targeted interventions (Figure 1).Figure 1.: Image A shows an ultrasound on the initial presentation in 2019, coarse echotexture of the hepatic parenchyma can be appreciated, no lesions were seen. Image B is the patient's ultrasound from a subsequent encounter in 2023. Numerous lesions can be seen. The patient did not undergo any imaging in between. Images C and D are cross-sections from a CT scan performed during his encounter in 2023. Image C: Innumerable liver lesions can be seen (Portal venous phase). Image D: multiple liver lesions with ascites (portal venous phase, hepatic window). An image-guided paracentesis was performed revealing 700 mL of old blood. Imaging findings along with ascitic fluid findings suggested that the patient had likely sustained a rupture of a subcapsular liver mass, resulting in intraperitoneal bleeding.
Metabolic dysfunction-associated fatty liver disease (MAFLD) is a growing global health concern which is driven by the increasing prevalence of diabetes and obesity. MAFLD is characterized by excessive fat accumulation in the liver, which encompasses a range of conditions, from simple hepatic steatosis to more severe forms. This condition is associated with various complications, including chronic kidney disease (CKD), Cardiovascular Disease (CVD), liver cirrhosis, and even malignancy. Recent research has highlighted a potential connection between gut dysbiosis and MAFLD, particularly in relation to CKD. This has underscored the significance of the gut-liver-kidney axis in understanding MAFLD's pathogenesis. Inflammation triggered by MAFLD increases the risk of CVD through multiple mechanisms linked to metabolic dysfunction. These mechanisms include heightened oxidative stress, systemic and hepatic insulin resistance, low-grade inflammation, and endothelial dysfunction. Hepatic steatosis and metabolic dysfunction are major diagnostic criteria for MAFLD, often coexisting with other liver ailments. This prospective review emphasizes the intricate associations between MAFLD, cardiovascular complications, renal issues, and hepatic diseases. Understanding the underlying pathophysiological pathways is crucial in comprehending the increased risk of CKD, CVD, and other hepatic complications in individuals with MAFLD.
Biliary strictures or narrowing of a portion of the biliary tree can have benign and malignant etiologies. One third of these will originate from iatrogenic injury and these are typically managed endoscopically. We present the case of a 76-year-old man with history of laparoscopic cholecystectomy ten years prior, who presented with one week of jaundice, dark urine, and pruritus. Along with non-invasive biliary imaging, he underwent cholangioscopy during endoscopic retrograde cholangiopancreatography revealing inflammatory-appearing stenosis of the common hepatic duct with embedded suture material. The stenotic area was biopsied using mini forceps and subsequently dilated with a balloon dilator. A plastic biliary stent was placed with improvement in the patient’s hepatic function, with final cytology and pathology being negative for malignancy. Cholangioscopy facilitated detailed visual inspection of strictures and biopsies under direct visualization. The visual impression increased the sensitivity of the biopsy and assisted in ruling out malignancy from the most critical portion of the stricture. While timing of cholangioscopy remains to be determined, its use is a valuable tool in the diagnosis of indeterminate biliary strictures.
Abstract Introduction To analyze cardiovascular disease (CVD) studies from the United States registered on ClinicalTrials.gov focusing on characteristics associated with their external validity; the presence of Data Monitoring Committee/Data Safety Monitoring Board (DMC/DSMB), randomization, blinding, and gender of the principal investigators (PIs). Methods We queried the Application Programming Interface (API) of ClinicalTrials.gov to extract data on characteristics of the identified studies, most notably, DMC/DSMB status, Design Allocation, Design masking, and gender of PIs. Results We identified 536 studies pertinent to CVD for this analysis. Out of 536, 471 (88%) were interventional studies (Clinical trials) and 65 (12%) were observational studies with interventions. Amongst these, 261 (49%) reported having a DMC, 312 (66%) reported randomization, 224 (48%) reported masking and 122 (19%) of the PIs were women. No trend was seen in the annual proportion of studies with DMC, randomization, masking, and women as PIs (P-trend > 0.05 for all). Multivariable logistic regression analyses were notable for higher odds of DMC (aOR, 5.28; 95% CI, 2.70 – 10.90; P < 0.05) and blinding (aOR, 2.42; 95% CI, 1.29 – 4.64; P < 0.05) in NIH-funded studies and higher odds of being terminated/suspended or withdrawn in basic science studies (aOR, 2.83; 95% CI, 1.07 - 6.90; P < 0.05). No relation was seen between any characteristics and the study being completed. Conclusions We report on the absence of DMCs, randomization, blinding, women as PIs, and lack of cross-gender collaboration in the leadership of CVD studies without any favorable trend over the past decade. This calls for comprehensive efforts to improve these trends and ultimately, the external validity of studies. We also call for an overhaul of the definition of the phase of a clinical trial that centers around a drug being the intervention.
Introduction: We examine cardiovascular medicine clinical trials (CTs) from the United States over the past decade focusing on characteristics that are important for assessing the reliability of evidence derived from them. Methods: The Clinicaltrials.gov API interface was queried with a comprehensive search strategy to identify trials in the field of cardiovascular medicine from the US registered from 1/1/2012 till the 12/31/2021. We extracted data on the presence of data monitoring committees (DMC), masking status and allocation methods used in the CTs. Results: Our initial query identified 1299 CTs. After reviewing and excluding unrelated trials, 536 were found to be cardiovascular medicine CTs. Of these, 507 (95%) reported if they had a DMC or not, 261 (49%) reported having a DMC while 246 (46%) reported not having one. 471 (88%) CTs reported on their design allocation method, most common being randomized as reported by 312 (58%) of the trials, 43 (8%) were non-randomized and 116 (22%) reported that a design allocation was not applicable to them. 471 (88%) CTs reported on their masking status, most common being open label as seen in 247 (46%) of the trials followed by double masking seen in 71 (13%) of the trials. On performing a Cox and Stuart trend test, no trend was seen in the annual proportion of trials with randomization, a DMC or masking over the past decade [P > 0.05 for all three]. Conclusions: In these analyses of 536 CTs, we found that > 50% did not have a DMC or any masking and no favorable trend was seen in the annual proportion of same over the past decade. Additionally, majority of the trials reported randomization as the design allocation method.
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