Sub-acute liver failure is a term that describes the relatively sudden loss of liver function, usually >21 days and <26 weeks, with impaired synthetic function and associated encephalopathy in a person with no pre-existing liver disease or cirrhosis. It is commonly caused by viruses and drugs, less so by malignancy. Our patient is a 71-year-old Japanese man who presented with signs of sub-acute liver failure. A subsequent liver biopsy demonstrated involvement by B-cell non-Hodgkin lymphoma. Evaluation of the bone marrow demonstrated significant marrow involvement by B-cell lymphoma. The fluorescence in situ hybridization (FISH) returned positive for t(14; 18). Noted was the patient’s clinical presentation of cholestasis secondary to hepatic lymphoma with no evidence of lymphadenopathy or peripheralized lymphoma. Given the disease distribution, the overall findings are consistent with primary hepatic follicular lymphoma as described in few case reports and small case series in the literature.
Background:The fragility index (FI) represents the number of participants whose status in a trial would have to change from a non-event (not experiencing the primary endpoint) to an event (experiencing the primary endpoint) in order to turn a statistically significant result into a non-significant result. We sought to evaluate the fragilityMethods: Irritable bowel syndrome trials published in high-impact journals were identified from Medline. Trials had to be in adults, randomized, parallel-armed, with at least one statistically significant binary outcome, and an achieved primary endpoint of therapeutic efficacy. FI and correlation coefficients were calculated, and regression modeling used to identify predictors of a high FI.Key Results: Twelve trials were analyzed with a median FI of 6 (range: 0-38). Median sample size in all trials was 366 (range: 44-856). Trial publication year (p = 0.71), journal impact factor (p = 0.52), duration of study (p = 0.12), and number need to treat [NNT] (p = 0.29) were not predictive of a high FI. While a lower p-value correlated with a higher FI (p = 0.039), no correlation was noted between FI and impact factor (R = −0.20, p = 0.52), trial publication year (R = 0.12, p = 0.71), duration of trial (R = −0.46, p = 0.13), NNT (R = −0.34, p = 0.29), and sample size (R = 0.23, p = 0.5). The highest FI was in a Ramosetron trial (FI = 30) for IBS-D. Conclusion & Inferences:A median of six participants is needed to nullify results in the included IBS trials suggesting how easily statistical significance based on a threshold p-value may be overturned.
INTRODUCTION: Fecal incontinence (FI) is a common yet underappreciated condition for which many gastroenterologists (GE) lack training to address in their patients. A potential therapy for FI is sacral nerve evaluation (SNE), a 1-week trial procedure in which electrodes are placed temporarily to stimulate the sacral nerve. A successful SNE trial may then prompt permanent surgical implant of sacral electrodes to provide long term control of FI. Despite encountering many FI patients, GE have been slow to adopt SNE in the management for FI. The goal of this study was to document the experience of introducing the SNE procedure into a GE practice, with a focus on measuring the initial success rate of SNE, and identifying factors that impact patient selection and transition to permanent implant. METHODS: SNE was introduced to a single GE practice beginning in October 2017 and the study period ended in April 2019. Patient demographics and clinical data were collected and post-SNE outcomes were assessed. The primary outcome was SNE success defined as ≥ 50% decrease in FI events during the 7-day SNE trial. Factors associated with SNE success were evaluated. RESULTS: SNE was performed on 42 patients [31 (76%) female; mean age 62 years (range 27–80)] during the study period with a median follow up time of 49 weeks. In intent-to-treat analysis, SNE success was achieved in 71% (30/42). Of these, 11 (37%) proceeded to permanent implant with 75–100% improvement in FI. Factors associated with SNE success included female gender (OR 2.0), age ≥ 65 (OR 2.4), and absence of complicating diagnoses (OR 4.1; Crohn's, colitis, prior anal surgery). The most common reason for not proceeding to permanent implant was FI improvement from reduction in diarrhea, followed by personal opposition to implant, unrelated new-onset medical condition, and socioeconomic barriers. Only one SNE complication (rash) was reported. CONCLUSION: SNE introduced into a GE practice achieved favorable initial success in improving FI and is a safe, viable procedural modality that can ecpand therapeutic options. Older, traditional FI patients were associated with better SNE results. The transition from successful SNE to permanent implant is reduced by multiple disparate factors, some of which could be addressed with more intensive follow up.
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