Project description:Interventions: Antibiotics
Without antibiotics
Primary outcome(s): The rate of post electrocoagulation syndrome after colorectal endoscopic submucosal dissection
Study Design: Parallel Randomized
Project description:Interventions: Non-closure
Endoscopic closure
Primary outcome(s): The rate of PECS and delayed perforation
Study Design: Parallel Randomized
Project description:Background and study aims While gastric endoscopic submucosal dissection (ESD) has become a treatment with fewer complications, delayed bleeding remains a challenge. Post-ESD coagulation (PEC) is performed to prevent delayed bleeding. Therefore, we developed an artificial intelligence (AI) to detect vessels that require PEC in real time. Materials and methods Training data were extracted from 153 gastric ESD videos with sufficient images taken with a second-look endoscopy (SLE) and annotated as follows: (1) vessels that showed bleeding during SLE without PEC; (2) vessels that did not bleed during SLE with PEC; and (3) vessels that did not bleed even without PEC. The training model was created using Google Cloud Vertex AI and a program was created to display the vessels requiring PEC in real time using a bounding box. The evaluation of this AI was verified with 12 unlearned test videos, including four cases that required additional coagulation during SLE. Results The results of the test video validation indicated that 109 vessels on the ulcer required cauterization. Of these, 80 vessels (73.4%) were correctly determined as not requiring additional treatment. However, 25 vessels (22.9%), which did not require PEC, were overestimated. In the four videos that required additional coagulation in SLE, AI was able to detect all bleeding vessels. Conclusions The effectiveness and safety of this endoscopic treatment-assisted AI system that identifies visible vessels requiring PEC should be confirmed in future studies.
Project description:ObjectivesTo retrospectively validate the new Chinese DIC scoring system (CDSS).MethodsThis study retrospectively collected the information of 619 patients (371 cases with non-hematologic malignancies, 248 cases with hematologic malignancies) who suspected of DIC in Wuhan Union Hospital during 2013-4 to 2014-6. We validated CDSS by comparing it with three leading scoring systems, from International Society on Thrombosis and Haemostasis (ISTH), Japanese Association for Acute Medicine (JAAM) and Japanese Ministry of Health and Welfare (JMHW), and evaluated its prognostic value by 28 days mortality, APACHE II and SOFA score.ResultsIn non-hematologic malignancies, CDSS was more specific than JAAM (72.55% vs. 50.49%, p<0.05) and more sensitive than ISTH (77.07% vs. 62.03%, p<0.05). In hematologic malignancies, the area under the ROC curve of CDSS was larger than ISTH and JMHW (0.933 vs. 0.889, p<0.01 with ISTH, 0.944 vs. 0.845, p<0.01 with JMHW). In addition, the 28-day mortality rate, SOFA scores, APACHE II scores of DIC patients diagnosed by CDSS were significantly greater than non-DIC (P <0.05).ConclusionsWe are the first group to propose CDSS. It emphasized the values of the clinical manifestations, the rapidly declining platelet count, APTT in the diagnosis of DIC and used D-dimer as the fibrin-related maker. DIC with hematological malignancies was treated as a special part. In this study we can see that CDSS displayed an acceptable property for the diagnosis of DIC with appropriate sensitivity and specificity, and also had a good prognostic value for DIC patients.
Project description:Background Lower limb deep vein thrombosis (DVT) is associated with significant morbidity and death. DVT can result in complications such as postphlebitic syndrome, pulmonary embolism, and death. Combining pretest probability, D-dimer testing, and compression ultrasound imaging enables a safe and convenient study of suspected lower-extremity thrombosis. This study aimed to assess the expanding body of research supporting thrombectomy as a form of DVT therapy. Materials and Methods A retrospective study was performed on individuals with venous Doppler-confirmed DVT and occlusive thrombus. Four-hundred fifty-one consecutive patients were selected for the study based on the inclusion and exclusion criteria. In this investigation, thrombectomy was the preferred therapeutic approach. Results The study reports a male predominance of 56.1%. Most patients (25.7%) were between the age of 51 and 60, with 84.7% reporting pain and lower-extremity swelling as the two most common clinical symptoms. The femoral vein was noted as the most frequent site of thrombus in the current research (51.0%), with acute DVT accounting for most cases (85.1%). Most of the patients (97.3%) were primarily asymptomatic after one year of follow-up. Conclusion Thrombectomy is a reliable treatment modality for DVT patients in regaining venous patency, preventing DVT recurrence, treating post-thrombotic syndrome, and preventing pulmonary embolism.
Project description:Background The CAVA (Ultrasound-Accelerated Catheter-Directed Thrombolysis Versus Anticoagulation for the Prevention of Post-Thrombotic Syndrome) trial did not show a reduction of post-thrombotic syndrome (PTS) after additional ultrasound-accelerated catheter-directed thrombolysis in patients with acute iliofemoral deep vein thrombosis at 1-year follow-up. This prespecified analysis of the CAVA trial aimed to determine the impact of additional thrombolysis on outcomes of PTS at long-term follow-up. Methods and Results Patients aged 18 to 85 years with a first-time acute iliofemoral deep vein thrombosis were included and randomly assigned (1:1) to either standard treatment plus ultrasound-accelerated catheter-directed thrombolysis or standard treatment alone. The primary outcome was the proportion of PTS (Villalta score ≥5 on 2 occasions ≥3 months apart or venous ulceration) at the final follow-up visit. Additionally, PTS according to the International Society on Thrombosis and Haemostasis (ISTH) consensus definition was assessed to allow external comparability. Major bleedings were the main safety outcome. At a median follow-up of 39.0 months (interquartile range, 23.3-63.8), 120 patients (79.8%) participated in the final follow-up visit: 62 from the intervention group and 58 from the standard treatment group. PTS developed in 19 (30.6%) versus 26 (44.8%) patients, respectively (odds ratio [OR], 0.54; 95% CI, 0.26 to 1.15 [P=0.11]), with an absolute difference between groups of -14.2% (95% CI, -32.0% to 4.8%). Using the ISTH consensus definition, a significant reduction in PTS was observed (29 [46.8%] versus 40 [69.0%]) (OR, 0.40; 95% CI, 0.19-0.84 [P=0.01]) with an absolute difference between groups of -22.2% (95% CI, -39.8% to -2.8%). No new major bleedings occurred following the 12-month follow-up. Conclusions The impact of additional ultrasound-accelerated catheter-directed thrombolysis on the prevention of PTS was found to increase with time. Although this study was limited by its sample size, the overall findings indicate a reduction of mild PTS without impact on quality of life. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00970619.
Project description:Here, we developed a clinical-grade bioartificial liver (BAL) device by implanting with directly reprogrammed human hepatocytes (hiHep) manufactured and cryopreserved under current good manufacturing practice (cGMP) conditions. Notably, in a porcine PHLF model induced by 85% hepatectomy, hiHep-BAL treatment showed a remarkable survival benefit, as well as improvements of liver metabolic gene expression, ammonia detoxification, and liver regeneration. Furthermore, an investigator-initiated study in seven patients with extended liver resection (NCT05035108) demonstrated that hiHep-BAL treatment was well tolerated without complications and associated with ameliorative liver function and remarkable liver regeneration, meeting the primary outcome of safety and feasibility. These encouraging results warrant the further efficacy testing of hiHep-BAL for PHLF followed by the future broadening the patients eligible for liver resection in clinics.
Project description:Richter syndrome (RS) occurs in up to 15% of patients with chronic lymphocytic leukemia (CLL). While RS, usually represented by the histologic transformation to a diffuse large B-cell lymphoma (DLBCL), is associated with a very poor outcome, especially when clonally related to the pre-existing CLL, mechanisms leading to RS have not been clarified yet. To better understand the pathogenesis of RS, we analyzed a series of cases including: 59 RS, 28 CLL-phase of RS, 315 CLL and 127 de novo DLBCL. RS demonstrated a genomic complexity intermediate between CLL and DLBCL. Cell cycle deregulation via inactivation of TP53 and of CDKN2A was a main mechanism in the histologic transformation from CLL-phase, being present in approximately half of the cases, and affected the outcome of the RS patients. A second major subgroup was characterized by the presence of trisomy 12 and comprised one third of the cases. While RS shared some of the lesions seen in de novo DLBCL, its genomic profile was clearly separate. The CLL-phase preceding RS had not a generalized increase in genomic complexity when compared with untransformed CLL, but it presented clear differences in the frequency of specific genetic lesions. Genomic profiling of Richter-syndrome Chronic Lymphocytic Leukemia
Project description:Although different hypotheses have been formulated to explain schizophrenia pathogenesis, the links between them are weak. The observation that five psychotic patients on chronic warfarin therapy for deep-vein thrombosis showed long-term remission of psychotic symptoms made us suspect that abnormalities in the coagulation pathway, specifically low tissue plasminogen activator (tPA) activity, could be one of the missing links. Our hypothesis is supported by a high prevalence of conditions affecting tPA activity in drug-naive schizophrenia, such as antiphospholipid antibodies, elevated cytokine levels, hyperinsulinemia and hyperhomocysteinemia. We recently screened a group of schizophrenia patients and controls for conditions affecting tPA activity. Free-protein S deficiency was highly prevalent among patients, but not found in controls. Free-protein S and functional protein C are natural anticoagulants that form complexes that inhibit tPA inhibitors. All participants had normal protein C levels, suggesting that protein S could have a role in schizophrenia, independent of protein C. Chronic patients and those studied during acute episodes had between three and six conditions affecting tPA and/or protein S activity, while patients in remission had up to two, which led us to postulate that multiple conditions affecting tPA and/or protein S activity could contribute to the full expression of schizophrenia phenotype. This paper describes the physiological roles of tPA and protein S, reviewing how their activity influences pathogenesis and comorbidity of schizophrenia. Next, it analyzes how activity of tPA and protein S is influenced by biochemical abnormalities found in schizophrenia. Last, it suggests future directions for research, such as studies on animal models and on therapeutic approaches for schizophrenia aiming at increasing tPA and protein S activity.