EUS-guided choledochoduodenostomy with electrocautery-enhanced lumen-apposing metal stents in patients with malignant distal biliary obstruction: multicenter collaboration from the United Kingdom and Ireland.

BACKGROUND AND AIMS: EUS-guided choledochoduodenostomy (EUS-CDD) with an electrocautery-enhanced lumen-apposing metal stent (EC-LAMS) has emerged as a viable method of establishing biliary drainage in patients with malignant distal biliary obstruction (MDBO). Our aim was to assess the efficacy, safety, and outcomes in patients with MDBO who underwent EUS-CDD with an EC-LAMS. METHODS: A retrospective review of consecutive patients with MDBO who underwent EUS-CDD with EC-LAMSs at 8 tertiary institutions across the United Kingdom and Ireland between September 2016 and November 2020 was undertaken. RESULTS: One hundred twenty patients (55% men) with a median age of 73 years (interquartile range, 17; range, 43-94) were included. The median follow-up period in 117 patients was 70 days (interquartile range, 169; range, 3-869), and 23 patients (19.2%) were alive at the end of the follow-up. Three patients were lost to follow-up. Technical success was achieved in 109 patients (90.8%). Clinical success (reduction of serum bilirubin to ≤50% of original value within 14 days) was achieved in 94.8% of patients (92/97). The adverse event rate was 17.5% (n = 21). Biliary reintervention after initial technical success was required in 9 patients (8.3%). CONCLUSIONS: EUS-CDD with EC-LAMSs at tertiary institutions within a regional hepatopancreatobiliary network for treatment of MDBO was effective in those where ERCP was not possible or was unsuccessful. When technical failures or adverse events occur, most patients can be managed with conservative or endoscopic therapy.

Hemostatic powder TC-325 treatment of malignancy-related upper gastrointestinal bleeds: International registry outcomes.

BACKGROUND AND AIM: Upper gastrointestinal tumors account for 5% of upper gastrointestinal bleeds. These patients are challenging to treat due to the diffuse nature of the neoplastic bleeding lesions, high rebleeding rates, and significant transfusion requirements. TC-325 (Cook Medical, North Carolina, USA) is a hemostatic powder for gastrointestinal bleeding. The aim of this study was to examine the outcomes of upper gastrointestinal bleeds secondary to tumors treated with Hemospray therapy. METHODS: Data were prospectively collected on the use of Hemospray from 17 centers. Hemospray was used during emergency endoscopy for upper gastrointestinal bleeds secondary to tumors at the discretion of the endoscopist as a monotherapy, dual therapy with standard hemostatic techniques, or rescue therapy. RESULTS: One hundred and five patients with upper gastrointestinal bleeds secondary to tumors were recruited. The median Blatchford score at baseline was 10 (interquartile range [IQR], 7-12). The median Rockall score was 8 (IQR, 7-9). Immediate hemostasis was achieved in 102/105 (97%) patients, 15% of patients had a 30-day rebleed, 20% of patients died within 30 days (all-cause mortality). There was a significant improvement in transfusion requirements following treatment (P < 0.001) when comparing the number of units transfused 3 weeks before and after treatment. The mean reduction was one unit per patient. CONCLUSIONS: Hemospray achieved high rates of immediate hemostasis, with comparable rebleed rates following treatment of tumor-related upper gastrointestinal bleeds. Hemospray helped in improving transfusion requirements in these patients. This allows for patient stabilization and bridges towards definitive surgery or radiotherapy to treat the underlying tumor.

Hemospray® (hemostatic powder TC-325) as monotherapy for acute gastrointestinal bleeding: a multicenter prospective study.

Background: Hemostatic powders are used as second-line treatment in acute gastrointestinal (GI) bleeding (AGIB). Increasing evidence supports the use of TC-325 as monotherapy in specific scenarios. This prospective, multicenter study evaluated the performance of TC-325 as monotherapy for AGIB. Methods: Eighteen centers across Europe and USA contributed to a registry between 2016 and 2022. Adults with AGIB were eligible, unless TC-325 was part of combined hemostasis. The primary endpoint was immediate hemostasis. Secondary outcomes were rebleeding and mortality. Associations with risk factors were investigated (statistical significance at P≤0.05). Results: One hundred ninety patients were included (age 51-81 years, male: female 2:1), with peptic ulcer (n=48), upper GI malignancy (n=79), post-endoscopic treatment hemorrhage (n=37), and lower GI lesions (n=26). The primary outcome was recorded in 96.3% (95% confidence interval [CI]: 92.6-98.5) with rebleeding in 17.4% (95%CI 11.9-24.1); 9.9% (95%CI 5.8-15.6) died within 7 days, and 21.7% (95%CI 15.6-28.9) within 30 days. Regarding peptic ulcer, immediate hemostasis was achieved in 88% (95%CI 75-95), while 26% (95%CI 13-43) rebled. Higher ASA score was associated with mortality (OR 23.5, 95%CI 1.60-345; P=0.02). Immediate hemostasis was achieved in 100% of cases with malignancy and post-intervention bleeding, with rebleeding in 17% and 3.1%, respectively. Twenty-six patients received TC-325 for lower GI bleeding, and in all but one the primary outcome was achieved. Conclusions: TC-325 monotherapy is safe and effective, especially in malignancy or post-endoscopic intervention bleeding. In patients with peptic ulcer, it could be helpful when the primary treatment is unfeasible, as bridge to definite therapy.

The IBD-F Patient Self-Assessment Scale Accurately Depicts the Level of Fatigue and Predicts a Negative Effect on the Quality of Life of Patients With IBD in Clinical Remission.

BACKGROUND: Fatigue is highly prevalent among patients with inflammatory bowel disease (IBD) and may have an unfavorable impact on quality of life (QoL). The IBD-Fatigue scale (with components SCORE1 and SCORE2) is a recently developed disease-specific questionnaire. We sought to validate a Greek version of IBD-F and use it to assess the severity and characteristics of fatigue and its effect on QoL in our study population. METHODS: The IBD-F scale was validated and used to obtain fatigue-related data from patients with IBD attending a tertiary care hospital. Correlations with other fatigue and QoL instruments were performed. RESULTS: The Greek IBD-F showed high internal consistency and test-retest reliability (Cronbach's alpha = 0.901/0.966 and intraclass correlation coefficient = 0.876/0.895 for SCORE1/SCORE2, respectively). A SCORE1 >7.5 suggested "significant" fatigue. In a cohort of 157 patients (mean age = 35.8 y; male patients = 52.2%; patients with Crohn disease = 65.6%), both SCORE1 and SCORE2 were significantly associated with Crohn disease (odds ratio [OR] = 4.17; 95% confidence interval [CI], 2.05-8.47; b = 8.5; 95% CI, 2.8-14.1, respectively), female sex (OR = 7.27; 95% CI, 3.19-16.6; b = 15.3; 95% CI, 9-21.6), and Harvey-Bradshaw Index/Simple Clinical Colitis Activity Index score (OR = 1.22; 95% CI, 1.06-1.39; b = 1.8; 95% CI, 0.9-2.8). A SCORE1 >7.5 was present in 46% of patients in remission, and 82% of patients with a baseline SCORE1 >7.5 remained fatigued at serial measurements. The SCORE1 was significantly associated with impaired QoL (P < 0.001). CONCLUSIONS: The validated IBD-F scale is a useful and applicable instrument for use in the IBD population. A large proportion of patients have significant fatigue, which is maintained longitudinally, independent of inflammatory activity. Fatigue impairs QoL, thus necessitating interventions that may lead to its amelioration in the IBD population.

Severe cytomegalovirus infection in apparently immunocompetent patients: a systematic review.

BACKGROUND: The morbidity and mortality associated with cytomegalovirus (CMV) infection in immunocompromised patients (especially in HIV-infected patients and transplant recipients), as well as with congenital CMV infection are well known. In contrast, relatively little attention has been paid to the morbidity and mortality that CMV infection may cause in immunocompetent patients. METHODS: We reviewed the evidence associated with severe manifestations of CMV infection in apparently immunocompetent patients and the potential role of antiviral treatment for these infections. We searched in PubMed, Scopus, and the Cochrane Library for the period of 1950-2007 to identify relevant articles. RESULTS: We retrieved 89 articles reporting on severe CMV infection in 290 immunocompetent adults. Among these reports, the gastrointestinal tract (colitis) and the central nervous system (meningitis, encephalitis, transverse myelitis) were the most frequent sites of severe CMV infection. Manifestations from other organ-systems included haematological disorders (haemolytic anaemia, thrombocytopenia), thrombosis of the venous or arterial vascular system, ocular involvement (uveitis), and lung disease (pneumonitis). The clinical practice reported in the literature has been to prescribe antiviral treatment for the most severe manifestations of monophasic meningoencephalitis (seizures and coma), ocular involvement, and lung involvement due to CMV. CONCLUSION: Severe life-threatening complications of CMV infection in immunocompetent patients may not be as rare as previously thought.

The assessment of hepatocellular carcinoma risk in patients with chronic hepatitis B under antiviral therapy.

Hepatocellular carcinoma (HCC) is a primary concern for patients with chronic hepatitis B (CHB). Antiviral therapy has been reasonably the focus of interest for HCC prevention, with most studies reporting on the role of the chronologically preceding agents, interferon-alfa and lamivudine. The impact of interferon-alfa on the incidence of HCC is clearer in Asian patients and those with compensated cirrhosis, as several meta-analyses have consistently shown HCC risk reduction, compared to untreated patients. Nucleos(t)ide analogues also seem to have a favorable impact on the HCC incidence when data from randomized or matched controlled studies are considered. Given that the high-genetic barrier agents, entecavir and tenofovir, are mainly used in CHB because of their favorable effects on the overall long-term outcome of such patients, the most clinically important challenge is the identification of patients who require close HCC surveillance despite on-therapy virological remission. Several risk scores have been developed for HCC prediction in CHB patients. Most of them, such as GAG-HCC, CU-HCC and REACH-B, have been developed and validated in Asian untreated and treated CHB patients, but they do not seem to offer good predictability in Caucasian CHB patients for whom a newer score, PAGE-B, has been recently developed.

Reliability and applicability of two-dimensional shear-wave elastography for the evaluation of liver stiffness.

BACKGROUND/AIM: Two-dimensional shear-wave elastography (2D-SWE) is a new elastographic technique that is increasingly being used across several indications. We assessed the reliability and applicability of 2D-SWE in patients with various chronic liver diseases and attempted to identify parameters potentially affecting liver stiffness. METHODS: We included all patients with chronic liver disease who underwent 2D-SWE examination over a 15-month period. Patients with acute hepatitis, active cholestatic disease, or severe heart failure were excluded. The procedures were performed by three adequately trained operators. Standard operating procedures for liver ultrasonography and elastography were followed. RESULTS: 2D-SWE was reliable in 98% of 605 patients. SD to mean liver stiffness value ratio greater than 9.14%, which was considered an indicator of reliability, was associated independently with age more than 50 years, obesity, or overweight, and use of statins for hyperlipidemia. 2D-SWE was applicable, requiring a median time of 7 min per examination and exceeding 15 min in only 5.5% of patients. Worse applicability expressed as duration more than 0.7 min per reliable measurement was associated independently with age more than 50 years and obesity. The mean and median liver stiffness values were 11.6 and 7.7 kPa, respectively. Liver stiffness more than 7.7 kPa was associated independently with age more than 50 years and increased waist circumference. CONCLUSION: 2D-SWE represents an applicable method of assessment of liver fibrosis that can provide reliable results in the vast majority of patients with chronic liver diseases. Older age and obesity may affect the reliability and applicability of the method as well as the severity of liver fibrosis.

Use of ACE inhibitors and risk of community-acquired pneumonia: a review.

BACKGROUND: The administration of angiotensin-converting enzyme (ACE) inhibitors has been suggested as an alternative strategy for lowering the risk of community-acquired pneumonia (CAP) in the elderly, especially in patients with neurological and cerebrovascular comorbidity. METHODS: We critically examined the relevant data from studies regarding the impact of ACE inhibitors in lowering the risk of CAP and/or mortality due to CAP in the elderly. We searched PubMed, Cochrane Database, and references of initially retrieved articles, and http://clinicaltrials.gov for ongoing trials. RESULTS: We identified 285 evaluable studies. Fourteen studies met the inclusion criteria and were evaluated further, of which seven were prospective studies, two randomized controlled trials, and five retrospective studies. Eight of ten studies including patients of Asian origin demonstrated a statistical significance in favor of ACE inhibitors. On the contrary, only one of five studies including patients of non-Asian origin demonstrated results in favor of ACE inhibitors. CONCLUSION: The available data suggest that ACE inhibitors may contribute to the reduction of the risk of CAP. Nevertheless, clinical data are scarce and mainly comprise studies including patients of Asian origin. As there seem to be differences regarding the genetic polymorphism of ACE among patients of different origins, future studies are needed that incorporate relevant genetics data that may help clarify the role, if any, of ACE inhibitors in preventing CAP.