The Efficacy and Safety of Endoscopic Balloon Dilatation in the Treatment of Functional Post-Sleeve-Gastrectomy Stenosis.

Background and Objectives: Functional gastric stenosis, a consequence of sleeve gastrectomy, is defined as a rotation of the gastric tube along its longitudinal axis. It is brought on by gastric twisting without the anatomical constriction of the gastric lumen. During endoscopic examination, the staple line is deviated with a clockwise rotation, and the stenosis requires additional endoscopic manipulations for its transposition. Upper gastrointestinal series show the gastric twist with an upstream dilatation of the gastric tube in some patients. Data on its management have remained scarce. The objective was to assess the efficacy and safety of endoscopic balloon dilatation in the management of functional post-sleeve gastrectomy stenosis. Patients and Methods: Twenty-two patients with functional post-primary-sleeve-gastrectomy stenosis who had an endoscopic balloon dilatation between 2017 and 2023 were included in this retrospective study. Patients with alternative treatment plans and those undergoing endoscopic dilatation for other forms of gastric stenosis were excluded. The clinical outcomes were used to evaluate the efficacy and safety of balloon dilatation in the management of functional gastric stenosis. Results: A total of 45 dilatations were performed with a 30 mm balloon in 22 patients (100%), a 35 mm balloon in 18 patients (81.82%), and a 40 mm balloon in 5 patients (22.73%). The patients' clinical responses after the first balloon dilatation were a complete clinical response (4 patients, 18.18%), a partial clinical response (12 patients, 54.55%), and a non-response (6 patients, 27.27%). Nineteen patients (86.36%) had achieved clinical success at six months. Three patients (13.64%) who remained symptomatic even after achieving the maximal balloon dilation of 40 mm were considered failure of endoscopic dilatation, and they were referred for surgical intervention. No significant adverse events were found during or following the balloon dilatation. Conclusions: Endoscopic balloon dilatation is an effective and safe minimally invasive procedure in the management of functional post-sleeve-gastrectomy stenosis.

Endoscopic injection sclerotherapy versus N-Butyl-2 Cyanoacrylate injection in the management of actively bleeding esophageal varices: a randomized controlled trial.

BACKGROUND: The management of acute esophageal variceal bleeding remains a clinical challenge. Band ligation is the main therapeutic option, but it may be technically difficult to perform in active bleeders. This may necessitate an alternative therapy for this group of patients. This study was conducted to assess the safety and efficacy of sclerotherapy versus cyanoacrylate injection for management of actively bleeding esophageal varices in cirrhotic patients. METHODS: This prospective study included 113 cirrhotic patients with actively bleeding esophageal varices. They were randomly treated by endoscopic sclerotherapy or cyanoacrylate injection as banding was not suitable for those patients due to profuse bleeding making unclear endoscopic visual field. Primary outcome was incidence of active bleeding control and secondary outcomes were incidence of six weeks rebleeding, complications, and mortality among the studied patients. RESULTS: Initial bleeding control was significantly higher in cyanoacrylate versus sclerotherapy groups (98.25, 83.93% respectively, P = 0.007). No significant differences between sclerotherapy and cyanoacrylate groups regarding rebleeding (26.79, 19.30% respectively, P = 0.344), complications, hospital stay or mortality rate were observed. CONCLUSIONS: Based on this single-center prospective study, both of these therapies appear to have relatively favorable outcomes, although cyanoacrylate injection may be superior to sclerotherapy for initial control of active bleeding. TRIAL REGISTRATION: [ClinicalTrials.gov Identifier: NCT03388125 ]-Date of registration: January 2, 2018 "Retrospectively registered".

Sofosbuvir/Ledipasvir for Treatment of Chronic Hepatitis C Infection in Adult Patients with ß- Thalassemia Major: A Real-Life Study.

BACKGROUND & AIMS: Patients with thalassemia have a lifelong need for blood transfusion, which makes them more risky to hepatitis C virus (HCV). Iron overload and chronic HCV are considered risk factors for patients with thalassemia to develop liver insults. The aim of the present study is to investigate the safety and efficacy of sofosbuvir/ledipasvir in the treatment of chronic HCV infection in Egyptian adult patients with ß- thalassemia major. METHODS: A retrospective study included 53 patients with ß-thalassemia major with chronic HCV treated with sofosbuvir (400 mg) and ledipasvir (90 mg) as a single pill fixed-dose combination once daily for 12 weeks. The effectiveness of the treatment was assessed by the sustained virologic response (SVR) at 12 weeks after the end of the treatment. RESULTS: SVR was achieved in 96.23% of patients. 47.17% of patients had minor side effects. There was a significant reduction in ALT, AST, and serum ferritin 12 weeks post-therapy. There was an insignificant change in hemoglobin level or blood transfusion requirement 12 weeks posttherapy. There was no change in iron chelators doses throughout the study period. CONCLUSION: Sofosbuvir/ledipasvir regimen seems to be safe and highly effective in the treatment of chronic HCV in patients with ß-thalassemia major.

Association of Serum Osteoprotegerin Level With Myocardial Injury and Cardiovascular Calcification in Chronic Kidney Disease Patients.

Background: Chronic kidney disease has emerged as a significant independent risk factor for cardiovascular disease. Cardiovascular calcification is an active process involving a complex interaction of inducers and inhibitors. High sensitivity cardiac troponin T assay detects troponin T with higher sensitivity and precision at an earlier point of time than the conventional assays, and is associated with poor outcomes. Serum osteoprotegerin is classed as an inhibitory factor for cardiovascular calcification. It is involved in the pathological processes of vascular damage and linked to the excess cardiovascular morbidity. The aim of the present study was to evaluate the extent of cardiovascular calcification and serum high sensitivity cardiac troponin T level, and their association with serum osteoprotegerin level in patients with chronic kidney disease stages 3-5. Methods: 90 chronic kidney disease patients were enrolled in this study, and they were divided into two groups: group (1) included 45 non-dialysis-dependent chronic kidney disease patients (stages 3-5) and group (2) included 45 chronic hemodialysis patients. Each group further subdivided according to the presence of cardiovascular calcification into subgroup A and B. Vascular calcifications were assessed by lateral lumbar, pelvis and hands X-ray radiographs. Valvular calcification was assessed by echocardiography. Serum cardiac troponin T was measured by high sensitivity assay and serum osteoprotegerin was measured by ELISA. Results: Cardiovascular calcification distribution was 22.2% in group (1) and 33.3% in group (2). Serum osteoprotegerin and troponin T in calcification groups (1A and 2A) were significantly higher than non-calcification groups (1B and 2B; P < 0.001). Osteoprotegerin correlated positively with high sensitivity cardiac troponin T (rs = 0.72, P < 0.001). cardiovascular calcification correlated positively with osteoprotegerin, troponin T, and phosphorus. osteoprotegerin and phosphorus were significant independent predictors of cardiovascular calcification at cut-off values ≥4.6 ng/L and ≥6.95 mg/dl, respectively (P < 0.001). Serum phosphorus and creatinine were independent predictors of osteoprotegerin (P < 0.001 and 0.048, respectively). Conclusion: Osteoprotegerin is strongly associated with cardiovascular calcification and high sensitivity cardiac troponin T. In addition, there is a positive association between calcification and troponin T. This suggests a role for osteoprotegerin in the pathogenesis and risk stratification of cardiovascular calcification and myocardial injury in chronic kidney disease patients with a potential role as a therapeutic target.

Resolved hepatitis B infection in patients receiving immunosuppressive therapy: Monitor versus prophylaxis against viral reactivation.

Risk of hepatitis B virus reactivation (HBVr) in patients with resolved HBV infection receiving immunosuppressive therapy has been a growing concern, particularly in the era of biological and targeted therapies. HBV monitoring versus antiviral prophylaxis against HBVr in those patients remains controversial. The aim of the study was to determine the incidence of HBVr and HBV-related hepatitis in resolved HBV patients who received immunosuppressive therapy with or without antiviral prophylaxis. This retrospective study included 64 patients with resolved HBV infection who received different regimens of immunosuppressive medications, with moderate risk of HBVr, for variable underlying diseases. Patients who had chronic HBV infection or other viral infections were excluded. Patients who received B-cell depleting therapies were ruled out. They were divided into 2 groups: group 1 included 31 patients who received immunosuppressive therapy without antiviral prophylaxis, and group 2 included 33 patients who received antiviral prophylaxis (entecavir) within 2 weeks of commencing the immunosuppressive therapy. HBVr, HBV-related hepatitis, and HBV-unrelated hepatitis were assessed along a 1-year duration. The overall HBVr incidence was 1.56% (1/64). This patient who had HBVr was seen in group 1. There were no significant differences between the 2 groups regarding the incidence of HBVr, HBV-related hepatitis, HBV-unrelated hepatitis, and immunosuppressive therapy interruption along a 1-year duration. Based on this retrospective study, close monitoring was equal to antiviral prophylaxis regarding the outcome of resolved HBV patients who received moderate risk immunosuppressive therapy. HBV treatment should commence once HBVr is confirmed.

Intermittent versus Daily Eltrombopag Dosage Protocols for the Treatment of Primary Immune Thrombocytopenia: Real-Life Experience.

INTRODUCTION/AIM: Eltrombopag is recommended for the treatment of refractory immune thrombocytopenia (ITP). Based on its half-life, it may be practical to use an intermittent dosage. Our aim was to compare the effectiveness and safety of intermittent vs daily eltrombopag dosage protocols for the treatment of primary ITP refractory to prior therapies. PATIENTS AND METHODS: This was a retrospective study, and 34 adult primary ITP patients refractory to prior therapies were included in our analysis. Eltrombopag was used in this study. The patients were divided into daily eltrombopag dosage and intermittent eltrombopag dosage groups. Eltrombopag effectiveness was assessed regarding platelet count and bleeding resolution. Safety was assessed via adverse events reporting. RESULTS: In the daily eltrombopag dosage group, overall response (OR), complete response (CR), partial response (PR), and relapse rates were 69.23%, 53.85%, 15.38%, and 30.77%, respectively. In the intermittent eltrombopag dosage group, OR, CR, PR, and relapse rates were 68.75%, 50%, 18.75%, and 31.25%, respectively. Comparison between daily and intermittent eltrombopag dosage groups as regards CR, PR, relapse, relapse-free survival and adverse events showed insignificant differences. CONCLUSION: Intermittent eltrombopag dosage is safe and effective in patients with ITP refractory to prior therapies and comparable to the daily eltrombopag dosage.

Outcomes of Treatment and Predictors of Response to Sofosbuvir Plus Simeprevir in Hepatitis C Virus with Genotype-4 Infection.

BACKGROUND & AIMS: Treatment plan of chronic HCV infection has dramatically improved after the introduction of different groups of Direct-Acting Antiviral (DAA) drugs. These drugs have been found to be safe and effective. Sofosbuvir (SOF) plus simeprevir (SMV) regimen has been shown to be tolerable and effective in treatment of patients with HCV genotype 1. The aim of the study was to evaluate the safety and the efficacy of combined sofosbuvir plus simeprevir treatment in genotype 4 chronic HCV patients. METHODS: This open-label multicenter prospective study was carried out on 381 Egyptian patients with chronic hepatitis C virus- infection. Treatment experienced and treatment-naive patients were included. Subjects administrated a regimen of sofosbuvir (400 mg/ day) plus semiprevir (150 mg /day) for twelve weeks. Sustained Virological Response (SVR) was confirmed by undetectable HCV RNA by quantitative PCR 3 months after the end of the treatment. RESULTS: 97.6% (372 /381) of patients had SVR. None of the studied clinical and demographic characteristics were associated with the SVR status. However, patients who failed to achieve SVR showed low albumin level and high total leucocyte. The most common side effects of the studied regimen were headache, fatigue, itching, photosensitivity, and cough. CONCLUSIONS: Twelve weeks' regimen of sofosbuvir plus simeprevir was considered to be safe and tolerable in the treatment of HCV genotype 4; also it was associated with high SVR (97.6%).

Predictors for eltrombopag response in patients with hepatitis C virus-associated thrombocytopenia.

BACKGROUND AND AIMS: Thrombocytopenia is a common hematological abnormality observed in patients infected with hepatitis C virus (HCV). The use of eltrombopag has been approved for HCV-associated thrombocytopenia. This is the first study aiming to determine the predictive factors of response to eltrombopag therapy in patients with HCV-associated thrombocytopenia. PATIENTS AND METHODS: This prospective study was carried out on 130 patients with chronic HCV-associated thrombocytopenia (<50,000×109/L) that precludes the initiation of HCV therapy. Eltrombopag was initiated at a dose of 25 mg once daily; the dose was adjusted with 25 mg increments every 2 weeks to achieve the target platelet count. The primary end point was to achieve stable target platelet count (50,000-100,000×109/L) required to initiate antiviral therapy. RESULTS: Treatment response was achieved in 111 (85.38%) patients. This prospective study showed that megakaryocyte hypoplasia or aplasia and splenectomy were independent risk factors for eltrombopag nonresponse in chronic HCV-associated thrombocytopenic patients. CONCLUSION: Eltrombopag is safe and effective for patients with HCV-associated thrombocytopenia. Bone marrow examination should be considered before initiating treatment with eltrombopag in chronic HCV-associated thrombocytopenic patients, especially in patients with splenectomy.

Galectin-3 as a prognostic biomarker for diabetic nephropathy.

INTRODUCTION: Diabetic nephropathy (DN) represents one of the main causes of end-stage renal disease in type 2 diabetes mellitus (DM) patients. Galectin-3 has been implicated in pathogenesis of many pathological conditions. To date, there are limited data regarding the relationship between galectin-3 and DN. AIM OF THE STUDY: Evaluation of serum galectin-3 as a novel prognostic biomarker in patients with DN. PATIENTS AND METHODS: This prospective study was carried out in the Internal Medicine and Clinical Pathology Departments, Tanta University Hospital, Egypt, from March 2015 to March 2018 on 300 patients with type 2 DM. Patients were divided into three groups: group I included 100 patients with albumin/creatinine ratio (ACR) <30 mg/g (normoalbuminuria), group II included 100 patients with ACR within 30-300 mg/g (microalbuminuria), and group III included 100 patients with ACR >300 mg/g (macroalbuminuria). All patients were subjected to the following: full history taking, clinical examination, and laboratory evaluation (HbA1c, creatinine, estimated glomerular filtration rate, ACR, and serum galectin-3). RESULTS: The mean levels of galectin-3 were significantly higher in patients with macroalbuminuria than in those with microalbuminuria and normoalbuminuria. Galectin-3 was a significant predictor for progression to microalbuminuria, macroalbuminuria, dialysis, and death among patients with type 2 DM. CONCLUSION: Based on this single center prospective study, serum galectin-3 is considered a significant predictor for DN progression among patients with type 2 DM.

Impact of Helicobacter pylori Infection on Gastric Variceal Bleeding among Patients with Liver Cirrhosis.

BACKGROUND AND AIMS: Currently, it is well known that Helicobacter pylori- (H. pylori-) related peptic ulcer is one of the main causes of nonvariceal bleeding in cirrhotic patients. However, there is a lack of data to identify the exact effect of H. pylori infection on variceal bleeding. This study was conducted to identify the impact of H. pylori infection on gastric variceal bleeding in cirrhotic patients. PATIENTS AND METHODS: 76 cirrhotic patients with gastric varices were included in this prospective study and divided into 2 groups: nonbleeding gastric varices (32 patients) and bleeding gastric varices (44 patients). The fasting serum gastrin level was measured. Mucosal biopsies from the gastric body and antrum were examined to determine the patterns of gastritis and the presence of H. pylori. RESULTS: The frequency of H. pylori infection in the studied patients was 59.2%. There were significant differences between both groups regarding liver decompensation (P = 0.001), red color sign over gastric varices (P = 0.0011), prevalence of H. pylori infection (P = 0.0049), histological patterns of gastritis (P = 0.0069), and serum gastrin level (P = 0.0200). By multivariate analysis, Child C cirrhosis, red color sign over gastric varices, and H. pylori-induced follicular gastritis were independent risk factors for bleeding from gastric varices. CONCLUSION: H. pylori-induced follicular gastritis is considered as an additional risk factor for bleeding from gastric varices.

Outcomes and predictors of treatment response with sofosbuvir plus daclatasvir with or without ribavirin in Egyptian patients with genotype 4 hepatitis C virus infection.

BACKGROUND AND AIMS: Treatment of hepatitis C virus (HCV) changed dramatically with the introduction of oral direct-acting antiviral drugs due to their high antiviral potency and safety profile. Sofosbuvir plus daclatasvir combination therapy was extensively investigated in HCV genotypes 1, 2, and 3, while published data regarding its real-life application in the treatment of genotype 4 is lacking. Therefore, we conducted this study to assess the outcomes and predictors of treatment response with sofosbuvir plus daclatasvir with or without ribavirin in Egyptian patients with genotype 4 hepatitis C virus infection. PATIENTS AND METHODS: This prospective study included 300 Egyptian patients with chronic genotype 4 HCV, treated with sofosbuvir plus daclatasvir with or without ribavirin for 12-24 weeks. Primary outcome was the number of patients who achieved sustained virologic response (SVR12), and secondary outcome was the occurrence of adverse events. RESULTS: A total of 92.67% of all patients achieved SVR12. SVR12 rates of 96.55% and 84.54% were reported in non-cirrhotic and cirrhotic patients, respectively. SVR12 in treatment-naïve and treatment-experienced patients were 94.12% and 87.01%, respectively. A total of 19.7% of patients experienced mild adverse events. Older age, cirrhosis, and low platelet count were the predictors of treatment non-response. CONCLUSION: Based on this multi-center prospective study, sofosbuvir plus daclatasvir with or without ribavirin for 12-24 weeks appears to have favorable outcomes in the treatment of genotype 4 HCV-infected Egyptian patients. Older age, cirrhosis, especially Child-Pugh class B, and low platelet count are independent risk factors of treatment non-response.

Predictors of in-hospital mortality in a cohort of elderly Egyptian patients with acute upper gastrointestinal bleeding.

Acute upper gastrointestinal bleeding (UGIB) affects large number of elderly with high rates of morbidity and mortality. Early identification and management of the factors predicting in-hospital mortality might decrease mortality. This study was conducted to identify the causes of acute UGIB and the predictors of in-hospital mortality in elderly Egyptian patients.286 elderly patients with acute UGIB were divided into: bleeding variceal group (161 patients) and bleeding nonvariceal group (125 patients). Patients' monitoring was done during hospitalization to identify the risk factors that might predict in-hospital mortality in elderly.Variceal bleeding was the most common cause of acute UGIB in elderly Egyptian patients. In-hospital mortality rate was 8.74%. Increasing age, hemodynamic instability at presentation, co-morbidities (especially liver cirrhosis associated with other co-morbidity) and failure to control bleeding were the predictors of in-hospital mortality.Increasing age, hemodynamic instability at presentation, co-morbidities (especially liver cirrhosis associated with other co-morbidity) and failure to control bleeding should be considered when triaging those patients for immediate resuscitation, close observation, and early treatment.