GastroHep

Background. Electrogastrography and electroenterography are noninvasive methods for measuring gastric and intestinal electrical activities, respectively. Few studies have measured electroenterography in healthy humans; however, no studies have measured electrogastrography and electroenterography simultaneously. This study was performed to provide basic electrogastrography and electroenterography data for comparison with future studies in patients. Methods. Simultaneous preprandial and postprandial measurements of electrogastrography and electroenterography were taken for 30 min each in 50 healthy volunteers. Power spectrum analysis was performed to calculate dominant frequency, dominant power, and power ratio. Results. Gastric and small intestinal dominant frequencies were not significantly different between preprandial and postprandial periods. In preprandial and postprandial periods, normogastria was seen in 49 (98%) and 44 (88%) patients (), bradygastria in 1 (2%) and 6 (12%) patients (), and tachygastria in 0 (0%) patients, respectively. Dominant power was significantly increased in the stomach (828 [460–3203] μV² vs. 1526 [759–2958] μV², ) and small intestine (49 [27–86] μV² vs. 68 [37–130] μV², ). The power ratio was 1.6 (0.9–2.5) in the stomach and 1.4 (1.0–2.5) in the small intestine. Body mass index showed a negative correlation with the stomach and small intestinal dominant power in preprandial and postprandial periods (, ; , ; , ; and , , respectively). The Bristol Stool Form Scale correlated positively with the small intestinal power ratio (, ). Conclusion. There was no change in frequency in the stomach or small intestine, but power significantly increased in both the stomach and small intestine.

Background and Aims. Regulatory pathways compare biosimilars with originator molecules only and not with other biosimilars. With the development of multiple infliximab biosimilars, patients may be asked to transition between them. Data is emerging but there is still a gap in the evidence on switching between infliximab biosimilars. Our aim was to conduct a full evaluation of switching a cohort of IBD patients from one biosimilar (CT-P13) to another (SB2) in a real-world setting including clinical and patient experience and molecular and drug immunogenicity aspects of the process. Methods. Prospective, phase IV interventional study of patients on CT-P13 switched to SB2. Demographics, disease history, validated disease activity scores, PROMs, and laboratory measurements were collected. Semistructured qualitative interviews were also conducted. Results. 133 out of 158 patients agreed to participate. Mean disease duration was 9.2 years. There was no difference in mean haemoglobin, platelet count, albumin, and C-reactive protein before and after switching. Mean faecal calprotectin at baseline and at week 30/32 was 306 μg/g versus 210 μg/g. Mean pMCS and mHBI at baseline were 1.54 and 3.14 versus 1.18 and 2.91 at week 30/32, respectively. Thirty-five subjects discontinued. There were 16 serious adverse events. Thematic analysis identified six major themes that reflected the patient experience—trust, clinical status at the point of switching, past experience, general disposition, information provision, and concerns/anxiety. Conclusions. Switching from CT-P13 to SB2 is safe and effective. Certain factors must be considered in supporting patient decision-making. These results support the development of clear, streamlined, and well-monitored biosimilar switching programmes.

Background and Aims. The NAFLD disease spectrum includes simple steatosis, nonalcoholic steatohepatitis (NASH), advanced fibrosis, and cirrhosis. Progression from NASH, the forerunner of developing cirrhosis, portends a poor outcome as mortality is proportionately increased. This study sought to propose a new diagnostic model for advanced fibrosis in an Asian population cohort affected with NAFLD. Methods. Cross-sectional study conducted in the Department of Medical Gastroenterology, Medical College, Trivandrum. The study period was 2 years. After excluding secondary causes of hepatic steatosis, patients were subjected to vibration-controlled transient elastography or transient elastography (VCTE or TE) to assess hepatic fibrosis. Subjects were grouped into those with advanced fibrosis ( Kpa) and those without ( Kpa) based on the estimation of TE. A new scoring system was then developed. This was then validated in a cohort of 84 biopsy-proven patients.Results. 1617 NAFLD patients were included in the study. Independent predictors of advanced fibrosis in this cohort were hip circumference, triglycerides, aspartate aminotransferase (AST), and diabetes mellitus (duration more than 10 years). The coefficient of beta for these variables was calculated. T-HAD score was calculated using the following formula: . The AUROC of the T-HAD score was 0.929. The T-HAD score had a sensitivity of 90% and a specificity of 77% at a cut off of >2 for advanced fibrosis. We validated this score in another cohort of liver biopsy with advanced fibrosis. In the validation cohort, the T-HAD score had an AUROC of 0.926 in diagnosing advanced fibrosis (sensitivity of 89% and specificity of 71% at a cut off of >2). Conclusion. The T-HAD score based on data from the Asian population is a new diagnostic model which is beneficial in estimating the risk of advanced fibrosis. It is a simple yet effective tool that could be in-cooperated into day-to-day practice in a resource-limited setting.

Background. The prognosis of patients with hepatocellular carcinoma (HCC) not eligible to curative treatment is poor. Little information is available on treatment modalities and outcomes of these patients in everyday practice. The aim of this analysis was to describe the characteristics of patients with a newly diagnosed intermediate, advanced, or terminal (IAT) stage of HCC (ICD-10: C220) between 2015 and 2017, either present at diagnosis of HCC or having occurred after disease progression; treatment patterns, HCC aetiologies, and the associated survival were determined using the nationwide claims database. Methods. Patients with HCC were identified using the ICD-10 code C220. IAT stages, defined according to the terminology used in the Barcelona Clinic Liver Cancer classification, were indirectly identified by the presence of at least one of the following treatments: transarterial chemoembolization (TACE), transarterial radioembolization (TARE), HCC systemic therapy, best supportive care (BSC), or an ICD-10 code of metastatic HCC. Treatment patterns were described with an algorithm based on a ranking of palliative treatments identified. Survival was analysed by using Kaplan-Meier curves. Results. 19,649 eligible patients were identified. Their mean age was 70.5 years (SD: 11.0), and 82.5% were males. For 68.8% of patients, the IAT stage was present at HCC diagnosis. On the whole population, 5,114 patients (26.0%) were treated initially with a TACE or TARE, and 4,681 (23.8%) received a targeted systemic therapy at any moment during follow-up with sorafenib in 99.5% of cases. About 7,628 patients (45.6%) received only BSC. Survival since the diagnosis of the AIT stage of HCC differed according to the type of the first received palliative treatment. Median overall survival was 23.8, 9.6, 7.4, and 1.0 months in patients initially receiving TACE, TARE, systemic therapy, and BSC only, respectively. Conclusion. Over the period 2015-2017, hepatocellular carcinoma was still often diagnosed in France at late-stage disease with a very poor prognosis.

Background. Haemochromatosis is a rare autosomal genetic disease that can cause multiple organ failure. In the past, this condition was not considered to affect pregnancy. The objectives of this study are to update the management of haemochromatosis in general as there are new treatments being investigated other than phlebotomy and to summarise the effects of the condition on pregnancy and vice versa. Methods. The initial search was in Ovid Medline® from 2002 to 2013. Review articles for haemochromatosis and case reports of its related complications in pregnancy were found. None of the reviews addressed pregnancy in detail. A second search in PubMed from 2014 to 2016 included studies regarding haemochromatosis and pregnancy and iron metabolism association with other metals and biomarkers, defining the mechanism of foetomaternal risks in maternal haemochromatosis. A third search at PubMed from 2017 to 2022 using key words haemochromatosis and pregnancy was done to look at the new data. Results. The results are qualitative indicating that even in the absence of abnormal iron parameters, haemochromatosis increases the risk of foetomaternal complications due to genetic predisposition, necessitating antenatal monitoring. Newer medications targeting the pathophysiology of the disease to eliminate it are being developed. The coabsorption of lead with iron causes increased risk of maternal preeclampsia, gestational hypertension, foetal congenital abnormalities, and growth problems. There is risk of neurodevelopmental delays, large for gestational age and childhood leukaemia in babies whose mothers and themselves have mutations for haemochromatosis. Conclusion. Previously, women with haemochromatosis were thought to have no higher risk of complications than the general population. However, there is evidence of foetomaternal complications. As a result, pregnancy with haemochromatosis necessitates additional monitoring for both mother and baby.

Background and Aims. Endoscopic variceal ligation (EVL) of esophageal varices alters the portal pressure. We observed the changes in 2D-shear wave elastography (2D-SWE) measurements of spleen and liver following EVL and tried to identify the predictors for rebleeding and mortality at 6 months. Methods. A prospective observational study of 202 patients who underwent EVL for bleeding esophageal varices was done. 2D-SWE measurements of liver stiffness (LS) and spleen stiffness (SS) and spleen volume (SV) were measured half an hour before, 1 hour, 2 weeks, and 6 weeks after EVL. All were followed up for 6 months for rebleeding and all-cause mortality. Results. 83 patients were in child C (41%). Difference in SV, SS, and LS at 2 and 6 weeks from baseline was noted as Delta 2 (2^nd week post-EVL - pre-EVL SV, LS, and SS) and Delta 3 (6^th week post EVL - pre - EVL SV, LS and SS), respectively. Mean Delta 2 VOL and Delta 3 VOL were lower in the bleeding and mortality groups. Delta 2 SS, Delta 3 SS, Delta 2 LS, and Delta 3 LS were higher in the rebleeding and mortality groups. These changes were statistically significant. AUROC in predicting rebleeding was the highest for Delta 2 VOL (0.773) and Delta 3 LS (0.764) amongst the USG parameters that performed better than MELD score (0.677). AUROC in predicting mortality was the highest for Delta 3 VOL and Delta 2 VOL-0.873 and 0.842, respectively, and higher than MELD’s (0.641). Statistically significant variables in binary logistic regression analysis for rebleeding were Delta 3 LS and Delta 3 SS and none for mortality. Conclusion. LS, SS, and SV change after EVL. Changes in liver and spleen stiffness at 6 weeks from baseline had good diagnostic accuracy for predicting rebleeding at 6 months.