Indian Journal of Gastroenterology最新文献

Background and aim: The study aimed at assessing the course of portal hypertension and safety of non-selective beta blockers (NSBB) in pregnant patients with portal hypertension.

Methods: Pregnant women with portal hypertension (PHT), diagnosed preconceptionally or during pregnancy, were included in this retrospective study. Medical records were assessed for NSBB prescription, liver decompensation (ascites, variceal bleed, hepatic encephalopathy), overall and pregnancy-related outcomes. All outcomes were documented at discharge from the hospital.

Results: One-hundred thirty-four pregnancies in 93 patients (median age: 26, range [17-39 years]). The study included 54 primigravidas. Among the 93 patients, the etiology of portal hypertension was vascular in 48 and cirrhosis in 45. Of the 134 pregnancies, 90 were diagnosed with portal hypertension prior to pregnancy. Of these, 46/90 (51.1%) had a history of prior GI bleed. In the remaining 44/134, PHT was diagnosed during the index pregnancy. Of the 134 pregnancies, NSBB was prescribed during 51 pregnancies (38%; primary prophylaxis: 18, secondary prophylaxis: 33). Of these, 36 (26.9%) were started on NSBB preconceptionally, while 15 (11.2%) were initiated during pregnancy-one in first, 10 in second and four in third trimester. Sixteen (12%) patients presented with acute decompensation (ascites:13; GI bleed: 5; both 2). Of the remaining 118 pregnancies, not presenting initially with decompensation, 12 pregnancies were associated with hepatic decompensation either during antenatal or immediate post-partum period. Decompensation during pregnancy was similar in patients on NSBB (6/51, 11.8%, ascites: 3, GI bleed: 3) and not on NSBB (6/67, 8.9%; ascites: 6, GI bleed:0). Although maternal (100% survival) outcome was good, adverse fetal outcomes were noted (live: 116; abortion: 10, stillbirth: 7, neonatal death: 1). Hepatic decompensation was associated with poor fetal outcomes (live births: 69% vs. 91%, p = .03). NSBB was well tolerated with no effect on fetal outcome (p = .82), birth weight (2.5, 1.2-3.4 kg vs. 2.7, 1.1-3.7 kg; p = .12) or intra-uterine growth retardation (34% vs. 28%; p = .40).

Conclusions: Pregnancy is well tolerated in patients with portal hypertension, with favorable maternal outcomes. De novo decompensation was associated with adverse fetal outcomes. NSBB use appears safe and well tolerated in this subset of expectant mothers with portal hypertension.

Background and aim: Outcomes of drainage in hilar biliary obstruction may depend on volume of liver drained with previous studies showing better survival if more volume is drained. We aimed at determining the effect of draining > 50% of liver volume on clinical success after intervention in complex hilar blocks.

Methods: In this prospective observational study, advanced unresectable malignant hilar biliary obstruction with Bismuth-Corlette type II and above were recruited prospectively from October 2022 till April 2024. Patients underwent computed tomography (CT) abdomen and volumetric analysis using TeraRecon™ software. Patients were then subjected to endoscopic or percutaneous drainage. Based on intra-procedure details, patients were categorized into those achieving ≥ 50% (group A) and < 50% (group B) drainage groups. The primary outcome was clinical success. Secondary outcomes were complete drainage, cholangitis, reinterventions and overall survival.

Results: Eighty patients (mean age 54.9 ± 13.59 years; 53.8% females) were analyzed in the study. Forty-eight patients (60%) underwent ≥ 50% drainage. Clinical success was achieved in 47 patients (58.75%). Clinical success was achieved in 35 out of 48 (72.9%) and 12 out of 32 (37.5%) in group A and B, respectively. Clinical success was significantly higher in the ≥ 50% drainage group (OR 3.411; p = 0.025), with lesser cholangitis (15% vs. 26.3%; p = 0.001), reinterventions (12.5% vs. 23.8%; p = 0.001) and improved 90-day survival (58.8% vs. 10%; p = 0.013). On multivariate analysis, clinical success was a significant predictor for lesser episodes of cholangitis, reduced reinterventions, with higher complete drainage.

Conclusion: More than or equal to 50% biliary drainage leads to better clinical success and improved 90-day survival, with lesser cholangitis and lesser biliary reintervention rate. CT volumetry acts as a guiding tool.

Background and objective: Plasma exchange (PLEX) is used to treat liver failure patients who have coagulopathy. There is no consensus regarding pre-procedural blood product transfusion prior to PLEX port placement among patients with acute liver failure (ALF) and acute-on-chronic liver failure (ACLF). The primary objective was to study the difference in prophylactic blood product use in patients with ALF and ACLF who had rotational thromboelastometry (ROTEM) done prior to PLEX port insertion (ROTEM group -RG) compared with those patients in whom ROTEM was not done (conventional coagulation group-CG). Secondary objectives were to study local port site-related bleeding events between these groups and the correlation between ROTEM parameters and conventional coagulation tests (CCT), in patients with ALF and ACLF.

Methods: We retrospectively analyzed consecutive patients who underwent PLEX for ALF and ACLF using central venous access (11.5 F and 10 F catheter for adult and pediatric patients, respectively) between October 2016 and February 2022. The prophylactic transfusion strategy in CG was based on CCT and RG was based on CCT and ROTEM parameters. Propensity score matching (PSM) was done separately for ALF and ACLF between RG and CG.

Results: Total 88/113 patients with ALF/ACLF underwent PLEX. In PSM matched 77 ALF/108 ACLF patients, prophylactic blood products use was significantly less in RG (18/50 [36%]/12/85 [14%]) compared CG (21/27 [78%]/18/23 [78%]; p < 0.001). Local port site bleeding events were noted in two ACLF patients (one in RG and one in CG) and none in ALF. In ALF/ACLF patients, the correlation between clotting time (CT, ROTEM) and prothrombin time international normalized ratio (PT-INR, CCT) was 0.29/0.35 (weak), respectively, between maximum clot firmness (MCF, ROTEM) and fibrinogen was 0.68/0.76 (strong), respectively, and between maximum clot firmness (MCF, ROTEM) and platelet was 0.56/0.71 (moderate/strong), respectively.

Conclusion: The use of a ROTEM-based transfusion strategy prior to PLEX port insertion helped reduce prophylactic blood product transfusion among patients with ALF and ACLF.

Background and objectives: Obesity is a leading risk factor for fatty liver disease and weight loss has been shown to improve liver parameters. This study evaluates the efficacy of oral semaglutide for weight loss in individuals with overweight or obesity, excluding those with diabetes mellitus.

Methods: A randomized, open-label, controlled trial was conducted at the Asian Institute of Gastroenterology, Hyderabad, from June 2022 to December 2023. Adults (≥ 18 years) with a body mass index (BMI) ≥ 30 or ≥ 27 with comorbidities (pre-diabetes, hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease) were randomized into two groups. Both groups received counselling on a reduced-calorie diet and increased physical activity. Group 1 also received oral semaglutide, starting at 3 mg/day and titrated to 14 mg/day over two to four weeks. The objectives were to assess the effects of semaglutide on weight loss, non-invasive markers of liver fibrosis and cardiometabolic parameters. (ClinicalTrials.gov ID: NCT05442450).

Results: Total 116 participants (58 per group) completed the study. At 28 weeks, the mean percentage weight reduction was -10.47% (SD 5.3) in the Semaglutide group vs. -2.4% (SD 4.5) in the control group (p < 0.001). Semaglutide treatment significantly improved alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) levels, along with reductions in the aspartate aminotransferase to platelet ratio index (APRI) score, liver fat content and liver stiffness. However, NFS (NAFLD fibrosis score) and FIB-4 (fibrosis-4 index) did not show significant reductions. Improvements in BMI, waist circumference, HbA1c, fasting insulin and C-reactive protein (CRP) were significantly greater with semaglutide (p < 0.001). Total fat mass decreased by 7.3 kg vs. 1.74 kg (p < 0.0001) in controls, while visceral fat ratings dropped by 3.67 vs. 0.6 (p < 0.0001).

Conclusions: In adults with overweight or obesity without diabetes, oral semaglutide, combined with dietary and lifestyle modifications, led to significant and clinically meaningful weight loss and metabolic improvements compared to lifestyle modifications alone.

Background and objectives: Anti-reflux mucosal ablation (ARMA) is a minimally invasive therapy for patients with proton pump inhibitor (PPI) controlled gastro-esophageal reflux disease (GERD). This study evaluated the safety and efficacy of ARMA over 12 months.

Methods: This single-center prospective study included PPI-dependent GERD patients (acid exposure time [AET] > 6% or AET > 4.2% with reflux episodes > 80 on 24-h-pH-impedance monitoring). ARMA was performed in a standardized fashion using hybrid technique (sub-mucosal lift followed by ablation). Patients were evaluated using the GERD health-related quality of life questionnaire (HRQL) at baseline, three months and 12 months, with 24-h-pH-impedance monitoring at baseline and 12 months.

Results: Total 216 patients (67.1% males, mean age = 38.7 years) underwent ARMA. At baseline, 123 (56.9%) patients had Hill's grade I and 93 (43.1%) had Hill's grade II on endoscopy. Ninety (41.7%) patients had Los Angeles (LA) grade A and 2 (0.93%) had LA grade B. There was a significant improvement in GERD-HRQL score from 43.8 (12.6) at baseline to 20.6 (13.8) at three months and to 8.3 (12.3) at 12 months (p = 0.001). The mean (SD) heartburn and regurgitation scores improved from 22.9 (10.8) and 20.6 (9.4) at baseline to 11.1 (8.7) and 9.5 (8.7) at three months and 3.9 (6.9) and 3.9 (6.9) at 12 months, respectively (p = 0.001). The AET (median [IQR]) decreased from 11.9 (15.9) to 7.6 (10.8) (n = 125, p = 0.009) at 12 months and the median DeMeester score reduced from 42.4 (47.1) to 26.2 (32.3) (p = 0.001). There was also a significant decrease in number of patients with AET 4% to 6% and > 6% and reflux episodes 40-80 and > 80 and DeMeester score > 14.72, as well as an increase in patients with AET < 4% and reflux episodes < 40. There was a significant improvement in Hill's grading and endoscopic esophagitis at one year. No major adverse events were observed.

Conclusion: In PPI-dependent GERD patients, ARMA resulted in sustained symptom reduction and improved quality of life at 12 months. This procedure is relatively simple, widely accessible and has a good safety profile.

Clinical trial registration: ClinicalTrials.gov (NCT04243668).

Evolution of the diagnostic criteria for functional gastrointestinal disorders (FGID) from Rome I to Rome IV in the past three decades represents a transformative shift from simplistic, symptom-based definitions to a nuanced framework that reflects the complex interplay between the gut and brain. Initial iterations, i.e. Rome-I and II criteria, established a standardized model that focused on clusters of symptoms rather than structural abnormalities, while Rome-III criteria introduced stricter symptom duration thresholds and acknowledged the influence of psychological factors. The introduction of Rome IV criteria in 2016 marked a watershed moment. FGIDs were renamed as 'disorders of gut-brain interaction' (DGBI), integrating advances in neurogastroenterology and emphasizing the pathophysiological roles of central neural processes, altered motility, immune regulation, dysbiosis, etc. These criteria redefined the diagnostic thresholds and emphasized on 'bothersome' symptoms that affect daily activities. For diagnosis of irritable bowel syndrome, abdominal pain, rather than discomfort, was essentially required and the sub-types of functional dyspepsia were more precisely defined. The Multidimensional Clinical Profile framework was added, which incorporated the sub-type, severity and psychological and physiological modifiers of DGBIs. However, the application of the Rome-IV criteria in the past eight years in clinical and research settings has faced a number of challenges, including the risk of underdiagnosing patients with milder symptoms, under-recognition of the overlaps of DGBIs and the lack of universal applicability due to socio-cultural and economic disparities in different geographical regions, Additionally, the new term, 'DGBI', while scientifically correct, can be discerned as potentially over-simplified and can itself be stigmatizing for patients who may inadvertently perceive these disorders as being primarily 'neuro-psychological'. The selective retention of the term 'functional' to name individual disorders such as functional dyspepsia and functional diarrhea remains to be justified. Advancements in neurogastroenterology research in the past decade have highlighted the significant prevalence of organic mimickers of DGBIs, most common being small intestinal bacterial overgrowth and non-celiac gluten sensitivity, which need to be ruled out, especially in 'refractory' DGBI cases. Substantial data on post-infectious DGBIs, especially post-COVID DGBIs, have been published. Importantly, multiple objective biomarkers have been proposed, which may complement and strengthen the symptom-based diagnostic criteria for DGBIs. By addressing the challenges, incorporating recent scientific advances and striking a balance between clinical practicality and global applicability, the future iterations of the Rome criteria have the potential to set new standards for the diagnosis and treatment of DGBIs.

Background and objectives: Endoscopic retrograde cholangiopancreatography (ERCP)-related perforations (EPs) are rare but serious adverse events, with a reported frequency of 0.4% to 0.6% and mortality rates reaching 8%. The lack of a uniform classification system for injury patterns and evidence-based management guidelines poses significant challenges in clinical decision-making. This systematic review evaluates therapeutic approaches and outcomes of EPs using the Stapfer classification to address these gaps.

Methods: We conducted a systematic review of studies that utilized the Stapfer classification to categorize EPs into four types, ranked by severity: type I (lateral/medial duodenal wall perforation), type II (periampullary injuries), type III (bile duct injuries) and type IV (retroperitoneal air alone). The study protocol was registered in PROSPERO (ID CRD42023473841).

Results: Among 287 patients from 18 eligible studies, type-I perforations were associated with significantly higher mortality (adjusted OR = 3.17, 95% CI 1.45-6.99). Surgical management did not significantly increase mortality risk compared to non-operative treatment (adjusted OR = 1.99, 95% CI 0.66-6.00) but was linked to prolonged hospital stays (coefficient 8.58, 95% CI 2.71-14.46). In contrast, perforation type did not significantly influence hospitalization duration (coefficient - 0.64, 95% CI - 4.04 to 2.76).

Conclusions: Our findings underscore the need for individualized treatment strategies based on perforation type and patient-specific factors. While the Stapfer classification aids in risk stratification, the heterogeneity of current evidence limits generalizability. Large-scale prospective studies are essential to establish standardized management protocols.

Background and objectives: Chronic pancreatitis (CP) is a fibroinflammatory disease causing functional injury. Abdominal pain is the predominant symptom negatively impacting the quality of life. The Comprehensive Pain Assessment Tool (COMPAT-SF) questionnaire, designed and validated to assess pain in CP, was previously only available in English and Danish. Given the high prevalence of CP in India, translating and validating COMPAT-SF into different languages becomes crucial.

Methods: The COMPAT-SF underwent translation into three Indian languages (Hindi, Telugu and Bengali) and was back-translated to English to ensure cross-cultural equivalence. Validation was conducted at two tertiary care centers in India. As Hindi is the most widespread language, bilingual CP patients answered the COMPAT-SF in Hindi and English at a three-week interval. All sub-group answers were compared with patient data from the US. Structural equation modeling and confirmatory factor analysis were employed for validation.

Results: Total 64 patients (19 Hindi-speaking,15 Telugu and 30 Bengali) were included and compared with 91 English-speaking patients. Translation adequacy was confirmed with > 85% concordance. Despite modest Cronbach alpha values in reliability analysis, structural equation modeling demonstrated high consistency with the original COMPAT-SF study. Some cultural differences in responses were observed, but the responses were comparable overall. Confirmatory factor analysis on the pooled data indicated an acceptable model fit and the Hindi version showed good accordance with the English version.

Conclusion: The translated COMPAT-SF versions proved to be valid and reliable pain assessment tools for CP patients. The study underscores the importance of addressing pain comprehensively.