Efficacy and safety of self-expandable metallic stents for management of benign gastric outlet obstruction-A prospective study.

INTRODUCTION: We aimed at evaluating the safety and efficacy of self-expandable metallic stent (SEMS) insertion for managing patients with benign gastric outlet obstruction (GOO). METHODS: This prospective interventional study included 23 patients. All consecutive treatment-naïve symptomatic patients with benign GOO were recruited. Fully covered SEMS were deployed across the stricture under fluoroscopic and endoscopic guidance. Technical success, clinical success and sustained treatment response (STR) were assessed. Technical success was defined as the successful deployment of SEMS at the desired anatomic location. Clinical success was defined as the resolution of symptoms and an increase in Gastric Outlet Obstruction Scoring System (GOOSS) of at least 1 point from the baseline score on Day 7. STR was assessed at four and eight weeks post stent removal in patients who had a response at week four. Factors associated with stent migration and non-response at week four were also assessed. RESULTS: The median age of the study population was 30 years (range 19-65 years). Males constituted 65.22%. Most patients presented with vomiting (100%) and abdominal pain (95.65%). Peptic stricture was most common etiology for GOO (60.9%) followed by tubercular (26.1%) and corrosive (13%). Most common site of obstruction was junction of first and second part of duodenum (69.57%) followed by pyloric (30.43%). Median length of stricture was 2 cm (range 1.5-4). Technical success was achieved in all 23 patients (100%). Clinical success was achieved in 21 patients (91.3%). Response at Day 28 was seen in 20 patients (86.95%). Eighteen of 20 (90%) patients who had a response at week four had STR at week four and week eight after stent removal. Stent migration occurred in five (21.7%) patients. On univariate analysis, stricture length, calibre and stent length were found to predict migration. CONCLUSIONS: Fully covered SEMS was an effective and safe management modality in patients with benign GOO. Stent migration remains a troublesome disadvantage.

Motorized Power Spiral Enteroscopy (MSE): Is Routine Bougienage of the Upper Esophageal Sphincter (UES) Necessary?

Introduction Wire-guided bougienage of the upper esophageal sphincter (UES) was performed routinely before per-oral motorized power spiral enteroscopy (MSE). In the present study, we aimed to answer the clinical question of whether routine bougienage of UES is required. Methods This was a retrospective study that included 20 patients who underwent antegrade spiral enteroscopy for various indications. The feasibility and safety of anterograde MSE without prior bougie dilatation of the upper esophageal sphincter were assessed. The technical success rate (TSR), diagnostic yield, and adverse events (AEs) were also assessed. Results In 16 out of the 20 patients, a spiral enteroscope was taken directly across UES into the esophagus without a prior bougie dilatation. The spiral enteroscope could not be negotiated across UES only in one patient, and bougie dilatation was done. The technical success rate was 100%. The diagnostic yield was 80%. Four patients reported AEs. Conclusions MSE had a good technical success rate and diagnostic yield. Routine dilatation of the UES before the procedure may be unnecessary.

Severe Acute Liver Injury: First Manifestation of Systemic Lupus Erythematosus.

Systemic lupus erythematosus (SLE) is a common multisystem disease characterised by a wide variety of presentation patterns and complex manifestations. As a lymphoid organ, the liver plays an important role in the immune response and is a target of autoimmune responses.1 SLE can affect the liver in approximately 25-60 % of patients during their disease course.2,3 Liver dysfunction and SLE can present with complicated differential diagnoses. Liver dysfunction in SLE is usually mild and rarely leads to advanced liver diseases such as cirrhosis and liver failure.4,5 Liver dysfunction in SLE is usually caused by non-SLE-related causes such as drug toxicity, fatty liver, alcoholism, and associated autoimmune hepatitis. However, primary liver involvement in SLE is also well-recognised. Patients with SLE who present with acute liver failure are rare. We report a rare case of SLE-associated acute severe liver injury along with a literature review.

Nutritional therapy for persistent cognitive impairment after resolution of overt hepatic encephalopathy in patients with cirrhosis: A double-blind randomized controlled trial.

BACKGROUND AND AIM: Minimal hepatic encephalopathy (MHE) reflects cognitive impairment in patients with liver cirrhosis and is associated with poor prognosis. We assessed the effects of nutritional therapy on cognitive functions, health-related quality of life (HRQOL), anthropometry, endotoxins, and inflammatory markers in cirrhotic patients with MHE. METHODS: In a double-blind randomized controlled trial, cirrhotic patients with MHE were randomized to nutritional therapy (group I: 30-35 kcal/kg/day and 1.0-1.5 g of protein/kg/day) and no nutritional therapy (group II: diet as patients were taking before) for 6 months. MHE was diagnosed based on psychometric hepatic encephalopathy score (PHES). Anthropometry, ammonia, endotoxins, inflammatory markers, myostatin, and HRQOL were assessed at baseline and after 6 months. Primary endpoints were improvement or worsening in MHE and HRQOL. RESULTS: A total of 150 patients were randomized to group I (n = 75, age 46.3 ± 12.5 years, 58 men) and group II (n = 75, age 45.2 ± 9.3 years, 56 men). Baseline PHES (-8.16 ± 1.42 vs -8.24 ± 1.43; P = 0.54) was comparable in both groups. Reversal of MHE was higher in group I (73.2% vs 21.4%; P = 0.001) than group II. Improvement in PHES (Δ PHES 4.0 ± 0.60 vs -4.18 ± 0.40; P = 0.001), HRQOL (Δ Sickness Impact Profile 3.24 ± 3.63 vs 0.54 ± 3.58; P = 0.001), anthropometry, ammonia, endotoxins, cytokines, and myostatin levels was also significantly higher in group I than group II. Overt hepatic encephalopathy developed in 6 patients in group I and 13 in group II (P = 0.04). CONCLUSIONS: Nutritional therapy is effective in treatment of MHE and associated with improvement in nutritional status, HRQOL, ammonia, endotoxins, inflammatory markers, and myostatin levels.

Diagnostic utility of urine neutrophil gelatinase-associated lipocalin and renal resistive index in patients of decompensated cirrhosis with acute kidney injury.

BACKGROUND: The differentiation between types of acute kidney injury(AKI) in decompensated cirrhosis(DC) patients in clinical practice is done by clinical adjudication. Biomarkers have good diagnostic accuracy for predicting acute tubular necrosis(ATN), however they are not available routinely. AIMS: We compared the diagnostic accuracy of urine neutrophil gelatinase-associated lipocalin(UNGAL) and renal resistive index(RRI) in predicting type of AKI among DC patients. METHODS: Consecutive DC patients with AKI stage≥1B seen between June/2020 to May/2021 were evaluated. UNGAL levels and RRI were measured at diagnosis of AKI(Day 0) and 48hrs(Day 3) after volume expansion. Diagnostic accuracy of UGNAL and RRI was compared for differentiating ATN and non-ATN AKI by area under receiver operating characteristic curve(AUROC), using clinical adjudication as gold standard. RESULTS: 388 DC patients were screened, 86 patients(Pre-renal AKI[PRA] n=47,55%; Hepatorenal syndrome[HRS] n=25,29%;ATN n= 14,16%) were included. The AUROC of UNGAL for differentiating ATN-AKI and non-ATN AKI at day 0 was 0.97(95%CI, 0.95-1.0) and on day 3 was 0.97(95%CI, 0.94-1.0). The AUROC of RRI for differentiating ATN and non-ATN AKI at day 0 was 0.68(95%CI, 0.55-0.80) and on day 3 was 0.74(95%CI, 0.63-0.84). CONCLUSION: UNGAL has an excellent diagnostic accuracy in predicting ATN-AKI in DC patients both at day 0 and 3.

Validity and Reliability of the European Organization Research and Treatment of Cancer Quality of Life Questionnaire-Oesophagogastric 25 in Indian Patients With Corrosive-Induced Benign Refractory Esophageal Strictures.

Background The European organization Research and Treatment of Cancer Quality of Life Questionnaire-Oesophagogastric 25 (EORTC QLQ-OG 25) is designed for patients with esophagogastric cancer. Its performance has never been tested with benign disorders. A health-related quality-of-life questionnaire does not exist for patients with benign corrosive-induced esophageal strictures. Hence, we evaluated the EORTC QLQ-OG 25 in Indian patients with corrosive strictures. Methods The English or Hindi version of QLQ-OG 25 was administered to 31 adult patients undergoing outpatient esophageal dilation at GB Pant hospital, New Delhi. These patients had refractory or recurrent esophageal strictures due to corrosive ingestion and had not undergone reconstructive surgery. Score distribution was analyzed, and item performance was determined based on floor and ceiling effects. Convergent validity, discriminant validity, and internal consistency were checked. Results The average time to finish the questionnaire was 6.70 minutes. Most scales fulfilled convergent validity (corrected item-total correlation >0.4), barring the Odynophagia scale and one item of the Dysphagia scale. Most scales exhibited divergent validity except for odynophagia and one item of dysphagia. Cronbach's alpha was >0.70 for all scales except odynophagia. Responses to questions evaluating taste, cough, swallowing saliva, and talking were highly skewed and had prominent floor effects. Overall, the questionnaire demonstrated good internal consistency, convergent validity, and divergent validity in benign corrosive-induced refractory esophageal strictures patients. Conclusion The EORTC QLQ-OG 25 can be satisfactorily used in patients with benign esophageal strictures to assess health-related quality of life.

Natural History of Asymptomatic Walled-off Necrosis in Patients With Acute Pancreatitis.

Background and objectives Studies on the natural history of asymptomatic walled-off necrosis (WON) in acute pancreatitis (AP) are scarce. We conducted a prospective observational study to look for the incidence of infection in WON. Material and methods In this study, we included 30 consecutive AP patients with asymptomatic WON. Their baseline clinical, laboratory, and radiological parameters were recorded and followed up for three months. Mann Whitney U test and unpaired t-tests were used for quantitative data and chi-square and Fisher's exact tests were used for qualitative data analysis. A p-value <0.05 was considered significant. Receiver operating characteristic curve (ROC) analysis was done to identify the appropriate cutoffs for the significant variables. Results Of the 30 patients enrolled, 25 (83.3%) were males. Alcohol was the most common etiology. Eight patients (26.6%) developed an infection on follow-up. All were managed by drainage either percutaneously (n=4, 50%) or endoscopically (n=3, 37.5%). One patient required both. No patient required surgery and there was no mortality. Median baseline C-reactive protein (CRP) was higher in infection group 76 (IQR=34.8) mg/L vs asymptomatic group, 9.5 mg/dl (IQR=13.6), p<0.001. IL-6 and tumor necrosis factor (TNF)-alpha was also higher in the infection group. The size of the largest collection (157.50±33.59 mm vs 81.95±26.22 mm, P<0.001) and CT severity index (CTSI) (9.50±0.93 vs 7.82±1.37, p<0.01) were also higher in infection group as compared to the asymptomatic group. ROC curve analysis of baseline CRP (cutoff 49.5mg/dl), size of WON (cutoff 127mm) and CTSI (cutoff of 9) showed AUROC (area under ROC) of 1, 0.97, and 0.81 respectively for the future development of infection in WON. Conclusion Around one-fourth of asymptomatic WON patients developed an infection during three-months follow-up. Most patients with infected WON can be managed conservatively.

A double blind randomized controlled trial to assess efficacy of nutritional therapy for prevention of recurrence of hepatic encephalopathy in patients with cirrhosis.

BACKGROUND AND AIM: Overt hepatic encephalopathy (OHE) has high risk of recurrence and is associated with poor survival. The role of nutrition therapy is well documented in cirrhosis, but its efficacy in preventing the recurrence of OHE has not been studied. METHODS: In double blind RCT, we randomly assigned 150 patients with liver cirrhosis, with history of OHE in recent past to receive nutrition therapy (group I) or no nutrition therapy (group II) and followed up for 6 months. The primary efficacy end points were occurrence of breakthrough episodes and time to breakthrough episode of OHE. Secondary end points were OHE related hospitalizations and time to hospitalization involving OHE. Other parameters included anthropometry, changes in serum cytokines (IL-1, IL-6, IL-10, and TNF-α), endotoxin and myostatin. RESULTS: There was significant reduction in occurrence of breakthrough episodes of OHE in group I [10 vs 36, hazard ratio 0.20; P < 0.001], OHE-related hospitalization [8 vs 24, hazard ratio 0.27; P < 0.001)]. Times to breakthrough episode of OHE and OHE-related hospitalization were longer in group I. At the end of 6 months, inflammatory and anthropometry parameters showed significant improvement in group I compared with worsening of serum albumin, anthropometric parameters, IL-6, IL-10 and TNF-α in group II. At the end of 6 months, ascites (50 vs 66, P = 0.01), gastrointestinal bleed (2 vs 11, P = 0.007), and jaundice (16 vs 41, P < 0.001) were lower in group I. CONCLUSIONS: Treatment with nutrition therapy prevented recurrence of OHE and decreased OHE-related hospitalizations as compared with no nutrition therapy.

Comparing Myelosuppression Frequency in Indian Inflammatory Bowel Disease Patients: A Randomized Trial of Full Dose Versus Gradual Escalation of Thiopurines.

INTRODUCTION: We aimed to compare the frequency of myelosuppression in patients initiating azathioprine (AZA) at full dose versus those undergoing gradual dose escalation. METHODS: Forty patients with inflammatory bowel disease were recruited over one year and randomized into two groups of 20. Group A initiated AZA at a full dose of 2 mg/kg, while group B started at 1 mg/kg with subsequent dose increases at regular intervals. RESULTS: Seventeen patients from each group were included in the final analysis. During follow-up, two patients (11.8%) from group A and four patients (23.5%) from group B experienced relapses (p=0.65). Myelosuppression occurred in two patients (11.8%) from each group. Absolute neutrophil counts in group A tended to have lower median values than those in group B, particularly four weeks after AZA initiation. Univariate analysis identified serum proteins, albumin, and bilirubin as significantly associated with leukopenia, but these factors were not significant according to multivariate analysis. CONCLUSIONS: The incidence of myelosuppression was similar between the groups. Patients with full-dose initiation of AZA had numerically fewer relapses during the follow-up period.

Indian tubercular belly: A prospective study of 140 patients of abdominal tuberculosis and their outcomes.

Background: Abdominal tuberculosis is an important yet ignored entity in the spectrum of tuberculosis which has been dominated by pulmonary tuberculosis. Diagnosis and treatment are often delayed due to nonspecific symptoms. In this study, we aimed to highlight the clinical features, diagnostic methods and outcomes of abdominal tuberculosis. Methods: A prospective study was conducted in tertiary referral centre where all patients referred to drug distribution centres (DOTS centre) for abdominal tuberculosis were identified. Their demographic clinical and radiological profile was evaluated. These patients were followed-up for their treatment course for complications and outcomes. Results: A total of 140 patients who were labelled abdominal tuberculosis over a period of 2 years were reviewed at tuberculosis drug distribution centre (DOTS). Mean age of study population was 35.42 ± 12.53 years and majority of the population were males, 58.6% (82). The most common presenting symptom was abdominal pain which was seen in 82.8% (n = 116) of the patients, followed by feverin 65.6% (n = 92); 22.8% (n = 32) were seropositive for HIV and 44.2% (n = 62) had luminal tuberculosis of which ileocecal was the most common site. Peritoneum was second most common site which was involved in 26.4% (n = 37) of the patients followed by mixed tuberculosis involving more than one type. Confirmed diagnosis was achieved in 74 patients (52.8%), while the remaining 66 patients (47.14%) were diagnosed clinically. During follow-up, 12 patients were lost to follow-up; 113 (80.7%) had complete response, while 3 (2.14%) patients died during treatment. Conclusion: Abdominal tuberculosis usually presents with nonspecific complaints which require high index of suspicion. Most patients require only medical therapy which has good results.

Enhanced Liver Fibrosis Score: Is It Useful for Evaluation of Fibrosis Severity in Chronic Hepatitis C Infection?

INTRODUCTION: The assessment of liver fibrosis is important in patients with chronic hepatitis C (CHC). In recent years, non-invasive tests like enhanced liver fibrosis (ELF) have been developed as an alternative to liver biopsy for estimating the severity of liver fibrosis. Therefore, we aimed to assess whether the ELF score can be used for fibrosis severity estimation using liver biopsy as the gold standard. MATERIALS AND METHODS: Forty-nine patients with CHC were enrolled in this study. Liver biopsy, ELF assessment, and transient elastography (TE) were performed in all patients, and severity of fibrosis on histopathology was assessed by meta-analysis of histological data in viral hepatitis (METAVIR) score. In addition, the diagnostic performance of ELF was evaluated by receiver operator characteristic curve (ROC) analyses, and liver biopsy histopathology was taken as the gold standard for the severity of liver fibrosis. RESULTS: The area under receiver operator characteristic curve (AUROC) for significant fibrosis of ELF score was 0.64 (95% confidence interval {CI}, 0.48-0.79) and of TE was 0.85 (95% CI, 0.73-0.96). The AUROC for advance fibrosis of ELF was 0.77 (95% CI, 0.57-0.97) and TE was 0.98 (95% CI, 0.94-1.0). The calculated cut-offs of ELF overestimated fibrosis in 53.06% (26/49) of patients and underestimated fibrosis in 6.12% (3/49) patients. AUROC of TE was significantly better than ELF for diagnosis of significant fibrosis (p=0.004) and advanced fibrosis (p=0.034). CONCLUSION: The ELF score can be used for estimating the severity of fibrosis but it is inferior to TE in estimating liver fibrosis severity.

Endoscopic retrograde cholangiopancreaticography-related complications - Experience from tertiary care teaching centre over half a decade.

Introduction: Endoscopic retrograde cholangiopancreaticography (ERCP) is an essential therapeutic procedure with a significant risk of complications. Data regarding the complications and predictors of adverse outcomes such as mortality are scarce, especially from India and Asia. We aimed to look at the incidence and outcome of complications in ERCP patients. Materials and Methods: This study is a retrospective analysis of prospectively collected data of all the patients who underwent ERCP and had a complication from January 2012 to December 2018. Data were recorded in predesigned pro forma. The data analysis was done by appropriate statistical tests. Results: : A total of 17,163 ERCP were done. A total of 570 patients (3.3%) had complications; perforation (n = 275, 1.6%) was most common followed by pancreatitis (n = 177, 1.03%) and bleeding (n = 60, 0.35%). The majorities of perforations were managed conservatively (n = 205, 74.5%), and 53 (19%) required surgery. Overall, 69 (0.4%) patients died. Of these, 30 (10.9%) patients died with perforation. Age (odds ratio [OR]: 1.04, 95% confidence interval [CI]: 1.005-1.07) and need of surgery (OR: 5.11, 95% CI: 1.66-15.77) were the predictors of mortality in patients with perforation. The majority pancreatitis were mild (n = 125, 70.6%) and overall mortality was 5.6% (n = 10). Conclusion: ERCP complications have been remained static over the years, with perforation and pancreatitis contributing the most. Most perforations can be managed conservatively with good clinical outcomes.

Acute Variceal Bleed in Cirrhosis is Associated With Reversible Changes in Tight Junction Protein Expression in the Intestine: A Proof-of-Concept Study.

BACKGROUND: Tight junction proteins (TJPs) play an important role in gut-barrier dysfunction in cirrhosis and its complications such as acute variceal bleed (AVB). However, the dynamics of TJPs expression after AVB, its relation to bacterial translocation, and impact on clinical outcome is largely unknown. AIMS: The aim of this study was to study the expression of TJPs in cirrhosis and assess its dynamic changes in AVB. In addition, the relation of TJP expression to endotoxemia and clinical outcomes was assessed. METHODS: In this prospective pilot study, 17 patients of cirrhosis with AVB, 59 patients of cirrhosis without AVB (non-AVB cirrhosis), and 20 controls were assessed for claudin-2 and claudin-4 expression in the duodenal biopsy. In the AVB-cirrhosis group, additional biopsies were obtained after 3 weeks. Endotoxemia was assessed by measuring IgG anti-endotoxin antibody levels. Claudin expression was correlated with a 6-month survival. RESULTS: Claudin-2 expression was downregulated in patients with AVB and non-AVB cirrhosis in villi (P < 0.001 and 0.013) and crypts (P < 0.001 and 0.012), respectively, compared with the controls. Claudin-4 expression was similar in villi (P = 0.079), but lower in crypts (P = 0.007) in patients with cirrhosis. Claudin-2 expression was upregulated on serial biopsies in both villi and crypts (P = 0.003 and 0.001, respectively) in AVB-cirrhosis with postbleed expression comparable with those with non-AVB cirrhosis. IgG anti-endotoxin antibody levels were elevated in cirrhosis with no correlation with claudin-2/4 expression. Claudin-2 expression independently predicted survival at 6 months. CONCLUSION: Both claudin-2 and claudin-4 expression are downregulated in cirrhosis. AVB is associated with dynamic changes in TJPs expression. Gut-barrier dysfunction might predict outcomes independent of bacterial endotoxemia in cirrhosis.

L-ornithine L-aspartate in acute treatment of severe hepatic encephalopathy: A double-blind randomized controlled trial.

BACKGROUND AND AIMS: Data on the use of intravenous L-ornithine L-aspartate (LOLA) in the treatment of overt HE (OHE) is limited. We evaluated the role of intravenous LOLA in patients of cirrhosis with OHE grade III-IV. APPROACH AND RESULTS: In a double-blind randomized placebo-controlled trial, 140 patients were randomized to a combination of LOLA, lactulose, and rifaximin (n = 70) or placebo, lactulose, and rifaximin (n = 70). LOLA was given as continuous intravenous infusion at a dose of 30 g over 24 h for 5 days. Ammonia levels, TNF-α, ILs, and endotoxins were measured on days 0 and 5. The primary outcome was the improvement in the grade of HE at day 5. Higher rates of improvement in grade of HE (92.5% vs. 66%, p < 0.001), lower time to recovery (2.70 ± 0.46 vs. 3.00 ± 0.87 days, p = 0.03), and lower 28-day mortality (16.4% vs. 41.8%, p = 0.001) were seen in the LOLA group as compared with placebo. Levels of inflammatory markers were reduced in both groups. Significantly higher reductions in levels of blood ammonia, IL-6, and TNF-α were seen in the LOLA group. CONCLUSIONS: Combination of LOLA with lactulose and rifaximin was more effective than only lactulose and rifaximin in improving grades of HE, recovery time from encephalopathy, with lower 28-day mortality.