Sofosbuvir plus ribavirin in treatment-naïve patients with chronic hepatitis C virus genotype 1 or 3 infection in India.

Until 2014, pegylated interferon plus ribavirin was the recommended standard of care for the treatment of chronic hepatitis C virus (HCV) infection in India. This open-label phase 3b study, conducted across 14 sites in India between 31 March 2014 and 30 November 2015, evaluated the efficacy and safety of sofosbuvir plus ribavirin therapy among treatment-naïve patients with chronic genotype 1 or 3 HCV infection. A total of 117 patients with genotype 1 or 3 HCV infection were randomized 1:1 to receive sofosbuvir 400 mg and weight-based ribavirin (1000 or 1200 mg) daily for 16 or 24 weeks. Among those with genotype 1 infection, the primary efficacy endpoint of sustained virologic response at 12 weeks post-treatment (SVR12) was reported in 90% (95% confidence intervals [CI], 73-98) and 96% (95% CI, 82-100) of patients following 16 and 24 weeks of treatment, respectively. For patients with genotype 3 infection, SVR12 rates were 100% (95% CI, 88-100) and 93% (95% CI, 78-99) after 16 and 24 weeks of therapy, respectively. Adverse events, most of which were mild or moderate in severity, occurred in 69% and 57% of patients receiving 16 and 24 weeks of treatment, respectively. The most common treatment-emergent adverse events were asthenia, headache and cough. Only one patient in the 24-week group discontinued treatment with sofosbuvir during this study. Overall, sofosbuvir plus ribavirin therapy achieved SVR12 rates ≥90% and was well tolerated among treatment-naïve patients with chronic genotype 1 or 3 HCV infection in India.

Aggressive bougie dilatation and intralesional steroids is effective in refractory benign esophageal strictures secondary to corrosive ingestion.

Endoscopic dilatation of corrosive esophageal strictures is effective, but some patients are refractory to it and require long-term repeated dilatations. The present study was carried out to analyze whether rigorous schedule of endoscopic bougie dilatation along with intralesional injection of triamcinolone in patients refractory to endoscopic dilatation alone could decrease the number and frequency of endoscopic dilatations. The inclusion criterion for this prospective study was patients with refractory corrosive esophageal stricture of any age group. Refractory benign esophageal stricture is defined as an anatomic fibrotic esophageal restriction with inability to achieve dilatation of ≥14 mm or to maintain dilatation for 4 weeks once ≥14 mm diameter is achieved. The patients were followed up prospectively for 1 year. Patients with refractory strictures were subjected to weekly bougie dilatation (Savary-Gilliard) of the strictures along with injections of intralesional triamcinolone (40 mg/mL, 1 mL diluted in 1 mL of saline, 0.5 mL injected per quadrant of stricture) for consecutive 5 weeks, referred to as rigorous schedule. Further dilatation was done on an 'on-demand' basis. Eleven patients were enrolled for the study. Dysphagia score improved from pre-intervention score of 3.54 ± 0.52 to 0.45 ± 0.52 post-intervention (P < 0.001). The maximum dilatation achieved pre-intervention was 9.90+1.04 mm Savary-Gilliard and post-intervention significantly improved to 14.7 + 0.7 mm Savary-Gilliard (P < 0.001). The periodic dilatation index defined as number of dilatations per month also significantly improved from pre-intervention score of 2.54 ± 1.06 to post-intervention score of 0.19 + 0.13 (P < 0.001). No adverse effects were reported by the patients. Rigorous weekly schedule of bougie dilatation and intralesional triamcinolone in combination is safe and effective in achieving significant dilatation, reducing the frequency dilatations, maintaining dilatation and improving dysphagia till 1 year of follow-up.

Alcohol metabolism is not affected by sleeve gastrectomy.

INTRODUCTION: It has been published that patients who underwent gastric bypass surgery have impaired alcohol metabolism, predisposing them to higher rates of intoxication and DUI arrests. Yet the impact of laparoscopic sleeve gastrectomy (LSG) on alcohol metabolism and in particular the long-term effects are still unclear. We hypothesized that LSG does not alter alcohol metabolism. METHODS: A prospective cohort study of patients undergoing LSG was evaluated. Blood alcohol concentration (BAC) was extrapolated using a Breathalyzer(®). Alcohol metabolism was evaluated by determining BAC every 5 min after a single dose of alcohol (5 oz. glass of 14% v/v Malbec wine), until BAC was equal to zero. Subjects were queried about alcohol intoxication symptoms. All parameters were obtained and analyzed preoperatively and at 3 and 12 months postoperatively. RESULTS: Our study consisted of 10 patients (9 female) with a mean age of 46.6 ± 2.2 years and BMI of 43.5 ± 2.2 kg/m(2). The mean percentage excess weight loss was 39.5 ± 3.3 at 3 months and 55.6 ± 4.4 at 12 months. Peak BAC at 20 min was not different at 3 months (0.068 ± 0.007, p = 0.77) or at 12 months (0.047 ± 0.008, p = 0.19) when compared to the preoperative assessment (0.059 ± 0.014). In addition, the time to BAC equal to zero was not significantly different between baseline and the follow-up values (preoperative: 70 ± 9 min, 3 months: 95 ± 18 min, and 12 months: 57 ± 8 min, (p > 0.05). Symptoms of intoxication were not significantly different in patients before and after surgery. CONCLUSIONS: Our study suggests that LSG does not alter alcohol metabolism. Patients who undergo LSG do not have higher levels of intoxication following alcohol consumption and are therefore not prone to higher rates of DUI charges than the general public, in contrast to that previously reported following in patients who undergo gastric bypass surgery.

Mitomycin-C: 'a ray of hope' in refractory corrosive esophageal strictures.

Increasingly frequent dilation may become a self-defeating cycle in refractory stricture as recurrent trauma enhance, scar formation, and ultimately recurrence and potential worsening of the stricture. In 12 patients of caustic induced esophageal stricture, who failed to respond despite rigorous dilatation regimen for more than one year, a trial of topical mitomycin-C application to improve dilatation results was undertaken, considering the recently reported efficacy and safety of this agent. Mitomycin-C was applied for 2-3 minutes at the strictured esophageal segment after dilation with wire-guided Savary-Gilliard dilator. Patient was kept nil by mouth for 2-3 hours. After 4-6 sessions of mitomycin-C treatment, resolution of symptoms and significant improvement in dysphagia score and periodic dilatation index was seen in all 12 patients. Mitomycin-C topical application may be a useful strategy in refractory corrosive esophageal strictures and salvage patients from surgery.

A multicenter double-blind, placebo-controlled randomized trial to evaluate the safety and efficacy of bovine colostrum in the treatment of severe alcoholic hepatitis (SAH).

BACKGROUND: Severe alcoholic hepatitis (SAH) is associated with high mortality. Numerous studies and meta-analysis have reported that corticosteroids reduce the 28-day mortality in SAH, but not the 6-month mortality. Therefore, newer treatments for SAH need to be studied. A pilot study from our group had recently treated ten patients with SAH with bovine colostrum (BC) [20 g thrice in a day for 8 weeks] and prednisolone. This therapy improved the biological functions and 3-month mortality. However, as more and more data showed the failure of corticosteroids to improve the 3- and 6-month mortality, especially in patients with high mDF and MELD scores, we planned this trial to study the safety and efficacy of BC (without corticosteroids) in the treatment of SAH. METHOD: This is a multicenter, parallel, double-blind, randomized (1:1) placebo-controlled trial, which will enroll 174 patients with SAH from 5 academic centers in the India. Patients will receive freeze-dried BC or placebo by random 1:1 allocation for 4 weeks. The primary outcome measure is survival at 3 months. The secondary outcome measures are survival at 1 month, change in mDF and MELD scores, change in endotoxin and cytokines (alpha TNF, IL6, and IL8) levels, number of episodes of sepsis [pneumonia, spontaneous bacterial peritonitis (SBP), cellulitis, urinary tract infection (UTI)] from baseline to 4 weeks. DISCUSSION: This study will evaluate the safety and efficacy of bovine colostrum in improving the survival of patients with SAH. TRIAL REGISTRATION: ClinicalTrials.gov NCT02473341. Prospectively registered on June 16, 2015.

Transcallosal resection of hypothalamic hamartoma for gelastic epilepsy.

INTRODUCTION: Hypothalamic hamartomas (HHs) are commonly associated with severe epilepsy resistant to anticonvulsant therapy. Historically, surgical resection of HHs resulted in considerable morbidity. DISCUSSION: Two series of patients who successfully underwent resection using a transcallosal approach have now been published; we report the first UK experience of this technique in a series of five patients with HHs and gelastic epilepsy resistant to anticonvulsant therapy. Patients were assessed pre- and postoperatively for seizure activity, endocrine function, ophthalmology, and neurocognitive function. Two patients had precocious puberty and all had evidence of developmental delay and behavioral problems. Postoperatively, all children experienced at least a 50% reduction in seizure frequency with abolition of major seizure types; one child remains seizure-free. One child developed a mild postoperative right hemiparesis and one developed transient diabetes insipidus. CONCLUSION: There were no adverse developmental effects of surgery. Transcallosal resection of HHs ameliorates resistant epilepsy syndromes associated with HH.

Quality of life and nutritional status in alcohol addicts and patients with chronic liver disease.

OBJECTIVE: The aim of the study was to assess and compare the nutritional status and quality of life in chronic liver disease (alcoholic and non-alcoholic) patients and alcohol addicts. METHODS: Patients with alcoholic liver disease (n=41), nonalcoholic liver disease (n=40), alcohol addicts (n=25) without liver disease and healthy controls (n=25) were randomly selected. Nutritional status was assessed using anthropometric measurements viz. skin fold thickness, arm muscle circumference and area. Biochemical estimations included liver function tests. Food intake was assessed using 48 hour recall and macro-nutrient intake was calculated. Quality of life was assessed using the SF-36 questionnaire. RESULTS: The mean value of mid-arm muscle area was significantly lower in patients from the non-alcoholic liver disease group when compared with the other 2 groups (p= 0.0). Body fat store depletion was significantly lower in the alcohol addict group when set against the alcoholic liver disease and non-alcoholic liver disease groups (p= 0.0). The mean percentages of ideal calories (p= 0.0) and proteins (p= 0.0) were significantly higher in alcohol addicts but no significant differences in the mean percentage of fat intake (p= 0.1) was observed. The frequency of macro-nutrient deficiency was highest in the non-alcoholic liver disease group (p= 0.0). Ethanol consumption was not significantly different between alcohol addicts and patients suffering from alcoholic liver disease (p=0.06). Patients with liver disease (irrespective of aetiology) scored significantly lower on the quality of life scale when compared to alcohol addicts. CONCLUSIONS: Malnutrition is more frequent and severe in patients suffering from chronic liver disease in comparison to alcohol addicts. The health status is significantly poorer in patients suffering from alcoholic liver disease. Alcohol does not seem to play a primary role in the pathogenesis of liver disease and malnutrition.

Achalasia cardia: A study of 113 patients managed with indigenous dilator.

BACKGROUND: Endoscopic dilatation of achalasia cardia is an effective nonsurgical management option. It requires costly pneumatic dilators which are used under fluoroscopic guidance. This study assesses the efficacy and safety of an indigenous pneumatic dilator used without fluoroscopic guidance. METHODS: Over a period of eleven years, 113 patients (69M, 44F) ofachalasia cardia underwent dilatation with indigenous pneumatic dilators without fluoroscopic guidance. The dilatation was performed under endoscopic vision. RESULTS: The procedure was successful in all patients. After six weeks following dilatation, there was significant improvement in the mean dysphagia score 3.63 + 0.61 to 0.53 + 0.93 (P<0.01). The response was still significant (0.78 + 1.03, P <0.05) at the end of one year. Excellent response with single dilatation was seen in 70.7% patients. After two dilatation sessions 92% of patients showed an excellent response. One patient had perforation. There was no mortality. CONCLUSION: Pneumatic dilatation under endoscopic vision without fluoroscopic assistance with the indigenous dilator is very effective and safe for short term treatment of achalasia carida.

Endoscopic variceal ligation in children.

Endoscopic variceal ligation, a mechanical mode of variceal obliteration, was used in the management of patients having extrahepatic portal vein obstruction. Fifteen patients (10 males, 5 females) had grade III varices. Their mean age was 8.13 years (range, 3 to 14 years). Obliteration was achieved in 14 patients (93.33%) after a mean number of 1.86 (range, 1 to 4) sessions. The mean number of bands required for variceal obliteration was 4.33 (range, 1 to 9). The number of bands required to obliterate each variceal column was 1.38. No patient required a blood transfusion, and there was only one recurrence of varices during the mean follow-up period of 9 months (range, 4 to 12 months). Postligation hemorrhage was encountered in one patient; there was no other complications. Endoscopic variceal ligation is an effective and safe method for early variceal obliteration in children.

Chronic hepatitis in a large Indian hospital.

BACKGROUND: In developed countries as well as in Southeast Asia, the hepatitis B and C viruses are the main causes of chronic hepatitis. In India, however, there have been no major investigations on the aetiology of chronic hepatitis. (The hepatitis E virus which is responsible for half the sporadic and most of the epidemic cases of acute viral hepatitis in India does not cause chronic disease.) We, therefore, studied the profile of chronic hepatitis in India. METHODS: The clinical presentation, aetiology, serology and histological changes were studied prospectively in 48 patients with chronic hepatitis admitted to the All India Institute of Medical Sciences, New Delhi. Of these, 44 (92%) had chronic active hepatitis, 3 (6.3%) had chronic persistent hepatitis and 1 (2%) had chronic lobular hepatitis. RESULTS: The hepatitis B virus was the aetiological agent in 24 (50%) of these patients, the hepatitis D virus in association with hepatitis B virus in 10 (21%), the hepatitis C virus in 7 (15%) and the non-A, non-B viruses other than the hepatitis C virus in 6 (13%). One patient (2.0%) had autoimmune chronic active hepatitis. Jaundice at presentation was seen in 33 (69%) patients and more than half had hypoalbuminaemia (< 3 g/dl) with a prolonged prothrombin time. Alanine aminotransferase levels were less than 5 times above normal in over two-thirds of the patients. The highest alanine aminotransferase values were observed in patients with hepatitis D virus infection whereas the lowest were seen in patients with non-A, non-B related chronic active hepatitis. Histological examination revealed bridging necrosis in 40 (91%) patients with chronic active hepatitis indicating a severe form of disease. Replication of the hepatitis B virus was seen in 13 patients with chronic hepatitis, 5 of whom had hepatitis D virus-induced chronic hepatitis. Patients with hepatitis B virus replication had higher alanine aminotransferase values and more severe bridging necrosis than patients who did not have replicating viruses. Higher alanine aminotransferase values, ascites and oesophageal varices were encountered more frequently in patients with hepatitis B and D virus than in those with non-A, non-B related chronic hepatitis. CONCLUSION: Chronic hepatitis is not uncommon in India. It presents with evidence of severe disease and, as elsewhere, is most frequently caused by the hepatitis B virus.

Pneumatic dilatation of achalasia cardia with indigenous pneumatic dilator.

Fifteen patients with achalasia cardia underwent pneumatic dilatation using an indigenous pneumatic dilator. The dilator was prepared using a Levin's tube, latex condoms and silk cloth and was introduced under vision with the help of an endoscope. Clinical improvement was seen in all the patients whereas radiological improvement occurred in 11 patients. There were no procedure-related complications.

Improvized pneumatic dilator for achalasia cardia.

The indigenous pneumatic dilator for achalasia cardia reported previously by the authors was being placed alongside the endoscope to perform dilatation under direct vision. It has now been improvised to make the procedure wire-guided and fluoroscopy-assisted as well. The improvization includes insertion of a central Teflon tube for passage of a guidewire and presence of three radio-opaque markers, which define the proximal, central and distal ends of the dilator and help in precise positioning under fluoroscopy. Dilatation for achalasia cardia using the improvized pneumatic dilator with fluoroscopic guidance was performed successfully on 10 patients at our center. All patients had clinical response with greater than 50% improvement in total symptom score. Barium swallow examination after dilatation showed improvement in esophageal transit in all patients. None of the patients developed any complication. Cost of the dilator is approximately 50 times less than that of commercially available dilators. The dilator can be re-used by sterilizing it, which further reduces the cost.

Endoscopic band ligation for non variceal bleed.

Endoscopic band ligation (EBL) is an infrequently used modality for treatment of non-variceal hemorrhage. We report the successful use of this technique for the management of bleed from blue rubber bleb nevus syndrome lesions and post polypectomy bleeding stalk.

Endoscopic variceal ligation: an effective method of variceal obliteration.

Endoscopic variceal ligation was performed in 20 patients with portal hypertension of varied etiology. Variceal obliteration was achieved in 18 patients (90%) while recurrence of bleeding occurred in two patients (10%). The average number of bands required was four per patient and average number of sessions required for variceal obliteration was two. We found the procedure to be cheap, safe and effective in achieving early variceal obliteration.

Evaluation of garlic oil as a contact dissolution agent for gallstones: comparison with monooctanoin.

AIM: To find a better contact solvent to dissolve gallstones we studied invitro use of garlic oil and compared it with monooctanoin. METHODS: In the first stage gall stones obtained from patients after cholecystectomy were subjected to dissolution in different concentrations of garlic oil. Then the rate of dissolution of gall stones in garlic oil was compared to that in monooctanoin in stage II. Efficacy of various concentration of garlic oil and monoocatanoin in dissolving gallstones in artificial gall bladder and common bile duct models were compared in stage III. RESULTS: Garlic oil dissolved the cholesterol gall stones in proportion to the concentration used. The gall stone fragmentation was faster [6 hours V/s 36 hours] and more [88.30% V/s 71.01%] by garlic oil in comparison to monooctanoin in test tubes and even in artificial gallbladder and common bile duct models. CONCLUSIONS: Garlic oil is a better contact dissolving agent of gallstones than monooctanoin.

Unusual foreign bodies of upper gastrointestinal tract.

We report management of unusual foreign bodies of upper gastrointestinal tract, namely beer bottle cap, raisins and pistachu, mango peel, betelnut and plum seed at a university hospital in Northern India.

Jejunal perforation: a complication of colonoscopy.

Perforation of a hollow viscus following fibreoptic endoscopy is rare. Perforation following colonoscopy has been reported to occur in the large intestine. We report a case. Small bowel perforation subsequent to colonoscopy.