Randomized trial of high-dose rectal diclofenac suppository and epinephrine spray on duodenal papilla for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis.

BACKGROUND AND AIMS: High-dose rectal diclofenac suppository and epinephrine spray on duodenal papilla during endoscopic retrograde cholangiopancreatography (ERCP) may reduce the incidence of post-ERCP pancreatitis. We performed randomized trial to compare the effect of combination of rectal diclofenac and epinephrine spray on papilla (group A) vs. combination of rectal diclofenac with saline spray (group B) for prevention of post-ERCP pancreatitis. METHODS: We performed a double-blind trial at tertiary care center from April 2018 to May 2020 on 882 patients with naive papilla undergoing ERCP. The patients were randomly assigned to groups, A (n=437) or B (n=445). All patients received a single dose of rectal diclofenac 100 mg within 30 minutes before ERCP; 20 mL of diluted epinephrine 0.02% (group A) or saline (group B) was then sprayed on the duodenal papilla at the end of ERCP. The primary outcome was to compare incidence of post-ERCP pancreatitis (PEP) in two groups. RESULTS: The groups had similar baseline characteristics. PEP developed in 28 patients in group A (6.4%) and 35 patients in group B (7.9%) (relative risk, 1.1; 95% CI, 0.87-1.39; p=0.401). CONCLUSION: Our study showed that addition of epinephrine spray on duodenal papilla did not reduce the risk of post-ERCP pancreatitis. There is need for further studies to evaluate the role of different concentrations of epinephrine spray on papilla for prevention of post-ERCP pancreatitis. TRIAL REGISTRATION: Clinical Trials Registry- India (CTRI/2018/04/013396).

Impact of Vitamin D Status in Chronic Liver Disease.

BACKGROUND: Vitamin D deficiency is extremely common in chronic liver disease (CLD) patients. Up to 93% of these patients have some degree of vitamin D insufficiency. Liver plays an important role in the metabolism and pleiotropic functions of vitamin D. Vitamin D deficiency has been associated with increased mortality, bacterial infections, portal hypertension complications, and fibrosis severity. We aimed to determine the impact of vitamin D level in CLD. METHODS: One hundred fifty individuals consisting of 75 cirrhotic patients (cases) and 75 respective attendants (controls) were enrolled between July 2015 and July 2017. A detailed clinical and laboratory evaluation was done along with estimation of vitamin D level. Unpaired t-test and analysis of variance was used to compare difference in the level of continuous variables between different groups. Linear regression analysis was performed to analyze the correlation between vitamin D deficiency and severity of liver disease. RESULTS: The age of patients ranged from 18 years to 69 years with mean of 48.85 ± 13.6 years in the case group and 46.57 ± 17.24 years in the control group. Out of 75 CLD patients, vitamin D deficiency (<20 ng/dl) was found in 31 (41.4%) patients, out of which 14(18.7%) suffered from severe vitamin D deficiency (<10 ng/ml). On applying analysis of variance test, there was significant difference in vitamin D level and serum albumin and serum bilirubin (P < 0.05). On linear regression, vitamin D level showed significant negative correlation with Child-Pugh score (r = -0.7379, P < 0.0001) and Model For End-Stage Liver Disease score (r = -0.6671, P < 0.0001). CONCLUSION: Our study concluded that CLD is associated with a significantly low level of vitamin D, which was independent to patient's gender, body mass index, residence, and education level. The findings of our study suggest that awareness of serum vitamin D level in patients with CLD is important. Further studies are required to validate the importance of vitamin D levels and impact of vitamin D supplementation on CLD.