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).

Noradrenaline versus terlipressin in the management of type 1 hepatorenal syndrome: A randomized controlled study.

BACKGROUND: Hepatorenal syndrome (HRS) occurs in decompensated liver disease and carries high mortality. Vasoconstrictors are the drug of choice. Terlipressin is widely used and is expensive. In this study, we compared noradrenaline and terlipressin in the management of type 1 HRS. METHODS: Sixty consecutive patients with type 1 HRS were managed with noradrenaline (Group A, n = 30) or terlipressin (Group B, n = 30) with albumin in a randomized controlled trial at a tertiary center. RESULTS: Reversal of type 1 HRS was achieved in 16 (53%) patients in group A and 17 (57%) in group B. There was statistically insignificant difference between the two groups in decreasing serum creatinine and increasing urine output (p > 0.05). On univariate analysis, Child-Turcotte-Pugh (CTP) score, serum sodium, serum urea, serum albumin, prothrombin time, International normalized ratio (INR), serum alanine aminotransferase (ALT), ascitic fluid protein, and history of bleeding were associated with response to treatment (noradrenaline/terlipressin). However, on multivariate analysis, only baseline CTP score, serum urea, serum albumin, and prothrombin time were independent predictors of response. All patients who responded were discharged alive with no mortality within 30 days. CONCLUSIONS: There is no difference in outcome of patients with type 1 HRS treated with noradrenaline or terlipressin. Thus, noradrenaline, which is cheaper, can be used instead of terlipressin (Clinical Trials Registry-India [CTRI] No. CTRI/2011/09/002032).