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

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Abstract

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).

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Authors and Affiliations

  1. Department of Gastroenterology, Sher- i- Kashmir Institute of Medical Sciences, Srinagar, Kashmir, 190 011, India

    Hilal Ahmad Dar, Altaf Shah, Gul Javid, Mushtaq Ahmad Khan, Bhagat Singh, Nadeem Ahmad Sheikh & Aadil Ashraf

  2. Department of Internal Medicine, Government Medical College, Baramulla, Kashmir, 193 101, India

    Hilal Ahmad Dar

  3. Department of Microbiology, Sher- i- Kashmir Institute of Medical Sciences, Srinagar, Kashmir, 190 011, India

    Sozia Mohammad

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  1. Hilal Ahmad Dar
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Correspondence to Hilal Ahmad Dar.

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HAD, AS, GJ, MAK, BS, NAS, AS, and SM declare that they have no conflict of interest.

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The study was performed conforming to the Helsinki declaration of 1975, as revised in 2000 and 2008 concerning human andanimal rights, and the authors followed the policy concerning informed consent as shown on Springer.com.

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Dar, H.A., Shah, A., Javid, G. et al. Randomized trial of high-dose rectal diclofenac suppository and epinephrine spray on duodenal papilla for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis. Indian J Gastroenterol 40, 483–491 (2021). https://doi.org/10.1007/s12664-021-01161-z

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