Pancreatitis Clinical Trial
Official title:
Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin: A Multi-center, Double-blind, Randomized Controlled Trial
Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to
30% of procedures. It accounts for substantial morbidity and represents a substantial cost to
health-care systems. European Society of Gastrointestinal Endoscopy and Japanese Society of
Hepato-Biliary-Pancreatic surgery guidelines and recently large-scale RCT recommended routine
use of NSAIDs indomethacin rectally before ERCP. Nonsteroidal anti-inflammatory drugs
(NSAIDs) have been shown to inhibit prostaglandin synthesis, phospholipase A2 activity, and
neutrophil/endothelial cell attachment, which is believed to play a key role in the
pathogenesis of acute pancreatitis.
Other possible mechanisms have been suggested in the occurrence of pancreatitis. Papillary
edema caused by manipulations during cannulation or endoscopic treatment has received the
most attention. The papillary edema may cause temporary outflow obstruction of pancreatic
juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis.
Topical application of epinephrine on the papilla may reduce papillary edema by decreasing
capillary permeability or by relaxing the sphincter of Oddi. A meta-analysis (including 2
existing RCTs and post-hoc analysis of our previous study) of papillary epinephrine spraying
compared with saline spraying or no intervention indicates a potential relative risk
reduction of PEP (RR 0.34, 95%CI 0.19-0.61). Papillary epinephrine spraying may be an
inexpensive and convenient alternative for prevention of post-ERCP pancreatitis. A large
pragmatic RCT to determine whether routine using papillary epinephrine spraying can reduce
post-ERCP pancreatitis is needed.
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