Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) has been a well-recognized complication with significant morbidity and even mortality. A variety of possible mechanisms has been suggested in the occurrence of pancreatitis, but 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. Moreover, it is reported that epinephrine sprayed on the papilla may be effective to prevent PEP. However, it is still unclear that epinephrine sprayed on the papilla can prevent acute pancreatitis after endoscopic retrograde cholangiopancreatography. We therefore designed a prospective randomized trial to determine whether epinephrine sprayed on the papilla prevent PEP after ERCP.

Brief Title

Epinephrine Sprayed on the Papilla for the Prevention of Post-ERCP Pancreatitis

Official Title

Brief Summary

Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) has been a<br /> well-recognized complication with significant morbidity and even mortality. A variety of<br /> possible mechanisms has been suggested in the occurrence of pancreatitis, but papillary edema<br /> caused by manipulations during cannulation or endoscopic treatment has received the most<br /> attention. The papillary edema may cause temporary outflow obstruction of pancreatic juice,<br /> and then increase ductal pressure, resulting in the occurrence of pancreatitis. Topical<br /> application of epinephrine on the papilla may reduce papillary edema. Moreover, it is<br /> reported that epinephrine sprayed on the papilla may be effective to prevent PEP. However, it<br /> is still unclear that epinephrine sprayed on the papilla can prevent acute pancreatitis after<br /> endoscopic retrograde cholangiopancreatography. We therefore designed a prospective<br /> randomized trial to determine whether epinephrine sprayed on the papilla prevent PEP after<br /> ERCP.

Detailed Description

Between July 2016 and December 2017, 670 consecutive patients older than 18 years who are
scheduled to undergo diagnostic or therapeutic ERCP at the Anhui Provincial Hospital will be
recruited for the study. Patients were randomized using opaque, sealed envelopes containing
random numbers assigning them to undergo a spray of epinephrine (epinephrine group) or saline
(control group) on the major papilla. A two proportion equality test will be conducted to
explore whether incidence rates are different. Descriptive statistics including number (N),
mean, median, standard deviation, minimum and maximum, will be produced for all continuous
variables. Frequency tables of number (N) and percentage of subjects will be produced for all
categorical variables.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.