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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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Department of Gastroenterology, Successful Hospital of Xiamen university
Xiamen, Fujian, China
Department of Gastroenterology, Zhongshan Hospital of Xiamen university
Xiamen, Fujian, China
Department of General Surgery, The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Endoscopy Center, Ankang Central Hospital
Ankang, Shaanxi, China
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China
Department of Gastroenterology, No. 451 Hospital
Xi'an, Shaanxi, China
Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University
Shihezi, Xinjiang, China
Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region
Ürümqi, Xinjiang, China
Department of Gastroenterology, Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University
Yinchuan, China
Start Date
February 1, 2017
Primary Completion Date
October 26, 2017
Completion Date
October 26, 2017
Last Updated
October 27, 2017
3,300
ACTUAL participants
Papillary epinephrine spraying
DRUG
Papillary saline spraying
DRUG
Indomethacin
DRUG
Lead Sponsor
Air Force Military Medical University, China
NCT04408482
NCT07440342
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07406698