Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin
- Conditions
- PancreatitisEndoscopic Retrograde Cholangiopancreatography
- Interventions
- Registration Number
- NCT03057769
- Lead Sponsor
- Air Force Military Medical University, China
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3300
- 18-80 years old patients planned for ERCP.
- contraindications to ERCP
- allergy to epinephrine or NSAIDs
- Not suitable for pre-ERCP indomethacin (received NSAIDs within 7 days before the procedure; gastrointestinal hemorrhage within 4 weeks; renal dysfunction [Cr >1.4mg/dl=120umol/l]; presence of coagulopathy before the procedure)
- previous biliary sphincterotomy without planned pancreatic duct manipulation
- ERCP for biliary stent removal or exchange without planned pancreatic duct manipulation
- acute pancreatitis within 3 days before the procedure
- unwilling or inability to provide consent
- pregnant or breastfeeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PES group Papillary epinephrine spraying All patients in this group receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla, over a period of 10-15 seconds using sphincterotome, at the end of procedure, just before the withdrawal of endoscope. Control group Papillary saline spraying All patients in this group receive 20 ml of saline sprayed on the duodenal papilla, over a period of 10-15 seconds using sphincterotome, at the end of procedure, just before the withdrawal of endoscope. Control group Indomethacin All patients in this group receive 20 ml of saline sprayed on the duodenal papilla, over a period of 10-15 seconds using sphincterotome, at the end of procedure, just before the withdrawal of endoscope. PES group Indomethacin All patients in this group receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla, over a period of 10-15 seconds using sphincterotome, at the end of procedure, just before the withdrawal of endoscope.
- Primary Outcome Measures
Name Time Method Overall post-ERCP pancreatitis (PEP) 30 days
- Secondary Outcome Measures
Name Time Method Moderate to severe PEP 30 days Clinical significant gastrointestinal bleeding 30 days Overall ERCP complications 30 days
Trial Locations
- Locations (10)
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 Hepatobiliary Surgery, General Hospital of Ningxia Medical University
🇨🇳Yinchuan, China
Department of Gastroenterology, Zhongshan Hospital of Xiamen university
🇨🇳Xiamen, Fujian, China
Department of Gastroenterology, Successful Hospital of Xiamen university
🇨🇳Xiamen, Fujian, 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
🇨🇳Urumqi, Xinjiang, China
Department of Gastroenterology, Hangzhou First People's Hospital
🇨🇳Hangzhou, Zhejiang, China