Clinical trial NCT03057769: Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin
Official title: Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin: A Multi-center, Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatitis
Endoscopic Retrograde Cholangiopancreatography
Keywords: ERCP, post-ERCP pancreatitis, indomethacin, epinephrine
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 3300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 18-80 years old patients planned for ERCP.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overall post-ERCP pancreatitis (PEP)
timeFrame: 30 days
Secondary outcomes:
measure: Moderate to severe PEP
timeFrame: 30 days
measure: Clinical significant gastrointestinal bleeding
timeFrame: 30 days
measure: Overall ERCP complications
timeFrame: 30 days
Other outcomes:
measure: Severity of PEP evaluated by updated Atlanta criteria
timeFrame: 30 days
measure: ERCP-related perforation
timeFrame: 30 days
measure: Biliary infection
timeFrame: 30 days
measure: Length of post-procedure hospital stay
timeFrame: 30 days
measure: Death
timeFrame: 30 days
Locations:
city: Xiamen
country: China
facility: Department of Gastroenterology, Successful Hospital of Xiamen university
state: Fujian
city: Xiamen
country: China
facility: Department of Gastroenterology, Zhongshan Hospital of Xiamen university
state: Fujian
city: Lanzhou
country: China
facility: Department of General Surgery, The First Hospital of Lanzhou University
state: Gansu
city: Ankang
country: China
facility: Endoscopy Center, Ankang Central Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
city: Xi'an
country: China
facility: Department of Gastroenterology, No. 451 Hospital
state: Shaanxi
city: Shihezi
country: China
facility: Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University
state: Xinjiang
city: Urumqi
country: China
facility: Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region
state: Xinjiang
city: Hangzhou
country: China
facility: Department of Gastroenterology, Hangzhou First People's Hospital
state: Zhejiang
city: Yinchuan
country: China
facility: Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University
Study officials:
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