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Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057769
Recruitment Status : Terminated (This study was terminated because of an interim analysis suggesting futility of papillary epinephrine spraying in PEP prevention.)
First Posted : February 20, 2017
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, 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.


Condition or disease Intervention/treatment Phase
Pancreatitis Endoscopic Retrograde Cholangiopancreatography Drug: Papillary epinephrine spraying Drug: Papillary saline spraying Drug: Indomethacin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin: A Multi-center, Double-blind, Randomized Controlled Trial
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : October 26, 2017
Actual Study Completion Date : October 26, 2017


Arm Intervention/treatment
Experimental: PES group
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.
Drug: 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.
Other Name: PES

Drug: Indomethacin
All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.

Placebo Comparator: Control group
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.
Drug: 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.
Other Name: Control

Drug: Indomethacin
All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.




Primary Outcome Measures :
  1. Overall post-ERCP pancreatitis (PEP) [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Moderate to severe PEP [ Time Frame: 30 days ]
  2. Clinical significant gastrointestinal bleeding [ Time Frame: 30 days ]
  3. Overall ERCP complications [ Time Frame: 30 days ]

Other Outcome Measures:
  1. Severity of PEP evaluated by updated Atlanta criteria [ Time Frame: 30 days ]
  2. ERCP-related perforation [ Time Frame: 30 days ]
  3. Biliary infection [ Time Frame: 30 days ]
  4. Length of post-procedure hospital stay [ Time Frame: 30 days ]
  5. Death [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057769


Locations
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China, Fujian
Department of Gastroenterology, Successful Hospital of Xiamen university
Xiamen, Fujian, China, 361000
Department of Gastroenterology, Zhongshan Hospital of Xiamen university
Xiamen, Fujian, China, 361004
China, Gansu
Department of General Surgery, The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
China, Shaanxi
Endoscopy Center, Ankang Central Hospital
Ankang, Shaanxi, China, 725000
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
Department of Gastroenterology, No. 451 Hospital
Xi'an, Shaanxi, China, 710068
China, Xinjiang
Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University
Shihezi, Xinjiang, China, 832008
Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region
Urumqi, Xinjiang, China, 830000
China, Zhejiang
Department of Gastroenterology, Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310006
China
Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University
Yinchuan, China, 750004
Sponsors and Collaborators
Air Force Military Medical University, China
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yanglin Pan, Associate professor, Air Force Military Medical University, China
ClinicalTrials.gov Identifier: NCT03057769    
Other Study ID Numbers: KY20162097-1
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanglin Pan, Air Force Military Medical University, China:
ERCP, post-ERCP pancreatitis, indomethacin, epinephrine
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Indomethacin
Epinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors