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

Sponsor
Air Force Military Medical University, China (Other)
Overall Status
Terminated
CT.gov ID
NCT03057769
Collaborator
(none)
3,300
Enrollment
10
Locations
2
Arms
8.8
Actual Duration (Months)
330
Patients Per Site
37.6
Patients Per Site Per Month

Study Details

Study Description

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
N/A

Study Design

Study Type:
Interventional
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 :
Feb 1, 2017
Actual Primary Completion Date :
Oct 26, 2017
Actual Study Completion Date :
Oct 26, 2017

Arms and Interventions

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 Names:
  • 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 Names:
  • Control

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

    Outcome Measures

    Primary Outcome Measures

    1. Overall post-ERCP pancreatitis (PEP) [30 days]

    Secondary Outcome Measures

    1. Moderate to severe PEP [30 days]

    2. Clinical significant gastrointestinal bleeding [30 days]

    3. Overall ERCP complications [30 days]

    Other Outcome Measures

    1. Severity of PEP evaluated by updated Atlanta criteria [30 days]

    2. ERCP-related perforation [30 days]

    3. Biliary infection [30 days]

    4. Length of post-procedure hospital stay [30 days]

    5. Death [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Gastroenterology, Successful Hospital of Xiamen university Xiamen Fujian China 361000
    2 Department of Gastroenterology, Zhongshan Hospital of Xiamen university Xiamen Fujian China 361004
    3 Department of General Surgery, The First Hospital of Lanzhou University Lanzhou Gansu China 730000
    4 Endoscopy Center, Ankang Central Hospital Ankang Shaanxi China 725000
    5 Xijing Hospital of Digestive Diseases Xi'an Shaanxi China 710032
    6 Department of Gastroenterology, No. 451 Hospital Xi'an Shaanxi China 710068
    7 Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University Shihezi Xinjiang China 832008
    8 Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region Urumqi Xinjiang China 830000
    9 Department of Gastroenterology, Hangzhou First People's Hospital Hangzhou Zhejiang China 310006
    10 Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University Yinchuan China 750004

    Sponsors and Collaborators

    • Air Force Military Medical University, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yanglin Pan, Associate professor, Air Force Military Medical University, China
    ClinicalTrials.gov Identifier:
    NCT03057769
    Other Study ID Numbers:
    • KY20162097-1
    First Posted:
    Feb 20, 2017
    Last Update Posted:
    Oct 27, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yanglin Pan, Associate professor, Air Force Military Medical University, China
    ERCP, post-ERCP pancreatitis, indomethacin, epinephrine
    Additional relevant MeSH terms:
    Pancreatitis
    Indomethacin
    Epinephrine

    Study Results

    No Results Posted as of Oct 27, 2017