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

October 25, 2017 updated by: Yanglin Pan, Air Force Military Medical University, China

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall post-ERCP pancreatitis (PEP)
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Moderate to severe PEP
Time Frame: 30 days
30 days
Clinical significant gastrointestinal bleeding
Time Frame: 30 days
30 days
Overall ERCP complications
Time Frame: 30 days
30 days

Other Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: 30 days
30 days
Severity of PEP evaluated by updated Atlanta criteria
Time Frame: 30 days
30 days
ERCP-related perforation
Time Frame: 30 days
30 days
Biliary infection
Time Frame: 30 days
30 days
Length of post-procedure hospital stay
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

October 26, 2017

Study Completion (Actual)

October 26, 2017

Study Registration Dates

First Submitted

February 15, 2017

First Submitted That Met QC Criteria

February 15, 2017

First Posted (Actual)

February 20, 2017

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20162097-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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