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

Primary Purpose

Pancreatitis, Endoscopic Retrograde Cholangiopancreatography

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Papillary epinephrine spraying
Papillary saline spraying
Indomethacin
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatitis focused on measuring ERCP, post-ERCP pancreatitis, indomethacin, epinephrine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Gastroenterology, Successful Hospital of Xiamen university
  • Department of Gastroenterology, Zhongshan Hospital of Xiamen university
  • Department of General Surgery, The First Hospital of Lanzhou University
  • Endoscopy Center, Ankang Central Hospital
  • Xijing Hospital of Digestive Diseases
  • Department of Gastroenterology, No. 451 Hospital
  • Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University
  • Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region
  • Department of Gastroenterology, Hangzhou First People's Hospital
  • Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PES group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall post-ERCP pancreatitis (PEP)

Secondary Outcome Measures

Moderate to severe PEP
Clinical significant gastrointestinal bleeding
Overall ERCP complications

Full Information

First Posted
February 15, 2017
Last Updated
October 25, 2017
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT03057769
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated because of an interim analysis suggesting futility of papillary epinephrine spraying in PEP prevention.
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
October 26, 2017 (Actual)
Study Completion Date
October 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Endoscopic Retrograde Cholangiopancreatography
Keywords
ERCP, post-ERCP pancreatitis, indomethacin, epinephrine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PES group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Papillary epinephrine spraying
Other Intervention Name(s)
PES
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Papillary saline spraying
Other Intervention Name(s)
Control
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Intervention Description
All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.
Primary Outcome Measure Information:
Title
Overall post-ERCP pancreatitis (PEP)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Moderate to severe PEP
Time Frame
30 days
Title
Clinical significant gastrointestinal bleeding
Time Frame
30 days
Title
Overall ERCP complications
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Severity of PEP evaluated by updated Atlanta criteria
Time Frame
30 days
Title
ERCP-related perforation
Time Frame
30 days
Title
Biliary infection
Time Frame
30 days
Title
Length of post-procedure hospital stay
Time Frame
30 days
Title
Death
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Gastroenterology, Successful Hospital of Xiamen university
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China
Facility Name
Department of Gastroenterology, Zhongshan Hospital of Xiamen university
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
Department of General Surgery, The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Facility Name
Endoscopy Center, Ankang Central Hospital
City
Ankang
State/Province
Shaanxi
ZIP/Postal Code
725000
Country
China
Facility Name
Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Department of Gastroenterology, No. 451 Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710068
Country
China
Facility Name
Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University
City
Shihezi
State/Province
Xinjiang
ZIP/Postal Code
832008
Country
China
Facility Name
Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Facility Name
Department of Gastroenterology, Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University
City
Yinchuan
ZIP/Postal Code
750004
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin

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