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Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Octreotide

Primary Purpose

Post-ERCP Acute Pancreatitis, Epinephrine

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Epinephrine sprayed on the papilla
Saline sprayed on the papilla
Sponsored by
The Second Hospital of Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-ERCP Acute Pancreatitis

Eligibility Criteria

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

Inclusion Criteria:

  1. ERCP surgery is required
  2. Signed inform consent form and agreed to follow-up on time.

Exclusion Criteria:

  1. Acute pancreatitis.
  2. Pregnancy or history of allergy to epinephrine.
  3. Serious liver, kidney, heart and coagulation disorders
  4. Unwilling or inability to provide consent

Sites / Locations

  • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Epinephrine sprayed on the papilla

Saline sprayed on the papilla

Arm Description

Patients received sublingual Nitroglycerin will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla before the withdrawal of endoscope.

Patients received sublingual Nitroglycerin will receive 20 ml of normal saline sprayed on the duodenal papilla before the withdrawal of endoscope; followed by octreotide.

Outcomes

Primary Outcome Measures

Incidence of post-ERCP pancreatitis in the groups
The primary outcome is the incidence of PEP as defined by the consensus guidelines as 1) New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc, and 2) amylase or lipase ≥ 3x the upper limit of normal 48 hours after the procedure.

Secondary Outcome Measures

Others complications
Others complications are the cute cholecystitia, acute cholangitis,hemorrhage and perforation，et al.

Full Information

First Posted
October 16, 2018
Last Updated
November 26, 2018
Sponsor
The Second Hospital of Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03756116
Brief Title
Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Octreotide
Official Title
Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Sublingual Nitroglycerin: A Multi-center, Single-blind, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Nanjing Medical University

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
Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication with high costs, significant morbidity and even mortality. The major mechanisms of PEP is the papillary edema which is caused by manipulations during cannulation or endoscopic treatment. The papillary edema may cause temporary outflow obstruction of pancreatic juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis. Nitroglycerin can reduce the Oddis sphincter tension, the internal pressure of the biliary tract and the pancreatic duct. Therefore, it is widely used in clinical to prevent and treat pancreatitis. Many studies found nitroglycerin might be effective in preventing PEP. And topical application of epinephrine on the papilla may reduce papillary edema by decreasing capillary permeability or by relaxing the sphincter of Oddi. There are reports that epinephrine sprayed on the papilla may be effective to prevent PEP. The investigators therefore designed a prospective randomized trial to determine whether routine using papillary epinephrine spraying in patients received octreotide can reduce post-ERCP pancreatitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-ERCP Acute Pancreatitis, Epinephrine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epinephrine sprayed on the papilla
Arm Type
Experimental
Arm Description
Patients received sublingual Nitroglycerin will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla before the withdrawal of endoscope.
Arm Title
Saline sprayed on the papilla
Arm Type
Active Comparator
Arm Description
Patients received sublingual Nitroglycerin will receive 20 ml of normal saline sprayed on the duodenal papilla before the withdrawal of endoscope; followed by octreotide.
Intervention Type
Procedure
Intervention Name(s)
Epinephrine sprayed on the papilla
Intervention Description
Patients received sublingual Nitroglycerin will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla before the withdrawal of endoscope.
Intervention Type
Procedure
Intervention Name(s)
Saline sprayed on the papilla
Intervention Description
Patients received sublingual Nitroglycerin will receive 20 ml of normal saline sprayed on the duodenal papilla before the withdrawal of endoscope.
Primary Outcome Measure Information:
Title
Incidence of post-ERCP pancreatitis in the groups
Description
The primary outcome is the incidence of PEP as defined by the consensus guidelines as 1) New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc, and 2) amylase or lipase ≥ 3x the upper limit of normal 48 hours after the procedure.
Time Frame
48 hours after ERCP
Secondary Outcome Measure Information:
Title
Others complications
Description
Others complications are the cute cholecystitia, acute cholangitis,hemorrhage and perforation，et al.
Time Frame
1 weeks after ERCP

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: ERCP surgery is required Signed inform consent form and agreed to follow-up on time. Exclusion Criteria: Acute pancreatitis. Pregnancy or history of allergy to epinephrine. Serious liver, kidney, heart and coagulation disorders Unwilling or inability to provide consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miao Lin
Phone
086-25-58509932
Email
miaolinxh@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miao Lin
Organizational Affiliation
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Miao, MD
Phone
086-25-58509932
Email
miaolinxh@163.com

12. IPD Sharing Statement

Learn more about this trial

Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Octreotide

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