Epinephrine Sprayed on the Papilla for the Prevention of Post-ERCP Pancreatitis

Post-ERCP Acute Pancreatitis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02839356
• Other study ID #: Epinephrine001
• Status: Recruiting
• Phase: Phase 4
• First received: July 18, 2016
• Last updated: March 2, 2017
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Anhui Provincial Hospital
• Contact: Shao Feng, MD
• Phone: 8613033090788
• Email: tagsmile1985[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) has been a well-recognized complication with significant morbidity and even mortality. A variety of possible mechanisms has been suggested in the occurrence of pancreatitis, but 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. Moreover, it is reported that epinephrine sprayed on the papilla may be effective to prevent PEP. However, it is still unclear that epinephrine sprayed on the papilla can prevent acute pancreatitis after endoscopic retrograde cholangiopancreatography. We therefore designed a prospective randomized trial to determine whether epinephrine sprayed on the papilla prevent PEP after ERCP.

Description:

Between July 2016 and December 2017, 670 consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP at the Anhui Provincial Hospital will be recruited for the study. Patients were randomized using opaque, sealed envelopes containing random numbers assigning them to undergo a spray of epinephrine (epinephrine group) or saline (control group) on the major papilla. A two proportion equality test will be conducted to explore whether incidence rates are different. Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 670
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Males and females, age > 18 years.

2. Normal amylase level before undergoing ERCP.

3. Signed inform consent form and agreed to follow-up on time.

Exclusion Criteria:

1. Pregnancy or history of allergy to epinephrine.

2. Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.

3. Patients involved in other study within 60 days.

4. Billroth II or Roux-en-Y anatomy

5. Acute pancreatitis.

6. All contraindications to epinephrine.

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Drug:
• epinephrine
20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla
• normal saline
20-mL irrigation with physiological saline over the entire papilla

Locations

Country	Name	City	State
China	Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University	He Fei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prophylaxis effect of epinephrine sprayed on the papilla on post-ERCP pancreatitis	If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in high risk patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis). Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.; Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.	PEP occurence rate at 24 h after ERCP in two groups.
Secondary	Compare epinephrine group with control group on the incidence of hyperamylasemia/adverse events.	Hyperamylasemia will be defined as the serum amylase 3 times more than the upper normal values, without clinical symptoms. During the study, any unexpected medical issue will be called adverse event.; Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.	the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups