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

Phase 4

• Conditions: Post-ERCP Acute Pancreatitis
• Interventions: Drug: normal saline; Drug: epinephrine

• Registration Number: NCT02839356
• Lead Sponsor: Anhui Provincial Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-07
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 670

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The prophylaxis effect of epinephrine sprayed on the papilla on post-ERCP pancreatitis	PEP occurence rate at 24 h after ERCP in two groups.	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.

Secondary Outcome Measures

Name	Time	Method
Compare epinephrine group with control group on the incidence of hyperamylasemia/adverse events.	the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups	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.

Trial Locations

Locations (1)

Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University; 🇨🇳 He Fei, Anhui, China

Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University

🇨🇳He Fei, Anhui, China

Shao Feng, MD

Principal Investigator