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

University of Science and Technology of China (USTC)

Status and phase: Unknown; Phase 4

Conditions: Post-ERCP Acute Pancreatitis

Treatments: Drug: epinephrine; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02839356

Epinephrine001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 670 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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670 participants in 2 patient groups, including a placebo group

Drug: epinephrine

Experimental group

Description:

20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla

Treatment:

Drug: epinephrine

Drug: normal saline

Placebo Comparator group

Description:

20-mL irrigation with physiological saline over the entire papilla

Treatment:

Drug: normal saline