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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

670 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-ERCP Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Drug: epinephrine

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

Group Type EXPERIMENTAL

epinephrine

Intervention Type DRUG

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

Drug: normal saline

20-mL irrigation with physiological saline over the entire papilla

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

20-mL irrigation with physiological saline over the entire papilla

Interventions

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epinephrine

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

Intervention Type DRUG

normal saline

20-mL irrigation with physiological saline over the entire papilla

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No