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

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ClinicalTrials.gov Identifier: NCT02839356
Recruitment Status : Unknown
Verified July 2016 by Anhui Provincial Hospital.
Recruitment status was:  Recruiting
First Posted : July 21, 2016
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Post-ERCP Acute Pancreatitis Drug: epinephrine Drug: normal saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : July 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: Drug: epinephrine
20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla
Drug: epinephrine
20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla

Placebo Comparator: Drug: normal saline
20-mL irrigation with physiological saline over the entire papilla
Drug: normal saline
20-mL irrigation with physiological saline over the entire papilla




Primary Outcome Measures :
  1. The prophylaxis effect of epinephrine sprayed on the papilla on post-ERCP pancreatitis [ Time Frame: 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 :
  1. Compare epinephrine group with control group on the incidence of hyperamylasemia/adverse events. [ Time Frame: 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.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839356


Contacts
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Contact: Shao Feng, MD 8613033090788 tagsmile1985@163.com

Locations
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China, Anhui
Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University Recruiting
He Fei, Anhui, China, 230001
Contact: Shao Feng, MD    8613033090788    tagsmile1985@163.com   
Principal Investigator: Shao Feng, MD         
Sponsors and Collaborators
Anhui Provincial Hospital
Investigators
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Study Director: Shao Feng, MD Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University

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Responsible Party: Anhui Provincial Hospital
ClinicalTrials.gov Identifier: NCT02839356     History of Changes
Other Study ID Numbers: Epinephrine001
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents