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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 18, 2016
First Posted Date  ICMJE July 21, 2016
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epinephrine Sprayed on the Papilla for the Prevention of Post-ERCP Pancreatitis
Official Title  ICMJE Not Provided
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Post-ERCP Acute Pancreatitis
Intervention  ICMJE
  • Drug: epinephrine
    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
Study Arms  ICMJE
  • Experimental: Drug: epinephrine
    20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla
    Intervention: Drug: epinephrine
  • Placebo Comparator: Drug: normal saline
    20-mL irrigation with physiological saline over the entire papilla
    Intervention: Drug: normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 2, 2017)
670
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2016)
360
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02839356
Other Study ID Numbers  ICMJE Epinephrine001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anhui Provincial Hospital
Study Sponsor  ICMJE Anhui Provincial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shao Feng, MD Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
PRS Account Anhui Provincial Hospital
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP