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

NCT02839356 | Unknown Phase 4 DMC

• 1 other identifier: Epinephrine001
• Study Type: interventional
• Target: 670
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-ERCP Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• The prophylaxis effect of epinephrine sprayed on the papilla on post-ERCP pancreatitis

  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.

  PEP occurence rate at 24 h after ERCP in two groups.

Secondary Outcomes (1)

• 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

Study Arms (2)

Drug: epinephrine

EXPERIMENTAL

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

Drug: epinephrine

Drug: normal saline

PLACEBO COMPARATOR

20-mL irrigation with physiological saline over the entire papilla

Drug: normal saline

Interventions

epinephrine DRUG

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

Drug: epinephrine

normal saline DRUG

20-mL irrigation with physiological saline over the entire papilla

Drug: normal saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, age \> 18 years.
• Normal amylase level before undergoing ERCP.
• Signed inform consent form and agreed to follow-up on time.

You may not qualify if:

• Pregnancy or history of allergy to epinephrine.
• Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.
• Patients involved in other study within 60 days.
• Billroth II or Roux-en-Y anatomy
• Acute pancreatitis.
• All contraindications to epinephrine.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

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

Hefei, Anhui, 230001, China

RECRUITING

MeSH Terms

Interventions

Epinephrine; Saline Solution

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Shao Feng, MD

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

  STUDY DIRECTOR

Central Study Contacts

Shao Feng, MD

CONTACT

8613033090788; tagsmile1985@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 21, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)