Reactions to Contrast Media (CM) Administered at the Time of the Endoscopic Retrograde Cholangiopancreatography (ERCP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00900640
First received: May 11, 2009
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

The aim of this study is to prospectively document the incidence of CM adverse reactions at the time of ERCP and to determine whether various perceived risk factors are predictive of adverse reaction.

Adverse reactions to iodine containing contrast media (CM) have been described after endoscopic retrograde cholangiopancreaticography (ERCP) but have been difficult to study due to their extremely low incidence. Adverse reactions can be classified by severity (mild, moderate or severe) or underlying mechanism (idiosyncratic versus nonidiosyncratic). Nonidiosyncratic reactions are related to the dose and osmolality of the CM; these are not observed during ERCP due to the relative small amount of systemic absorption of CM. Idiosyncratic reactions on the other hand are not dose-dependent and generally occur shortly after administration of CM.

Premedication with corticosteroids, H1/H2 -blockers and the use of low osmolality CM is beneficial in preventing nonidiosyncratic reactions during intravascular administration. However their role in during ERCP is unclear as CM is not injected into the intravascular space. Currently there are no formal recommendations and clinical practice varies considerably. The general purpose of this study is to determine the incidence of CM reactions during ERCP and to determine whether various risk factors are predictive of idiosyncratic reactions. Based on these results, we hope to develop guidelines for the use of prophylaxis to prevent CM reactions in ERCP.


Condition Intervention
Contrast Allergies
Procedure: ERCP as medically indicated by subjects referring physician

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reactions to Contrast Media (CM) Administered at the Time of Endoscopic Retrograde Cholangiopancreatography (ERCP)

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Determine the incidence of adverse reactions to CM administered during ERCP in patients with prior reaction to IV CM administration and/or shellfish allergy. [ Time Frame: at the time of the subjects ERCP ] [ Designated as safety issue: No ]

Estimated Enrollment: 780
Study Start Date: May 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ERCP group
All patients who have been scheduled for an ERCP due to medical necessity will be considered for this study.
Procedure: ERCP as medically indicated by subjects referring physician
Determine the incidence of adverse reactions to CM administered during ERCP in patients with prior reaction to IV CM administration and/or shellfish allergy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients who medically need an ERCP to further evaluate or treat their medical condition.

Criteria

Inclusion Criteria:

  1. Age 18 years or older.
  2. Scheduled to undergo ERCP at the University of Florida, Gainesville, FL
  3. History of prior reaction to IV CM and/or shellfish allergy
  4. Subject must be able to give informed consent

Exclusion Criteria:

  1. Any contraindication to performing ERCP.
  2. Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
  3. The subject is unable/unwilling to give informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900640

Contacts
Contact: Peter V Draganov, MD 352-392-2877 peter.draganov@medicine.ufl.edu

Locations
United States, Florida
Shands UF endoscopy Center Recruiting
Gainesville, Florida, United States, 32610
Contact: Peter V Draganov, MD    352-392-2877    peter.draganov@medicine.ufl.edu   
Principal Investigator: Pater V Draganov, MD         
Sub-Investigator: Christopher E Forsmark, MD         
Sub-Investigator: Mihir Wagh, MD         
Sub-Investigator: Shailendra Chauhan, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter V. Draganov, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00900640     History of Changes
Other Study ID Numbers: ERCP Contrast 144-09
Study First Received: May 11, 2009
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014