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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 October 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: October 21, 2014
Last verified: October 2014

May 11, 2009
October 21, 2014
May 2009
May 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00900640 on ClinicalTrials.gov Archive Site
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Reactions to Contrast Media (CM) Administered at the Time of the Endoscopic Retrograde Cholangiopancreatography (ERCP)
Reactions to Contrast Media (CM) Administered at the Time of Endoscopic Retrograde Cholangiopancreatography (ERCP)

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

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

Contrast Allergies
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.
ERCP group
All patients who have been scheduled for an ERCP due to medical necessity will be considered for this study.
Intervention: Procedure: ERCP as medically indicated by subjects referring physician
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
780
May 2016
May 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Peter V Draganov, MD 352-392-2877 peter.draganov@medicine.ufl.edu
United States
 
NCT00900640
ERCP Contrast 144-09
No
University of Florida
University of Florida
Not Provided
Principal Investigator: Peter V. Draganov, MD University of Florida
University of Florida
October 2014

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