Reactions to Contrast Media (CM) Administered at the Time of the Endoscopic Retrograde Cholangiopancreatography (ERCP)
NCT ID: NCT00900640
Last Updated: 2017-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
27 participants
OBSERVATIONAL
2009-05-31
2017-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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ERCP group
All patients who have been scheduled for an ERCP due to medical necessity will be considered for this study.
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.
Interventions
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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 Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Peter V. Draganov, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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Shands UF endoscopy Center
Gainesville, Florida, United States
Countries
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Other Identifiers
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ERCP Contrast 144-09
Identifier Type: -
Identifier Source: org_study_id
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