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

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ClinicalTrials.gov Identifier: NCT00900640
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Contrast Allergies Procedure: ERCP as medically indicated by subjects referring physician

Study Design

Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reactions to Contrast Media (CM) Administered at the Time of Endoscopic Retrograde Cholangiopancreatography (ERCP)
Actual Study Start Date : May 2009
Primary Completion Date : March 2017
Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900640


Locations
United States, Florida
Shands UF endoscopy Center
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter V. Draganov, MD University of Florida
More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00900640     History of Changes
Other Study ID Numbers: ERCP Contrast 144-09
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017