Reactions to Contrast Media (CM) Administered at the Time... | NCT00900640

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

NCT00900640

Sponsor

University of Florida

Status

Completed

Last Update Posted

Mar 16, 2017Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Contrast Allergies

Interventions

ERCP as medically indicated by subjects referring physician

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009Actual

Primary Completion Date

Mar 2017Actual

Completion Date

Mar 2017Actual

First Submitted Date

May 11, 2009

First Submission Date that Met QC Criteria

May 12, 2009

First Posted Date

May 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2017

Last Update Posted Date

Mar 16, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ERCP as medically indicated by subjects referring physician	Procedure	Determine the incidence of adverse reactions to CM administered during ERCP in patients with prior reaction to IV CM administration and/or shellfish allergy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine the incidence of adverse reactions to CM administered during ERCP in patients with prior reaction to IV CM administration and/or shellfish allergy.		at the time of the subjects ERCP

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Any contraindication to performing ERCP.
Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
The subject is unable/unwilling to give informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter V. Draganov, MD	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shands UF endoscopy Center		Gainesville	Florida	32610	United States

Intervention Browse Module

MeSH Terms

ID	Term
D002760	Cholangiopancreatography, Endoscopic Retrograde

Ancestor Terms

ID	Term
D002758	Cholangiography
D011860	Radiography, Abdominal
D011859	Radiography
D003952	Diagnostic Imaging

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