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A Pilot Study to Assess the Value of EUS vs EGD in Emergency Room Patients Referred for EGD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03432208
Recruitment Status : Terminated (Closed by CHUM REB for lack of documentation related to the recruitment of participants.)
First Posted : February 14, 2018
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
A Sahai, Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:
Emergency room patients referred for esophago-gastro-duodenoscopy (EGD) often have many possible causes for their symptoms. These inevitably undergo further testing if EGD is inconclusive, which adds costs and inevitably prolongs emergency room length of stay (LOS).EUS has traditionally been used after EGD for a myriad of costs reasons that no longer apply. We therefore propose a prospective pilot study to determine whether PEUS can reduce LOS and resource utilisation in emergency room patients referred for EGD.

Condition or disease Intervention/treatment Phase
Abdominal Pain Procedure: GI consult Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Assess the Potential Value of Adding Endoscopic Ultrasound (EUS) to Esophago-gastro-duodenoscopy (EGD) in Emergency Room Patients Referred for Egd
Actual Study Start Date : May 27, 2016
Actual Primary Completion Date : June 14, 2019
Actual Study Completion Date : June 14, 2019

Arm Intervention/treatment
Active Comparator: ESOPHAGO-GASTRO-DUODENOSCOPY (EGD)
GI consult Procedure performed is EGD
Procedure: GI consult
Experimental: ENDOSCOPIC ULTRASOUND (EUS)
GI consult Procedure performed is EUS
Procedure: GI consult



Primary Outcome Measures :
  1. time to GI diagnosis [ Time Frame: 1 day ]
    The primary outcome will be "time to GI diagnosis" (with T0 starting immediately after the procedure report is read and signed by the referring physician). A "GI diagnosis" is defined as diagnosis or confirmation of any condition sufficient to start treatment or to modify the existing therapeutic regimen.


Secondary Outcome Measures :
  1. frequency of conversion to the alternate procedure (EGD to EUS, or EUS to EGD) [ Time Frame: 1 day ]
    Number of subjects who were sent to do the alternate procedure

  2. number of subsequent imaging procedures other than endoscopy [ Time Frame: 1 day ]
    Includes scans, ultrasounds, MRI, etc.

  3. Complications [ Time Frame: 1 day ]
    Defined as any event that prolongs hospital stay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • EGD requested by the consulting gastroenterologist
  • Informed consent

Exclusion Criteria

  • Evidence of hemodynamic instability and/or ongoing active GI bleeding.
  • Any suspicion of obstruction distal to the angle of Treitz.
  • EGD or EUS cannot be performed before 12PM.
  • Previous barium study, EGD, US, abdomino-pelvic CT, or abdomino-pelvic MRI within the last 6 months.

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): NCT03432208


Locations
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Canada, Quebec
CHUM
Montreal, Quebec, Canada
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Anand Sahai, M.D CRCHUM
Publications:

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Responsible Party: A Sahai, Professeur Adjoint, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03432208    
Other Study ID Numbers: CE 14.320
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Emergencies
Abdominal Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive