Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

EUS vs EGD in Emergency Room Patients Referred for EGD (EUSvsEGD)

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: NCT04408872
Recruitment Status : Withdrawn (Study was not approved by the institution's scientific committee.)
First Posted : May 29, 2020
Last Update Posted : January 15, 2021
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 patients inevitably undergo further testing if EGD is inconclusive, which adds costs and prolongs emergency room length of stay (LOS).EUS has traditionally been used after EGD for a myriad of reasons that no longer apply. The investigators therefore propose a prospective pilot study to determine whether adding primary EUS to EGD can reduce LOS and resource utilisation in emergency room patients referred for EGD.

Condition or disease Intervention/treatment Phase
Abdominal Pain Diagnostic Test: Esophago-gastro-duodenoscopy (EGD) Diagnostic Test: Endoscopic ultrasound (EUS) Not Applicable

Detailed Description:

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).

Endoscopic ultrasound (EUS) combines EGD with high-resolution ultrasound imaging of pancreas, liver and biliary system and is the best test to diagnose bile duct stones, early chronic pancreatitis, and small [<2cm] pancreatic cancers (all of which cannot be seen by regular ultrasound or CT scanning or MRI, yet are included in the differential diagnosis of EGD-negative abdominal pain).

EUS has traditionally been used after EGD, due to lack of availability, increased cost, and to increased risk due to larger scope diameter. However, the latest generation of EUS scopes have the same outer diameter as conventional gastroscopes, there is much wider availability of EUS in university and community hospital settings, and the cost per procedure is lower, due to increased procedural numbers and reduced maintenance costs.

In experienced hands, diagnostic EUS is now as safe and as accurate as EGD for diagnosing mucosal pathology and takes approximately 1 minute longer.(1; 2) Previously published work by our group suggests that EUS may reduce resource consumption in patients with unexplained abdominal pain.(3) The investigators also showed that in refractory dyspepsia with normal EGD and CT, EUS identified signs of occult chronic pancreatitis in up to 20% of cases.(4) More recently, EUS was found to identify previously undiagnosed, potential causes of unexplained abdominal pain in up to 9% of patients, or at least provides the same, if not more information than EGD and abdominal US alone.(2; 5; 6)

There are no previous studies that have prospectively compared the yield of EGD and PEUS in emergency room patients. The investigators hypothesize that adding EUS to EGD ("primary EUS" [PEUS]) can safely and more efficiently diagnose or exclude significant gastro-intestinal and pancreatico-biliary pathology in emergency room patients in whom EGD has been requested. The investigators therefore propose a prospective pilot study to perform a preliminary analysis of the potential impact of PEUS on the ability to make an early GI diagnosis (EGID), length of stay (LOS) and resource utilisation in emergency room patients referred for EGD. If there is sufficient evidence of a clinically useful impact, an appropriately powered study to determine whether PEUS is clinically superior to EGD with respect to these variables will be performed.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an open-label two-arm, single center, superiority trial with 1:1 allocation ratio between EUS and standard intervention EGD.
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
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: EGD
SUBJECT WILL UNDERGO ESOPHAGO-GASTRO-DUODENOSCOPY (EGD)
Diagnostic Test: Esophago-gastro-duodenoscopy (EGD)
EGD: ENDOSCOPIC PROCEDURE DURING WHICH THE ESOPHAGUS, STOMACH AND DUODENUM ARE VISUALISED WITH A TINY CAMERA IMPLANTED AT THE END OF AN ENDOSCOPE.

Experimental: EUS
SUBJECT WILL UNDERGO ENDOSCOPIC ULTRASOUND (EUS)
Diagnostic Test: Endoscopic ultrasound (EUS)
EUS: SAME AS EGD, BUT IN ADDITION HAS AN INTEGRATED ULTRASOUND PROBE WHICH ALLOWS TO EXAMINE THE PANCREAS, LIVER AND BILIARY SYSTEM.




Primary Outcome Measures :
  1. Length of stay (LOS) at the emergency room [ Time Frame: 48 hours ]
    The primary outcome will be time (hours) to discharge, or admission (for a GI diagnosis) after receipt of the endoscopy (EGD or EUS) report by the consulting gastroenterologist.


Secondary Outcome Measures :
  1. Frequency of conversion to the alternate procedure (EGD to EUS, or EUS to EGD) [ Time Frame: 48 hours ]
    Number of subjects who need to undergo both procedures

  2. Alternate procedures undergone during emergency room stay [ Time Frame: 48 hours ]
    Number of subsequent imaging procedures other than endoscopy

  3. Complications during emergency room stay [ Time Frame: 96 hours ]
    Defined as any event that prolongs hospital stay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. EGD requested by the consulting gastroenterologist
  2. Informed consent

Exclusion Criteria:

  1. Evidence of hemodynamic instability and/or ongoing active GI bleeding.
  2. Any suspicion of obstruction distal to the angle of Treitz.

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): NCT04408872


Locations
Layout table for location information
Canada, Quebec
CHUM
Montreal, Quebec, Canada
Centre de recherche du Centre hospitalier de l'université de Montréal
Montréal, Quebec, Canada, H2X 0A9
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Layout table for investigator information
Principal Investigator: ANAND SAHAI Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Layout table for additonal information
Responsible Party: A Sahai, Gastroenterologist, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04408872    
Other Study ID Numbers: 2021-9005
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Abdominal Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive