EUS vs EGD in Emergency Room Patients Referred for EGD (EUSvsEGD)
Primary Purpose
Abdominal Pain
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Esophago-gastro-duodenoscopy (EGD)
Endoscopic ultrasound (EUS)
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Pain
Eligibility 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.
Sites / Locations
- CHUM
- Centre de recherche du Centre hospitalier de l'université de Montréal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
EGD
EUS
Arm Description
SUBJECT WILL UNDERGO ESOPHAGO-GASTRO-DUODENOSCOPY (EGD)
SUBJECT WILL UNDERGO ENDOSCOPIC ULTRASOUND (EUS)
Outcomes
Primary Outcome Measures
Length of stay (LOS) at the emergency room
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
Frequency of conversion to the alternate procedure (EGD to EUS, or EUS to EGD)
Number of subjects who need to undergo both procedures
Alternate procedures undergone during emergency room stay
Number of subsequent imaging procedures other than endoscopy
Complications during emergency room stay
Defined as any event that prolongs hospital stay
Full Information
NCT ID
NCT04408872
First Posted
May 26, 2020
Last Updated
January 13, 2021
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT04408872
Brief Title
EUS vs EGD in Emergency Room Patients Referred for EGD
Acronym
EUSvsEGD
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not approved by the institution's scientific committee.
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EGD
Arm Type
Active Comparator
Arm Description
SUBJECT WILL UNDERGO ESOPHAGO-GASTRO-DUODENOSCOPY (EGD)
Arm Title
EUS
Arm Type
Experimental
Arm Description
SUBJECT WILL UNDERGO ENDOSCOPIC ULTRASOUND (EUS)
Intervention Type
Diagnostic Test
Intervention Name(s)
Esophago-gastro-duodenoscopy (EGD)
Intervention Description
EGD: ENDOSCOPIC PROCEDURE DURING WHICH THE ESOPHAGUS, STOMACH AND DUODENUM ARE VISUALISED WITH A TINY CAMERA IMPLANTED AT THE END OF AN ENDOSCOPE.
Intervention Type
Diagnostic Test
Intervention Name(s)
Endoscopic ultrasound (EUS)
Intervention Description
EUS: SAME AS EGD, BUT IN ADDITION HAS AN INTEGRATED ULTRASOUND PROBE WHICH ALLOWS TO EXAMINE THE PANCREAS, LIVER AND BILIARY SYSTEM.
Primary Outcome Measure Information:
Title
Length of stay (LOS) at the emergency room
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Frequency of conversion to the alternate procedure (EGD to EUS, or EUS to EGD)
Description
Number of subjects who need to undergo both procedures
Time Frame
48 hours
Title
Alternate procedures undergone during emergency room stay
Description
Number of subsequent imaging procedures other than endoscopy
Time Frame
48 hours
Title
Complications during emergency room stay
Description
Defined as any event that prolongs hospital stay
Time Frame
96 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANAND SAHAI
Organizational Affiliation
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUM
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre de recherche du Centre hospitalier de l'université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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EUS vs EGD in Emergency Room Patients Referred for EGD
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