EUS vs EGD in Emergency Room Patients Referred for EGD (EUSvsEGD)
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|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Recruitment Status : Withdrawn (Study was not approved by the institution's scientific committee.)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
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Pain||Diagnostic Test: Esophago-gastro-duodenoscopy (EGD) Diagnostic Test: Endoscopic ultrasound (EUS)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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)|
|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|
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.
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.
- 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.
- 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
- Alternate procedures undergone during emergency room stay [ Time Frame: 48 hours ]Number of subsequent imaging procedures other than endoscopy
- Complications during emergency room stay [ Time Frame: 96 hours ]Defined as any event that prolongs hospital stay
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
|Montreal, Quebec, Canada|
|Centre de recherche du Centre hospitalier de l'université de Montréal|
|Montréal, Quebec, Canada, H2X 0A9|
|Principal Investigator:||ANAND SAHAI||Centre de Recherche du Centre Hospitalier de l'Université de Montréal|