EUS vs EGD in Emergency Room Patients Referred for EGD

NCT04408872 | Withdrawn

• 1 other identifier: 2021-9005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  48 hours

Secondary Outcomes (3)

• Frequency of conversion to the alternate procedure (EGD to EUS, or EUS to EGD)

  48 hours

• Alternate procedures undergone during emergency room stay

  48 hours

• Complications during emergency room stay

  96 hours

Study Arms (2)

EGD

ACTIVE COMPARATOR

SUBJECT WILL UNDERGO ESOPHAGO-GASTRO-DUODENOSCOPY (EGD)

Diagnostic Test: Esophago-gastro-duodenoscopy (EGD)

EUS

EXPERIMENTAL

SUBJECT WILL UNDERGO ENDOSCOPIC ULTRASOUND (EUS)

Diagnostic Test: Endoscopic ultrasound (EUS)

Interventions

Esophago-gastro-duodenoscopy (EGD) DIAGNOSTIC_TEST

EGD: ENDOSCOPIC PROCEDURE DURING WHICH THE ESOPHAGUS, STOMACH AND DUODENUM ARE VISUALISED WITH A TINY CAMERA IMPLANTED AT THE END OF AN ENDOSCOPE.

EGD

Endoscopic ultrasound (EUS) DIAGNOSTIC_TEST

EUS: SAME AS EGD, BUT IN ADDITION HAS AN INTEGRATED ULTRASOUND PROBE WHICH ALLOWS TO EXAMINE THE PANCREAS, LIVER AND BILIARY SYSTEM.

EUS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• EGD requested by the consulting gastroenterologist
• Informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (2)

Centre de recherche du Centre hospitalier de l'université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

CHUM

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Abdominal Pain

Interventions

Endosonography

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• ANAND SAHAI

  Centre de Recherche du Centre Hospitalier de l'Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist

Model Details: This is an open-label two-arm, single center, superiority trial with 1:1 allocation ratio between EUS and standard intervention EGD.

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 29, 2020
• Study Start: October 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)