Abdominal PainEUSvsEGDNCT04408872
EUS vs EGD in Emergency Room Patients Referred for EGD
A study testing Esophago-gastro-duodenoscopy (EGD) and Endoscopic ultrasound (EUS) in people with Abdominal Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- Esophago-gastro-duodenoscopy (EGD) and Endoscopic ultrasound (EUS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2020to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- EGD requested by the consulting gastroenterologist
- Informed consent
Who cannot join
- Evidence of hemodynamic instability and/or ongoing active GI bleeding.
- Any suspicion of obstruction distal to the angle of Treitz.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Centre de recherche du Centre hospitalier de l'université de Montréal
Montreal, Quebec, H2X 0A9
CHUM
Montreal, Quebec
About this study
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
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.
Read the 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.
- Conditions
- Abdominal Pain
- Being tested
- Esophago-gastro-duodenoscopy (EGD), Endoscopic ultrasound (EUS)
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| EGD | Active comparator | SUBJECT WILL UNDERGO ESOPHAGO-GASTRO-DUODENOSCOPY (EGD) Receives: Diagnostic Test: Esophago-gastro-duodenoscopy (EGD) |
| EUS | Experimental | SUBJECT WILL UNDERGO ENDOSCOPIC ULTRASOUND (EUS) Receives: Diagnostic Test: Endoscopic ultrasound (EUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
Secondary outcomes (3)
Frequency of conversion to the alternate procedure (EGD to EUS, or EUS to EGD)
Number of subjects who need to undergo both procedures
Measured: 48 hours
Alternate procedures undergone during emergency room stay
Number of subsequent imaging procedures other than endoscopy
Measured: 48 hours
Complications during emergency room stay
Defined as any event that prolongs hospital stay
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study startOct 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: Study was not approved by the institution's scientific committee.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A Sahai, Centre hospitalier de l'Université de Montréal (CHUM)
- Investigators
- ANAND SAHAI, Principal investigator, Centre de Recherche du Centre Hospitalier de l'Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408872
- Sponsor's protocol ID
- 2021-9005
- Acronym
- EUSvsEGD
- Status last verified
- Jan 2021
- First submitted
- 26 May 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04408872
- Acronym / sponsor ID
- EUSvsEGD / 2021-9005
- Conditions
- Abdominal Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not approved by the institution's scientific committee.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label two-arm, single center, superiority trial with 1:1 allocation ratio between EUS and standard intervention EGD.
| Arm | Type | Receives |
|---|---|---|
| EGD | Active comparator | Diagnostic Test: Esophago-gastro-duodenoscopy (EGD)SUBJECT WILL UNDERGO ESOPHAGO-GASTRO-DUODENOSCOPY (EGD) |
| EUS | Experimental | Diagnostic Test: Endoscopic ultrasound (EUS)SUBJECT WILL UNDERGO ENDOSCOPIC ULTRASOUND (EUS) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- EGD requested by the consulting gastroenterologist
- Informed consent
Key exclusion criteria (2 listed)
- Evidence of hemodynamic instability and/or ongoing active GI bleeding.
- Any suspicion of obstruction distal to the angle of Treitz.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | EGD |
| 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. | Diagnostic test | EUS |
Primary outcome
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.
3 secondary outcomes
Frequency of conversion to the alternate procedure (EGD to EUS, or EUS to EGD)
Time frame: 48 hours
Alternate procedures undergone during emergency room stay
Time frame: 48 hours
Complications during emergency room stay
Time frame: 96 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANAND SAHAI principal investigator
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophago-gastro-duodenoscopy (EGD) and Endoscopic ultrasound (EUS) in people with Abdominal Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (LOS) at the emergency room (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.