NCT03432208

Brief Summary

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).EUS has traditionally been used after EGD for a myriad of costs reasons that no longer apply. We therefore propose a prospective pilot study to determine whether PEUS can reduce LOS and resource utilisation in emergency room patients referred for EGD.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

May 27, 2016

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2019

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

3 years

First QC Date

May 11, 2016

Last Update Submit

May 12, 2020

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (1)

  • time to GI diagnosis

    The primary outcome will be "time to GI diagnosis" (with T0 starting immediately after the procedure report is read and signed by the referring physician). A "GI diagnosis" is defined as diagnosis or confirmation of any condition sufficient to start treatment or to modify the existing therapeutic regimen.

    1 day

Secondary Outcomes (3)

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

    1 day

  • number of subsequent imaging procedures other than endoscopy

    1 day

  • Complications

    1 day

Study Arms (2)

ESOPHAGO-GASTRO-DUODENOSCOPY (EGD)

ACTIVE COMPARATOR

GI consult Procedure performed is EGD

Procedure: GI consult

ENDOSCOPIC ULTRASOUND (EUS)

EXPERIMENTAL

GI consult Procedure performed is EUS

Procedure: GI consult

Interventions

GI consultPROCEDURE
ENDOSCOPIC ULTRASOUND (EUS)ESOPHAGO-GASTRO-DUODENOSCOPY (EGD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • EGD or EUS cannot be performed before 12PM.
  • Previous barium study, EGD, US, abdomino-pelvic CT, or abdomino-pelvic MRI within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUM

Montreal, Quebec, Canada

Location

Related Publications (6)

  • Haider S, Kahaleh M. The use of endoscopic clipping devices in the treatment of iatrogenic duodenal perforation. Gastroenterol Hepatol (N Y). 2010 Oct;6(10):660-1. No abstract available.

    PMID: 21103446BACKGROUND

  • Chang KJ, Erickson RA, Chak A, Lightdale C, Chen YK, Binmoeller KF, Albers GC, Chen WP, McLaren CE, Sivak MV, Lee JG, Isenberg GA, Wong RC. EUS compared with endoscopy plus transabdominal US in the initial diagnostic evaluation of patients with upper abdominal pain. Gastrointest Endosc. 2010 Nov;72(5):967-74. doi: 10.1016/j.gie.2010.04.007. Epub 2010 Jul 22.

    PMID: 20650452BACKGROUND

  • Sahai AV, Penman ID, Mishra G, Williams D, Pearson A, Wallace MB, van Velse A, Hoffman BJ, Hawes RH. An assessment of the potential value of endoscopic ultrasound as a cost-minimizing tool in dyspeptic patients with persistent symptoms. Endoscopy. 2001 Aug;33(8):662-7. doi: 10.1055/s-2001-16223.

    PMID: 11490381BACKGROUND

  • Sahai AV, Mishra G, Penman ID, Williams D, Wallace MB, Hadzijahic N, Pearson A, Vanvelse A, Hoffman BJ, Hawes RH. EUS to detect evidence of pancreatic disease in patients with persistent or nonspecific dyspepsia. Gastrointest Endosc. 2000 Aug;52(2):153-9. doi: 10.1067/mge.2000.107910.

    PMID: 10922084BACKGROUND

  • Thompson MB, Ramirez JC, De La Rosa LM, Wood AS, Desai S, Arjunan A, Song J, Erickson RA. Endoscopic ultrasound in the evaluation of chronic upper abdominal pain of unknown etiology: a retrospective chart review examining the efficacy of EUS in determining a new diagnosis. J Clin Gastroenterol. 2015 Feb;49(2):e17-20. doi: 10.1097/MCG.0000000000000174.

    PMID: 25569224BACKGROUND

  • Attasaranya S, Ovartlarnporn B. The possible diagnostic role of endoscopic ultrasound in patients with dyspepsia. J Med Assoc Thai. 2005 Nov;88(11):1660-5.

    PMID: 16471116BACKGROUND

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Anand Sahai, M.D

    CRCHUM

    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
Professeur Adjoint

Study Record Dates

First Submitted

May 11, 2016

First Posted

February 14, 2018

Study Start

May 27, 2016

Primary Completion

June 14, 2019

Study Completion

June 14, 2019

Last Updated

May 13, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)