AzTrials
AzTrials

Small Bowel BleedingNCT05108844

Early Videocapsule Endoscopy for Upper Gastrointestinal Bleeding

A study testing Videocapsule endoscopy in people with Small Bowel Bleeding, run by University of Alberta at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The objective of this study is to determine whether early video capsule endoscopy (VCE) immediately after a negative gastroscopy in the setting of suspected upper gastrointestinal bleeding (UGIB) improves patient outcomes as compared to the standard approach which typically involves performing colonoscopy prior to… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Small Bowel Bleeding
What is being tested?
Videocapsule endoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteCanada
Study dates
1 Sep 2021to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • New onset of acute gastrointestinal bleeding defined as:
  • The presence of melena/maroon stool on physical exam OR history of melena/maroon stool within 48 hours of emergency room presentation PLUS
  • Hemoglobin drop of ≥ 20 g/L from patient's baseline
  • Have capacity to consent
  • Hemodynamically stable (i.e. blood pressure >100/60 or pulse <110 at the time of consent)
  • Initial gastroscopy negative for active bleeding or potential bleeding source

Who cannot join

  • Inability to provide consent due to lack of capacity, language barrier or other reasons
  • Pregnant women
  • Prior history of small bowel surgery
  • Prior history of Crohn's disease
  • Prior history of small bowel or colonic strictures
  • Prior history of abdominal radiation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sergio Zepeda-Gomez, MD contact

780-248-1578

zepedago@ualberta.ca

David Yang, MD contact

647-502-7658

dyyang@ualberta.ca

Canada1 site, 1 recruiting
  • University of Alberta Hospital

    Edmonton, Alberta

    Sergio Zepeda-Gomez, 7802481578, zepedago@ualberta.ca

    David Yang, 6475027658, dyyang@ualberta.ca

    Recruiting

Other trials in Canada

About this study

Official title: A Randomized Controlled Trial Evaluating the Efficacy of Early Videocapsule Endoscopy Following Negative Gastroscopy in Patients Presenting With Suspected Upper Gastrointestinal Bleeding

The objective of this study is to determine whether early video capsule endoscopy (VCE) immediately after a negative gastroscopy in the setting of suspected upper gastrointestinal bleeding (UGIB) improves patient outcomes as compared to the standard approach which typically involves performing colonoscopy prior to small bowel investigations. We aim to examine the differences in diagnostic yield, total number of procedures, length of hospitalization, mortality rates, and healthcare cost between the two groups.

Read the detailed description

UGIB is common medical emergency with an annual hospitalization rate of 67 cases per 100,000 and costing in excess of 1 billion dollars in the US.1 In Alberta, Canada, annual incidence of UGIB due to peptic ulcers alone is between 35.4 to 41.2 cases per 100,000 with an overall in-hospital mortality rate of 8.5%.2 The presentation of acute UGIB are variable, but most have visible signs of bleeding such as hematemesis, coffee-ground-emesis or melena.3 Clinically, these findings are used to guide management plans. For instance, a patient with suspected UGIB based on clinical presentation will typically undergo gastroscopy as the initial diagnostic test.4,5 However, it is becoming increasingly clear that clinical signs of bleeding do not always correlate with location of bleeds. Despite melena being the most common presenting symptom for UGIB, more than 10% of melena arise from the small bowel or right colon.3,4 Similarly, 15% of hematochezia, which are thought to be signs of colonic bleeding, in fact have bleeding sources in the upper GI tract.6 In essence, bleeding can be anywhere along the gastrointestinal tract regardless of patient's presentation. This poses a significant challenge for clinicians in determining which investigations to pursue in patients with suspected UGIB after a negative gastroscopy. Currently, there are no clear guidelines on this subject matter.4,5 In clinical practice, such patients often undergo colonoscopy to rule out colonic sources of bleed, before small bowel investigations with cross-sectional imaging and VCE. This is a time-consuming approach that requires multiple invasive procedures, leading to patient discomfort, prolonged hospitalization, and increased cost. The utility of colonoscopy in suspected UGIB have also been questioned by previous study that reported a diagnostic yield of less than 5%.7 Furthermore, proceeding with colonoscopy first will cause delays in small bowel investigation which may lower the detection rate of small bowel lesions.8 With these in mind, we propose the study of an alternative diagnostic approach which prioritizes small bowel investigation over colonic investigation. We propose early VCE following negative gastroscopy instead of colonoscopy. VCE is a pill shaped camera that is well tolerated, non-invasive, and offers superior mucosal imaging of the small bowel compared to cross-sectional imaging in the setting of GI bleeding.9 This approach would likely have higher diagnostic yield than the traditional approach of conducting colonoscopy first.

At the present, patients with suspected UGIB and negative gastroscopy pose significant diagnostic challenges for clinicians. This study aims to help determine the importance of prioritizing small bowel investigation in this clinical setting. If this study can demonstrate the safety and efficacy of the early small bowel investigation, the results will fundamentally change the approach and management of patients with acute GI bleeding, potentially leading to better patient outcomes, reduced hospitalization, and healthcare savings.

Being tested
Videocapsule endoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Videocapsule endoscopyProcedure or surgery

    Endoscopic drop of videocapsule in duodenum after initial negative gastroscopy

Study groups in NCT05108844
Study groupRoleWhat they receive
Early small bowel investigationExperimentalPatients in the early small bowel investigation group will undergo VCE immediately after their initial negative gastroscopy
Receives: Procedure: Videocapsule endoscopy
ColonoscopyActive comparatorParticipants with negative gastroscopy will undergo bowel preparation and colonoscopy the next day
Receives: Procedure: Videocapsule endoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic yield

    Diagnostic yield of videocapsule endoscopy after initial negative gastroscopy

    Measured: 30 days

  2. Diagnostic yield of colonoscopy after initial negative gastroscopy

    Measured: 30 days

Secondary outcomes (4)
  1. Time from presentation to localization of bleeding source

    Measured: 30 days

  2. Recurrence of bleeding

    Measured: 30 days

  3. Length of stay in hospital

    Measured: 30 days

  4. Adverse events in both groups

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2021
  2. Study start1 Sep 2021
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

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
Single group
Masking
Single blind
Who is masked
Care provider
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05108844
Sponsor's protocol ID
Pro00111216
Status last verified
Mar 2026
First submitted
26 Oct 2021
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Videocapsule endoscopy in people with Small Bowel Bleeding, run by University of Alberta at 1 site 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sergio Zepeda-Gomez, MD (780-248-1578, zepedago@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic yield (time frame: 30 days). The study lists 2 primary outcomes in all. 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 16 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in