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.
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.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta Hospital
Edmonton, Alberta
Sergio Zepeda-Gomez, 7802481578, zepedago@ualberta.ca
David Yang, 6475027658, dyyang@ualberta.ca
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.
- Conditions
- Small Bowel Bleeding
- 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 group | Role | What they receive |
|---|---|---|
| Early small bowel investigation | Experimental | Patients in the early small bowel investigation group will undergo VCE immediately after their initial negative gastroscopy Receives: Procedure: Videocapsule endoscopy |
| Colonoscopy | Active comparator | Participants 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.
Diagnostic yield
Diagnostic yield of videocapsule endoscopy after initial negative gastroscopy
Measured: 30 days
Diagnostic yield of colonoscopy after initial negative gastroscopy
Measured: 30 days
Secondary outcomes (4)
Time from presentation to localization of bleeding source
Measured: 30 days
Recurrence of bleeding
Measured: 30 days
Length of stay in hospital
Measured: 30 days
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.
- First posted5 Nov 2021
- Study start1 Sep 2021
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel BleedingStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Efficacy of Early Videocapsule Endoscopy Following Negative Gastroscopy in Patients Presenting With Suspected Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT05108844
- Acronym / sponsor ID
- Pro00111216
- Conditions
- Small Bowel Bleeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 5 Nov 2021 (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.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early small bowel investigation | Experimental | Procedure: Videocapsule endoscopyPatients in the early small bowel investigation group will undergo VCE immediately after their initial negative gastroscopy |
| Colonoscopy | Active comparator | Procedure: Videocapsule endoscopyParticipants with negative gastroscopy will undergo bowel preparation and colonoscopy the next day |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- New onset of acute gastrointestinal bleeding defined as:
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Videocapsule endoscopyEndoscopic drop of videocapsule in duodenum after initial negative gastroscopy | Procedure or surgery | Colonoscopy, Early small bowel investigation |
Primary outcome
Diagnostic yield
Time frame: 30 days
Diagnostic yield of videocapsule endoscopy after initial negative gastroscopy
Diagnostic yield of colonoscopy after initial negative gastroscopy
Time frame: 30 days
4 secondary outcomes
Time from presentation to localization of bleeding source
Time frame: 30 days
Recurrence of bleeding
Time frame: 30 days
Length of stay in hospital
Time frame: 30 days
Adverse events in both groups
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
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.