Gastrointestinal BleedingPhase 3NCT01424254
The Effectiveness of Video-capsule Endoscopy in Gastrointestinal Bleeding of Obscure Origin
A Phase 3 study testing Capsule GIVEN IMAGING and Push-Enteroscopy in people with Gastrointestinal Bleeding, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The study objective is to compare the cost-effectiveness of VCE to push enteroscopy in patients with gastrointestinal bleeding of obscure origin with a negative initial work-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Bleeding
- What is being tested?
- Capsule GIVEN IMAGING and Push-Enteroscopy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2003to Mar 2011
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Normal gastroscopy, colonoscopy and small bowel follow through in the last 3 months
Who cannot join
- Demonstrable source of blood outside the GI tract
- Significant cardiopulmonary disease
- Suspicion of strictures or fistulae of the GI tract
- Pregnancy
- Numerous small intestinal diverticula
- Zenker's diverticulum
- Extensive Crohn's enteritis
Trial locations and contacts
1 site in 1 country.
About this study
The study objective is to compare the cost-effectiveness of VCE to push enteroscopy in patients with gastrointestinal bleeding of obscure origin with a negative initial work-up.
Read the detailed description
Background: The introduction of the wireless capsule endoscopy (WCE) may dramatically alter the management of patients with small bowel disease such as chronic gastrointestinal bleeding of obscure origin (CGB). Yet, to date, this non invasive technique has undergone widespread diffusion in the absence of properly designed prospective comparative cost-effectiveness evaluations.
Objectives: To examine the clinical impact and cost-effectiveness of a novel approach employing WCE compared to that of push enteroscopy (PE).
Hypothesis: WCE is more cost-effective than PE in patients with CGB. Study design: We propose a randomized clinical trial comparing WCE to PE. Study population: Patients with CGB having undergone initial normal assessment with gastroscopy, colonoscopy and radiological examination of the small bowel.
Outcomes: Primary objective: To compare the detection rates of "clinically significant" small bowel lesions using WCE versus PE in CGB patients randomized to either modality. Secondary objectives: To determine the "cure rate" for each technique after 6 months, the cost-effectiveness of WCE versus PE, the type of small bowel lesions most likely to impact on clinical care, inter-rater variability in reading WCE examinations, the feasibility of WCE interpretation by a dedicated technician, the safety of each imaging modality, and to compare patient satisfaction and quality of life between the two groups.
- Conditions
- Gastrointestinal Bleeding
- Being tested
- Capsule GIVEN IMAGING, Push-Enteroscopy
- Keywords
- Gastrointestinal Bleeding of Obscure Origin
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule GIVEN IMAGINGDevice
Injection of Capsule Endoscopy
Push-EnteroscopyProcedure or surgery
currently recommended standard
| Study group | Role | What they receive |
|---|---|---|
| Video-Capsule Endoscopy | Experimental | VCE will be performed in the early morning following 200 mg of simethicone and 250 - 500 mg of erythromycin (as per physician's prescription), ingestion also in the absence of contra-indications Receives: Device: Capsule GIVEN IMAGING |
| Push Enterosopy | Experimental | Not described Receives: Procedure: Push-Enteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the detection rate of clinically significant lesions thought to be responsible for the patients with gastrointestinal bleeding of obscure origin
Measured: 12 months
Secondary outcomes (6)
resolution of the anemia/recurrent bleeding
Measured: 12 months
blood transfusion requirements
Measured: 12 months
Number of required imaging tests (i.e: gastroscopy, colonoscopy, etc)
Measured: 12 months
hospitalization/length of stay
Measured: 12 months
days away from usual activities (protocol unrelated)
Measured: 12 months
patient satisfaction
Patient satisfaction questionnaire
Measured: Following procedure at randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startOct 2003
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy, American College of Gastroenterology, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Alan Barkun, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424254
- Sponsor's protocol ID
- REC#03-025
- Status last verified
- Aug 2011
- First submitted
- 18 Aug 2011
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Video-capsule Endoscopy in Gastrointestinal Bleeding of Obscure Origin
- ClinicalTrials.gov ID
- NCT01424254
- Acronym / sponsor ID
- REC#03-025
- Conditions
- Gastrointestinal Bleeding
- Keywords
- Gastrointestinal Bleeding of Obscure Origin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy, American College of Gastroenterology, Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2003
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 26 Aug 2011 (estimated)
- 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 study objective is to compare the cost-effectiveness of VCE to push enteroscopy in patients with gastrointestinal bleeding of obscure origin with a negative initial work-up.
Detailed description
Background: The introduction of the wireless capsule endoscopy (WCE) may dramatically alter the management of patients with small bowel disease such as chronic gastrointestinal bleeding of obscure origin (CGB). Yet, to date, this non invasive technique has undergone widespread diffusion in the absence of properly designed prospective comparative cost-effectiveness evaluations.
Objectives: To examine the clinical impact and cost-effectiveness of a novel approach employing WCE compared to that of push enteroscopy (PE).
Hypothesis: WCE is more cost-effective than PE in patients with CGB. Study design: We propose a randomized clinical trial comparing WCE to PE. Study population: Patients with CGB having undergone initial normal assessment with gastroscopy, colonoscopy and radiological examination of the small bowel.
Outcomes: Primary objective: To compare the detection rates of "clinically significant" small bowel lesions using WCE versus PE in CGB patients randomized to either modality. Secondary objectives: To determine the "cure rate" for each technique after 6 months, the cost-effectiveness of WCE versus PE, the type of small bowel lesions most likely to impact on clinical care, inter-rater variability in reading WCE examinations, the feasibility of WCE interpretation by a dedicated technician, the safety of each imaging modality, and to compare patient satisfaction and quality of life between the two groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-Capsule Endoscopy | Experimental | Device: Capsule GIVEN IMAGINGVCE will be performed in the early morning following 200 mg of simethicone and 250 - 500 mg of erythromycin (as per physician's prescription), ingestion also in the absence of contra-indications |
| Push Enterosopy | Experimental | Procedure: Push-Enteroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years old
- Normal gastroscopy, colonoscopy and small bowel follow through in the last 3 months
Key exclusion criteria (7 listed)
- Demonstrable source of blood outside the GI tract
- Significant cardiopulmonary disease
- Suspicion of strictures or fistulae of the GI tract
- Pregnancy
- Numerous small intestinal diverticula
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 |
|---|---|---|
| Capsule GIVEN IMAGINGInjection of Capsule Endoscopy | Device | Video-Capsule Endoscopy |
| Push-Enteroscopycurrently recommended standard | Procedure or surgery | Push Enterosopy |
Primary outcome
The primary outcome measure is the detection rate of clinically significant lesions thought to be responsible for the patients with gastrointestinal bleeding of obscure origin
Time frame: 12 months
6 secondary outcomes
resolution of the anemia/recurrent bleeding
Time frame: 12 months
blood transfusion requirements
Time frame: 12 months
Number of required imaging tests (i.e: gastroscopy, colonoscopy, etc)
Time frame: 12 months
hospitalization/length of stay
Time frame: 12 months
days away from usual activities (protocol unrelated)
Time frame: 12 months
patient satisfaction
Time frame: Following procedure at randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capsule GIVEN IMAGING and Push-Enteroscopy in people with Gastrointestinal Bleeding, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 26 Aug 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome measure is the detection rate of clinically significant lesions thought to be responsible for the patients with gastrointestinal bleeding of obscure origin (time frame: 12 months). 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 26 Aug 2011.