Capsule Endoscopy vs. Push Enteroscopy in Occult Gastrointestinal Bleeding OGIB (NCT00224627) | Clinical Trial Compass
CompletedPhase 3
Capsule Endoscopy vs. Push Enteroscopy in Occult Gastrointestinal Bleeding OGIB
France45 participantsStarted 2002-03
Plain-language summary
Capsule endoscopy (CE) is a safe and effective tool for the assessment of obscure gastrointestinal bleeding (OGIB). However, its real efficacy and its position in the diagnostic algorithm of OGIB vs. push enteroscopy (PE) remain unknown since in previous studies both techniques were performed in all included patients The purpose of this protocol is to conduct a randomized prospective controlled trial in patients with OGIB comparing a strategy based on CE or PE followed by the alternative exploration only when the first line exploration was negative. The main outpoint of this study concerns the diagnostic yield of the two explorations. Second endpoint concerns the clinical relevance of the two strategies tested (CE ± PE vs. CE ± PE) in terms of diagnostic yield, clinical outcome, therapeutic impact and added explorations
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients may suffer from episodes of active bleeding within the last 6 months or chronic iron-deficiency anemia (hemoglobin \< 10 g/dl).
* A gynecologic or proctologic bleeding source had to be excluded.
* All patients had to have negative workup including upper gastrointestinal endoscopy, colonoscopy and small-bowel barium series or computed tomography enteroclysis.
* Medical reports and/or the imaging documents were available and reviewed in all patients. Usually these investigations were repeated several times before inclusion.
* Abdominal angiography was only performed when there were signs of active bleeding during the diagnostic work-up (n = 3). Meckel scintigraphy was usually carried out in patients under 30 years of age (n = 14).
Exclusion Criteria:
* Patient presenting a digestive bleeding with an echo hemodynamic major and\\or requiring urgent therapeutic measures
* Wait presenting a gynaecological cause or a cause proctology of sure imputability or syndrome of malabsorption or deficiency of contribution not formally excluded
* Patient presenting an occlusive syndrome or a hurt of stenosis hail objectivized by a radiological exploration
* Surrounding wall(Speaker) or in age waits to procreate without effective contraception
* The mental or physical state of the patient not allowing a maid compliance in the conditions of the try(essay) and or in the correct use of the device Patient carrier of a pacemaker or another electromechanical implant
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary end point was the diagnostic yield of CE and PE (first line exploration allocated by randomization) for the identification of a definitive source of bleeding.