A Prospective Study Comparing Urgent Video Capsule Endoscopy With Urgent Double-balloon Enteroscopy (NCT01654770) | Clinical Trial Compass
CompletedPhase 4
A Prospective Study Comparing Urgent Video Capsule Endoscopy With Urgent Double-balloon Enteroscopy
Thailand27 participantsStarted 2010-10
Plain-language summary
Overt obscure gastrointestinal bleeding (OGIB) is a distinct clinical entity with significantly worse outcomes compared with colonic bleeding and upper GI bleeding. The mortality rate for patients with acute small bowel bleeding was 10%.1 Recently, a meta-analysis of 10 studies showed that VCE and DBE have an equivalent diagnosis yields in patients with obscure GIB (62% for VCE and 56% for DBE).2 The limitation of this meta-analysis study was that the included studies examined patients with occult OGIB and overt OGIB. Comparing with occult OGIB, patients with overt OGIB are more likely to present a significant lesion that causes a recurrent bleeding which subsequently increases risk of morbidity and mortality.3 According to emergency endoscopy concept from upper and lower GIB, patients with overt OGIB have been demonstrated the usefulness of urgent VCE and urgent DBE in a diagnosis tool with an impact on clinical management.4-7 Although previous studies showed promising data about the use of urgent enteroscopy, the debate about using VCE or DBE first in patients with massive overt OGIB is still uncertain. Thus in this study, we conducted the prospective study to compare urgent VCE with urgent DBE in patients with massive overt OGIB.
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:
* The consecutive patients with massive overt OGIB defined as a visible gastrointestinal bleeding (GIB) (eg, melena or hemotochezia) of unknown origin that persists after an initial negative esophagogastroduodenoscopy (EGD) and colonoscopy were recruited. Massive was defined as the need for at least 3 units of blood transfusion. All patients underwent an EGD and colonoscopy within the first 48 hrs of hospitalization.
Exclusion Criteria:
* Exclusion Criteria pregnancy, patients with a suspected intestinal obstruction or stricture, cardiac pacemaker implantation or other electromedical device implantation, diabetic gastroparesis, a history of gastrectomy and small bowel surgery.
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.