Capsule Endoscopy Versus Conservative Therapy for Obscure Gastrointestinal Bleeding (NCT01837030) | Clinical Trial Compass
WithdrawnNot Applicable
Capsule Endoscopy Versus Conservative Therapy for Obscure Gastrointestinal Bleeding
Stopped: not feasible due to funding
United States0Started 2013-03
Plain-language summary
This study is a single center prospective randomized control trial comparing the utility of performing capsule endoscopy compared to conservative management with oral iron therapy as the initial course of action in patients with non-severe obscure occult or obscure overt gastrointestinal (GI) bleeding. The investigators hypothesize that outcomes in patients with non-severe obscure GI bleeding who receive conservative therapy with oral iron will not differ to those on oral iron who undergo capsule endoscopy.
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:
* Adult men and post-menopausal women with iron deficiency anemia and pre-menopausal women with iron deficiency anemia and a negative gynecologic workup or adults with overt GI bleeding as defined by melena or hematochezia with a ≥2 gram drop in hemoglobin after stabilization (Iron deficiency is defined as hemoglobin \<13.7 g/dL in men and \<12 g/dL in women with serum ferritin level \<50 ng/mL). Also, patients with an otherwise unexplained drop in hemoglobin of ≥ 2 g/dL in the setting of hemoccult positive stool
* Negative EGD and colonoscopy for source of GI bleeding within six months of enrollment into the study.
Exclusion Criteria:
* Ongoing overt gastrointestinal bleeding requiring ≥4 units of packed RBC's on any given day in the setting of overt bleeding, blood transfusions on separate days (separated by ≥12 hours), or ≥6 units of packed RBC's over the previous 7-day period prior to presentation, in the setting of overt bleeding.
* Myocardial infarct, acute neurologic event, sepsis, or respiratory failure within the previous 1 week
* History of small bowel obstruction
* Pregnant women
* Prisoners
* Age less than 18
* Known GI or hematologic malignancy
* Achalasia
* Contraindications to capsule endoscopy (inability to take prep), or felt unsafe to undergo capsule as per study investigators
* Esophageal stricture that precludes even endoscopic capsule placement
* History of upper GI or small bowel surgery
* Inability to take oral iron.
* Active IV i…
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
Time to first blood transfusion after randomization