Status:
WITHDRAWN
Capsule Endoscopy Versus Conservative Therapy for Obscure Gastrointestinal Bleeding
Lead Sponsor:
Medical University of South Carolina
Conditions:
Hemorrhage
Anemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 cours...
Detailed Description
Although the American Gastroenterological Association suggests that patients with obscure GI bleeding undergo a capsule endoscopy after a negative esophagogastroduodenoscopy (EGD) and colonoscopy, cur...
Eligibility Criteria
Inclusion
- 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
- 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 iron use.
- Alternate source of blood loss (e.g., menorrhagia)
- Hematemesis sufficient to be the cause of the hemoglobin decline
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01837030
Start Date
March 1 2013
End Date
March 1 2013
Last Update
June 14 2018
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425