Capsule Endoscopy Versus Conservative Therapy for Obscure Gastrointestinal Bleeding

Although the American Gastroenterological Association suggests that patients with obscure GI
bleeding undergo a capsule endoscopy after a negative esophagogastroduodenoscopy (EGD) and
colonoscopy, current recommendations from the British Society of Gastroenterology argue that
unless there is an inadequate response to iron therapy, further imaging of the small bowel is
probably not necessary. Several studies have demonstrated that this approach is reasonably
safe. Furthermore, Laine et al demonstrated that when patients with obscure GI bleeding were
randomized to either capsule endoscopy or dedicated small bowel contrast radiography, the
rates of further bleeding, measured by subsequent hospitalization and blood transfusion
events, were similar between the two groups. No study has randomized patients with obscure GI
bleeding to receive capsule endoscopy vs. conservative therapy with oral iron.

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 bleeding. All patients will be recruited in the G.I. clinic, the endoscopy
unit, or during inpatient consults after negative upper endoscopy and colonoscopy. The study
will be explained to patients who qualify at that time. During this visit, patients will be
questioned with regard to lower or upper G.I. symptoms, including abdominal pain, dyspepsia,
nausea, vomiting, weight loss, diarrhea, change in stool character, melena and intermittent
hematochezia. All patients will be started on standard dose oral iron therapy after informed
consent. If the patient is already taking iron supplements, their dose with be adjusted to
the standard regimen after informed consent. Patients will then be randomized to undergo
capsule endoscopy or not. For patients randomized to undergo capsule endoscopy, all
subsequent evaluation and treatment will be determined by capsule findings (i.e. capsule
directed management) and standard of care at our institution.

Patients will be followed for 1 year. Follow up lab draws will occur at 1, 3, 6 and 12
months. They will consist of a complete blood count (CBC) and ferritin and can be performed
at either the Medical University of South Carolina (MUSC) or an outside facility or office.
If performed outside of MUSC, a standard medical records release form will be utilized to
obtain the lab information. Patients will be provided with a paper card indicating their date
of enrollment in the study. This card will be kept by the patient for the entire 12 month
follow up period and will be collected at the end of the follow up period. The card will have
an area where the patient can write the date of their first blood transfusion after
enrollment. There will also be numerical checkboxes that the patient will check off for each
unit of packed red blood cells (RBCs) they receive during the 12 month follow up period.
Telephone calls will be made to each patient every 3 months after enrollment to inquire about
hospitalizations and bleeding related procedures (including endoscopy, capsule, small bowel
radiology, interventional radiology and surgery). Records of these hospitalizations and
procedures will be obtained using a standard medical records release form.

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 iron use.

- Alternate source of blood loss (e.g., menorrhagia)

- Hematemesis sufficient to be the cause of the hemoglobin decline