Diagnostic Evaluation of Obscure Gastrointestinal Bleeding

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00593021

Enrollment

Registered

2008-01-14

Start date

2007-10-31

Completion date

2009-09-30

Last updated

2013-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obscure Gastrointestinal Bleeding

Keywords

Obscure Gastrointestinal Bleeding, Occult Gastrointestinal Bleeding, Overt Gastrointestinal Bleeding, Capsule Endoscopy, CT Enterography

Brief summary

Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by EGD and colonoscopy, the presumed source of bleeding in these patients being the small intestine. These patients fall under the category of obscure gastrointestinal bleeding, and frequently require an extensive diagnostic work-up. For these reasons, most patients who present with obscure or occult gastrointestinal bleeding typically undergo multiple endoscopic evaluations, including capsule endoscopy and various radiologic imaging studies, including enteroclysis, small bowel series, CT scan, angiography, and radionuclide scan. Recently, many centers (included the Brigham and Women's Hospital) have begun using capsule endoscopy and CT enterography (CTE) for evaluation of suspected small bowel pathology. This is an observational study enrolling patients referred to the Brigham and Women's Hospital for obscure gastrointestinal bleeding designed to compare the diagnostic yield of various diagnostic modalities, in particular capsule endoscopy and CT enterography in the evaluation of obscure gastrointestinal bleeding.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Anemia, hematochezia, melena, Hematemesis, heme positive stool with negative EGD+/-colonoscopy

Exclusion criteria

* Under the age of 18 * Unable to give consent * IV Contrast Allergy (excluded from CT) * Renal insufficiency (excluded from CT) * Unable to swallow (excluded from capsule) * Small bowel obstruction or stricturing disease (excluded from capsule)

Design outcomes

Primary

Measure	Time frame
Diagnostic yield of capsule endoscopy and CT Enterography in patients with obscure GI bleeding	Continuous

Secondary

Measure	Time frame
Hospital course, clinical improvement	120 days from enrollment

Countries

United States

Outcome results