Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy between video capsule endoscopy and CT enterography in diagnosis of obscure gastrointestinal bleeding.

Detailed Description
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All adult patients with obscure gastrointestinal bleeding will undergo both video capsule endoscopy and CT enterography. The interval between two tests will be less than 1 month. The capsule reading gastroenterologist and the CT reading radiologist are blinded to each others' results.

Official Title
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Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding : Prospective Blinded Comparative Study

Conditions
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Gastrointestinal Bleeding

Intervention / Treatment
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* Procedure: CT enterography
* Device: video capsule endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who present with passing melena or hematochezia or have iron deficiency anemia no lesion found on both esophagogastroduodenoscopy and colonoscopy age at least 18 years Exclusion Criteria: allergy to iodinated intravenous contrast chronic kidney disease stage at least 3 patients who do not on regular dialysis suspected small bowel obstruction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: obscure gastrointestinal bleeding<br>Those patients who developed obscure gastrointestinal bleeding either overt or occult bleeding who will then undergo video capsule endoscopy and CT enterography. | Procedure: CT enterography<br>* CT enterography is performed using 64-channel multi-detector row CT scanners (Siemens Sensation 64, Siemens Medical solution, Forchiem, Germany). Prior to the scan, 1500 cc of a neutral oral-enteric contrast material, polyethylene glycol (NIFLEC) is taken by the patient. During the scan, 2cc/kg of intravenous contrast (iohexol, Ominipaque Amersham GE-Health care, Princeton, NJ) is injected at the velocity 5 cc/sec.<br>Device: video capsule endoscopy<br>* Video capsule endoscopy is performed using PillCam SB (Given Imaging, Yokneam, Israel). Polyethylene glycol (NIFLEC) is used for bowel preparation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of significant gastrointestinal lesions detected | Significant gastrointestinal lesions are ulcers, mucosal inflammation, angiodysplasia, and mass. | up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obscure gastrointestinal bleeding, CT enterography