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

Not Applicable

Completed

• Conditions: Gastrointestinal Bleeding
• Interventions: Procedure: CT enterography; Device: video capsule endoscopy

• Registration Number: NCT02219568
• Lead Sponsor: Mahidol University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-08-15
• Study First Submitted QC: 2014-08-18
• Study First Posted: 2014-08-19
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
obscure gastrointestinal bleeding	video capsule endoscopy	Those patients who developed obscure gastrointestinal bleeding either overt or occult bleeding who will then undergo video capsule endoscopy and CT enterography.
obscure gastrointestinal bleeding	CT enterography	Those patients who developed obscure gastrointestinal bleeding either overt or occult bleeding who will then undergo video capsule endoscopy and CT enterography.

Primary Outcome Measures

Name	Time	Method
number of significant gastrointestinal lesions detected	up to 1 month	Significant gastrointestinal lesions are ulcers, mucosal inflammation, angiodysplasia, and mass.

Trial Locations

Locations (1)

Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand