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Completed

NCT Number: NCT02219568

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

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

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Key information

Conditions

Gastrointestinal Bleeding Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT enterography

Procedure

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.

Video Capsule Endoscopy

Device

Video capsule endoscopy is performed using PillCam SB (Given Imaging, Yokneam, Israel). Polyethylene glycol (NIFLEC) is used for bowel preparation.

Primary outcomes

  1. number of significant gastrointestinal lesions detected

    Time frame: up to 1 month

    Significant gastrointestinal lesions are ulcers, mucosal inflammation, angiodysplasia, and mass.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 19, 2014
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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