Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding
|ClinicalTrials.gov Identifier: NCT02219568|
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : July 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Bleeding||Procedure: CT enterography Device: video capsule endoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding : Prospective Blinded Comparative Study|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Experimental: obscure gastrointestinal bleeding
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
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.
Device: video capsule endoscopy
Video capsule endoscopy is performed using PillCam SB (Given Imaging, Yokneam, Israel). Polyethylene glycol (NIFLEC) is used for bowel preparation.
- number of significant gastrointestinal lesions detected [ Time Frame: up to 1 month ]Significant gastrointestinal lesions are ulcers, mucosal inflammation, angiodysplasia, and mass.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219568
|Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University|
|Bangkok, Thailand, 10700|
|Principal Investigator:||Julajak Limsrivilai, M.D.||Mahidol University|