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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219568
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Julajak Limsrivilai, 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Bleeding Procedure: CT enterography Device: video capsule endoscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. number of significant gastrointestinal lesions detected [ Time Frame: up to 1 month ]
    Significant gastrointestinal lesions are ulcers, mucosal inflammation, angiodysplasia, and mass.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219568


Locations
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Thailand
Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Julajak Limsrivilai, M.D. Mahidol University
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Responsible Party: Julajak Limsrivilai, Instructor in Internal medicine, Gastroenterlogy Division, Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT02219568    
Other Study ID Numbers: Si624/2013
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015
Keywords provided by Julajak Limsrivilai, Mahidol University:
obscure gastrointestinal bleeding, CT enterography
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases