Back to resultsEfficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding
Primary Purpose
Gastrointestinal Bleeding
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
CT enterography
video capsule endoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastrointestinal Bleeding focused on measuring obscure gastrointestinal bleeding, CT enterography
Eligibility 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
Sites / Locations
- Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
obscure gastrointestinal bleeding
Arm Description
Those patients who developed obscure gastrointestinal bleeding either overt or occult bleeding who will then undergo video capsule endoscopy and CT enterography.
Outcomes
Primary Outcome Measures
number of significant gastrointestinal lesions detected
Significant gastrointestinal lesions are ulcers, mucosal inflammation, angiodysplasia, and mass.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02219568
Brief Title
Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding
Official Title
Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding : Prospective Blinded Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Bleeding
Keywords
obscure gastrointestinal bleeding, CT enterography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
obscure gastrointestinal bleeding
Arm Type
Experimental
Arm Description
Those patients who developed obscure gastrointestinal bleeding either overt or occult bleeding who will then undergo video capsule endoscopy and CT enterography.
Intervention Type
Procedure
Intervention Name(s)
CT enterography
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
video capsule endoscopy
Intervention Description
Video capsule endoscopy is performed using PillCam SB (Given Imaging, Yokneam, Israel). Polyethylene glycol (NIFLEC) is used for bowel preparation.
Primary Outcome Measure Information:
Title
number of significant gastrointestinal lesions detected
Description
Significant gastrointestinal lesions are ulcers, mucosal inflammation, angiodysplasia, and mass.
Time Frame
up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julajak Limsrivilai, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding
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