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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02219568
Other study ID # Si624/2013
Secondary ID
Status Completed
Phase N/A
First received August 15, 2014
Last updated July 27, 2015
Start date February 2014
Est. completion date October 2014

Study information

Verified date July 2015
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

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.

Locations

Country Name City State
Thailand Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of significant gastrointestinal lesions detected Significant gastrointestinal lesions are ulcers, mucosal inflammation, angiodysplasia, and mass. up to 1 month No
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