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

Gastrointestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219568
• Other study ID #: Si624/2013
• 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

Related Conditions & MeSH terms

• Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

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