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

NCT02219568 | Completed

• 1 other identifier: Si624/2013
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Bleeding

Keywords

obscure gastrointestinal bleeding, CT enterography

Outcome Measures

Primary Outcomes (1)

• number of significant gastrointestinal lesions detected

  Significant gastrointestinal lesions are ulcers, mucosal inflammation, angiodysplasia, and mass.

  up to 1 month

Study Arms (1)

obscure gastrointestinal bleeding

EXPERIMENTAL

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; Device: video capsule endoscopy

Interventions

CT enterography PROCEDURE

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.

obscure gastrointestinal bleeding

video capsule endoscopy DEVICE

Video capsule endoscopy is performed using PillCam SB (Given Imaging, Yokneam, Israel). Polyethylene glycol (NIFLEC) is used for bowel preparation.

obscure gastrointestinal bleeding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• allergy to iodinated intravenous contrast
• chronic kidney disease stage at least 3 patients who do not on regular dialysis
• suspected small bowel obstruction

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Capsule Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Julajak Limsrivilai, M.D.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Internal medicine, Gastroenterlogy Division, Siriraj Hospital

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 19, 2014
• Study Start: February 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

TH (1)