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

NCT ID: NCT02219568

Last Updated: 2015-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Bleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

CT enterography

Intervention Type 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.

video capsule endoscopy

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

video capsule endoscopy

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Julajak Limsrivilai

Instructor in Internal medicine, Gastroenterlogy Division, Siriraj Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julajak Limsrivilai, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Bangkok, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Si624/2013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Emergency Capsule Endoscopy in Severe GI-bleeding
NCT01584869 COMPLETED PHASE2/PHASE3