Gastrointestinal BleedingNCT02219568
Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding
A study testing CT enterography and video capsule endoscopy in people with Gastrointestinal Bleeding, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Bleeding
- What is being tested?
- CT enterography and video capsule endoscopy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- allergy to iodinated intravenous contrast
- chronic kidney disease stage at least 3 patients who do not on regular dialysis
- suspected small bowel obstruction
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
Official title: Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding : Prospective Blinded Comparative Study
The purpose of this study is to compare the efficacy between video capsule endoscopy and CT enterography in diagnosis of obscure gastrointestinal bleeding.
Read the 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.
- Conditions
- Gastrointestinal Bleeding
- Being tested
- CT enterography, video capsule endoscopy
- Keywords
- obscure gastrointestinal bleeding, CT enterography
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT enterographyProcedure or surgery
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 endoscopyDevice
Video capsule endoscopy is performed using PillCam SB (Given Imaging, Yokneam, Israel). Polyethylene glycol (NIFLEC) is used for bowel preparation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: CT enterography; Device: video capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of significant gastrointestinal lesions detected
Significant gastrointestinal lesions are ulcers, mucosal inflammation, angiodysplasia, and mass.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julajak Limsrivilai, Mahidol University
- Investigators
- Julajak Limsrivilai, M.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219568
- Sponsor's protocol ID
- Si624/2013
- Status last verified
- Jul 2015
- First submitted
- 15 Aug 2014
- Last updated
- 28 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding : Prospective Blinded Comparative Study
- ClinicalTrials.gov ID
- NCT02219568
- Acronym / sponsor ID
- Si624/2013
- Conditions
- Gastrointestinal Bleeding
- Keywords
- obscure gastrointestinal bleeding, CT enterography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obscure gastrointestinal bleeding | Experimental | Procedure: CT enterography, Device: video capsule endoscopyThose patients who developed obscure gastrointestinal bleeding either overt or occult bleeding who will then undergo video capsule endoscopy and CT enterography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- allergy to iodinated intravenous contrast
- chronic kidney disease stage at least 3 patients who do not on regular dialysis
- suspected small bowel obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT enterographyCT 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. | Procedure or surgery | obscure gastrointestinal bleeding |
| video capsule endoscopyVideo capsule endoscopy is performed using PillCam SB (Given Imaging, Yokneam, Israel). Polyethylene glycol (NIFLEC) is used for bowel preparation. | Device | obscure gastrointestinal bleeding |
Primary outcome
number of significant gastrointestinal lesions detected
Time frame: up to 1 month
Significant gastrointestinal lesions are ulcers, mucosal inflammation, angiodysplasia, and mass.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julajak Limsrivilai, M.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT enterography and video capsule endoscopy in people with Gastrointestinal Bleeding, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of significant gastrointestinal lesions detected (time frame: up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.