Recurrent Gastrointestinal BleedingNCT01114295
Computed Tomography Enterography (CTE) Versus Capsule Endoscopy for Overt, Obscure Gastrointestinal (GI) Bleeding
A study testing Capsule Endoscopy and CT Enterography in people with Recurrent Gastrointestinal Bleeding, run by Brigham and Women's Hospital.
Trial summary
Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by upper endoscopy and colonoscopy, the presumed source of bleeding in these patients being the small intestine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Gastrointestinal Bleeding
- What is being tested?
- Capsule Endoscopy and CT Enterography
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Jan 2012
- 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 presenting with signs and symptoms of "overt, obscure GI bleeding" including hematemesis, melena, and hematochezia within the past 14 days with negative endoscopic evaluation (including upper endoscopy for hematemesis, and both upper and lower endoscopy for hematochezia) despite clinical evidence of GI bleeding.
Who cannot join
- Known renal insufficiency (or blood Creat >1.5 or estimated glomerular filtration rate [eGFR]<60)
- Allergy to iodinated intravenous (IV) contrast media
- Swallowing difficulties
- Known small bowel strictures
- Suspected bowel obstruction
- Under the age of 18
- Unable to give consent
- Currently pregnant
About this study
Official title: Comparative Effectiveness of Wireless Capsule Endoscopy and Dual Energy, Phase CT Enterography in the Evaluation of Overt Obscure GI Bleeding
Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by upper endoscopy and colonoscopy, the presumed source of bleeding in these patients being the small intestine. These patients fall under the category of "obscure gastrointestinal bleeding," and frequently require an extensive diagnostic work-up.
Obscure gastrointestinal bleeding (OGIB) refers to bleeding undiagnosed by upper endoscopy and colonoscopy. In 40-70% of cases of OGIB, a bleeding lesion is localizable to the small bowel. In OGIB, capsule endoscopy (CE) has a diagnostic yield of 40-80%, and has demonstrated diagnostic superiority to push enteroscopy, barium studies, angiography, CT angiography, and routine abdominal CT scan. When CE is non-diagnostic, however, the subsequent diagnostic algorithm is not well-defined. There is currently no established role for cross-sectional imaging for this indication. CT enterography (CTE) combines the spatial and temporal resolution of CT with an orally administered neutral enteric contrast material that permits detailed visualization of the small bowel. Unlike other imaging modalities such as nuclear medicine techniques and catheter angiography, CT is less labor-intensive, more readily available, and provides precise anatomic localization. A novel OGIB-protocol available at Brigham and Women's Hospital for CTE utilizes a dual-phase, dual energy technique that obtains images at two time points to better identify active bleeding in the mesentery. We, the investigators, plan to prospectively study an algorithm that employs CTE and compare to capsule endoscopy to investigate the effectiveness of both modalities and to evaluate the potential role of CTE in OGIB.
Read more
The goal of our study is to determine observationally the contribution of both CE and the new protocol for CTE to the evaluation and management of overt obscure GI bleeding and accordingly revise the clinical algorithm.
We hypothesize that CTE will be as or more effective than CE at identifying culprit lesions in overt, obscure gastrointestinal bleeding.
- Conditions
- Recurrent Gastrointestinal Bleeding
- Being tested
- Capsule Endoscopy, CT Enterography
- Keywords
- overt, obscure, gastrointestinal, bleeding, hemorrhage
- Medical subject headings
- Gastrointestinal Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule EndoscopyDevice
Prior to the test, patients will be on a clear liquid diet for 24 hours and will have undergone an overnight fast. If a clear liquid diet is not possible, some patients may undergo a bowel preparation the day before the procedure. On the morning of the test, patients will swallow a video capsule with water. Clear liquids will be permitted after 2 hours, and a light meal permitted 4 hours after swallowing the capsule, if appropriate. No medications will be allowed 2 hours before the procedure and drugs that can delay gastric emptying will be avoided until the study is complete. At 8 hours after ingestion, the sensor array and recorder/battery belt pack will be disconnected and the data will be downloaded onto a computer equipped with software for image viewing. Images are sent through 8 skin electrodes to the recorder, stored and viewed on a RAPID workstation. At the end of the recording, the video is transferred to a computer for analysis.
CT EnterographyRadiation
CT enterography at the Brigham and Women's hospital is performed by using intravenous iodinated contrast material (Ultravist 300) and a neutral oral-enteric contrast material containing methylcellulose (Volumen). During scanning, 150 mL of nonionic intravenous contrast medium will be administered at a rate of 3mL/sec and the imaging conducted 40 and 70 seconds after the administration of the intravenous contrast medium. All imaging will be performed on a Dual-Energy multi-detector row CT scanner, Somatom Definition (Siemens Healthcare, Forcheim, Germany). Two independent X-ray tube/detector system will be used for image acquisition. One tube operates at 140 kV and the other at 80 kV . Slice collimation will be 0.6 mm and images reconstructed at 3 mm thickness with 3 mm reconstruction intervals. Coronal and sagittal images will be reconstructed at 3 mm thickness with 3 mm increments. Images will be reviewed by a radiologist experienced in the interpretation of CT enterography.
| Study group | Role | What they receive |
|---|---|---|
| Overt Obscure Gastrointestinal Bleeders | Experimental | The only cohort in this study are those patients identified as having overt, obscure gastrointestinal bleeding who will then undergo CE or CTE. Receives: Device: Capsule Endoscopy; Radiation: CT Enterography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of an actively bleeding lesion or lesion believed to be causing bleeding symptoms.
Patients enrolled in the study will undergo either capsule endoscopy or CT enterography first, and this decision will generally be based on which test the clinical providers have already scheduled or availability of testing as is done with routine clinical care. The results of each the test will be read by an experienced gastroenterologist or radiologist respectively. These reviewers will be blinded to the results of any other diagnostic studies. The patient will then undergo the second test.
Measured: 2-3 days
Secondary outcomes (3)
Contribution of diagnostic test to clinical management
We will assess whether either CT or CTE changes managemet based on findings
Measured: 30 days
Overall cost of evaluation
We will assess the cost of each test and cost based on findings
Measured: 30 days
Adverse events
We will measure any and all adverse outcomes based on CT or CTE for the month following whichever study is performed last.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionJan 2012
Why it stopped: The study was stopped before the first patient was enetered due to logistical issues and lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Robinson Saltzman, MD, Brigham and Women's Hospital
- Investigators
- John Saltzman, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114295
- Sponsor's protocol ID
- CTE vs Capsule 2010
- Status last verified
- Aug 2013
- First submitted
- 29 Apr 2010
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Wireless Capsule Endoscopy and Dual Energy, Phase CT Enterography in the Evaluation of Overt Obscure GI Bleeding
- ClinicalTrials.gov ID
- NCT01114295
- Acronym / sponsor ID
- CTE vs Capsule 2010
- Conditions
- Recurrent Gastrointestinal Bleeding
- Keywords
- overt, obscure, gastrointestinal, bleeding, hemorrhage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped before the first patient was enetered due to logistical issues and lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 May 2010 (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.
Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by upper endoscopy and colonoscopy, the presumed source of bleeding in these patients being the small intestine. These patients fall under the category of "obscure gastrointestinal bleeding," and frequently require an extensive diagnostic work-up.
Obscure gastrointestinal bleeding (OGIB) refers to bleeding undiagnosed by upper endoscopy and colonoscopy. In 40-70% of cases of OGIB, a bleeding lesion is localizable to the small bowel. In OGIB, capsule endoscopy (CE) has a diagnostic yield of 40-80%, and has demonstrated diagnostic superiority to push enteroscopy, barium studies, angiography, CT angiography, and routine abdominal CT scan. When CE is non-diagnostic, however, the subsequent diagnostic algorithm is not well-defined. There is currently no established role for cross-sectional imaging for this indication. CT enterography (CTE) combines the spatial and temporal resolution of CT with an orally administered neutral enteric contrast material that permits detailed visualization of the small bowel. Unlike other imaging modalities such as nuclear medicine techniques and catheter angiography, CT is less labor-intensive, more readily available, and provides precise anatomic localization. A novel OGIB-protocol available at Brigham and Women's Hospital for CTE utilizes a dual-phase, dual energy technique that obtains images at two time points to better identify active bleeding in the mesentery. We, the investigators, plan to prospectively study an algorithm that employs CTE and compare to capsule endoscopy to investigate the effectiveness of both modalities and to evaluate the potential role of CTE in OGIB.
The goal of our study is to determine observationally the contribution of both CE and the new protocol for CTE to the evaluation and management of overt obscure GI bleeding and accordingly revise the clinical algorithm.
We hypothesize that CTE will be as or more effective than CE at identifying culprit lesions in overt, obscure gastrointestinal bleeding.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overt Obscure Gastrointestinal Bleeders | Experimental | Device: Capsule Endoscopy, Radiation: CT EnterographyThe only cohort in this study are those patients identified as having overt, obscure gastrointestinal bleeding who will then undergo CE or CTE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting with signs and symptoms of "overt, obscure GI bleeding" including hematemesis, melena, and hematochezia within the past 14 days with negative endoscopic evaluation (including upper endoscopy for hematemesis, and both upper and lower endoscopy for hematochezia) despite clinical evidence of GI bleeding.
Key exclusion criteria (8 listed)
- Known renal insufficiency (or blood Creat >1.5 or estimated glomerular filtration rate [eGFR]<60)
- Allergy to iodinated intravenous (IV) contrast media
- Swallowing difficulties
- Known small bowel strictures
- Suspected 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 |
|---|---|---|
| Capsule EndoscopyPrior to the test, patients will be on a clear liquid diet for 24 hours and will have undergone an overnight fast. If a clear liquid diet is not possible, some patients may undergo a bowel preparation the day before the procedure. On the morning of the test, patients will swallow a video capsule with water. Clear liquids will be permitted after 2 hours, and a light meal permitted 4 hours after swallowing the capsule, if appropriate. No medications will be allowed 2 hours before the procedure and drugs that can delay gastric emptying will be avoided until the study is complete. At 8 hours after ingestion, the sensor array and recorder/battery belt pack will be disconnected and the data will be downloaded onto a computer equipped with software for image viewing. Images are sent through 8 skin electrodes to the recorder, stored and viewed on a RAPID workstation. At the end of the recording, the video is transferred to a computer for analysis. | Device | Overt Obscure Gastrointestinal Bleeders |
| CT EnterographyCT enterography at the Brigham and Women's hospital is performed by using intravenous iodinated contrast material (Ultravist 300) and a neutral oral-enteric contrast material containing methylcellulose (Volumen). During scanning, 150 mL of nonionic intravenous contrast medium will be administered at a rate of 3mL/sec and the imaging conducted 40 and 70 seconds after the administration of the intravenous contrast medium. All imaging will be performed on a Dual-Energy multi-detector row CT scanner, Somatom Definition (Siemens Healthcare, Forcheim, Germany). Two independent X-ray tube/detector system will be used for image acquisition. One tube operates at 140 kV and the other at 80 kV . Slice collimation will be 0.6 mm and images reconstructed at 3 mm thickness with 3 mm reconstruction intervals. Coronal and sagittal images will be reconstructed at 3 mm thickness with 3 mm increments. Images will be reviewed by a radiologist experienced in the interpretation of CT enterography. | Radiation | Overt Obscure Gastrointestinal Bleeders |
Primary outcome
Detection of an actively bleeding lesion or lesion believed to be causing bleeding symptoms.
Time frame: 2-3 days
Patients enrolled in the study will undergo either capsule endoscopy or CT enterography first, and this decision will generally be based on which test the clinical providers have already scheduled or availability of testing as is done with routine clinical care. The results of each the test will be read by an experienced gastroenterologist or radiologist respectively. These reviewers will be blinded to the results of any other diagnostic studies. The patient will then undergo the second test.
3 secondary outcomes
Contribution of diagnostic test to clinical management
Time frame: 30 days
Overall cost of evaluation
Time frame: 30 days
Adverse events
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
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The Efficacy of Aescin in Combination With Micronized Purified Flavonoid Fraction (MPFF) in the Control of Bleeding and Prevent Recurrence of Acute Internal Hemorrhoids, A Randomized Controlled Trial, A Pilot Study
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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.
John Saltzman, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Capsule Endoscopy and CT Enterography in people with Recurrent Gastrointestinal Bleeding, run by Brigham and Women's Hospital.
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 1 inclusion and 8 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: withdrawn, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Detection of an actively bleeding lesion or lesion believed to be causing bleeding symptoms. (time frame: 2-3 days). 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 9 Aug 2013.