- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02609100
Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy
June 19, 2018 updated by: Washington University School of Medicine
Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy: A Randomized Controlled Trial
Acute gastrointestinal bleeding is a common medical problem.
When patients with gastrointestinal bleeding present with melena (dark, tarry stool) the blood loss is usually originating in the upper gastrointestinal tract (esophagus, stomach or duodenum) and first step in evaluating the patient is an upper endoscopy; which allows direct visualization of the esophagus, stomach and duodenum.
However, the cause of bleeding is located in the small bowel or colon in 20-30% of patients who present with melena.
Traditionally colonoscopy has been the next test preformed if upper endoscopy does not identify the cause of melena/ gastrointestinal bleeding, however less than 25% of patients who present with melena have bleeding originating in the colon, and the remainder of patients have bleeding originating in the small intestine, which can only be fully evaluated with video capsule endoscopy (a pill camera which is swallowed and takes pictures while it travels thought the small bowel and colon).
Currently patients only undergo video capsule endoscopy if colonoscopy does not identify the cause of bleeding.
The investigators are preforming a randomized study which seeks to determine if colonoscopy or video capsule endoscopy is a better way to identify the cause of gastrointestinal bleeding in patients who present with melena and have normal findings on upper endoscopy.
To do this the investigators will enroll patients who present with melena prior to their upper endoscopy and if the cause of bleeding is not identified at that time patients will be randomized to video capsule endoscopy (with the capsule being placed into the small bowel during the upper endoscopy) or next day colonoscopy.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Center for Advanced Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Inpatients >18 years of age presenting with lower gastrointestinal bleeding and have melenic stool
Exclusion Criteria:
- Unable to provide written informed consent
- A probable bleeding source is identified on upper endoscopy
- Pregnancy or lactation
- Swallowing Disorder
- Unable to tolerate sedation or anesthesia due to medical co-morbidities
- Uncorrected coagulopathy (platelet count <50,000, INR> 2, PTT> 2x upper limit of normal)
- Known or suspected gastrointestinal obstruction or stricture
- Cardiac pacemaker or other implanted electromedical device
- Contraindication to bowel preparation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Video Capsule Endoscopy
Randomization arm one is to video capsule endoscopy (VCE) a non-invasive procedure in which a patient swallows a disposable 1.0 X 2.5 cm 'pill' containing a camera electronically linked to equipment outside the patient which records images as it passes from the esophagus through the entire tract and is excreted in feces.
It images the small intestine in areas beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy.
Its greatest use is in identifying points of bleeding and ulcers.
|
Video Capsule Endoscopy allows for imaging of the small intestine between the distant duodeno-jejunal junction, which is beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy.
It is of greatest use in identifying points of bleeding and ulcers.
|
ACTIVE_COMPARATOR: Next Day Colonoscopy
Randomization arm two is to colonoscopy, a test that allows the doctor to look at the inner lining of the large intestine (rectum and colon).
He or she uses a thin, flexible tube called a colonoscope to look at the colon.
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The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Video Capsule Endoscopy
Time Frame: Up to twenty four hours
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Video Capsule Endoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata
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Up to twenty four hours
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Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Colonoscopy
Time Frame: Up to one hour
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Colonoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata
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Up to one hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Therapeutic Yield of Video Capsule Endoscopy
Time Frame: Up to 7 days
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Therapeutic yield of video capsule endoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.
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Up to 7 days
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Therapeutic Yield of Colonoscopy
Time Frame: Up to 7 days
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Therapeutic yield of colonoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.
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Up to 7 days
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Number of Blood Units Transfused
Time Frame: Up to 60 days
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Number of blood units transfused measured in units of packed red blood cells
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Up to 60 days
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Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding
Time Frame: Up to 60 days
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Includes repeat endoscopies or imaging
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Up to 60 days
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Duration of Hospital Stay
Time Frame: Up to 60 days
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The duration of hospital stay will be recorded in number of days
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Up to 60 days
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Procedure Related Adverse Events
Time Frame: Up to 60 days
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Adverse events related to the video capsule endoscopy and colonoscopy will be recorded
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Up to 60 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (ACTUAL)
December 6, 2016
Study Completion (ACTUAL)
December 6, 2016
Study Registration Dates
First Submitted
November 16, 2015
First Submitted That Met QC Criteria
November 18, 2015
First Posted (ESTIMATE)
November 20, 2015
Study Record Updates
Last Update Posted (ACTUAL)
June 20, 2018
Last Update Submitted That Met QC Criteria
June 19, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201507101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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