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Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy

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ClinicalTrials.gov Identifier: NCT02609100
Recruitment Status : Terminated (Poor enrollment)
First Posted : November 20, 2015
Results First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Hemorrhage Procedure: Video Capsule Endoscopy Procedure: Colonoscopy Device: 1.0 X 2.5 cm 'pill' containing a camera Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy: A Randomized Controlled Trial
Study Start Date : November 2015
Actual Primary Completion Date : December 6, 2016
Actual Study Completion Date : December 6, 2016

Resource links provided by the National Library of Medicine


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.
Procedure: Video Capsule Endoscopy
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.

Device: 1.0 X 2.5 cm 'pill' containing a camera
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.
Procedure: Colonoscopy
The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.




Primary Outcome Measures :
  1. 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 ]
    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

  2. 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 ]
    Colonoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata


Secondary Outcome Measures :
  1. Therapeutic Yield of Video Capsule Endoscopy [ Time Frame: Up to 7 days ]
    Therapeutic yield of video capsule endoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.

  2. Therapeutic Yield of Colonoscopy [ Time Frame: Up to 7 days ]
    Therapeutic yield of colonoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.

  3. Number of Blood Units Transfused [ Time Frame: Up to 60 days ]
    Number of blood units transfused measured in units of packed red blood cells

  4. Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding [ Time Frame: Up to 60 days ]
    Includes repeat endoscopies or imaging

  5. Duration of Hospital Stay [ Time Frame: Up to 60 days ]
    The duration of hospital stay will be recorded in number of days

  6. Procedure Related Adverse Events [ Time Frame: Up to 60 days ]
    Adverse events related to the video capsule endoscopy and colonoscopy will be recorded



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609100


Locations
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United States, Missouri
Center for Advanced Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Vladimir M Kushnir, MD Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02609100    
Other Study ID Numbers: 201507101
First Posted: November 20, 2015    Key Record Dates
Results First Posted: June 20, 2018
Last Update Posted: June 20, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases