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

Study Overview
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Brief Summary
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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.

Official Title
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Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy: A Randomized Controlled Trial

Conditions
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Gastrointestinal Hemorrhage

Intervention / Treatment
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* Procedure: Video Capsule Endoscopy
* Procedure: Colonoscopy
* Device: 1.0 X 2.5 cm 'pill' containing a camera


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Video Capsule Endoscopy<br>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<br>* 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.<br>Device: 1.0 X 2.5 cm 'pill' containing a camera<br> <br> |
| Active Comparator: Next Day Colonoscopy<br>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<br>* The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.<br>|

What is the study measuring?
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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 | 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 | Up to twenty four hours | 
| 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 | Colonoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata | Up to one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic Yield of Video Capsule Endoscopy | Therapeutic yield of video capsule endoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention. | Up to 7 days | 
| Therapeutic Yield of Colonoscopy | Therapeutic yield of colonoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention. | Up to 7 days | 
| Number of Blood Units Transfused | Number of blood units transfused measured in units of packed red blood cells | Up to 60 days | 
| Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding | Includes repeat endoscopies or imaging | Up to 60 days | 
| Duration of Hospital Stay | The duration of hospital stay will be recorded in number of days | Up to 60 days | 
| Procedure Related Adverse Events | Adverse events related to the video capsule endoscopy and colonoscopy will be recorded | Up to 60 days |