Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Video Capsule Endoscopy (Procedure)
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.
Intervention: 1.0 X 2.5 cm 'pill' containing a camera (Device)
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.
Intervention: Colonoscopy (Procedure)
Outcomes
Primary Outcomes
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
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 Outcomes
- Therapeutic Yield of Video Capsule Endoscopy(Up to 7 days)
- Therapeutic Yield of Colonoscopy(Up to 7 days)
- Number of Blood Units Transfused(Up to 60 days)
- Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding(Up to 60 days)
- Duration of Hospital Stay(Up to 60 days)
- Procedure Related Adverse Events(Up to 60 days)