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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
4
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.
The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.
Center for Advanced Medicine
St Louis, Missouri, United States
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
Time frame: 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
Time frame: Up to one hour
Therapeutic Yield of Video Capsule Endoscopy
Therapeutic yield of video capsule endoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.
Time frame: Up to 7 days
Therapeutic Yield of Colonoscopy
Therapeutic yield of colonoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.
Time frame: Up to 7 days
Number of Blood Units Transfused
Number of blood units transfused measured in units of packed red blood cells
Time frame: Up to 60 days
Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding
Includes repeat endoscopies or imaging
Time frame: Up to 60 days
Duration of Hospital Stay
The duration of hospital stay will be recorded in number of days
Time frame: Up to 60 days
Procedure Related Adverse Events
Adverse events related to the video capsule endoscopy and colonoscopy will be recorded
Time frame: Up to 60 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.