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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Washington University School of Medicine

Current Primary Outcome:

• Proportion 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
• Proportion 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• 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.
• Volume of blood transfused [ Time Frame: Up to 60 days ]
  Units of blood transfused measured in units of packed red blood cells
• Number of diagnostic studies performed for evaluation of gastrointestinal bleeding [ Time Frame: Up to 60 days ]
  Includes repeat endoscopies or imaging
• Duration of hospital stay [ Time Frame: Up to 60 days ]
  The duration of hospital stay will be recorded in number of days
• Procedure related adverse events [ Time Frame: Up to 60 days ]
  Adverse events related to the video capsule endoscopy and colonoscopy will be recorded

Original Secondary Outcome: Same as current

Information By: Washington University School of Medicine

Dates:
Date Received: November 16, 2015
Date Started: November 2015
Date Completion:
Last Updated: May 10, 2017
Last Verified: May 2017