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



Status:Terminated
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:6/22/2018
Start Date:November 2015
End Date:December 6, 2016

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

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.


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
We found this trial at
1
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Saint Louis, Missouri 63110
Phone: 314-747-1973
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Saint Louis, MO
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