Comparing Early Capsule Deployment to Current Standard of Care for Management of Gastrointestinal Bleeding

After 40 years of considering gastrointestinal bleeding as upper or lower and largely
ignoring the small intestine, there is accumulating evidence that the standard of care
approach to the assessment of non-hematemesis gastrointestinal bleeding could be improved by
early deployment of a video capsule (VCE) as the first diagnostic test. Currently, VCE is
considered the gold standard as the diagnostic test for small intestinal bleeding. In a
recent study at the University of Massachusetts (UMass) 336 patients who presented to the
emergency department (ED) with complaints of gastrointestinal bleeding 36 patients (10.7%)
were given a VCE during their stay.

In patients with hematemesis, upper endoscopy remains the diagnostic and therapeutic modality
of choice. However patients with melena and hematochezia may benefit from early VCE since
both signs and symptoms provide poor localization as to the origin of bleeding. Data from
this previous Umass study suggests that the ingestion of a VCE in the ED could quickly and
non-invasively provide clinicians accurate data as to the origin of the bleeding. This
information could provide a guide to further management of the patient. VCE is able to
visualize bleeding in the esophagus, stomach, duodenum, small intestine and right colon,
thereby eliminating the guess work of deciding which endoscopic approach to use.

At UMass, that same study showed that of the 36 patients who received a video capsule, 26
(72.2%) had diagnostic studies (i.e. bleeding was identified). In comparison, 152 patients
required upper endoscopy (of which 52.9% were diagnostic) and 64 patients required
colonoscopy (of which 47% were diagnostic). Of those 26 patients with diagnostic capsule
studies, 13 also required upper endoscopy, 1 required a colonoscopy, and 4 required both a
colonoscopy and endoscopy. It is important to recognize, however, that often capsule studies
are performed after upper endoscopy and colonoscopy and performed and are found to be
negative. This sequence is the standard of care work up of bleeding. Despite being performed
later in the hospital course of our patients, capsule studies have a high diagnostic yield.
In reality VCE is used uncommonly in acute bleeding because it is rarely considered in the
context of acute GI bleeding In this study, the investigators propose the approach of using
the video capsule as the first diagnostic test prior to colonoscopy and endoscopy; this may
lead to a shortened time to diagnosis, a reduction in length of stay, and a reduction in
numbers of procedures due to early, accurate localization of the source of bleeding. All of
these components could result in better quality of care and cost containment. Further, it is
known that 80% of patients stop bleeding spontaneously. Thus the earlier they are examined
the more likely the origin of the bleeding is likely to be found The use of VCE has been
approved by the FDA since 2001 for small intestinal bleeding obscure GI Bleeding. It is very
safe and no deaths associated with its use have been reported. More than two million capsules
have been used and complications of obstruction and perforation are extremely rare.

Interest in the broader use of VCE is accumulating. More recently studies of VCE deployed in
the ED, in patients with upper GI bleeding showed improved management. Our group recently
demonstrated that the closer a VCE is performed to the time of bleeding the higher the
likelihood of locating the sources and the higher the therapeutic intervention rate. The
investigators also have demonstrated that the use of capsule endoscopy in patients with
non-hematemesis gastrointestinal bleeding (NHGIB) has a higher diagnostic yield than does
colonoscopy. With improved diagnostic yields, capsule endoscopy may help clinicians by
providing guidance in the management of patients with NHGIB.

This protocol is be the first attempt to prospectively examine this concept in a large
randomized prospective trial. The questions the investigators are studying are: can early
capsule intervention decrease time to diagnosis, numbers of procedures and hospital length of
stay in patients with non-hematemesis gastrointestinal bleeding?

Inclusion Criteria:

- Age greater than 18 years old

- New onset of melena or hematochezia

- Able to sign consent

- Hemodynamically stable (i.e. blood pressure >100/60 or pulse <110 at the time of
consent)

- ED must plan to admit patient to the hospital or Clinical Decision Unit.

Exclusion Criteria:

- Adults unable to consent

- Individuals who are not yet adults (infants, children, teenagers)

- Pregnant women

- Prisoners

- Prior history of gastroparesis

- Prior history of gastric, or small bowel surgery

- Prior history of Crohn's disease

- Concern for infectious colitis

- Non-English speaking

- Evidence of dysphagia at the time of presentation

- Presence of bright red blood per rectum concerning for hemorrhoids

- Allergy to metoclopramide or erythromycin

- Code status of Do Not Resuscitate/Do Not Intubate (DNR/DNI) or Comfort Measures Only
(CMO)

- Prior history of abdominal radiation

- Presence of Implantable Cardioverter Defibrillator (ICD) or pacemaker or other
implanted electronic devices

- Abdominal pain suggesting an acute abdomen or obstruction. In clinical practice, only
patients with crampy abdominal pain due to Crohn's disease, previous intestinal
surgery and a previous history of radiation therapy require a patency capsule or CT
enterography before capsule endoscopy.

- Patients who cannot undergo surgery