Capsule Endoscopy for HEmorrhage in the ER

Status:	Recruiting
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - Any
Updated:	1/18/2019
Start Date:	April 17, 2018
End Date:	September 2019
Contact:	Andrew Meltzer, MD
Email:	ameltzer@mfa.gwu.edu
Phone:	202-741-2952

Capsule Endoscopy for Hemorrhage in the ER

This is a multi-center randomized controlled trial examining the use of Video Capsule
Endoscopy (VCE) to discharge low-moderate risk patients with suspected upper gastrointestinal
bleeds (UGIB) from the Emergency Department (ED.) The investigators will enroll 100 subjects
at 4 sites who present with signs of hemodynamically stable UGIBs and compare VCE risk
assessment to an Active Control (AC) group who receive inpatient upper endoscopy (EGD).

Inclusion Criteria:

- Individuals aged 18 years or older presenting to the Emergency Department with acute
overt UGIB, defined as bloody emesis and/or coffee ground vomiting and/or melena
within the previous 48 hours.

Exclusion Criteria:

- Stable for discharge without further testing (Glasgow Blatchford Score of 0

- Upper GI bleed with hemodynamic shock (BP <90mmHg and pulse > 120 beats per minute)

- Active hematemesis

- High- Risk Upper GI Bleed (Glasgow Blatchford Score greater than or equal to 6)

- Known history of gastric cancer

- Known history of gastric or esophageal varices

- GI surgery within the last 6 months

- Dysphagia, swallowing disorder, Zencker' s diverticulum, suspected bowel obstruction
or perforation.

- Gastroparesis, Gastric outlet obstruction, Crohn's disease, past UGI tract surgery

- Pregnancy/ lactation

- Altered mental status (e.g., hepatic encephalopathy) that limits the ability to
swallow a capsule

- Expected to have Magnetic Resonance Imaging examination within 7 days

- On medications that may coat the upper GI tract such as antacids or sucralfate or
Maalox.

- Patient either refuses or is unable to get traditional EGD.

- Patient does not have reliable contact information - no phone, no permanent address.

- Patient refuses

- Unable to provide written consent

- Prisoner

- Non-English Speaker

- Suspected small bowel or lower GI Bleeding

- Unable to follow up with confirmatory EGD.

We found this trial at

sites

George Washington University

Washington, District of Columbia 20052

Principal Investigator: Andrew Meltzer, MD

Phone: 202-741-2952

from

Washington,