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).
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
3
sites
Durham, North Carolina 27710
Principal Investigator: Alexandar T Limkakeng, MD, MHSc
Click here to add this to my saved trials
Temple University Temple University is many things to many people. A place to pursue life's...
Click here to add this to my saved trials
Washington, District of Columbia 20052
Principal Investigator: Andrew Meltzer, MD
Phone: 202-741-2952
Click here to add this to my saved trials