Capsule Endoscopy for Hemorrhage in the Emergency Room
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hospital, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/23/2018 |
| Start Date: | April 1, 2018 |
| End Date: | August 2018 |
Pilot Study to Investigate the Use of Wireless Capsule Endoscopy for Emergency Department Patients With Suspected Acute Upper Gastrointestinal Bleeding
The researcher's primary hypothesis is that VCE allows for safe outpatient management of ED
patients with suspected upper GI hemorrhage. A prospective multicenter randomized control
trial was designed to investigate the safety of this approach.
patients with suspected upper GI hemorrhage. A prospective multicenter randomized control
trial was designed to investigate the safety of this approach.
The typical primary care, urgent care or emergency care provider is unable to evaluate common
and serious conditions of the gastrointestinal tract such as a bleeding peptic ulcer. As
such, more than 80% of patients who present to US ED's with suspected bleeding in their upper
GI tract require hospitalization, procedural sedation by an anesthesiologist, and a
traditional tube-based upper endoscopy by a gastroenterologist. While this traditional
process is safe and effective, it is not efficient for our low-risk patients and not timely
for our high-risk patients. The opportunity to bring Video Capsule Endoscopy to the
front-lines of US medical care will revolutionize how we manage upper GI bleeding and shed
light on critical diseases that have heretofore been hidden from most providers. This trial
is an important step toward demonstrating that VCE is a safe and effective tool to
risk-stratify upper GI bleeding and improve quality of emergency care for all patients.
and serious conditions of the gastrointestinal tract such as a bleeding peptic ulcer. As
such, more than 80% of patients who present to US ED's with suspected bleeding in their upper
GI tract require hospitalization, procedural sedation by an anesthesiologist, and a
traditional tube-based upper endoscopy by a gastroenterologist. While this traditional
process is safe and effective, it is not efficient for our low-risk patients and not timely
for our high-risk patients. The opportunity to bring Video Capsule Endoscopy to the
front-lines of US medical care will revolutionize how we manage upper GI bleeding and shed
light on critical diseases that have heretofore been hidden from most providers. This trial
is an important step toward demonstrating that VCE is a safe and effective tool to
risk-stratify upper GI bleeding and improve quality of emergency care for all patients.
Subject Inclusion Criteria
1. Individuals aged ≥ 18 years 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.
Subject Exclusion Criteria
1. Upper GI Bleed with hemodynamic shock (BP<90mmHg and pulse>120 per minute)
2. Active hematemesis
3. Known history of gastric cancer
4. Known history of gastric or esophageal varices
5. GI surgery within the last 6 months
6. Dysphagia, swallowing disorder, Zencker's diverticulum, suspected bowel obstruction or
perforation
7. Gastroparesis, Gastric outlet obstruction, Crohn's disease, past UGI tract surgery
(e.g., Bilroth I or II, esophagectomy, gastrectomy, bariatric procedure)
8. Other contraindications to VCE per manufacturer (Medtronic)
9. Pregnancy/ lactation
10. Prisoner
11. Altered mental status (e.g., hepatic encephalopathy) that limits the ability to
swallow a capsule
12. Expected to have Magnetic Resonance Imaging examination within 7 days.
13. On medications that may coat the upper GI tract such as antacids or sucralfate or
Maalox.
14. Patient either refuses or is unable to get traditional EGD.
15. Patient does not have reliable contact information - no phone, no permanent address.
16. Patient refuses / chooses to withdraw (at any time) / unable to provide written
consent.
17. Non-English speaker
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