Status:
COMPLETED
Capsule Endoscopy for HEmorrhage in the ER
Lead Sponsor:
George Washington University
Collaborating Sponsors:
Medtronic
Conditions:
Upper Gastrointestinal Bleeding
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 t...
Detailed Description
Video capsule endoscopy (VCE) was initially approved in 2001 by the Food and Drug Administration. VCE offers potential advantages over traditional EGD including the ability to be performed 24 hours a ...
Eligibility Criteria
Inclusion
- 1\. Individuals aged ≥ 18 years presenting to the Emergency Department with likely upper GI bleed (bloody emesis and/or coffee ground vomiting and/or melena) that has occurred within the previous 48 hours.
Exclusion
- Upper GI Bleed with hemodynamic instability (BP\<90 mmHg, pulse\>120 beats per minute, and Hgb \< 9 g/dL)
- High Risk Upper GI Bleed (Glasgow Blatchford Score\* ≥ 6)
- Signs, symptoms or history of liver cirrhosis or liver failure
- Signs, symptoms or history of decompensated heart failure or congestive heart failure
- Presumed Pregnant, trying to conceive or breastfeeding
- Known history of gastric cancer
- Known history of gastric or esophageal varices
- GI surgery within the last 6 months
- Prior enrollment in the CHEER Study
- Prisoner or Ward of State
- Trouble swallowing, suspected bowel obstruction or perforation, per treating clinician
- Past UGI tract surgery (e.g., Bilroth I or II, esophagectomy, gastrectomy, bariatric procedure) that changes Gastrointestinal anatomy
- Known history of gastroparesis, esophageal stricture or Crohn's disease
- Altered mental status that limits the ability to swallow a capsule
- Expected to have Magnetic Resonance Imaging (MRI) examination within 7 days
- Consumed medications within the past 12 hours that may coat the upper GI tract such as antacids or sucralfate or Maalox and potentially limits capsule visualization
- 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
- Non-English speaker
- Suspected middle or lower GI bleeding
- Treating ED Physician is not amenable to admission or discharge based on randomization or Video Capsule Endoscopy results. \* As a modification, the GBS Score modified from the traditional GBS score to reduce the Hemoglobin cut-off for 6 points from 10g/dL to 9 g/dL (see Appendix B, CHEER 4; patient screening)
Key Trial Info
Start Date :
April 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03458000
Start Date
April 17 2018
End Date
September 7 2020
Last Update
June 1 2023
Active Locations (3)
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1
George Washington University
Washington D.C., District of Columbia, United States, 20037
2
Duke University School of Medicine
Durham, North Carolina, United States, 27710
3
Temple University
Philadelphia, Pennsylvania, United States, 19140