N/A
N=24
Capsule Endoscopy for HEmorrhage in the ER
Upper Gastrointestinal Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT03458000 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Number of Participants Discharged for Outpatient Management of Upper GI Bleeds — 3; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PillCam UGI (Device); Standard of Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- George Washington University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Discharged for Outpatient Management of Upper GI Bleeds |
3; 9 | — |
| SECONDARY Detection Rate of Video Capsule Endoscopy |
8; 1; 1; 2; 1; 3 | — |
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 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).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Upper GI Bleed with hemodynamic instability (BP 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)
Data sourced from ClinicalTrials.gov (NCT03458000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.