Clinical trial NCT03458000: Capsule Endoscopy for HEmorrhage in the ER
Official title: Capsule Endoscopy for Hemorrhage in the ER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Gastrointestinal Bleeding
Keywords: capsule endoscopy
PillCam
upper Endoscopy
emergency Department
upper gastrointestinal bleeding
GI bleed
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2018-03-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 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).

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 day without sedation and interpreted at the bedside by emergency physicians. In addition, VCE is much less invasive, is painless, and enables the patient to pursue normal daily activities after the procedure.

Our primary goal is to test whether ED Video Capsule Endoscopy (VCE) is able to safely discharge low risk patients for outpatient evaluation and management. Our secondary objective is to estimate the sensitivity and specificity of VCE compared to subsequent EGD in the detection of serious bleeding lesions in the upper gastrointestinal (GI) tract.

Research Coordinator will screen potential patients with signs of upper GI bleeding. Patients who screen as eligible will be approached about potential interest, to review of inclusion and exclusion criteria, and obtain informed consent. Research Coordinator will calculate traditional risk stratification scores and once enrolled, all subjects will be randomized to either Active Control (AC) \[admission plus EGD within hospital stay\] or experimental Capsule Endoscopy Risk Assessment (CERA) in ED. Only patients randomized to the experimental arm will receive video capsule endoscopy in the emergency department.Within 2 hours of presenting to the ED, patient will ingest video capsule-- RC will monitor progress on real-time viewer for passage through pylorus. Upon passing the pylorus, we will record 5 more minutes of video or until battery runs out - whichever occurs first. Patient data will be completed using a standardized data collection tool including the following elements: chief complaint of patient, history of present illness, past medical history, pertinent lab findings, current medications, vital signs, focused physical exam findings and all relevant treatments administered during the ED and hospital stay.

For Active Control (AC) group each patient will be admitted. During hospital admission, EGD will be performed on all subjects and hemostasis therapy applied as necessary. The study team decided against mandating that EGD be performed within 24 hours of hospital admission.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

1. Upper GI Bleed with hemodynamic instability (BP\<90 mmHg, pulse\>120 beats per minute, and Hgb \< 9 g/dL)
2. High Risk Upper GI Bleed (Glasgow Blatchford Score\* ≥ 6)
3. Signs, symptoms or history of liver cirrhosis or liver failure
4. Signs, symptoms or history of decompensated heart failure or congestive heart failure
5. Presumed Pregnant, trying to conceive or breastfeeding
6. Known history of gastric cancer
7. Known history of gastric or esophageal varices
8. GI surgery within the last 6 months
9. Prior enrollment in the CHEER Study
10. Prisoner or Ward of State
11. Trouble swallowing, suspected bowel obstruction or perforation, per treating clinician
12. Past UGI tract surgery (e.g., Bilroth I or II, esophagectomy, gastrectomy, bariatric procedure) that changes Gastrointestinal anatomy
13. Known history of gastroparesis, esophageal stricture or Crohn's disease
14. Altered mental status that limits the ability to swallow a capsule
15. Expected to have Magnetic Resonance Imaging (MRI) examination within 7 days
16. 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
17. Patient either refuses or is unable to get traditional EGD
18. Patient does not have reliable contact information - no phone, no permanent address
19. Patient refuses
20. Unable to provide written consent
21. Non-English speaker
22. Suspected middle or lower GI bleeding
23. 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)

Primary outcomes:
measure: Number of Participants Discharged for Outpatient Management of Upper GI Bleeds
timeFrame: 30 Days
Secondary outcomes:
measure: Detection Rate of Video Capsule Endoscopy
timeFrame: 30 Days
Other outcomes:
measure: Patient Satisfaction With VCE Procedure
timeFrame: 30 Days
measure: GI Physician Final Read and Site Physician Agreement on VCE Results
timeFrame: 30 Days
measure: Number of Participants With Serious Adverse Events at Day 7 and Day 30
timeFrame: 30 Days
measure: ED Length of Stay
timeFrame: 30 Days
measure: Hospital Length of Stay
timeFrame: 30 days
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: George Washington University- Department of Emergency Medicine
name: Andrew Meltzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meltzer AC, Ali MA, Kresiberg RB, Patel G, Smith JP, Pines JM, Fleischer DE. Video capsule endoscopy in the emergency department: a prospective study of acute upper gastrointestinal hemorrhage. Ann Emerg Med. 2013 Apr;61(4):438-443.e1. doi: 10.1016/j.annemergmed.2012.11.008.