Capsule Endoscopy for HEmorrhage in the ER (CHEER)

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).

Study Overview

• Status: Completed
• Conditions: Upper Gastrointestinal Bleeding
• Intervention / Treatment: Device: PillCam UGI; Other: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Meltzer, MD; Phone Number: 202-741-2952; Email: ameltzer@mfa.gwu.edu
• Study Contact Backup: Name: Maxine Le Saux, BS; Phone Number: 202-741-2917; Email: mlesaux@mfa.gwu.edu

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University School of Medicine
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Control; Video Capsule Endoscopy will be administered during ED, but video will not be read until after inpatient EGD. Subject will have hospital admission with an EGD conducted during hospital stay.	Other: Standard of Care; Patient was admitted to hospital for care and received in-patient EGD.; Other Names: SOC
Experimental: Experimental; Subject will have Video Capsule Endoscopy read during ED length of stay, disposition will be determined using Capsule Endoscopy Risk Assessment.	Device: PillCam UGI; An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Discharged for Outpatient Management of Upper GI Bleeds	Our primary goal is to determine whether ED VCE is able to discharge low risk patients for outpatient management of upper GI bleeds.	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection Rate of Video Capsule Endoscopy	Our secondary objective is to present the prevalence of clinical findings in VCE subjects based on gastroenterologist interpretation.	30 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay		30 days
Patient Satisfaction With VCE Procedure		30 Days
GI Physician Final Read and Site Physician Agreement on VCE Results		30 Days
Number of Participants With Serious Adverse Events at Day 7 and Day 30	Assess for mortality, re-bleeding, total blood transfusions, surgery (capsule-specific group)	30 Days
ED Length of Stay		30 Days

Collaborators and Investigators

• Sponsor: George Washington University
• Collaborators: Medtronic
• Investigators: Principal Investigator: Andrew Meltzer, MD, George Washington University- Department of Emergency Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2018
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): September 7, 2020

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: capsule endoscopy; upper gastrointestinal bleeding; PillCam; upper Endoscopy; emergency Department; GI bleed
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: ISR-2016-10770; IRB #041707 (Other Identifier: George Washington University Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No