Capsule Endoscopy for HEmorrhage in the ER

Upper Gastrointestinal Bleeding Clinical Trial

— CHEER  

Official title:

Capsule Endoscopy for Hemorrhage in the ER

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458000
• Other study ID #: ISR-2016-10770
• Secondary ID: IRB #041707
• Status: Completed
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: September 7, 2020

Study information

• Verified date: May 2023
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Other known NCT identifiers

• NCT01371591

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 7, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

Device:
• PillCam UGI
An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.

Other:
• Standard of Care
Patient was admitted to hospital for care and received in-patient EGD.

Locations

Country	Name	City	State
United States	Duke University School of Medicine	Durham	North Carolina
United States	Temple University	Philadelphia	Pennsylvania
United States	George Washington University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
George Washington University	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction With VCE Procedure		30 Days
Other	GI Physician Final Read and Site Physician Agreement on VCE Results		30 Days
Other	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
Other	ED Length of Stay		30 Days
Other	Hospital Length of Stay		30 days
Primary	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	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