Capsule Endoscopy for HEmorrhage in the ER

Not Applicable

Completed

• Conditions: Upper Gastrointestinal Bleeding
• Interventions: Device: PillCam UGI; Other: Standard of Care

• Registration Number: NCT03458000
• Lead Sponsor: George Washington University

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.

Study Timeline

• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-08
• Study Start: 2018-04-17
• Primary Completion: 2020-03-15
• Study Completion: 2020-09-07
• Results First Submitted: 2021-10-22
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-04
• Last Update Submitted: 2023-05-04
• Results First Posted: 2023-06-01
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	PillCam UGI	Subject will have Video Capsule Endoscopy read during ED length of stay, disposition will be determined using Capsule Endoscopy Risk Assessment.
Active Control	Standard of Care	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

Duke University School of Medicine; 🇺🇸 Durham, North Carolina, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States