Capsule Endoscopy for HEmorrhage in the ER

NCT ID: NCT03458000

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-17
• Study Completion Date: 2020-09-07

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.

Conditions

Upper Gastrointestinal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Patient was admitted to hospital for care and received in-patient EGD.

Experimental

Subject will have Video Capsule Endoscopy read during ED length of stay, disposition will be determined using Capsule Endoscopy Risk Assessment.

Group Type: EXPERIMENTAL

PillCam UGI

Intervention Type: DEVICE

An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.

Interventions

PillCam UGI

An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.

Intervention Type: DEVICE

Standard of Care

Patient was admitted to hospital for care and received in-patient EGD.

Intervention Type: OTHER

Other Intervention Names

SOC

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Andrew Meltzer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Meltzer, MD

Role: PRINCIPAL_INVESTIGATOR

George Washington University- Department of Emergency Medicine

Locations

George Washington University

Washington D.C., District of Columbia, United States

Duke University School of Medicine

Durham, North Carolina, United States

Temple University

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23398660 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB #041707

Identifier Type: OTHER

Identifier Source: secondary_id

ISR-2016-10770

Identifier Type: -

Identifier Source: org_study_id

NCT01371591

Identifier Type: -

Identifier Source: nct_alias