Capsule Endoscopy for HEmorrhage in the ER

Study Overview
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Brief Summary
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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
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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.

Official Title
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Capsule Endoscopy for Hemorrhage in the ER

Conditions
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Upper Gastrointestinal Bleeding

Intervention / Treatment
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* Device: PillCam UGI
* Other: Standard of Care


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Control<br>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<br>* Patient was admitted to hospital for care and received in-patient EGD.<br>* Other names: SOC;|
| Experimental: Experimental<br>Subject will have Video Capsule Endoscopy read during ED length of stay, disposition will be determined using Capsule Endoscopy Risk Assessment. | Device: PillCam UGI<br>* An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PillCam, upper Endoscopy, emergency Department, capsule endoscopy, upper gastrointestinal bleeding, GI bleed