Capsule Endoscopy for Hemorrhage in the Emergency Room

Peptic Ulcer Hemorrhage Clinical Trial

— CHEER  

Official title:

Pilot Study to Investigate the Use of Wireless Capsule Endoscopy for Emergency Department Patients With Suspected Acute Upper Gastrointestinal Bleeding

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01371591
• Other study ID #: GWIRB#: 080933
• Status: Not yet recruiting
• Phase: N/A
• First received: June 9, 2011
• Last updated: February 20, 2018
• Start date: April 1, 2018
• Est. completion date: August 2018

Study information

• Verified date: February 2018
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The researcher's primary hypothesis is that VCE allows for safe outpatient management of ED patients with suspected upper GI hemorrhage. A prospective multicenter randomized control trial was designed to investigate the safety of this approach.

Description:

The typical primary care, urgent care or emergency care provider is unable to evaluate common and serious conditions of the gastrointestinal tract such as a bleeding peptic ulcer. As such, more than 80% of patients who present to US ED's with suspected bleeding in their upper GI tract require hospitalization, procedural sedation by an anesthesiologist, and a traditional tube-based upper endoscopy by a gastroenterologist. While this traditional process is safe and effective, it is not efficient for our low-risk patients and not timely for our high-risk patients. The opportunity to bring Video Capsule Endoscopy to the front-lines of US medical care will revolutionize how we manage upper GI bleeding and shed light on critical diseases that have heretofore been hidden from most providers. This trial is an important step toward demonstrating that VCE is a safe and effective tool to risk-stratify upper GI bleeding and improve quality of emergency care for all patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Subject Inclusion Criteria

1. Individuals aged = 18 years presenting to the Emergency Department with acute, overt UGIB defined as bloody emesis and/or coffee ground vomiting and/or melena within the previous 48 hours.

Subject Exclusion Criteria

1. Upper GI Bleed with hemodynamic shock (BP<90mmHg and pulse>120 per minute)

2. Active hematemesis

3. Known history of gastric cancer

4. Known history of gastric or esophageal varices

5. GI surgery within the last 6 months

6. Dysphagia, swallowing disorder, Zencker's diverticulum, suspected bowel obstruction or perforation

7. Gastroparesis, Gastric outlet obstruction, Crohn's disease, past UGI tract surgery (e.g., Bilroth I or II, esophagectomy, gastrectomy, bariatric procedure)

8. Other contraindications to VCE per manufacturer (Medtronic)

9. Pregnancy/ lactation

10. Prisoner

11. Altered mental status (e.g., hepatic encephalopathy) that limits the ability to swallow a capsule

12. Expected to have Magnetic Resonance Imaging examination within 7 days.

13. On medications that may coat the upper GI tract such as antacids or sucralfate or Maalox.

14. Patient either refuses or is unable to get traditional EGD.

15. Patient does not have reliable contact information - no phone, no permanent address.

16. Patient refuses / chooses to withdraw (at any time) / unable to provide written consent.

17. Non-English speaker

Related Conditions & MeSH terms

• Emergencies
• Hematemesis
• Hemorrhage
• Melena
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Variceal Hemorrhage

Intervention

Device:
• Pill Cam, clinical evaluation
The Pill Cam, VCE, will be used for clinical decisions. VCE will be read by site PI or co-PI and by site GI doctor.
• Pill Cam, archived
VCE will not be used for clinical decisions. VCE video will be archived and read at a later date.

Locations

Country	Name	City	State
United States	George Washington University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Andrew Meltzer	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to test whether risk stratification ED Video Capsule Endoscopy (VCE) in the ER leads to decreased need for hospitalization	Our primary question is whether VCE can diagnose UGIH in the acute setting.is to test whether ED Video Capsule Endoscopy (VCE) in the ER is able to safely discharge low risk patients for outpatient evaluation	24 hours
Secondary	to estimate the sensitivity and specificity of VCE compared to subsequent EGD	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.	72