Overview

This trial is not yet open for recruitment.

Conditions melena, hematemesis, peptic ulcer hemorrhage, variceal hemorrhage
Treatments experimental capsule endoscopy, standard of care plus egd
Sponsor George Washington University
Collaborator Medtronic
Start date March 2017
End date March 2018
Trial size 100 participants
Trial identifier NCT01371591, GWIRB#: 080933

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.

United States District of Columbia
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
Patient will be monitored for a minimum of 4 hours. VCE will be read by site PI or co-PI and by site GI doc. Repeat CBC at q4 hours. Stable BP and pulse for 4 plus hours -> discharge home with follow up EGD within 3 days.
experimental capsule endoscopy
(Placebo Comparator)
VCE video will be archived and read at a later date. Pt will be admitted. VCE will not be used for clinical decisions. Same day or next day (<24 hour) Endoscopic examination of the upper GI tract will be offered to all patients within 24 hours, and hemostasis therapy was applied as necessary
standard of care plus egd

Primary Outcomes

Measure
to test whether risk stratification ED Video Capsule Endoscopy (VCE) in the ER leads to decreased need for hospitalization
time frame: 24 hours

Secondary Outcomes

Measure
to estimate the sensitivity and specificity of VCE compared to subsequent EGD
time frame: 72

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pilot Study to Investigate the Use of Wireless Capsule Endoscopy for Emergency Department Patients With Suspected Acute Upper Gastrointestinal Bleeding
Principal investigator Andrew C Meltzer, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by George Washington University.