Clinical Trial: Comparing Early Capsule Deployment to Current Standard of Care for Management of Gastrointestinal Bleeding

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: A Comparison of Early Deployment of a Video Capsule (Endocapsule EC-10: Olympus Tokyo. Japan) in the Emergency Department Versus Standard of Care Workup of Non-hematemesis Gastrointestinal Bleeding

Brief Summary: The objectives of this study are to test whether there are statistically significant differences between the standard of care workup workup of non-hematemesis gastrointestinal bleeding by endoscopy [upper, lower and other tests], compared with deployment of a video capsule as the first test followed by the most appropriate endoscopic procedure based on video capsule findings, if needed. The investigators propose to examine differences in time to diagnosis, reduction in numbers of procedures, and length of stay between a standard of care workup protocol and our proposed protocol of early capsule endoscopy deployment.

Detailed Summary:

After 40 years of considering gastrointestinal bleeding as upper or lower and largely ignoring the small intestine, there is accumulating evidence that the standard of care approach to the assessment of non-hematemesis gastrointestinal bleeding could be improved by early deployment of a video capsule (VCE) as the first diagnostic test. Currently, VCE is considered the gold standard as the diagnostic test for small intestinal bleeding. In a recent study at the University of Massachusetts (UMass) 336 patients who presented to the emergency department (ED) with complaints of gastrointestinal bleeding 36 patients (10.7%) were given a VCE during their stay.

In patients with hematemesis, upper endoscopy remains the diagnostic and therapeutic modality of choice. However patients with melena and hematochezia may benefit from early VCE since both signs and symptoms provide poor localization as to the origin of bleeding. Data from this previous Umass study suggests that the ingestion of a VCE in the ED could quickly and non-invasively provide clinicians accurate data as to the origin of the bleeding. This information could provide a guide to further management of the patient. VCE is able to visualize bleeding in the esophagus, stomach, duodenum, small intestine and right colon, thereby eliminating the guess work of deciding which endoscopic approach to use.

At UMass, that same study showed that of the 36 patients who received a video capsule, 26 (72.2%) had diagnostic studies (i.e. bleeding was identified). In comparison, 152 patients required upper endoscopy (of which 52.9% were diagnostic) and 64 patients required colonoscopy (of which 47% were diagnostic). Of those 26 patients with diagnostic capsule studies, 13 also required upper endoscopy, 1 required a colonoscopy, and 4 required both a colonoscopy and endoscopy. It is importa
Sponsor: University of Massachusetts, Worcester

Current Primary Outcome: Time to Diagnosis [ Time Frame: Patient's will be assessed for the duration of their hospital stay and for thirty days afterwards. ]

Time to diagnosis refers to the amount of time needed from the moment a patient presents with melena or hematochezia to the moment when a diagnosis has been made.


Original Primary Outcome: Time to Diagnosis [ Time Frame: On average time to diagnosis will be assessed one week after a patient is admitted to the hospital. The investigators plan to present this data two years after the start of our study. ]

Time to diagnosis refers to the amount of time needed from the moment a patient presents with melena or hematochezia to the moment when a diagnosis has been made.


Current Secondary Outcome:

  • Hospital Length of Stay [ Time Frame: Patient's will be assessed for the duration of their hospital stay and for thirty days afterwards. ]
    This measurement deals with the amount of time a patient is admitted in the hospital.
  • Number of procedures [ Time Frame: Patient's will be assessed for the duration of their hospital stay and for thirty days afterwards. ]
    This is an account of the number of procedures needed during a hospitalization.


Original Secondary Outcome:

  • Hospital Length of Stay [ Time Frame: On average hospital length of stay will be assessed two weeks after a patient is admitted to the hospital. The investigators plan on presenting this data two years after the start of our study. ]
    This measurement deals with the amount of time a patient is admitted in the hospital.
  • Number of procedures [ Time Frame: On average hospital the number of procedures needed for diagnosis will be assessed two weeks after a patient is admitted to the hospital. The investigators plan on presenting this data two years after the start of the study. ]
    This is an account of the number of procedures needed during a hospitalization.


Information By: University of Massachusetts, Worcester

Dates:
Date Received: April 23, 2015
Date Started: April 2015
Date Completion:
Last Updated: June 17, 2016
Last Verified: June 2016