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Comparing Early Capsule Deployment to Current Standard of Care for Management of Gastrointestinal Bleeding (EDCAP)

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ClinicalTrials.gov Identifier: NCT02442830
Recruitment Status : Completed
First Posted : May 13, 2015
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
Olympus Corporation
Information provided by (Responsible Party):
David Cave, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment Phase
Melena Gastrointestinal Hemorrhage Device: Early Video Capsule Endoscopy Not Applicable

Detailed Description:

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 important to recognize, however, that often capsule studies are performed after upper endoscopy and colonoscopy and performed and are found to be negative. This sequence is the standard of care work up of bleeding. Despite being performed later in the hospital course of our patients, capsule studies have a high diagnostic yield. In reality VCE is used uncommonly in acute bleeding because it is rarely considered in the context of acute GI bleeding In this study, the investigators propose the approach of using the video capsule as the first diagnostic test prior to colonoscopy and endoscopy; this may lead to a shortened time to diagnosis, a reduction in length of stay, and a reduction in numbers of procedures due to early, accurate localization of the source of bleeding. All of these components could result in better quality of care and cost containment. Further, it is known that 80% of patients stop bleeding spontaneously. Thus the earlier they are examined the more likely the origin of the bleeding is likely to be found The use of VCE has been approved by the FDA since 2001 for small intestinal bleeding obscure GI Bleeding. It is very safe and no deaths associated with its use have been reported. More than two million capsules have been used and complications of obstruction and perforation are extremely rare.

Interest in the broader use of VCE is accumulating. More recently studies of VCE deployed in the ED, in patients with upper GI bleeding showed improved management. Our group recently demonstrated that the closer a VCE is performed to the time of bleeding the higher the likelihood of locating the sources and the higher the therapeutic intervention rate. The investigators also have demonstrated that the use of capsule endoscopy in patients with non-hematemesis gastrointestinal bleeding (NHGIB) has a higher diagnostic yield than does colonoscopy. With improved diagnostic yields, capsule endoscopy may help clinicians by providing guidance in the management of patients with NHGIB.

This protocol is be the first attempt to prospectively examine this concept in a large randomized prospective trial. The questions the investigators are studying are: can early capsule intervention decrease time to diagnosis, numbers of procedures and hospital length of stay in patients with non-hematemesis gastrointestinal bleeding?


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : April 19, 2015
Actual Primary Completion Date : July 2, 2017
Actual Study Completion Date : July 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Video Capsule Endoscopy
The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the emergency department. Information from the video capsule will be obtained and reviewed to determine location of bleeding. Once that information has been obtained a decision will be made on which endoscopic test is most pertinent in finding and treating the source of bleeding.
Device: Early Video Capsule Endoscopy

The intervention is the use of video capsule endoscopy as the first test in a patient presenting to the ED with active bleeding. The capsule allows for visualization of the entire GI tract.

Once a capsule has been given to a study patient, a staff member will use the capsule's real-time viewer to see if there is any active bleeding in the stomach. If bleeding is seen the investigators will pursue an upper endoscopy. If no bleeding is seen a staff member will review the entire findings of the capsule and make a decision regarding which therapeutic measure to pursue.

Other Name: Olympus Endocapsule 10 (EC-10) System

No Intervention: Standard of Care Workup Group
In this arm, patients will receive "standard of care workup" for non-hematemesis gastrointestinal bleeding. This could include upper endoscopy, colonoscopy, and additional capsule or small bowel enteroscopy depending on the subject's presentation and the results of the workup performed by the gastroenterology team. For patients requiring a video capsule endoscopy as part of "standard of care workup" the patients will be given the same Olympus video capsule that is used in the "Early Capsule" group.



Primary Outcome Measures :
  1. Time to Localization of Bleeding [ Time Frame: Enrollment to localization of bleeding as measured in hours, up to 720 hours, whichever is sooner. ]
    Time to localization of bleeding refers to the time after a patient is admitted to the emergency room and a bleeding source is localized. We defined localization of bleeding as endoscopic visualization of stigmata of recent hemorrhage.


Secondary Outcome Measures :
  1. Number of Participants With Localization of Bleeding by the End of Admission [ Time Frame: Patient's will be assessed for the duration of their hospital stay and for thirty days afterwards. ]
    This measurement counts the number of participants with a bleeding source localized by the end of admission.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than 18 years old
  • New onset of melena or hematochezia
  • Able to sign consent
  • Hemodynamically stable (i.e. blood pressure >100/60 or pulse <110 at the time of consent)
  • ED must plan to admit patient to the hospital or Clinical Decision Unit.

Exclusion Criteria:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
  • Prior history of gastroparesis
  • Prior history of gastric, or small bowel surgery
  • Prior history of Crohn's disease
  • Concern for infectious colitis
  • Non-English speaking
  • Evidence of dysphagia at the time of presentation
  • Presence of bright red blood per rectum concerning for hemorrhoids
  • Allergy to metoclopramide or erythromycin
  • Code status of Do Not Resuscitate/Do Not Intubate (DNR/DNI) or Comfort Measures Only (CMO)
  • Prior history of abdominal radiation
  • Presence of Implantable Cardioverter Defibrillator (ICD) or pacemaker or other implanted electronic devices
  • Abdominal pain suggesting an acute abdomen or obstruction. In clinical practice, only patients with crampy abdominal pain due to Crohn's disease, previous intestinal surgery and a previous history of radiation therapy require a patency capsule or CT enterography before capsule endoscopy.
  • Patients who cannot undergo surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442830


Locations
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United States, Massachusetts
University of Massachusetts Memorial Medical Center -- University Campus
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
University of Massachusetts, Worcester
Olympus Corporation
Investigators
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Principal Investigator: David Cave, MD, PhD Professor of Medicine
  Study Documents (Full-Text)

Documents provided by David Cave, University of Massachusetts, Worcester:
Study Protocol  [PDF] April 22, 2016
Statistical Analysis Plan  [PDF] June 20, 2018


Publications:
Jawaid S, Gondal B, Singh, A, Marshall C, and Cave D. The epidemiology of gastrointestinal bleeding in an academic emergency department as a basis for reconfiguring the conventional approach to its diagnosis and management. Gastrointestinal Endsocopy 2013;77:Supplement, Page AB483.
Jawaid S, Marya N, Gondal B, Maranda L, Marshall C, Charpentier J, Singh A, Foley A, and Cave D. . A reconsideration of the diagnosis and management of gastrointestinal bleeding based on its epidemiology and outcomes analysis. Gastrointestinal Endsocopy 2014;79:Supplement, Page AB231.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Cave, Professor of Medicine, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT02442830     History of Changes
Other Study ID Numbers: H00006661
First Posted: May 13, 2015    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases