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

NCT02442830 | Completed Results FDA Device

• 1 other identifier: H00006661
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Melena; Gastrointestinal Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Time to Localization of Bleeding

  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.

  Enrollment to localization of bleeding as measured in hours, up to 720 hours, whichever is sooner.

Secondary Outcomes (1)

• Number of Participants With Localization of Bleeding by the End of Admission

  Patient's will be assessed for the duration of their hospital stay and for thirty days afterwards.

Study Arms (2)

Early Video Capsule Endoscopy

EXPERIMENTAL

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

Standard of Care Workup Group

NO INTERVENTION

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.

Interventions

Early Video Capsule Endoscopy DEVICE

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.

Also known as: Olympus Endocapsule 10 (EC-10) System

Early Video Capsule Endoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Olympus Corporation: collaborator

Study Sites (1)

University of Massachusetts Memorial Medical Center -- University Campus

Worcester, Massachusetts, 01605, United States

Location

Related Publications (4)

• Singh A, Marshall C, Chaudhuri B, Okoli C, Foley A, Person SD, Bhattacharya K, Cave DR. Timing of video capsule endoscopy relative to overt obscure GI bleeding: implications from a retrospective study. Gastrointest Endosc. 2013 May;77(5):761-6. doi: 10.1016/j.gie.2012.11.041. Epub 2013 Feb 1.

  PMID: 23375526 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Marya NB, Jawaid S, Foley A, Han S, Patel K, Maranda L, Kaufman D, Bhattacharya K, Marshall C, Tennyson J, Cave DR. A randomized controlled trial comparing efficacy of early video capsule endoscopy with standard of care in the approach to nonhematemesis GI bleeding (with videos). Gastrointest Endosc. 2019 Jan;89(1):33-43.e4. doi: 10.1016/j.gie.2018.06.016. Epub 2018 Jun 20.

  PMID: 29935143 DERIVED

MeSH Terms

Conditions

Melena; Gastrointestinal Hemorrhage

Interventions

Endoscopy; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Drug Therapy; Therapeutics

Limitations and Caveats

The study was performed in a single center with a relatively homogeneous population. Study personnel were not blinded to group allocation following randomization.

Results Point of Contact

• Title: Principal Investigator
• Organization: UMass Medical School

David.Cave@umassmemorial.org

(774) 442-4098

Study Officials

• David Cave, MD, PhD

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: May 13, 2015
• Study Start: April 19, 2015
• Primary Completion: July 2, 2017
• Study Completion: July 2, 2017
• Last Updated: August 7, 2018
• Results First Posted: August 7, 2018

Record last verified: 2018-07

Locations

US (1)