Study of Early Endocapsule (EC) in Clinical Decision Unit Versus Standard of Care Work-up for GI Bleeding

NCT03955055 | Completed Results DMC FDA Device

• 1 other identifier: H00015196
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the use of the Olympus EndoCapsule EC-10 video capsule compared with the standard of care workup for patients in the Clinical Decision Unit who have symptoms of gastrointestinal (GI) bleeding. Patients will be eligible if they have any symptoms of GI bleeding, either vomiting blood or symptoms without vomiting blood. Patients randomized to the early capsule arm will have an immediate video capsule endoscopy. Patients randomized to the standard of care arm will have no study intervention and will follow the treating physician's diagnostic workup. The primary goal of the study is to compare how often a source of bleeding is identified in patients in the two groups.

Conditions

Gastro Intestinal Bleeding; Hematemesis; Melena

Keywords

Gastro Intestinal Bleeding

Outcome Measures

Primary Outcomes (2)

• Rate of Detection of Bleeding

  Rate of detection of active bleeding or stigmata of recent bleeding \[blood clot or visible vessel\]

  Enrollment to time of detection of bleeding as measured in hours, up to 720 hours, whichever is sooner

• Time to Detection of Bleeding

  Time to detection of active bleeding or stigmata of recent bleeding \[blood clot or visible vessel\]

  Enrollment to time of detection of bleeding as measured in hours, up to 720 hours, whichever is sooner

Secondary Outcomes (5)

• Admission Rate

  Enrollment to time of admission as measured in hours, up to 720 hours, whichever is sooner

• Re-admission Rate

  Enrollment to 720 hours

• Hospital Length of Stay

  Enrollment to time of discharge as measured in hours, up to 720 hours, whichever is sooner

• Endoscopic Procedures

  Enrollment to 720 hours

• Therapeutic Procedures

  Enrollment to 720 hours

Other Outcomes (2)

• Complication Rates

  Enrollment to 720 hours

• Blood Product Transfusions

  Enrollment to one year

Study Arms (2)

Early Capsule Group

EXPERIMENTAL

The intervention for subjects in this arm will be to have a video capsule deployed as soon as possible after presentation to the clinical decision unit. 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: Video Capsule Endoscopy

Standard of Care Work-up

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

Video Capsule Endoscopy DEVICE

Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).

Also known as: Olympus EndoCapsule EC-10

Early Capsule Group

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 hematemesis, melena or hematochezia
• Able to sign consent
• Hemodynamically stable (that is, blood pressure \>100/60 or pulse \<110 at the time of consent)
• Emergency Department must plan to admit patient to the hospital or Clinical Decision Unit
• If patients have pacemakers and/or implantable cardioverter defibrillator (ICD), they will be placed on telemetry

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 inflammatory bowel disease
• concern for infectious colitis
• evidence of dysphagia at the time of presentation
• presence of small amounts of bright red blood per rectum
• 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
• abdominal pain suggesting an acute abdomen or obstruction.
• patients who cannot undergo surgery

Sponsors & Collaborators

• Christopher Marshall: lead
• Olympus Corporation of the Americas: collaborator

Study Sites (1)

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Related Publications (4)

• 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 BACKGROUND

• 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 Endoscopy 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 Endoscopy 2014;79:Supplement, Page AB231.

  BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Hematemesis; Melena

Interventions

Capsule Endoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

The trial was designed before the coronavirus pandemic began and several aspects of the trial were significantly impacted due to the pandemic. The Clinical Decision Unit was effectively closed and endoscopic procedures were limited. While we increased some enrollment in 2021, we were not able to meet our goals due to these unexpected constraints.

Results Point of Contact

• Title: Anne Foley, Senior Clinical Research Coordinator
• Organization: UMass Chan Medical School

anne.foley@umassmed.edu

774-442-4098

Study Officials

• Christopher Marshall, MD

  UMass Medical School Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 17, 2019
• Study Start: February 4, 2020
• Primary Completion: April 9, 2022
• Study Completion: April 9, 2022
• Last Updated: July 10, 2023
• Results First Posted: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)